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Comprehensive menu of state-of-the-art tests

No single test can determine the overall risk of cardiovascular disease. That’s why our test offering includes exclusive advanced risk and genotyping tests which aid in the selection of appropriate therapeutic options, and a comprehensive offering of lipid, lipoprotein, apolipoprotein, cardiometabolic, liver, kidney and muscle tests.

Chemistry
Alanine Aminotransferase (ALT)
Albumin
Alkaline Phosphatase
Anion Gap
Aspartate Aminotransferase (AST)
Blood Urea Nitrogen (BUN)
Creatinine
Calcium
Chloride
CO2
Direct Bilirubin
Potassium
Sodium
Total Protein
Total Bilirubin
Uric Acid

Kidney
BUN/Creatinine
Cystatin C
eGFR / Creatinine
eGFR / Cystatin C
Magnesium
Phosphorus

Muscle
Creatine Kinase (CK)
N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)

Iron
Ferritin
Iron
UIBC
TIBC

Hormones
Cortisol
Dehydroepiandrosterone Sulfate (DHEA-S)
Estradiol (Estrogen Fraction E2)
Follicle Stimulating Hormone (FSH)
Free Testosterone
Luteinizing Hormone (LH)
Parathyroid Hormone
Progesterone
PSA, Total
Sex Hormone Binding Globulin (SHBG)
Total Testosterone

Thyroid
Free T3
Free T4
Thyroid Stimulating Hormone (TSH)
Total T3
Total T4
TPO

Other
B12
Coenzyme Q10 (CoQ10)
Folate
Homocysteine
Vitamin D, 25-OH

Complete Blood Count (CBC)
Complete Blood Count (CBC)
CBC with Differential

Getting Started

Boston Heart HDL Map®

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Test Code

801

Description

The Boston Heart HDL Map® test measures the five most significant HDL subpopulations in CVD risk. A proprietary gel electrophoresis process measures the amount of apoA-I protein in each of the five HDL subclasses, providing information to accurately identify patients at increased CVD risk.

Methodology

Proprietary PAGE system

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: UNSTABLE
Refrigerated:  2 days (sample must be received within 2 days of collection)

Lab Values

Male

                   Optimal       Borderline     High Risk for CVD
α-1              >35.0           25.0-35.0       <25.0
α-2              >55.0           45.0-55.0       <45.0
α-3              <20.0           20.0-25.0       >25.0
α-4              <20.0           20.0-25.0       >25.0
Preβ-1        <20.0           20.0-25.0       >25.0

Female

                Optimal       Borderline     High Risk for CVD
α-1              >45.0           35.0-45.0       <35.0
α-2              >65.0           55.0-65.0       <55.0
α-3              <20.0           20.0-25.0       >25.0
α-4              <20.0           20.0-25.0       >25.0
Preβ-1        <20.0           20.0-25.0       >25.0

Clinical Significance
(α-1 levels)

 

  • Every 1mg/dL apoA-I increase in very large α-1 HDL is associated with a 26% decrease in CVD risk.
  • Low α-1 level is a significant predictor of recurrent CVD events.
  • Change in α-1 is significantly associated with change in coronary artery stenosis.

Treatment Options

  • Diet, exercise, weight loss if indicated and smoking cessation.
  • Initiate appropriate treatment after correcting contributing causes for low high-density lipoprotein cholesterol (HDL-C) and high triglycerides (TGs).
    • Niacin
    • Statins
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Boston Heart Cholesterol Balance®

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Test Code

501

Description

Boston Heart Diagnostics Cholesterol Balance® test measures markers of cholesterol production (lathosterol and desmosterol) and absorption (beta-sitosterol, campesterol, and cholestanol) 

Methodology

Lipid extraction followed by capillary column gas liquid chromatography and mass spectrometry (GC/MS)

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Alternate Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 5 days
Refrigerated: 5 days

Lab Values

 

Lathosterol
(Marker of cholesterol production)

  • Optimal: <90 μmol/mmol of total cholesterol (TC)
  • Borderline: 90–160 μmol/mmol of TC
  • High: >160 μmol/mmol of TC
  • Very high absolute value: >7.0 mg/L

Desmosterol
(Marker of cholesterol production)

  • Optimal: <70 μmol/mmol of TC
  • Borderline: 70–90 μmol/mmol of TC
  • High: >90 μmol/mmol of TC
  • Very high absolute value: >5.0 mg/L

Beta-sitosterol (Marker of cholesterol absorption)

  • Optimal: <100 μmol/mmol of TC
  • Borderline: 100–180 μmol/mmol of TC
  • High: >180 μmol/mmol of TC
  • Very high absolute value: >7.0 mg/L

Campesterol
(Marker of cholesterol absorption)

  • Optimal: <150 μmol/mmol of TC
  • Borderline: 150–260 μmol/mmol of TC
  • High: >260 μmol/mmol of TC
  • Very high absolute value: >10.0 mg/L

Cholestanol
(Marker of cholesterol absorption)

  • Very high absolute value: >15.0 mg/L

Cholesterol Balance Score
(Production/Absorption)

  • Very low: 0.2
  • Low: <0.5
  • Normal: 0.5-1.1
  • High: >1.1
  • Very high: >2.1

Clinical Significance

High lathosterol and desmosterol indicate cholesterol overproduction

  • Associated with higher LDL-C and increased CVD risk
  • Associated with familial combined hyperlipidemia

High campesterol and beta-sitosterol indicate cholesterol overabsorption

  • Associated with higher LDL-C and increased CVD risk
  • Associated with phytosterolemia

High absolute value of cholestanol indicates decreased conversion of cholesterol to the bile acid chenodeoxycholate

  • May be associated with tendon xanthomas, neurologic disease, and cerebrotendinous xanthomatosis

Treatment Options

Initiate appropriate treatment after correcting contributing causes for elevated LDL-C

  • Elevated lathosterol and desmosterol: statins
  • Elevated campesterol and  beta-sitosterol: ezetimibe
  • Elevated absolute cholestanol: chenodeoxycholate therapy
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Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype Test

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Test Code

835

Description

Solute carrier organic anion transporter (SLCO1B1) encodes for the organic anion transporting polypeptide 1B1 (OATP1B1) which is an influx transporter produced in the liver that mediates the hepatic uptake and metabolism of statins. Inherited variations in the SLCO1B1 gene known as SNPs (single nucleotide polymorphisms) affect the function of this transporter. The intended use of SLCO1B1 testing is as an aid in the selection of the appropriate statin for treatment in individuals. The genetic test identifies individuals with a specific drug transporter defect associated with statin-induced myopathy, thus allowing the healthcare provider to select a statin that is less likely to cause this adverse event.

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top) tube

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated 15 days

Lab  Values

  1. Normal Statin Metabolizer :  Genotype T/T (valine/valine)
  2. Decreased Statin Metabolizer:  Genotype T/C (valine/alanine)
  3. Markedly Decreased Statin Metabolizer:  Genotype C/C (alanine/alanine)

Clinical Significance

  1. The T/T genotype - normal statin metabolizer
  2. The T/C genotype – decreased statin metabolizer
    Increased risk of statin induced myopathy
    These subjects have a decreased ability to metabolize statins, get less LDL-C lowering response, and have a 4-fold increased risk of developing myopathy on statin therapy
  3. The C/C genotype  – markedly decreased statin metabolizer
    Markedly increased risk of statin induced myopathy
    These subjects have a significantly decreased ability to metabolize statins, get less
    LDL-C lowering, and are at a 17-fold increased risk of developing myopathy on statin therapy

Treatment Options

 

1) T/T genotype: standard doses of statins, if indicated, are recommendedThese subjects have a normal ability to metabolize statins

2) T/C genotype: Moderate to low doses of water soluble statins (in order of solubility: pravastatin, pitavastatin, rosuvastatin or fluvastatin), if indicated, are recommended

3) C/C genotype: Low doses of water soluble statins (in order of solubility: pravastatin, pitavastatin, rosuvastatin or fluvastatin), if indicated, are recommended

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Boston Heart HDL Map®

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Test Code

801

Description

The Boston Heart HDL Map® test measures the five most significant HDL subpopulations in CVD risk. A two-dimensional gel electrophoresis process measures the amount of apoA-I protein in each of the five HDL subclasses, providing information to accurately identify patients at increased CVD risk.

Methodology

Two-dimensional gel electrophoresis

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: UNSTABLE
Refrigerated: 2 days (sample must be received within 2 days of collection)

Lab Values

Male

                   Optimal       Borderline     High Risk for CVD
Preβ-1        <17.0           17.0-25.0       >25.0
α-4              <13.5           13.5-25.0       >25.0
α-3              <13.5           13.5-30.0       >30.0
α-2              >34.0           27.0-34.0       <27.0
α-1              >20.0          14.0-20.0       <14.0             

Female

                Optimal       Borderline     High Risk for CVD
Preβ-1        <17.0           17.0-25.0       >25.0
α-4              <13.5           13.5-25.0       >25.0
α-3              <13.5           13.5-30.0       >30.0
α-2              >45.0           34.0-45.0       <34.0
α-1              >30.0           20.0-30.0       <20.0

Clinical Significance
(α-1 levels)

 

  • Every 1mg/dL apoA-I increase in very large α-1 HDL is associated with a 26% decrease in CVD risk.
  • Low α-1 level is a significant predictor of recurrent CVD events.
  • Change in α-1 is significantly associated with change in coronary artery stenosis.

Treatment Options

  • Diet, exercise, weight loss if indicated, and smoking cessation.
  • Initiate appropriate treatment after correcting contributing causes for low high-density lipoprotein cholesterol (HDL-C) and high triglycerides (TGs).
    • Niacin
    • Statins
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Total Cholesterol (TC)

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Test Code

101

Description

Total cholesterol is a measure of the amount of cholesterol contained in the cholesterol- containing lipoproteins HDL, non-HDL and LDL

Methodology

Enzymatic Colorimetric

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only. (If ordered as part a stand-alone test, fasting is not required)

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days
Refrigerated: 7 days

Lab Values

 

  • Optimal: <200 mg/dL
  • Borderline: 200-240 mg/dL
  • High risk: >240 mg/dL

Clinical Significance

  • Total cholesterol used in combination with LDL-C and HDL-C provides information related to the determination of cardiovascular disease risk.

Treatment Options

  • Assess for elevations in LDL-C and VLDL-C.
  • Treatment is based on the parameter causing the elevation in TC.
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Low-Density Lipoprotein Cholesterol, Direct (LDL-C)

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Test Code

222

Description

LDL-C is a measure of the amount of cholesterol in the atherogenic low-density lipoproteins. LDL-C direct measurements are accurate when triglycerides are elevated; calculated LDL-C values are not.

Methodology

Enzymatic colorimetric.

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.  (If ordered as part of a stand-alone test, fasting is not required.)

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   7 days

Lab Values Without CVD

 

 

 

Lab Values With CVD

 

  • Optimal: <100 mg/dL
  • Borderline: 100-160 mg/dL
  • High risk: >160 mg/dL

 

  • Optimal: <70 mg/dL
  • Borderline: 70-100 mg/dL
  • High risk: >100 mg/dL

Clinical Significance

  • Elevated LDL-C is the primary risk factor for CVD per NCEP-ATP III.
  • Elevated levels are an independent risk factor for CVD.

Treatment Options

  • Diet, exercise and weight loss
  •  Statins
  •  Bile acid sequestrants
  •  Cholesterol absorption inhibitors
  •  Niacin
  •  Fibrates
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Small Dense LDL Cholesterol (sdLDL-C)

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Test Code

223

Description

The assay quantifies the amount of cholesterol in sdLDL particles which are more dense and more atherogenic LDL-particles.

Methodology

Enzymatic

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <20 mg/dL
  • Borderline: 20–40 mg/dL
  • High risk: >40 mg/dL

Clinical Significance

High levels are associated with a 2- to 3-fold increased risk for CVD events and rate of arteriographic progression.

Treatment Options

  • Diet, exercise and weight loss, if indicated
  • Control diabetes mellitus
  • Treat insulin resistance
  • Statins
  • Omega-3 fatty acids
  • Niacin
  • Fibrates
  • Metformin
  • Thiazolidinediones
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% Small Dense LDL Cholesterol (%sdLDL)

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Test Code

259  (includes direct LDL-C and direct sdLDL-C)

Description

This is a calculated value which indicates the percentage of total LDL-C due to sdLDL-C.

Methodology

% sdLDL-C is calculated as follows:
%sdLDL-C = (sdLDL-C/LDL-C ) X 100

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Optimal: <20%
  • Borderline: 20–30%
  • High risk: >30%

Clinical Significance

A high percentage of LDL as small dense LDL has been associated with an increased risk for CVD events and rate of progression of coronary disease.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present 
  • Statins
  • Cholesterol absorption inhibitors
  • Combination therapy
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Very Low Density Lipoprotein Cholesterol (VLDL-C)

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Test Code

255 (includes Total Cholesterol, Direct LDL, Direct HDL)

Description

VLDL-C is a calculation that indicates the amount of VLDL lipoproteins in the bloodstream.

Methodology

VLDL-C is calculated as follows:
TC - Direct LDL-C – Direct HDL-C = VLDL-C

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days 
Refrigerated: 7 days

Lab Values

 

  • Optimal: <30 mg/dL
  • Borderline: 30-40 mg/dL
  • High risk: >40 mg/dL

Clinical Significance

  • VLDL-C values >40 mg/dL are associated with increased CVD risk.

Treatment Options

  • Weight loss if indicated
  • Statins
  • If additional lowering is needed consider adding niacin, fish oil or fenofibrate.
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Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

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Test Code

250 (Includes total cholesterol, HDL and non-HDL)

Description

Non-HDL-C is a calculation that represents the cholesterol carried by all atherogenic particles including:

    • Chylomicron remnants
    • VLDL
    • IDL
    • LDL
    • Lp(a)

Methodology

Non-HDL-C is calculated as follows:
Non-HDL-C = Total cholesterol – High-density cholesterol

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Without CVD

  • Optimal: <130 mg/dL
  • Borderline: 130-190 mg/dL
  • High risk: >190 mg/dL

With CVD

  • Optimal: <100 mg/dL
  • Borderline: 100-130 mg/dL
  • High risk: >130 mg/dL

Clinical Significance

  • When TGs are high, LDL-C does not accurately reflect the amount of circulating atherogenic particles.  In this situation, non-HDL-C may be a better predictor of CVD risk than LDL-C.
  • Non-HDL-C has been shown in many studies to be superior to calculated LDL-C in predicting heart disease risk.

Treatment Options

  • Diet, exercise and weight loss
  • Statins
  • Bile acid sequestrants
  • Cholesterol absorption inhibitors
  • Niacin
  • Fibrates
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Total Cholesterol/High-Density Lipoprotein Cholesterol (TC/HDL-C)

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Test Code

254 (includes total cholesterol and HDL-C)

Description

The ratio of total cholesterol/high density lipoprotein cholesterol

Methodology

TC/HDL-C is calculated as follows:
TC/HDL-C = Total cholesterol/High-density cholesterol

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Without CHD

  • Optimal: <4.0
  • Borderline: 4.0–6.0
  • High risk: >6.0

With CHD or CHD Risk Equivalent

  • Optimal: <3.0
  • Borderline: 3.0–5.0
  • High risk: >5.0

Clinical Significance

  • The TC/HDL-C ratio has been shown in many studies to be a more significant CVD risk factor than either LDL-C or HDL-C alone, or in combination.

Treatment Options

  • Diet, exercise and weight loss
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy
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Triglycerides (TG)

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Test Code

102

Description

Triglycerides are composed of 3 fatty acids attached to glycerol that function as fat storage (adipose tissue) or may be used for energy.  Triglycerides are the primary lipid component in chylomicrons and very low-density lipoproteins.

Methodology

Enzymatic colorimetric

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

  • Optimal: <150 mg/dL
  • Borderline: 150-200 mg/dL
  • High risk: >200 mg/dL

Clinical Significance

  • Elevated TG is a secondary risk factor for CVD per NCEP-ATP III.
  • Elevated levels increase CVD risk by altering lipoprotein metabolism:
    • Enhances the formation of small dense LDL particles.
    • Contributes to low levels of large HDL particles.

Treatment Options

  • Avoid alcohol intake and initiate low simple carbohydrate diet.
  • Control diabetes and insulin resistance.
  • Niacin
  • Fibrates
  • Omega-3 fatty acids
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Very Low-Density Lipoprotein Cholesterol/Triglycerides Ratio (VLDL-C/TG)

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Test Code

257 (includes VLDL-C and triglycerides)  

Description

VLDL-C/TG ratio is a measure of the cholesterol content of VLDL.

Methodology

The VLDL-C ratio is  calculated as follows:
VLDL-C/TG ratio  = VLDL-C/TG

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

  • Optimal: < 0.20
  • Borderline: 0.20 – 0.30
  • High risk: > 0.30

Clinical Significance

  • When the VLDL-C/TG ratio is > 0.30 it indicates the presence of of cholesterol-rich chylomicron and VLDL remnant lipoproteins, which increase CVD risk
  • A VLDL-C/TG ratio of > 0.30 has been associated with an increased risk of CVD and dysbetalipoproteinemia often associated with the apoE2/2 genotype

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy
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Apolipoprotein B (apoB)

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Test Code

302

Description

ApoB is a protein produced in both the liver and intestine that provides structure to the triglyceride (TG) carrying atherogenic lipoprotein particles. Each particle carries only one apoB protein. Thus, apoB is a direct measure of the number of atherogenic particles in the circulation. ApoB is also a surrogate marker for LDL particle concentration or LDL particle number. ApoB is found on:

  • Very low-density lipoproteins (VLDL)
  • Intermediate-density lipoproteins (IDL)
  • Low-density lipoproteins (LDL)
  • Lp(a)
  • Chylomicrons

Methodology

Immunoturbidimetric

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 1 day
Refrigerated: 8 days

Lab Values

  • Optimal: <80 mg/dL
  • Borderline: 80–120 mg/dL
  • High risk: >120 mg/dL

Clinical Significance

Elevated levels of apoB are significant predictors of heart disease and are a more significant indicator of CVD than LDL-C.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy to optimize profile
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Apolipoprotein B/Apolipoprotein A-I Ratio (ApoB/ApoA-I)

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Test Code

303  (includes Apolipoprotein B and Apolipoprotein A-I) 

Description

The ratio of apolipoprotein B/apolipoprotein A-I is a strong predictor of heart disease risk. One molecule of apoB is carried per chylomicron, VLDL, LDL, and/or Lp(a) particle. ApoA-I is the major protein of HDL particles. 

Methodology

ApoB/ApoA-I is  calculated as follows:
ApoB/ApoA-I Ratio = ApoB/ApoA-I

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

 

Lab Values

 

Male

  • Optimal: <0.6 
  • Borderline: 0.6 – 0.9 
  • High risk: >0.90 

Female

  • Optimal: <0.5 
  • Borderline: 0.5 – 0.7 
  • High risk: >0.7

Clinical Significance

  • The apoB/apoA-I ratio has been shown in many studies to be a more significant CVD risk factor than either LDL-C or HDL-C alone, or in combination.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination Therapy
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Lipoprotein(a) (Lp(a))

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Test Code

224

Description

Lp(a) is a plasma lipoprotein that is composed of two parts:

  • LDL-like particle
  • Apolipoprotein (a) [apo(a)], a protein made in the liver and attached to the apoB portion of this particle

Methodology

Immunoturbidimetric assay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 2 weeks

Lab Values

  • Optimal: <30 mg/dL
  • Borderline: 30–50 mg/dL
  • High risk: >50 mg/dL

Clinical Significance

Elevated levels are an independent risk factor for myocardial infarction, coronary artery disease, cerebral vascular disease, vein graft stenosis and retinal artery occlusion.

Treatment Options

  • Optimize LDL-C, sdLDL-C and apoB
  • Niacin to lower Lp(a)
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High-Density Lipoprotein Cholesterol (HDL-C)

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Test Code

221

Description

HDL-C is a measure of the amount of cholesterol in non-atherogenic HDL particles.

Methodology

Enzymatic colorimetric.

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Male

  • Optimal: >50 mg/dL
  • Borderline: 40-50 mg/dL
  • High risk: <40 mg/dL

Female

  • Optimal: >60 mg/dL
  • Borderline: 50-60 mg/dL
  • High risk: <50 mg/dL

Clinical Significance

  • Low HDL-C is:
    • Independently associated with CVD risk.
    • A secondary risk factor for CVD per NCEP-ATP III Guidelines.
    • A  characteristic of the metabolic syndrome and insulin resistance.

Treatment Options

  • Weight loss
  • Treat diabetes  
  • Smoking cessation
  • Niacin
  • Statins
  • Fibrates
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High-Density Lipoprotein Cholesterol/Triglycerides Ratio (HDL-C/TG)

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Test Code

256 (includes HDL-C and triglycerides ) 

Description

The ratio of high density lipoprotein cholesterol/triglycerides is a calculated measure. Low levels of this ratio are very strongly linked to diabetes, insulin resistance, and metabolic syndrome.

Methodology

HDL-C/TG Ratio is calculated as follows:
HDL-C/TG Ratio = HDL-C/TG 

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

  • Optimal: >0.50
  • Borderline: 0.25–0.50  
  • High risk: <0.25

Clinical Significance

  • Low levels of the HDL-C/TG ratio are strongly linked to CVD risk, diabetes, insulin resistance, and metabolic syndrome. 

Treatment Options

  • Diet, exercise and weight loss
  • Niacin
  • Statins
  • Fibrates
  • Combination therapy
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Apolipoprotein A-I (apoA-I)

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Test Code

301

Description

ApoA-I is a protein produced in both the liver and intestine. It provides structure to HDL particles as well as activates enzymes that add a fatty acid to cholesterol (esterifies cholesterol) and allows it to enter the core of HDL. Reflects the amount of apoA-I protein available to form HDL particles.

Methodology

Immunoturbidimetric

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 1 day
Refrigerated: 8 days

Lab Values

Male

  • Optimal: >160 mg/dL
  • Borderline: 120–160 mg/dL
  • High risk: <120 mg/dL

Female

  • Optimal: >180 mg/dL
  • Borderline: 140–180 mg/dL
  • High risk: <140 mg/dL

Clinical Significance

Low level is associated with higher CVD risk.

Treatment Options

  • Niacin
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High Sensitivity C-Reactive Protein (hs-CRP)

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Test Code

601

Description

CRP is a protein that is produced in the liver in response to systemic inflammation and is an acute phase reactant. The “high sensitivity” CRP test is needed to detect very low levels of CRP that may be seen with vascular and/or systemic inflammation.

Methodology

Immunoturbidimetric  

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  11 days
Refrigerated:   2 months

Lab Values

  • Optimal: <1.0 mg/L
  • Borderline: 1.0–3.0 mg/L
  • High risk: >3.0 mg/L

Clinical Significance

Independent predictor of developing CVD events. Provides independent prognostic information after initiating treatment.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Statins
  • Metformin
  • Niacin
  • Fibrates
  • Thiazolidinediones
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Fibrinogen

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Test Code

701

Description

 

Fibrinogen or Factor I is an acute phase inflammatory plasma protein synthesized by the liver and is an essential component in the clotting cascade.

Methodology

Immunoturbidimetric

Patient Preparation

None

Preferred Specimen

0.5 mL EDTA plasma collected in plasma separator tube (Pearl Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <370 mg/dL
  • Borderline: 370-470 mg/dL
  • High risk: >470 mg/dL

Clinical Significance

  • Fibrinogen is converted by thrombin to form fibrin. Fibrin is then crosslinked by factor XIII, and is the final step in the formation of a blood clot.
  • Elevated levels are associated with inflammation.
  • Every 100 mg/dL increase in plasma fibrinogen level > 370 mg/dL has been associated with a 1.8 fold increased risk of CVD.

Treatment Options

  • Weight loss if indicated
  • Smoking cessation
  • Statins
  • Fibrates
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Lipoprotein-Associated Phospholipase A2 Activity [LpPLA2]

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Test Code

602

Description

 

LpPLA2 is an enzyme produced by monocytes/macrophages that breaks down phospholipids. Increased blood levels of LpPLA2 are associated with soft, active growing plaque. NOTE: Soft plaque is not stable calcified plaque.

Methodology

Enzyme Colormetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  1 day
Refrigerated:  14 days

Lab Values

  • Optimal:  <180 nmon/min/mL
  • Borderline: 180-224 nmol/min/mL
  • High risk: ≥225 nmol/min/mL

Clinical Significance

Predicts CVD risk independent of LDL-C and other inflammatory markers. Associated with:

  • 2-fold increased risk for coronary events
  • 2-fold increased risk for stroke

Treatment Options

  • Lifestyle Modification
  • Statins
  • Omega-3 fatty acids (especially EPA)
  • Combination therapy with Statin and Ezetimibe
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N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)

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Test Code

1101

Description

 

Brain natriuretic peptide (BNP) is a neurohormone that affects body fluid homeostasis via diuresis and natriuresis. Elevated levels are seen in patients with congestive heart failure, and a decreased ejection fraction. NT-proBNP is  the precursor molecule for BNP.

Methodology

Immunoassay 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top). 

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top).  Separate plasma as soon as possible after collection.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   6 days

Lab Values

Age: ≤75 yrs

  • Optimal: <125 pg/mL
  • Borderline: 125–450 pg/mL
  • High risk: >450 pg/mL

Age: >75 yrs

  • Optimal: <450 pg/mL
  • High risk: >450 pg/mL

Clinical Significance

Elevated levels Identify subjects with left ventricular dysfunction.

  • Every incremental increase in values above normal is associated with an incremental increase in CV risk.
  • Levels >450 pg/mL in subjects with stable CAD are associated with a 2- to 6-fold increased risk for cardiac morbidity and/or mortality.
  • Normal levels exclude cardiac dysfunction.

Treatment Options

Identify etiology of elevated NT-proBNP with physical assessment and additional diagnostic tests, such as echocardiography, as indicated.

Treatment is based on cause of elevated NT-proBNP and may include:

  • Preload  medications
  • Afterload medications
  • Rate control medications
  • Cardiac pacing
  • Stenting
  • Cardiac surgery
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Uric Acid

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Test Code

1009

Description

Uric acid is the final product of purine metabolism.

Methodology

Enzymatic colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  5 days

Lab Values    
                        

Male

  • Optimal/normal: <7.0 mg/dL
  • Borderline: 7.0-10.0 mg/dL
  • High risk: >10.0 mg/dL

Female

  • Optimal/normal: <6.0 mg/dL
  • Borderline: 6.0-10.0 mg/dL
  • High risk:  >10.0 mg/dL 

Clinical Significance

  • Elevated uric acid elevations are seen in renal disorders, gout, leukemia, psoriasis, starvation and patients receiving cytotoxic drugs.

Treatment Options

  • Identify etiology of elevated uric acid with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Homocysteine

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Test Code

603

Description

Homocysteine is a thiol-containing amino acid formed from methionine. Values >15 µmol/L have been associated with increased risk of cardiovascular disease. 

Methodology

Enzymatic 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top).  Centrifuge blood samples immediately after collection to separate the serum from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within an hour.

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top).  Centrifuge blood samples immediately after collection to separate the plasma from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within an hour.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  4 days
Refrigerated:   2 weeks

Lab  Values

  • Optimal: <10 µmol/L
  • Borderline: 10–14 µmol/L
  • High Risk: >14 µmol/L

Clinical Significance

Hyperhomocysteinemia is a risk factor for:

  • Cardiovascular disease
    • Ischemic heart disease
    • Fatal and non-fatal myocardial infarction and sudden cardiac death
    • Premature coronary artery disease
    • Extracranial carotid-artery stenosis
    • Venous thrombosis
  • Stroke
  • Peripheral vascular disease
  • Osteoporosis
  • Pregnancy complications
    • Spina bifida
    • Neural tube defects

Treatment Options

 

 

Treatment of hyperhomocysteinemia for high risk values >15 µmol/L:

  • Control all standard cardiovascular disease factors:
    • Blood glucose: <125 mg/dL
    • HbA1c: <6.5%
    • Systolic blood pressure: <130 mmHg
    • LDL-C: <100 mg/dL
  • Folate (800 µg/day),vitamin B12 (0.5 mg/day) and vitamin B6 (20 mg/day),and recheck values in 6 months

Treatment of borderline values between 10-15 µmol/L:

  • Daily multivitamin tablet containing the recommended daily allowances of folate (400 µg/day), vitamin B12 (2.4 µg/day) and vitamin B6 (1.5 mg/day)
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Hemoglobin A1c (HbA1c)

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Test Code

404

Description

This test measures the concentration of glucose attached to the hemoglobin in red blood cells. It assesses the average amount of glucose in blood over the last two to three months.

Methodology

Turbidimetric inhibition immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   7 days

Lab Values

  • Optimal: <5.7%
  • Borderline: 5.7–6.4%
  • High risk: >6.4%
  • Alert: >11.9 %

Clinical Significance

Monitors efficacy of diabetes treatment over time and identifies patients at risk of developing diabetes.

  • Increased risk: 5.7–6.4% 
  • Diagnosis of diabetes:  >6.4%      

Treatment Options

Mono, dual or triple therapy with:

  • Metformin
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Thiazolidinediones
  • α-glucosidase inhibitors
  • Sulfonylureas
  • Meglitinides
  • Insulin
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Glucose

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Test Code

401

Description

Glucose is the major short term source of energy for the body, and is obtained from the diet, as well as being produced in the liver.

Methodology

Enzymatic 

Patient Preparation

9 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top). Allow sample to clot for 30 minutes and centrifuge immediately thereafter.

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top). Centrifuge blood samples immediately after collection to separate the plasma from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within 30 minutes.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Normal:  70-99 mg/dL  
  • Borderline: 100 – 125 mg/dL
  • High: > 126 mg/dL, classified as diabetes mellitus
  • Critical values: <40, >500 mg/dL

Clinical Significance

A fasting glucose level of ≥ 126 mg/dL indicates the presence of diabetes mellitus, associated with a significantly increased risk of developing CVD, stroke, peripheral vascular disease, kidney failure, neuropathy, and retinopathy. The presence of diabetes mellitus needs to be confirmed by also having an elevated HbA1c level. A value < 30 mg/dL indicates significant hypoglycemia.

Treatment Options to Optimize Glucose and HbA1c levels

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Thiazolidinediones
  • Sulfonylureas
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Meglitinides
  • α-glucosidase inhibitors
  • Insulin
  • Combination therapy
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Insulin Resistance

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Test Code

408  (Includes glucose and insulin)

Description

The standard measure of insulin resistance is the homeostasis model, based on both fasting insulin and fasting glucose level.

Methodology

Insulin Resistance is calculated as:
Homeostasis Model of Insulin Resistance (HOMA-IR)  = [fasting insulin (uU/ml) X fasting glucose (mg/dl)] /401.85

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Optimal:  <2.0  
  • Borderline: 2.0 – 3.0 
  • High Risk: >3.0

Clinical Significance

The presence of insulin resistance (value > 3.0) indicates a high risk of developing:

  • Coronary heart disease
  • Stroke
  • Peripheral vascular disease
  • Type 2 diabetes mellitus
  • Hypertension
  • Hyperlipidemia

Treatment Options in Patients with Diabetes Mellitus Depending on Level of Insulin Resistance

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Thiazolidinediones
  • Sulfonylureas
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Meglitinides
  • α-glucosidase inhibitors
  • Insulin
  • Combination therapy
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Insulin

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Test Code

402

Description

 

Insulin is a hormone responsible for the transportation and storage of glucose in cells. It regulates glucose levels in blood. This test measures the amount of insulin in blood.

Methodology

Immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   5 days

Lab Values

  • Low : <5 µU/mL  An Insulin test result of < 5 uU/ml is normal in a non-diabetic, but low if the patient has diabetes (consistent with type 1 diabetes).
  • Optimal: 5-15 µU/mL
  • High: >15 µU/mL      

Clinical Significance

Insulin may be used in conjunction with glucose or glucose tolerance test to:

  • Diagnose insulin resistance
  • Diagnose insuloma
  • Monitor amount of endogenous insulin production
  • Determine when a type 2 diabetic may need to start insulin therapy

Presence of insulin resistance indicates a higher risk to develop:

  • Type 2 diabetes
  • Hypertension
  • Hyperlipidemia
  • Heart disease

Treatment Options (for elevated fasting insulin levels)

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Combination therapy
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Thyroid Stimulating Hormone (TSH)

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Test Code

1005

Description

TSH is a peptide hormone synthesized and secreted by the anterior pituitary gland.  TSH regulates thyroid gland function.

Methodology

Immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   7 days

Lab Values

  • Low:  <0.27 µlU/mL
  • Optimal/normal: 0.27-4.20 µlU/mL
  • High:  >4.20 µlU/mL   

Clinical Significance

  • TSH is used in the differential diagnosis of primary, secondary, & tertiary hypothyroidism.
  • Is also useful in screening for hyperthyroidism.
  • Allows adjustment of thyroid replacement in hypothyroid patients.

Treatment Options

  • Identify etiology of elevated or decreased TSH with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Vitamin D, 25-OH

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Test Code

625

Description

 

25-hydroxy vitamin D is a hormone precursor that promotes bone, calcium and phosphorus metabolism.

Methodology

Antibody-based chemiluminescence

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 5 days

Lab Values

  • Low: <30 ng/mL
    • Deficient: <10 ng/mL
    • Insufficient: 10–29 ng/mL   
  • Optimal: 30–100 ng/mL
  • High: >100 ng/mL

Clinical Significance

Vitamin D insufficiency is associated with:

  • Secondary hyperparathyroidism
  • Muscle weakness with increased fall risk
  • Myalgias

Vitamin D insufficiency may be associated with:

  • Deleterious effects on cardiovascular system
  • Impaired pancreatic function
  • Increased mortality

Treatment Options

 

 

 

 

 

 

 

Vitamin D Replacement Options for Vitamin D Deficiency:

  • Oral dose of 4,000 IU/day vitamin D if 25-hydroxy vitamin D level <10 ng/mL.
  • Oral dose of 2,000 IU/day vitamin D for 25-hydroxy vitamin D levels of 10–30 ng/mL.
  • Recheck levels after 3 months.

Maintenance therapy:

  • Oral dose of 1,000 IU/day vitamin D if 25-hydroxy vitamin D levels are >30 ng/mL, but <100 ng/mL
  • Obese individuals sequester vitamin D in body fat and may need up to 4,000 IU of vitamin D daily.
  • Sunlight exposure for 5–10 minutes for Caucasians between 10 AM and 3 PM; darker-skinned individuals need longer exposure time.
  • The goal is to achieve levels of serum 25-hydroxy vitamin D to >30 ng/mL, but <100 ng/mL.
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Aspartate Aminotransferase (AST)

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Test Code

1002

Description

AST is an enzyme that is widely distributed in tissue, mainly hepatic, cardiac, muscle, and kidney. 

Methodology

Enzymatic 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature 1 Day
Refrigerated:  7 Days

Lab Values

  • Optimal/normal: <40 U/L
  • Borderline: 40-120 U/L
  • High risk:   >120 U/L
  • Alert: >240 U/L

Clinical Significance

  • Elevated serum levels are found in diseases involving hepatic, cardiac, muscle, and kidney tissues.

Treatment Options

  • Identify etiology of elevated AST with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Alanine Aminotransferase (ALT)

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Test Code

1003

Description

ALT is an enzyme that has been reported as present in a variety of tissues.  The liver is the major source of ALT.

Methodology

Enzymatic  

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: <40 U/L
  • Borderline:  40-120 U/L
  • High risk:  >120 U/L  
  • Alert: >240 U/L

Clinical Significance

  • Elevated serum levels are found in liver diseases.

Treatment Options

  • Identify etiology of elevated ALT with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Alkaline Phosphatase (Alk Phos)

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Test Code

1004

Description

Alkaline phosphatase is an enzyme that is found primarily in liver and biliary tract cells, as well as bone.

Methodology

Colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: <130 U/L
  • Borderline: 130-200 U/L
  • High risk: >200 U/L
  • Alert: >400 U/L

Clinical Significance

  • Elevated levels of alkaline phosphatase may indicate injury to liver or biliary tracts cells or bone.

Treatment Options

  • Identify etiology of elevated alkaline phosphatase with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Blood Urea Nitrogen (BUN)

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Test Code

1006

Description

Urea is the major end product of protein nitrogen metabolism.  Urea is synthesized in the liver and excreted mostly by the kidneys.

Methodology

Enzymatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated: 7 days

Lab Values

  • Optimal/normal: 3.0-25.0 mg/dL
  • High risk: >25.0 mg/dL
  • Alert: >50.0 mg/dL

Clinical Significance

  • Elevated levels of BUN may indicate increased production of urea, reduced renal perfusion, renal disease, or mechanical obstruction of urine excretion.

Treatment Options

  • Identify etiology of elevated BUN with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Creatinine

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Test Code

1007

Description

Creatinine is the break-down product of creatine phosphate in muscle and is usually produced at a fairly constant rate. Creatinine is filtered by the kidneys and is not re-absorbed to any significant extent.

Methodology

Enzymatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values     
                         

Male

  • Optimal/normal: 0.67-1.17 mg/dL
  • High risk:>1.17 mg/dL

Female

  • Optimal/normal: 0.51-0.95 mg/dL
  • High risk: >0.95 mg/dL

Clinical Significance

  • Elevated levels of creatinine may indicate kidney dysfunction.
  • Creatinine is used to evaluate renal function and in monitoring renal dialysis.

Treatment Options

  • Identify etiology of elevated creatinine with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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BUN/Creatinine Ratio

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Test Code

1013 (test includes BUN and Creatinine) 

Description

BUN/Creatinine Ratio is a calculation using blood (serum) urea nitrogen (BUN) and creatinine.

Methodology

BUN/Creatinine ratio is calculated as follows:
BUN divided by Creatinine

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: ≤23
  • High: >23

Clinical Significance

  • An elevated BUN/Creatinine ratio may be present with dehydration or in acute or chronic renal disease, reduced renal perfusion, or urinary tract obstruction.
  • Increased urea production may also elevate the ratio.

Treatment Options

  • Identify etiology of elevated BUN and creatinine with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Creatine Kinase (CK)

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Test Code

1001

Description

CK is an enzyme that is found in muscle, heart, and brain tissues.

Methodology

Enzymatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  2 days
Refrigerated:   7 days

Lab Values 
                       

Male

  • Optimal/normal: <300 U/L
  • Borderline: 300-1500 U/L
  • High risk: >1500 U/L

Female

  • Optimal/normal: <200 U/L
  • Borderline:   200-1000 U/L
  • High Risk:    >1000 U/L

Clinical Significance

  • Elevated serum levels are found in skeletal muscle diseases, myocardial infarction, and cerebral ischemia/injury.

Treatment Options

  • Identify etiology of elevated CK with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Apolipoprotein E (apoE) Genotype Test

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Test Code

806

Description

ApoE is a critical protein component of very low-density lipoprotein (VLDL) and chylomicrons. ApoE is important for:

  • Cholesterol absorption from the intestine
  • Uptake of triglyceride-rich lipoproteins  by the liver
  • The intended use of ApoE genetic testing is an aid in the selection of optimal cholesterol lowering protocols by the healthcare provider. The genetic test identifies individuals with altered lipid transport. Depending on the apoE genotype, cholesterol-lowering dietary interventions are very effective in these individuals, so determination of the genotype allows the physician to select the most efficacious treatment regimen for the patient for lowering low density lipoprotein cholesterol and reducing heart disease risk.

The APOE gene has three common alleles (e2, e3, e4) that encode for three protein isoforms (E2, E3, E4). ApoE3 is the most common form of apoE. Population frequencies for these APOE alleles are:

  • e2 (15%)
  • e3 (65%) 
  • e4 (20%)

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • E3/E3
  • E2/E2, E2/E3
  • E4/E4, E3/E4
  • E2/E4

Clinical Significance

E3/E3

Most common genotype; associated with:

  • Decreased uptake of cholesterol by the liver
  • Lower total cholesterol and LDL-C

E2/E2, E2/E3

Associated with lower LDL-C levels than the common E3/E3 genotype

E4/E4, E3/E4

Associated with higher LDL-C levels than the common E3/E3 genotype

Also associated with increased:

  • Cholesterol absorption in the intestine
  • Uptake of intestinal cholesterol by the liver
  • Total cholesterol and LDL-C

Treatment Options

E3/E3

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

E2/E2, E2/E3

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

E4/E4, E3/E4

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, combination therapy with statin and ezetimibe is recommended

E2/E4

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

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Factor V Leiden Genotype Test

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Test Code

816

Description

 

Factor V is a coagulation protein produced by the liver. The factor V Leiden genotype is a variant form of factor V with a change in one of the amino acids resulting in increased clot formation. The intended use of Factor V Leiden testing is as an aid in selection of appropriate thrombosis prevention regimens. The genetic test identifies individuals with defects in clotting factors, thus allowing the physician to determine the need for more aggressive thrombosis prevention measures for these individuals. Such therapy prevents life-threatening clots, especially those that travel from veins in the legs to the lungs (pulmonary emboli).

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • Genotypes -/-, +/-, +/+

Clinical Significance

 

Genotype -/-

normal risk of clot formation

Genotypes +/-

increased risk of developing clots, especially if on oral estrogen therapy

Genotype +/+

markedly increased risk of developing clots, especially if on oral estrogen therapy


Treatment Options

  • Genotypes +/-, +/+:  consider low dose aspirin treatment

 

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Prothrombin (Factor II) G20210A Genotype Test

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Test Code

826

Description

Factor II (prothrombin) is a coagulation protein produced by the liver. The factor II
genotype is a variant form of factor II with a change in one of the amino acids resulting inincreased clot formation. The intended use for Prothrombin (Factor II) testing is as an aid in selection of appropriate thrombosis prevention regimens. The genetic test identifies individuals with defects in clotting factors, thus allowing the physician to determine the need for more aggressive thrombosis prevention measures for these individuals. Such therapy prevents life-threatening clots, especially those that travel from veins in the legs to the lungs (pulmonary emboli).

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • Genotypes -/-, +/-, +/+

Clinical Significance

  • Genotype -/-: normal risk of clot formation
  • Genotypes +/-:  increased risk of developing clots, especially if on oral estrogen therapy
  • Genotype +/+: markedly increased risk of developing clots, especially if on oral estrogen therapy

Treatment Options

  • Genotypes +/-, +/+:  consider low dose aspirin treatment
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Clopidogrel Response (CYP2C19) Genotype Test

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Test Code

830

Description

CYP2C19 polymorphisms are inherited variations in the DNA sequence of the gene that codes for the cytochrome P450 (CYP) enzyme 2C19.  This enzyme is found in the liver and converts the pro-drug clopidogrel (PLAVIX®) to its active form.  Knowing CYP2C19 genotype is important prior to angioplasty to assure proper treatment with clopidogrel or prasugrel to prevent the complications of either stent closure or significant bleeding.  The intended use of CYP2C19 testing is as an aid in treatment decisions related to dosage of clopidogrel (Plavix). The genetic test identifies individuals that have reduced metabolism of clopidogrel, thus requiring higher amounts of the drug in order to reach an efficacious dose of the active agent, or sometimes require a different agent such as prasurgrel or ticagrelor, because they do not metabolize clopidogrel to its active form at all. Moreover there is another group of patients identified by this testing who has increased metabolism of clopidogrel to its active form, and such patients require a decreased dose of clopidogrel to prevent bleeding complications.

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab  Values

  • Normal Clopidogrel Metabolizers
    • Genotype *1/*1
    • Genotype *2/*17 (metabolism is not known but is assumed to fall in the normal category)
    • Genotype *3/*17 (metabolism is not known but is assumed to fall in the normal category)
  • Increased Clopidogrel Metabolizer
    • Genotype *1/*17
  • Decreased Clopidogrel Metabolizers
    • Genotype *1/*2
    • Genotype *1/*3
  • Markedly Increased Clopidogrel Metabolizer
    • Genotype *17/*17
  • Markedly Decreased Clopidogrel Metabolizers
    • Genotype *2/*2
    • Genotype *3/*3
    • Genotype *2/*3
    •  

Clinical Significance

  • See lab values section above.

Treatment Options

 

 

 

 

 

 

 

  • Normal Clopidogrel Metabolizers (genotypes *1/*1, *2/*17, *3/*17)
    • Normal doses of clopidogrel can be used
  • Increased Clopidogrel Metabolizer (genotype *1/*17)
    • Only normal doses of clopidogrel, if indicated, are recommended
  • Decreased Clopidogrel Metabolizers (genotypes *1/*2, *1/*3)
    • The clopidogrel dose, if indicated, may need to be increased
  • Markedly Increased Clopidogrel Metabolizer (genotype *17/*17)
    • Only normal doses or lower than normal doses of clopidogrel are recommended, if indicated
  • Markedly Decreased Clopidogrel Metabolizers (genotypes *2/*2, *3/*3, *2/*3)
    • Another agent such as ticagrelor or prasugrel, if indicated, is recommended
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Anion Gap

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Test Code

N/A – automatically calculated when sodium, chloride and CO2 are ordered

Description

Anion gap is a chemistry calculation using results of an electrolyte panel to determine acid/base balance. This test is most commonly performed in patients who present with altered mental status, unknown exposures, acute renal failure, and acute illnesses.

Methodology

Anion GAP is calculated as follows: (Sodium ) - (Chloride + CO2)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 40 hours
Refrigerated: 7 days

Lab  Values

  • Low: <3 mmol/L
  • Optimal: 3-16 mmol/L
  • High: >16 mmol/L

Clinical Significance

  • Elevated level may indicate metabolic acidosis as in diabetic ketoacidosis, lactic acidosis; (rhabdomyolysis) severe muscle break down, kidney failure, aspirin overdose or methanol
  • Low levels very rare. May indicate low serum protein levels possibly due to kidney, liver disorders or malnutrition.

Treatment Options

  • Treatment depends on which electrolyte(s) is out of balance and the extent of that change.
  • Identify etiology of elevated Anion GAP
  • Most common symptoms in patients with abnormal anion gap are those who present with altered mental status, unknown exposures, acute renal failure, and acute illnesses.
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Calcium

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Test Code

1030

Description

Calcium is an important mineral needed for blood clotting and bone health. This test measures the amount of calcium in the blood.

Methodology

Photometric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab  Values

  • Low: <8.6 mg/dL
  • Optimal: 8.6-10.4 mg/dL
  • High: >10.4 mgl/dL
  • Alert: ≤6.0 or ≥13.0 mg/dL

Clinical Significance

  • Elevated levels can indicate dehydration, hyperparathyroidism, kidney disease, bone cancer or high Vitamin D, Vitamin A or Calcium intake.
  • Low levels can indicate hypoparathyroid gland problems, intestinal absorption problems, kidney failure.

Treatment Options

  • Identify etiology of elevated calcium with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Chloride

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Test Code

1023

Description

Chloride is a negatively charged electrolyte that helps regulate the body’s salt/water and acid/base balance.

Methodology

Ion Selective Electrode (ISE)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 14 days
Refrigereated: 14 days

Lab  Values

  • Low: <98 mmol/L
  • Optimal: 98-110 mmol/L
  • High: >110 mmol/L
  • Alert: ≤80 or ≥120 mmol/L

Clinical Significance

  • Elevated levels of chloride can indicate dehydration, high sodium or kidney disease also Cushings syndrome.
  • Low levels of chloride can indicate low sodium, emphysema or chronic lung disease or congestive heart failure also Addison disease.

Treatment Options

  • Assess etiology of elevation such as dehydration, vomiting, medications and kidney problems that may lead to abnormal electrolyte imbalance.
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CO2

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Test Code

1024

Description

Bicarbonate is an electrolyte used by the body to maintain acid/base balance. (pH). Measures the most prevalent form of total carbon dioxide in the blood which is bicarbonate.

Methodology

Enzymatic using phosphoenolpyruvate carboxylase (PEPC)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 40 hours
Refrigerated: 7 days

Lab  Values

  • Low: <20 mmol/L
  • Optimal: 20-31 mmol/L
  • High: >31 mmol/L


  • Alert: ≤10 or ≥40 mmol/L

Clinical Significance

  • Elevated levels of CO2 can indicate chronic obstructive pulmonary disease, emphysema, or pneumonia, hypertension, metabolic alkalosis.
  • Low levels can indicate cirrhosis or liver failure, diabetic ketoacidosis, metabolic or respiratory acidosis, kidney disease, aspirin overdose.

Treatment Options

  • Assess etiology of elevation such as dehydration, vomiting, medications and kidney problems that may lead to abnormal electrolyte imbalance
  • Some drugs may increase bicarbonate levels including fludrocortisone, barbiturates, bicarbonates, hydrocortisone, loop diuretics, and steroids.
  • Drugs that may decrease bicarbonate levels include methicillin, nitrofurantoin, tetracycline, thiazide diuretics, and triamterene
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Direct Bilirubin

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Test Code

1033

Description

Bilirubin is a protein and natural by-product of red blood cell breakdown. Measures amount of bilirubin formed in the liver to become water soluble.

Methodology

Photometric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 2 days
Refrigerated: 7 days

Lab  Values

  • Optimal: 0.0-0.3 mg/dL
  • High: >0.3 mg/dL

Clinical Significance

  • If direct bilirubin is elevated more than total bilirubin, there typically is a problem with decreased elimination of bilirubin by the liver cells.
  • Elevated serum levels could indicate liver diseases such as hepatitis, cirrhosis, neoplasm or gall bladder disease.
  • Low levels are generally not a concern and are not monitored.

Treatment Options

  • The course of treatment is dependent on the cause of the jaundice. The determination of direct as well as total bilirubin is used in differentiating certain types of jaundice.
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Potassium

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Test Code

1022

Description

Potassium is an electrolyte vital to cell metabolism.

Methodology

Ion Selective Electrode (ISE)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 14 days
Refrigerated: 14 days

Lab  Values

  • Low: <3.5 mmol/L
  • Optimal: 3.5-5.3 mmol/L
  • High: >5.3 mmol/L

  • Critical Values: ≤2.5 or ≥6.0 mmol/L

Clinical Significance

  • May be used to diagnose and evaluate hypertension, diabetic ketoacidosis, kidney disease and to monitor patient receiving dialysis, diuretics or IV therapy.
  • Elevated levels could indicate excessive potassium intake, kidney disease, diabetes, dehydration.
  • Low levels of potassium could indicate, dehydration or acetaminophen overdose.

Treatment Options

  • Assess etiology of elevation such as dehydration, vomiting, medications and kidney problems that may be result of abnormal electrolyte imbalance.
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Sodium

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Test Code

1021

Description

Sodium is an electrolyte present in all body fluids and is vital to normal body function, including nerve and muscle function. It helps cells function normally and helps regulate the amount of fluid in the body.

Methodology

Ion Selective Electrode (ISE)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 14 days
Refrigerated: 14 days

Lab  Values

  • Low: <135 mmol/L
  • Optimal: 135-146 mmol/L
  • High: >146 mmol/L
  • Alert: ≤120 or ≥160 mmol/L

Clinical Significance

  • May be used to detect the cause and help monitor treatment plan for patients with abnormal levels.
  • Elevated levels of sodium could indicate hypernatremia or dehydration.
  • Low levels could indicate hyponatremia, fluid retention or too much water intake.

Treatment Options

  • Assess etiology of elevation such as dehydration, vomiting, medications and kidney problems that may be results of abnormal electrolyte imbalance.
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Total Protein

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Test Code

1027

Description

Total protein is a measure of albumin - the main protein in the blood produced by the liver and globulins which include enzymes, antibodies, hormones, carrier proteins.

Methodology

Colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 1 week

Lab  Values

  • Low: <6.6 g/dL
  • Optimal: 6.6-8.7 g/dL
  • High: >8.7 g/dL

Clinical Significance

  • Elevated levels could indicate dehydration or high levels of albumin and/or globulin as a result of chronic inflammation or infections such as viral hepatitis or HIV. May be associated with bone marrow disorders such as multiple myeloma
  • Low total protein levels can indicate a liver or kidney disorder, malnutrition, malabsorption, celiac or inflammatory bowel disorder.

Treatment Options

  • Treatment is based on the etiology of elevation
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Total Bilirubin

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Test Code

1032

Description

Total Bilirubin measures total and indirect forms of bilirubin. Bilirubin is a protein and natural by-product of red blood cell breakdown. Any increase in formation or retention of bilirubin by the body may result in jaundice.

Methodology

Colormetric diazo method

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 1 day
Refrigerated: 7 days

Lab  Values

  • Optimal: 0.0–1.2 mg/dL
  • High: >1.2 mg/dL

Clinical Significance

  • Used to screen for or monitor liver disorders or hemolytic anemias.
  • Elevated levels could indicate hepatitis, cirrhosis, neoplasm, alcoholism, hemolytic disease, biliary obstruction or anorexia.
  • Low levels are generally not a concern and are not monitored.

Treatment Options

  • The course of treatment is dependent on the cause of the jaundice. The determination of direct as well as total bilirubin is used in differentiating certain types of jaundice
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Magnesium

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Test Code

1038

Description

Magnesium is a mineral that is vital for energy production, muscle contraction, nerve function, and the maintenance bone health.

Methodology

Colormetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days
Refrigerated: 7 days

Lab  Values

  • Low: <1.6 mg/dL
  • Optimal: 1.6–2.6 mg/dL
  • High: >2.6 mg/dL

  • Alert: ≤1.0 or ≥6.1 mg/dL

Clinical Significance

  • Hypomagnesemia may result from insufficient intake, alcoholism, impaired gastrointestinal absorption, or increased gastrointestinal or urinary loss. Hypermagnesemia is rarely due to dietary sources but is usually the result of an excretion problem or excessive supplementation. Increased levels may be seen in kidney failure, hyperparathyroidism, hypothyroidism , dehydration, and with the use of magnesium-containing antacids or laxatives.
  • Hypermagnesemia is rarely due to dietary sources but is usually the result of an excretion problem or excessive supplementation. Increased levels may be seen in kidney failure, hyperparathyroidism, hypothyroidism , dehydration, and with the use of magnesium-containing antacids or laxatives.

Treatment Options

  • Treatment of mild asymptomatic hypomagnesemia includes oral administration of magnesium salts. Parenteral magnesium sulfate is warranted for moderate to severe or symptomatic hypomagnesemia. Treatment of hypermagnesemia consists of elimination of exogenous magnesium and correction.
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Phosphorus

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Test Code

1036

Description

Phosphates are vital for energy production, muscle and nerve function, bone growth and play an important role as a buffer, helping to maintain the body's acid-base balance.

Methodology

Photometric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 24 hours
Refrigerated: 4 days

Lab  Values

  • Low: <2.5 mg/dL
  • Optimal: 2.5-4.5 mg/dL
  • High: >4.5 mg/dL
  • Alert: ≤1.0 or ≥6.5

Clinical Significance

  • Hypophosphatemia may be seen with malnutrition, malabsorption, acid-base imbalances, hypercalcemia, and with disorders that affect kidney function. Hyperphosphatemia may be seen with increased intake of the mineral, hypocalcemia, and with kidney dysfunction.
  • Hyperphosphatemia may be seen with increased intake of the mineral, hypocalcemia, and with kidney dysfunction.

Treatment Options

  • Moderate hypophosphatemia can be treated with oral phosphate supplements while intravenous phosphate replacement is recommended for severe (<1.0 mg/dL) hypophosphatemia.
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Ferritin

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Test Code

1045

Description

Ferritin is a blood cell protein that contains iron. It is the primary form of iron stored inside of cells.

Methodology

Particle enhanced immunoturbidimetric assay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days
Refrigerated: 7 days

Lab  Values

    Female:

  • Low: <15 ng/dL
  • Optimal: 15-150 ng/dL
  • High: >150 ng/dL

    Male:

  • Low: <30 ng/dL
  • Optimal: 30-400 ng/dL
  • High: >400 ng/dL

Clinical Significance

To determine the body's total iron storage capacity, often measured when levels of hemoglobin are low to help confirm diagnosis of iron deficiency anemia.

Ferritin levels are low in people who are iron deficient, or have chronic disease, and are elevated in those with hemolytic anemia, iron poisoning, hemochromatosis or who have had multiple blood transfusions.

Ferritin is also an acute phase reactant and can be increased in people with inflammation, liver disease, chronic infection, autoimmune disorders, and some types of cancer. Ferritin is not typically used to detect or monitor these conditions.

Iron stores, expressed as serum ferritin concentration, have also been proposed to be a component of the insulin-resistance syndrome.

Ferritin is inversely related to adiponectin

Treatment Options

Medical care starts with establishing the diagnosis and reason for the iron deficiency.

High Ferritin - Increased levels may be seen in alcohol abuse, acute hepatitis, and infections. In severe cases of hemochromatosis, periodic removal of a prescribed amount of blood, also known as therapeutic phlebotomy, may be necessary.

Low Ferritin - supplemental iron

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Iron

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Test Code

1040

Description

Iron is an important component of hemoglobin, the substance in red blood cells that carries oxygen from your lungs to transport it throughout your body. Hemoglobin represents about two-thirds of the body's iron. If you don't have enough iron you can't make hemoglobin.

Methodology

Colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days
Refrigerated: 1 week

Lab  Values

    Female:

  • Low: <37 µg/dL
  • Optimal: 37-145 µg/dL
  • High: >145 µg/dL

    Male:

  • Low: <59 µg/dL
  • Optimal: 59-158 µg/dL
  • High: >158 µg/dL

Clinical Significance

  • Serum iron, TIBC and transferrin are usually ordered together and, subsequently, the transferrin saturation can be determined and used to assess how much iron is being carried in the blood.
  • Low iron may meet nutrient deficiency or chronic illness

Treatment Options

  • Treatment is based on etiology of elevation.
  • High Iron - Increased levels may be seen in alcohol abuse, acute hepatitis, and infections. In severe cases of hemochromatosis , periodic removal of a prescribed amount of blood, also known as therapeutic phlebotomy, may be necessary.
  • Low Iron - supplemental iron
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UIBC

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Test Code

1042

Description

Unsaturated Iron Binding Capacity

Methodology

Colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 4 days
Refrigerated: 7 days

Lab  Values

  • Low: <112 µg/dL
  • Optimal: 112-347 µg/dL
  • High: >347 µg/dL

Clinical Significance

  • To assess the body's ability to transport iron in the blood.
  • Elevated unsaturated iron binding capacity (UIBC) may indicate:
  • Iron deficiency in the diet; Inability to absorb iron
  • Decreased unsaturated iron binding capacity (UIBC) may indicate:
  • Hemochromatosis, Chronic infection or illness, Hemolytic anemia
  • Sideroblastic anemia, Iron toxicity
  • Total Iron Binding Capacity (TIBC) measures the levels of transferrin bound with iron; whereas Unsaturated Iron Binding Capacity (UIBC) measures levels of transferrin that has not bound iron.
  • It is customary to test for transferrin (instead of TIBC or UIBC) when evaluating a person's nutritional status or liver function.

Treatment Options

  • Treatment is based on etiology of elevation.
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TIBC

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Test Code

N/A – automatically calculated when Iron and UIBC are ordered

Description

Total iron binding capacity (TIBC) is a blood test to see if there is too much or too little iron in the blood.

Methodology

TIBC is calculated as follows: Iron + UIBC

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 4 days
Refrigerated: 7 days

Lab  Values

  • Low: <250 µg/dL
  • Optimal: 250-370 µg/dL
  • High: >370 µg/dL

Clinical Significance

  • Total iron-binding capacity (TIBC) is most frequently used along with a serum iron test to evaluate people suspected of having either iron deficiency or iron overload. TIBC + serum iron are used to calculate transferrin saturation.
  • In iron deficiency, the iron level is low, the TIBC is increased, and the transferrin saturation becomes very low.
  • In iron overload states (i.e. hemochromatosis), the iron level is high, TIBC will be low or normal, and the transferrin saturation is increased.

Treatment Options

  • Treatment is based on etiology of elevation.
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Cortisol

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Test Code

1138

Description

Cortisol is a steroid hormone, in the glucocorticoid class of hormones. It is produced and secreted by the adrenal glands. Cortisol can be measured the blood, saliva, and urine and can be affected by many conditions, such as physical or emotional stress, strenuous activity, infection, or injury. It is involved in regulating blood sugar, blood pressure, and inflammation.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 5 days

Lab  Values

    7am-10am:

  • Low: <6 µg/dL
  • Optimal: 6-19 µg/dL
  • High: >19 µg/dL

    4pm-8pm:

  • Low: <2 µg/dL
  • Optimal: 2-12 µg/dL
  • High: >12 µg/dL

Clinical Significance

  • Cortisol testing is used to help diagnose problems of the pituitary gland or adrenal glands, such as making too much or too little hormones. Testing is used to diagnose Cushing syndrome, a condition associated with excess cortisol, or conditions associated with deficient cortisol such as adrenal insufficiency or Addison disease, tuberculosis, infection of the adrenal glands, or congenital adrenal hyperplasia (CAH). Cortisol levels can also be affected by thyroid abnormalities.
  • Elevated cortisol levels can have adverse effects on the immune system, memory, and sugar metabolism. If a patient has a high blood cortisol, HCPs may consider a cortisol challenge (i.e. adrenocorticotropic hormone (ACTH) to dx Addison's disease.
  • Many medications such as corticosteroid influence blood cortisol levels.

Treatment Options

  • Treatment is based on etiology of elevation.
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Parathyroid Hormone

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Test Code

1136

Description

PTH is a hormone secreted by the parathyroid glands that is important in bone remodeling. PTH functions as part of a feedback system that involves calcium, phosphorus (as phosphate), and vitamin D.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Patient Preparation

None

Preferred Specimen

1.0 mL EDTA plasma collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 2 days
Refrigerated: 3 days

Lab  Values

  • Low: <15 pg/dL
  • Optimal: 15-65 pg/dL
  • High: >65 pg/dL

Clinical Significance

  • Used to help diagnose the cause of a low or high calcium level and to help distinguish between parathyroid-related and non-parathyroid-related causes.
  • A calcium test is almost always ordered along with PTH to determine the balance between calcium and PTH and the response of the parathyroid glands to changing levels of calcium.
  • Most often ordered when calcium regulation is abnormal.

Treatment Options

  • Primary hyperparathyroidism - Surgery to remove adenoma or parathyroidectomy
  • Secondary hyperparathyroidism - Treat underlying cause/condition most often kidney disease. In some cases, medication may be used to reduce PTH secretion and/or high calcium levels in blood.
  • Patients with hypoparathyroidism are treated with calcium and vitamin D supplementation.
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TPO

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Test Code

1020

Description

TPO is an enzyme expressed mainly in the thyroid involved in the production of thyroid hormones T3 and T4.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab  Values

  • Optimal: <40 IU/mL
  • High: ≥40 IU/mL

Clinical Significance

  • Thyroid peroxidase antibody (TPO), is primarily ordered to help diagnose an autoimmune thyroid disease and to distinguish it from other forms of thyroid dysfunction. Abnormal TPO may indicate Graves Disease or Hashimotos.
  • Testing may be performed as a follow-up when other thyroid test results such as total or free T3, free T4, and/or TSH indicate thyroid dysfunction.
  • A high value usually indicates autoimmune damage to the thyroid due to disorders such as Hashimoto thyroiditis and Graves disease.

Treatment Options

  • Treatment is based on etiology of elevation.
  • With Graves and Hashimotos, Thyroid hormone replacement therapy is typically necessary when thyroid hormone production becomes significantly decreased and symptoms begin to emerge or worsen. Those with Hashimoto thyroiditis are closely monitored, and thyroid hormone replacement therapy is initiated and/or adjusted as necessary.
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B12

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Test Code

607

Description

Vitamin B12 is required for proper red blood cell formation, neurological function, and DNA synthesis. Vitamin B12 also functions as a cofactor for homocysteine metabolism.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 5 days

Lab  Values

  • Borderline: 300-450 pg/mL
  • Optimal: 451-946 pg/mL
  • High Risk: <300 or >946 pg/mL

Clinical Significance

  • Low levels of vitamin B12 can be seen in vegetarians who do not eat animal products, diseases that cause malabsorption such as pernicious anemia, celiac disease and inflammatory bowel disease, with the use of certain medications like proton pump inhibitors and metformin and alcoholism. Conditions that can increase B12 level include: Liver diseases, such as cirrhosis or hepatitis, and Myeloproliferative disorders like polycythemia vera and chronic myelogenous leukemia.

Treatment Options

  • Increase dietary intake of vitamin B12, or replace with B12 injections or oral supplements to normalize vitamin B12 levels
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Folate

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Test Code

610

Description

Folate is necessary for normal metabolism, DNA synthesis and red blood cell regeneration. Untreated deficiencies may lead to megaloblastic anemia. One of the most important folate-dependent reactions is the conversion of homocysteine to methionine.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Patient Preparation

8 hour fast prior to collection. Patient may drink water, black coffee or tea (no milk, cream or sugar).

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Transport Temperature

Refrigerate immediately (ship on frozen cold packs).

Stability

Room Temperature: 2 hours
Refrigerated: 2 days

Lab  Values

  • Low: <10.0 ng/Ml
  • Borderline: 10.0-14.0 ng/Ml
  • Optimal: >14.0 ng/Ml

Clinical Significance

  • Isolated folate deficiency is uncommon; it usually coexists with other nutrient deficiencies because of its strong association with poor diet, alcoholism, and, sometimes, malabsorptive disorders. Women with insufficient folate intakes are at increased risk of giving birth to infants with neural tube defects.

Treatment Options

  • Treatment is based on the cause of the folate deficiency. Folate supplementation may be necessary. Individuals with MTHFR 677T genotype may require supplementation with methyl folate instead of folate to adequately lower their homocysteine levels.
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CBC with Differential

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Test Code

720

Description

Measures and reports the following: White Blood Count (WBC), Red Blood Count (RBW), Hemoglobin, Hematocrit, MCV, MCH, MCHC, RDW, Platelets, MPV

Review the section on Complete Blood Count for details on the components listed above

Differential includes:

Neutrophils: Measures the number of neutrophils which are the most abundant white blood cell in healthy adults and are the body’s main defense against bacterial, viral and fungal infections.

Lymphocytes: Measures the number of lymphocytes, which are white blood cells that include B-cells, T-cells, and natural killer cells.

Monocytes: Measures the number of monocytes which are white blood cells that engulf bacteria and other foreign particles.

Eosinophils: Measures the number of eosinophils which are white blood cells that respond to infections caused by parasites, play a role in allergic reactions, and control the extent of immune responses and inflammation.

Basophils: Measures that number of basophils which are white blood cells that are involved in allergic reactions

Differential also includes the following (if identified): Immature granulocytes, Atypical lymphocytes, Bands, Metamyelocytes, Myelocytes, Promyelocytes, Bands, Plasmacytes, Nucleated RBC, RBC Morphology, Smear Review

Methodology

Impedance and Flow Cytometry

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerate

Stability

Room Temperature: 24 hours
Refrigerated: 2 days (sample must be received within 2 days of collection)

Lab  Values

Ranges below are given for absolute values:

    Neutrophils:

  • Low: <1.50 x10E3/µL
  • High: >7.80 x10E3/µL

    Lymphocytes:

  • Low: <0.86 x10E3/µL
  • High: >3.90 x10E3/µL

    Monocytes:

  • Low: <0.20 x10E3/µL
  • High: >0.95 x10E3/µL

    Eosinophils:

  • Low: <0.00 x10E3/µL
  • High: >0.50 x10E3/µL

    Basophils:

  • High >0.20 x10E3/µL

Clinical Significance

Neutrophils: High levels of neutrophils, can be caused by acute bacterial, viral or fungal infections, inflammatory diseases, physiological stress, rigorous exercise, smoking and chronic leukemia. Low levels of neutrophils, can be caused by myelodysplastic syndrome, medications, autoimmune disorders, cancers and aplastic anemia.

Lymphocytes: High levels of lymphocytes may be seen in Acute viral infections and certain bacterial infections. Low levels can be seen in autoimmune disorders, bone marrow damage and immune deficiency.

Monocytes: High levels of monocytes, monocytosis, can be caused by chronic infections, autoimmune diseases, monocytic leukemia and chronic myelomonocytic leukemia. Low levels of monocytes, monocytopenia, can be caused by bone marrow damage or failure or hairy-cell leukemia.

Eosinophils: High levels of eosinophils, eosinophilia, can be caused by asthma, allergies, drug reactions, eczema, dermatitis, parasitic infections, inflammatory disorders, and certain cancers. High levels of eosinopils, eosinopenia, on one or just occasionally is usually not medically significant.

Basophils: High levels of basophils, basophilia, can be caused by allergic reactions, food allergies, autoimmune diseases and chronic myeloid leukemia. Low levels of basophils, basopenia, is usually not medically significant.

Treatment Options

Treatment is based on the etiology of the elevated or low results.

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Complete Blood Count (CBC)

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Test Code

725

Description

Measures and reports the following:

White Blood Cell (WBC): White blood cells, or leukocytes, function as phagocytes of bacteria, fungi and viruses.

Red Blood Cell (RBC): Red blood cells, also called erythrocytes, are cells that circulate in the blood and carry oxygen throughout the body. A relatively stable number of red blood cells are maintained in the circulation by increasing or decreasing the rate of production by the bone marrow.

Hemoglobin: Hemoglobin is the iron-containing protein found in all red blood cells that enables them to bind to oxygen in the lungs and carry it to tissues and organs throughout the body.

Hematocrit: Hematocrit is a measurement of the proportion of the blood that is made up of red blood cells and is dependent on the number of and size of the red blood cells.

MCV: The mean red blood cell volume, mean corpuscular volume or MCV, is an evaluation of the average size of each red blood cell.

MCH: Mean corpuscular hemoglobin (MCH) is a calculation of the average amount of hemoglobin inside a single red blood cell.

MCHC: Mean corpuscular hemoglobin concentration (MCHC) is a calculation of the average amount of hemoglobin in the RBCs compared to the average size of the RBCs.

RDW: Red blood cell distribution width (RDW) is a numerical measure of the size variability of circulating red blood cells.

Platelets: Platelets are very small cells found in the blood and are essential for normal blood clotting.

Methodology

Impedance and Flow Cytometry

Patient Preparation

None

Preferred Specimen

300 µL (min.) collected in serum separator tube (SST/Tiger Top).

Transport Temperature

Refrigerate-Avoid direct contact with frozen cold pack

Stability

Room Temperature: 24 hours
Refrigerated: 2 days (sample must be received within 2 days of collection)

Lab  Values

    White Blood Cell (WBC):

  • Low: <3.5 x10E3/µL
  • High: >10.5 x10E3/µL
  • Alert:: ≤2.0 or ≥25.0 x10E3/µL

    Red Blood Cell (RBC):

    Male:

  • Low: <4.30 x10E6/µL
  • High: >5.70 x10E6/µL

    Female:

  • Low: <3.80 x10E6/µL
  • High: >5.10 x10E6/µL

    Hemoglobin:

    Male:

  • Low: <13.5 g/dL
  • High: >17.5 g/dL
  • Alert: ≤ 6.0 or ≥ 20.0 g/dL

    Female

  • Low: <11.7
  • High: >15.5 g/dL
  • Alert: ≤ 6.0 or ≥ 20.0 g/dL

    Hematocrit:

    Male:

  • Low <39.0%
  • High >50.0%
  • Alert: ≤ 22.0 and ≥ 60.0%

    Female:

  • Low <35.0%
  • High >45.0%
  • Alert: ≤ 22.0 and ≥ 60.0%

    MVC:

  • Low <80.0 fL
  • High >100.0 fL

    MCH:

  • Low <27.0 pg
  • High >33.0 pg

    MCHC:

  • Low <32.0 g/dL
  • High >36.0 g/dL

    RDW:

  • Low <11.0 %
  • High >15.0 %

    Platelets:

  • Low <150 x10E3/µL
  • High >450 x10E3/µL
  • Alert: ≤40 or ≥800 x10E3/µL

Clinical Significance

White Blood Cell (WBC): A low white blood cell count may result from bone marrow disorders, lymphoma and HIV. A high white blood cell count may result from infections, inflammation, leukemia, myeloproliferative neoplasms and allergic responses.

Red Blood Cell (RBC): Low levels of RBC may be seen in anemias, hemoglobinopathy, iron, vitamin B12 or folate deficiencies, bone marrow damage or disorders, chronic inflammatory diseases and kidney failure. Elevated RBC may be associated with dehydration, pulmonary disease, congenital heart disease, smoking, and polycythemia vera.

Hemoglobin: The hemoglobin test is often used to check for anemia, usually along with a hematocrit or as part of a complete blood count. Low hemoglobin level may be due blood loss, chronic kidney disease, bone marrow disorders or iron, folate, vitamin B12, and vitamin B6 deficiencies. A high hemoglobin level is most often caused by hypoxia, polycythemia vera, dehydration and smoking

Hematocrit: The hematocrit test is often used to check for anemia, usually along with a hemoglobin or as part of a complete blood count. Low hemoglobin level may be due blood loss, chronic kidney disease, bone marrow disorders or iron, folate, vitamin B12, and vitamin B6 deficiencies. A high hemoglobin level is most often caused by hypoxia, polycythemia vera, dehydration and smoking

MCV: A low MCV indicates microcytic RBCs which may be due to iron deficiency anemia or thalassemias. An elevated MCV indicates macrocytic RBCs which may be seen in anemia caused by vitamin B12 or folate deficiency, myelodysplasia, liver disease and hypothyroidism.

MCH: Mirrors MCV results.

MCHC: May be low when MCV is low; decreased MCHC values are seen in conditions such as iron deficiency anemia and thalassemia. Increased MCHC values are seen in autoimmune hemolytic anemia, in burn patients, and hereditary spherocytosis.

RDW: Increased RDW is believed to be closely associated with the risk of cardiovascular morbidity and mortality in patients with previous myocardial infarction. A low value indicates uniformity in size of RBCs. A high value Indicates a mixed population of small and large RBC which can signify iron deficiency anemia or pernicious anemia.

Platelets:

A platelet count is part of a complete blood count and may be used to screen for or diagnose various diseases and conditions that can cause problems with clot formation. A low platelet count may be a results of bone marrow disorders. A high platelet count may be caused by cancer, anemia, chronic inflammatory diseases, oral contraceptives, myeloproliferative disorders.

Treatment Options

  • White Blood Cell (WBC): Identify the etiology of the leukocytosis or leukopenia
  • Red Blood Cell (RBC): Identify the etiology of the anemia or polycyethemia
  • Hemoglobin: Identify the etiology of the anemia or polycyethemia
  • Hematocrit: Identify the etiology of the anemia or polycyethemia
  • MCV: Identify the etiology of low or elevated MCV
  • MCH: Treatment is based on the etiology of low or elevated MCH
  • MCHC: Treatment is based on the etiology of low or elevated MCHC
  • RDW: Treatment is based on the etiology of low or elevated RDW
  • Platelets: Identify the etiology of the thrombocytopenia or thromobocytosis
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Dehydroepiandrosterone Sulfate (DHEA-S)

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Test Code

1134

Description

DHEA-S is an androgenic steroid secreted by the adrenal cortex and is the major androgen precursor in females. 

Methodology

Immunoassay-Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  5 days

Lab Values

 

Females:
Age                                                   

ug/dL

10-14

33.9-280.0

15-19

65.1-368.0

20-24

148-407.0

25-34

98.8-340.0

35-44

60.9-337.0

45-54

35.4-256.0

55-64

18.9-205.0

65-74

9.40-246.0

≥75

12.0-154.0

Males:
Age

ug/dL

10-14

24.4-247.0

15-19

70.2-492.0

20-24

211-492.0

25-34

160-449.0

35-44

88.9-427.0

45-54

44.3-33.0

55-64

51.7-295.0

65-74

33.6-249.0

≥75

16.2-123.0

        Alert Values: N/A

Clinical Significance

  • Elevated DHEA-S values aid in the diagnosis of hirsutism and virilism
  • Elevated DHEA-S levels may be useful for the diagnosis of:
    • All forms of excess androgen
    • Hyperprolactinemia
    • Polycystic ovarian syndrome
    • Exclusion of an androgen producing tumor of the adrenal cortex
    • Genetic enzyme defects of the adrenal cortex (adrenogenital syndrome)
    • Hyperplasia of the adrenal cortex as well as androgen producing tumors

Treatment Options

  • Identify etiology of elevated DHEA-S levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Estradiol (Estrogen Fraction E2)

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Test Code

1128

Description

Estradiol is the most potent naturally occurring estrogen.  Estrogens are the female hormones produced by the ovaries, adrenal cortex, placenta and testes.  Estrogens prepare the uterus for implantation of the fertilized ovum and promotes the maturation of and maintenance of female secondary sex characteristics and reproductive organs.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

Sex/Phase 

pg/mL

Men

11.3 – 43.2

Women

Follicular phase

12.4 – 233.0

Ovulation phase

41.0 – 398.0

Luteal phase

22.3 – 341.0

Postmenopause

< 138.0

Clinical Significance

  • Estradiol is used in the assessment of menopausal status, fertility disorders in the hypothalamus-pituitary-gonad axis, gynecomastia, estrogen-producing ovarian and testicular tumors and in hyperplasia of the adrenal cortex
  •  Is also used for monitoring of fertility therapy and determining the time of ovulation within the framework of in vitro fertilization.

Treatment Options

  • Identify etiology of elevated or decreased estradiol levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Follicle Stimulating Hormone (FSH)

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Test Code

1122

Description

FSH is one of the gonadotropins of the anterior pituitary gland that stimulates the growth and maturity of graafian follicles in the ovary and spermatogenesis in the testes.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 2 days

Lab Values

 

Sex/Phase

mIU/mL

Men

1.5-12.4

Women

 

Follicular phase

6.8-12.5

Ovulation phase

4.7-21.5

Luteal phase

1.7-7.7

Postmenopause

25.8-134.8

Alert Values: N/A

Clinical Significance

  • FSH is used to assess for dysfunctions within the hypothalamic-pituitary-gonadal system
  • FSH in conjunction with LH is used for the following indications:
    • Menopausal syndrome
    • Polycystic ovarian syndrome (PCOS)
    • Testosterone deficiency
    • Amenorrhea (causes)
    • Congenital diseases with chromosomal aberrations

Treatment Options

  • Identify etiology of elevated or decreased FSH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on the etiology of abnormal hormone levels
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Luteinizing Hormone (LH)

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Test Code

1120

Description

LH is one of the gonadotropins of the anterior pituitary gland that works with FSH to induce ovulation of mature follicles and secretion of estrogen by the ovary.  LH is also involved with the formation of the corpus luteum.  In the male LH stimulates the development of the interstitial cells of the testes and their secretion of testosterone.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  14 days

Lab Values

 

Sex/Phase

mIU/mL

Men

1.7-8.6

Women

Follicular phase

2.4-12.6

Ovulation phase

14.0-95.6

Luteal phase

1.0-11.4

Postmenopause

7.7-58.5

Alert Values: N/A

Clinical Significance

  • LH is used to assess for dysfunctions within the hypothalamic-pituitary-gonadal system
  • LH in conjunction with FSH is utilized for the following indications:
    • Menopausal syndrome
    • Polycystic ovarian syndrome (PCOS)
    • Testosterone deficiency
    • Amenorrhea (causes)
    • Congenital diseases with chromosomal aberrations

Treatment Options

  • Identify etiology of elevated or decreased LH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on the etiology of abnormal hormone levels
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Progesterone

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Test Code

1124

Description

Progesterone is a steroid hormone secreted by the corpus luteum and placenta to promote normal sexual function and secondary sex characteristics in women, as well as to prepare the uterus for implantation of the fertilized ovum and to maintain pregnancy.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  2 days

Lab Values

 

Sex/Phase

ng/mL

Men

<0.05-0.15

Women

Follicular phase

0.06-0.89

Ovulation phase

0.12-12.0

Luteal phase

1.83-23.9

Postmenopause

<0.05-0.13

Clinical Significance

Progesterone is used in the assessment of menopausal status and fertility diagnosis.

Treatment Options

  • When giving estrogen to post-menopausal women with an intact uterus, also use oral micronized progesterone to prevent uterine cancer
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Sex Hormone Binding Globulin (SHBG)

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Test Code

1130

Description

SHBG is a glycoprotein that binds to sex hormones, specifically testosterone and estradiol.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  5 days

Lab Values

 

Sex/Age

SHBG (nmol/L)

Males 20-49 yrs

16.5-55.9

Males ≥50 yrs

19.3-76.4

Females 21-49 yrs

24.6-122

Females ≥50 yrs

17.3-125

Alert Values: N/A

Clinical Significance

  • Elevated SHBG levels can be seen
    • In elderly men
    • In patients with hyperthyroidism and cirrhosis of the liver
    • When oral contraceptives or antiepileptic drugs are taken
  • Markedly higher SHBG levels are seen in pregnant women due to their increased estrogen production
  • Decreased SHBG concentrations are often seen with
    • Hypothyroidism
    • Polycystic ovarian syndrome (PCOS)
    • Obesity
    • Hirsutism
    • Elevated androgen levels
    • Alopecia
    • Acromegaly

Treatment Options

  • Identify etiology of elevated or decreased LH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Total Testosterone

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Test Code

1126

Description

Total testosterone is a measurement of free and protein bound testosterone, and is the most potent naturally occurring androgen.  It is produced by interstitial cells in the testes in response to stimulation by luteinizing hormone (LH).  Testosterone is also produced by the ovary and adrenal cortex in small amounts, and is responsible for the regulation of gonadotropic secretion and spermatogenesis, as well as the development of male secondary sex characteristics.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

Sex/Age

ng/dL

Males
20-49 years

249-836

Males
≥50 years

193-740

Females
20-49 years

8.40-48.1

Females
≥50 years

2.90-40.8

Patients < 20 years old: Reference Range Not Established

Clinical Significance

  • Testosterone is used in the diagnosis and treatment of the following disorders:
    • Primary and secondary hypogonadism
    • Delayed or precocious puberty
    • Impotence in males
    • Hirsutism (excessive hair) and virilization (masculinization) in females due to polycystic ovaries, tumors and adrenogenital syndromes

Treatment Options

  • Identify etiology of elevated or decreased total testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Free Testosterone

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Test Code

1127

Description

Free testosterone is a measurement of testosterone that is not bound to SHBG.  Testosterone is the most potent naturally occurring androgen and is produced by the interstitial cells of the testes in response to stimulation by luteinizing hormone (LH).  Testosterone is also produced by the ovary and adrenal cortex in small amounts and is responsible for the regulation of gonadotropic secretion and spermatogenesis as well as the development of secondary sex characteristics.

Methodology

Calculation

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  5 days

Lab Values

 

Sex/Age

pg/mL

Males

50.0-210.0

Females

1.0-8.5

Alert Values: N/A

Clinical Significance

  • Testosterone is used in the diagnosis and treatment of the following disorders:
    • Primary and secondary hypogonadism
    • Delayed or precocious puberty
    • Impotence in males
    • Hirsutism (excessive hair) and virilization (masculinization) in females due to polycystic ovaries, tumors and adrenogenital syndromes

Treatment Options

  •  Identify etiology of elevated or decreased free testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Albumin

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Test Code

403

Description

Albumin is the major plasma protein responsible for regulating plasma osmotic pressure as well as providing transport for large organic anions and some drugs.  This test measures the amount of albumin in plasma.

Methodology

Colorimetric Principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  2.5 months
Refrigerated:  5 months

Lab Values

 

  • Optimal: 3.5-5.2 g/dL
  • Borderline: NA
  • Increased/High Risk: <3.5g/dL; >5.2 g/dL

 

Clinical Significance

  • Elevated levels associated with dehydration
  • Decreased levels associated with:
    • Liver disease
    • Chronic disease
    • Reduced protein intake
    • Increased catabolism due to tissue damage or inflammation
    • Malabsorption of amino acids
    • Nephrotic syndrome
    • Protein loss via stool in neoplastic disease

Treatment Options

  •  Identify etiology of elevated or decreased total testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Boston Heart Prediabetes Assessment®

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Test Name

Boston Heart Prediabetes Assessment™

Test Code

420 (Reflex) – Assessment only completed if fasting glucose level is in the prediabetic range (100-125 mg/dL).

Description

A method of predicting the risk of developing diabetes (fasting serum glucose > 125 mg/dL) in subjects with prediabetes (fasting serum glucose 100 – 125 mg/dL). This method uses information about the person’s height, weight, parental history of diabetes, and use of cholesterol lowering medications (statins and niacin) along with the following measurements:  fasting glucose, glycated serum protein, adiponectin, and triglycerides.  This method provides a highly accurate assessment of the 10 year diabetes risk (over 92% accurate). 

Methodology

Refer to individual assays for more detailed information.

  • Turbidimetric
  • Colorimetric
  • Enzymatic

Patient Preparation

9 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL  serum (0.5 mL minimum) collected in a serum separator tube (SST/Tiger Top)

Alternate Specimen

N/A

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

 

Prediabetes Assessment of the 10 year diabetes risk 

  • Low Risk: < 10%
  • Borderline Risk: 10 – 20% 
  • High Risk: > 20%

Clinical Significance

Prediabetes Assessment predicts the risk of developing diabetes in subjects with prediabetes

Treatment Options

Diet
Exercise
Medications

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Adiponectin

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Test Name

Adiponectin

Test Code

407

Description

Adiponectin is a measure of the amount of a hormone produced by fat cells that protects against developing heart disease and diabetes.

Methodology

Immunoassay - Competitive principle

Patient Preparation

9 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values    
                        

Male

  • Optimal: >10.0 µg/dL
  • Borderline: 7.0-10.0 µg /dL
  • High risk: <7.0 µg/dL

Female

  • Optimal: >13.0 µg/dL
  • Borderline: 9.0-13.0 µg /dL
  • High risk: <9.0 µg/dL

Alert Values: N/A

Clinical Significance

  • Low values indicate increased risk of diabetes

Treatment Options

  • Structured diet and exercise program
  • Medications
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Glycated Serum Protein (GSP)

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Test Name

Glycated Serum Protein (GSP)

Test Code

409

Description

GSP is the amount of glucose attached to total serum proteins that indicate the average amount of glucose in the blood over the previous two to three weeks.

Methodology

Immunoassay-Competitive principle

Patient Preparation

9 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values

 

  • Optimal: <200 µmol/L
  • Borderline: 200-250 µmol/L
  • High risk: >250 µmol/L

Alert Values: N/A

Clinical Significance

  • Borderline or high values indicate increased risk of diabetes

Treatment Options

  • Structured diet and exercise program
  • Medications
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Myeloperoxidase (MPO)

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Test Code

604

Description

 

This is an enzyme made by white blood cells in the artery wall. Elevated levels of MPO indicate the presence of unstable plaque or buildup in the arterial wall and a high risk of having a near term cardiovascular event (within one to six months). In patients with high levels of MPO, careful evaluation of CVD risk should be considered by the healthcare professional.

Methodology

Enzyme immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL EDTA plasma collected in plasma separator tube (Pearl Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <450 pmol/L
  • Borderline: 450-650 pmol/L
  • High risk: >650 pmol/L
  • Alert: >1658 pmol/L

Clinical Significance

  • Elevated MPO levels have been shown to be a significant independent risk factor for a major adverse cardiac event (MACE) over the ensuing one to six months in patients presenting with chest pain who have normal levels of troponin.
  • This is especially the case if levels of high sensitivity C- reactive protein (hs-CRP) are also elevated, along with increased lipoprotein associated phospholipase A2 (LpPLA2).
    • Elevated serum levels of CRP are a marker of generalized and liver inflammation.
    • Elevated levels of LpPLA2 are a marker of inflammation in the arterial wall.

Treatment Options

  • Evaluate cardiovascular disease (CVD) status with physical exam, stress testing and other CVD diagnostic modalities.
  • Modify all existing CVD risk factors.
  • Medications to reduce elevated MPO levels may include:
    • Statins
    • Beta-blockers
    • Angiotensin enzyme converting inhibitors
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Estimated Glomerular Filtration Rate (eGFR) / Creatinine

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Test Code

N/A -- automatically calculated when serum creatinine is ordered.

Description

 

Glomerular filtration rate (GFR) provides a measure of kidney filtering capacity. Total GFR can be used as an index of functioning renal mass.
Estimated GFR (eGFR) / Creatinine is derived from the equation shown below.

Methodology

Serum creatinine (Scr) and age are used to calculate eGFR, taking sex and race into account. The specific equation used is:

GFR = 141 x min(Scr/κ, 1)α x max(Scr/κ, 1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if African American]

κ = 0.7 if female
κ = 0.9 if male

α = -0.329 if female
α = -0.411 if male

min = The minimum of Scr/κ or 1
max = The maximum of Scr/κ or 1

Patient Preparation

None

Preferred Specimen

NA

Alternate Specimen

NA

Transport Temperature

NA

Stability

NA

Lab Values

  • Optimal: >60 mL/min/1.73 m2
  • Borderline: 30-60 mL/min/1.73 m2
  • High Risk:  <30 mL/min/1.73 m2

Clinical Significance

eGFR / Creatinine Reference Ranges and Associated Clinical Signficance

≥60 mL/min/1.73m2

“Optimal” - Normal unless proteinuria is present which indicates stage 1 CKD

30-60 mL/min/1.73m2

“Borderline” Stage 2 CKD – further evaluation to determine potential causes of kidney disease recommended

<30 mL/min/1.73m2

“High Risk” Stage 3 CKD – further evaluation and treatment of complications recommended

15-29 mL/min/1.73m2

Stage 4 CKD – recommend preparing for kidney replacement therapy (e.g., hemodialysis or kidney transplantation)

<15 mL/min/1.73m2

Stage 5 CKD – kidney replacement therapy recommended

  • A low or decreasing eGFR is an indicator of chronic kidney disease (CKD).
  • Monitoring changes in eGFR can delineate progression of kidney disease.
  • The level of GFR is a strong predictor of the time to onset of kidney failure as well as the risk of complications of CKD.
  • Monitoring eGFR allows proper dosing of drugs excreted by glomerular filtration to avoid drug toxicity.

Treatment Options

Treatment is based on the cause of the renal dysfunction.

Reference: National Kidney Foundation: K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification Kidney Disease Outcomes Quality Initiative. Am J Kidney Dis. 2002;39(suppl 1)S1-266.

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Total T4 (Thyroxine or T4)

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Test Code

1015

Description

 

Total T4 (thyroxine) is a hormone produced by the thyroid gland and is converted in the body’s tissue to the major active thyroid hormone T3.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days
Frozen -20°C: 30 days

Lab Values

  • Low: <4.5 µg/dL
  • Optimal: 4.5-11.7 µg/dL
  • High : >11.7 µg/dL

Clinical Significance

  • Low Total T4 levels are consistent with an underactive thyroid gland or inadequate thyroid hormone replacement.
  • High Total T4 levels are consistent with either an overactive thyroid gland or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of Total T4 elevation/reduction.
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Free T4 (Free Thyroxine or FT4)

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Test Code

1016

Description

 

The amount of T4 hormone that is freely circulating in blood.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days  (2 days on SST gel)
Frozen -20°C: 30 days

Lab Values

  • Low: <0.93 ng/dL
  • Optimal: 0.93-1.70 ng/dL
  • High: >1.70 ng/dL

 

Clinical Significance

  • Low Free T4 levels are consistent with an underactive thyroid gland or inadequate thyroid hormone replacement.
  • High Free T4 levels are consistent with either an overactive thyroid gland or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of FT4 elevation/reduction.
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Total T3 (Triiodothyronine or T3)

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Test Code

1014

Description

 

Total T3 (triiodothyronine) is a hormone generated by converting T4 to T3 in the body’s tissue.  T3 is the active thyroid hormone and is necessary for normal body metabolism.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days
Frozen -20°C: 30 days

Lab Values

  • Low: <0.8 ng/mL
  • Optimal: 0.8-2.0 ng/mL
  • High: >2.0 ng/mL

Clinical Significance

  • Low Total T3 levels are consistent with hypothyroidism or inadequate thyroid hormone replacement.
  • High Total T3 levels are consistent with either hyperthyroidism or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on cause of Total T3 elevation/reduction.
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Free T3 (Free Triiodothyronine or FT3)

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Test Code

1017

Description

 

The amount of T3 hormone that is freely circulating in blood.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days  (2 days on SST gel)
Frozen -20°C: 30 days

Lab Values

  • Low: <2.0 pg/mL
  • Optimal: 2.0-4.4 pg/mL
  • High: >4.4 pg/mL

Clinical Significance

  • Low Free T3 levels are consistent with hypothyroidism or inadequate thyroid hormone replacement.
  • High Free T3 levels are consistent with either hyperthyroidism or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of FT3 elevation/reduction.
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Boston Heart Fatty Acid Balance™ Test

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Test Code

575

Description

 

Measures all the major fatty acids in plasma and reports:

  • Saturated Fatty Acid  Index
  • Trans Fatty Acid Index
  • Monounsaturated Fatty Acid Index
  • Unsaturated/Saturated Ratio Index
  • Omega-3 Fatty Acid Index
  • Omega-6 Fatty Acid Index
  • AA/EPA Ratio Index
  • Omega-6/Omega-3 Ratio Index
  • Levels of all the major omega-3 fatty acids including EPA, DHA and ALA as well as the two major omega-6 fatty acids, AA and LA

Methodology

Gas liquid column chromatography/mass spectrometry (GC/MS) after lipid extraction

Patient Preparation

9 hour fast prior to collection. Patient may drink water only. Fasting includes refraining from supplements, such as fish oil. Non-fasting samples will be rejected.

Preferred Specimen

1.0 mL plasma collected in EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

Test Name

Optimal

Borderline

High

Saturated Fatty Acid Index

< 30.0

30.0 - 33.0

> 33.0 %

Trans Fatty Acid Index

< 0.50

0.50 - 0.80

> 0.80 %

 

Test Name

Optimal

Borderline

Low

Monounsaturated Fatty Acid Index

> 22.0

19.0 - 22.0

< 19.0 %

Unsaturated/Saturated Ratio Index

> 2.25

2.00 - 2.25

< 2.00

Omega-3 Fatty Acid Index

> 4.50

2.00 - 4.50

< 2.00 %

Eicosapentaenoic Acid (EPA)

> 50.0

15.6 - 50.0

< 15.6 µg/mL

Docosahexaenoic Acid (DHA)

> 100.0

45.0 - 100.0

< 45.0 µg/mL

Alpha-linolenic Acid (ALA)

> 30.0

14.0 - 30.0

< 14.0 µg/mL

 

Test Name

Low

Mid

High

Omega-6 Fatty Acid Index

< 41.0

41.0 - 46.0

> 46.0 %

Linoleic Acid (LA)

< 825.0

825.0 - 1040.0

> 1040.0 µg/mL

Arachidonic Acid (AA)

< 220.0

220.0 - 290.0

> 290.0 µg/mL

AA/EPA Index

< 13.0

13.0 - 25.0

> 25.0

Omega-6/Omega-3 Ratio Index

< 15.0

15.0 - 24.0

> 24.0%

Clinical Significance

  • A high saturated fatty acid index > 32% of fat increases heart disease risk.3
  • A high trans fatty acid index of > 1.10% increases heart disease risk.
  • A monounsaturated fatty acid index of < 19% increases heart disease risk.
  • A low unsaturated/saturated ratio index of < 2.0 increases heart disease risk.
  • An omega 3 fatty acid index of < 1.85% increases heart disease risk.
  • EPA levels > 150 ug/L have been associated with significant heart disease risk reductions using EPA supplementation.
  • ALA may be helpful for heart disease risk reduction.

Treatment Options

  • Choose poultry without skin, fish, low fat dairy products, and very lean cuts of meats. Replace butter with vegetable oil or tub margarine.
  • Replace foods high in trans fats with trans fat free tub margarine and vegetable oils.
  • Increase intake of olive oil and or canola oil in salads or use more of these oils in cooking.   
  • Increase intake of vegetable fats (nuts, seeds, canola, soybean or other oils) and decrease intake of animal fats (fatty meats, cheese, ice cream).
  • Increase intake of oily fish such as salmon, herring, tuna, or mackerel, or take at least two fish oil or pure EPA capsules daily. Use of fish oil capsules has been associated with heart disease risk reduction. Doses of about 6 grams per day of fish oil or 4 grams of concentrated fish oil can also significantly lower triglyceride levels.

 

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MTHFR Genotype Test

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Test Code

840

Description

 

MTHFR (methylenetetrahydrofolate reductase) is the enzyme responsible for metabolizing folate which, in turn, is essential for converting homocysteine to methionine. Homocysteine is a necessary amino acid that plays an important role in metabolism, but high levels are related to a higher risk of coronary heart disease, stroke and peripheral vascular disease. The intended use of MTHFR genetic testing is, along with assessing homocysteine levels, to assess and minimize a patient’s risk for cardiovascular disease (CVD) through nutritional therapy and possibly clot prevention with low dose aspirin

Methodology

Real time polymerase chain reaction (RT-PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL blood collected in a K2 EDTA whole blood tube (lavender top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room temperature or Refrigerated (2-8 C) for 14 days

Lab Values

  • Genotypes: 677C/C   1298A/A;  677C/T   1298A/A; 677T/T   1298A/A

                      677C/C   1298A/C;  677C/T   1298A/C;  677T/T   1298A/C
677C/C   1298C/C;  677C/T   1298C/C;  677T/T   1298C/C

Clinical Significance

  • Genotypes:
    • 677C/C   1298A/A:
      • 677(C/C) genotype – normal folate metabolism
      • 1298(A/A) genotype – no variant
    • 677C/T   1298A/A:
      • 677(C/T) genotype – single copy of variant
      • 1298(A/A) genotype – no variant
    • 677T/T   1298A/A:
      • 677(T/T) genotype - significant variant associated with reduced folate metabolism
      • 1298(A/A) genotype – no variant
    • 677C/C   1298A/C:
      • 677(C/C) genotype – no variant
      • 1298(A/C) genotype – single copy of variant
    • 677C/T   1298A/C:
      • 677(C/T) genotype – single copy of variant
      • 1298(A/C) genotype - single copy of variant
    • 677T/T   1298A/C:
      • 677(T/T) genotype - significant variant associated with reduced folate metabolism
      • 1298(A/C) genotype - single copy of variant
    • 677C/C   1298C/C:
      • 677(C/C) genotype – no variant
      • 1298(C/C) genotype – two copies of variant
    • 677C/T   1298C/C:
      • 677(C/T) genotype – single copy of variant
      • 1298(C/C) genotype – two copies of variant
    • 677T/T   1298C/C:
      • 677(T/T) genotype - significant variant associated with reduced folate metabolism
      • 1298(C/C) genotype – two copies of variant

Treatment Options

  • Genotypes:
    • 677C/C   1298A/A:  No therapy is recommended unless homocysteine levels are elevated
    • 677C/T   1298A/A: Consider nutritional therapy if homocysteine levels are elevated
    •  677T/T   1298A/A: Consider nutritional therapy if homocysteine levels are elevated, as well as clot prevention with low dose aspirin
    • 677C/C   1298A/C:  Consider nutritional therapy if homocysteine levels are elevated
    • 677C/T   1298A/C: Consider nutritional therapy if homocysteine levels are elevated
    • 677T/T   1298A/C: Consider nutritional therapy if homocysteine levels are elevated, as well as clot prevention with low dose aspirin
    •  677C/C   1298C/C: Consider nutritional therapy if homocysteine levels are elevated
    • 677C/T   1298C/C: Consider nutritional therapy if homocysteine levels are elevated
    •  677T/T   1298C/C: Consider nutritional therapy if homocysteine levels are elevated, as well as clot prevention with low dose aspirin

MTHFR interpretation is in accordance with recently published data.

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C-Peptide

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Test Code

410

Description

Connecting Peptide (C-peptide) is a polypeptide produced by β-cells of the pancreas along with insulin. It serves as an accurate measure of insulin production, even in patients receiving insulin treatment.

Methodology

Electrochemiluminescence immunoassay

Patient Preparation

Minimum 8 hour fast prior to collection. Patient may drink water only. 

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL (minimum) plasma collected in EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

 

  • Low:  < 1.40 ng/mL
  • Optimal:  1.40 - 3.30 ng/mL
  • High:  > 3.30 ng/mL

Clinical Significance

Elevated C-peptide levels found in:

  • hyperinsulinemia
  • insulin resistance
  • obesity
  • renal insufficiency

Decreased C-peptide levels observed in:

  • insulin deficiency
  • starvation
  • hypoglycemia
  • Addison's disease
  • post pancreatectomy

Treatment Options

  • Levels of serum C-peptide are useful in formulating treatment plans in patients with diabetes mellitus.
  • Diabetic patients with low levels are candidates for insulin treatment, while those with normal or elevated levels are candidates for treatment with lifestyle modification and other agents.
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Cystatin C

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Test Code

1008

Description

Cystatin C is a protein produced by all nucleated cells at a constant rate. It is the most reliable available serum marker of kidney function and is superior to creatinine in estimating glomerular filtration (eGFR) rate as it is much less affected by age, gender, muscle mass and/or ethnic background.  

Methodology

Immunoturbidimetric assay

Patient Preparation

None  

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (tiger top)

Alternate Specimen

1.0 mL (minimum) plasma collected in EDTA plasma separator tube (pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values

 

  • Optimal: ≤ 1.20 mg/L
  • High:  > 1.20 mg/L 

Clinical Significance

Cystatin C is used to calculate eGFR

Treatment Options

Patients with eGFR (Cystatin C) values:

  • < 30 mL/min/1.73 m2 at increased risk of kidney failure
  •    30 - 60 mL/min/1.73 m2 at borderline risk

Both groups need to have their diabetes and hypertension carefully controlled, if present.  

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Estimated Glomerular Filtration Rate (eGFR) / Cystatin C

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Test Code

N/A -- automatically calculated when serum cystatin C is ordered.

Description

 

Glomerular filtration rate (GFR) provides a measure of kidney filtering capacity. Total GFR can be used as an index of functioning renal mass.
Estimated GFR (eGFR) using cystatin C is derived from the equation shown below and performs significantly better in prediction models than eGFR calculated from creatinine.

Methodology

Serum cystatin C and age are used to calculate eGFR, taking age and sex into account. The specific equation used is:

When serum Cystatin C is <0.8 mg/L:
    Male: eGFR (Cystatin C) = 133 x (Cystatin C/0.8)-0.499 x 0.996Age
    Female: eGFR (Cystatin C) = 133 x (Cystatin C/0.8)-0.499 x 0.996Age x 0.932

When serum Cystatin C is >0.8 mg/L:
    Male: eGFR (Cystatin C) = 133 x (Cystatin C/0.8)-1.328 x 0.996Age
    Female: eGFR (Cystatin C) = 133 x (Cystatin C/0.8) -1.328 x 0.996Age x 0.932

Patient Preparation

None

Preferred Specimen

NA

Alternate Specimen

NA

Transport Temperature

NA

Stability

NA

Lab Values

  • Optimal:    >60 mL/min/1.73 m2
  • Borderline: 30-60 mL/min/1.73 m2
  • High Risk:  <30 mL/min/1.73 m2

Clinical Significance

eGFR / Cystatin C Reference Ranges and Associated Clinical Significance

60 mL/min/1.73 m2

“Optimal” - Normal unless proteinuria is present which may be indicative of stage 1 CKD

30-60 mL/min/1.73 m2

“Borderline” Stage 2 CKD – further evaluation to determine potential causes of kidney disease recommended

< 30 mL/min/1.73 m2

“High Risk” Stage 3 CKD – further evaluation and treatment of complications recommended

15-29 mL/min/1.73 m2

Stage 4 CKD – recommend preparing for kidney replacement therapy (e.g., hemodialysis or kidney transplantation)

<15 mL/min/1.73m2

Stage 5 CKD – kidney replacement therapy recommended

  • A low or decreasing eGFR is an indicator of chronic kidney disease (CKD).
  • Monitoring changes in eGFR can delineate progression of kidney disease.
  • The level of GFR is a strong predictor of the time to onset of kidney failure as well as the risk of complications of CKD.
  • Monitoring eGFR allows proper dosing of drugs excreted by glomerular filtration to avoid drug toxicity.

Treatment Options

Treatment is based on the cause of the renal dysfunction.

Reference: Inker LA et al. N Engl J Med. 2012;367:20-9

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PSA, Total

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Test Code

1123

Description

PSA is secreted by epithelial cells of the prostate gland, and is present in small quantities in the serum of men with healthy prostate glands. Total serum PSA assay is an excellent adjunct to a rectal examination for the diagnosis of prostate cancer, as well in follow-up of patients with diagnosed prostate cancer.

Methodology

Electrochemiluminescence immunoassay

Patient Preparation

Recommend waiting at least 24 hours after a rectal exam before testing PSA  

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

1.0 mL (minimum) plasma collected in EDTA plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values

 

  • Optimal:  < 4.0 ng/mL
  • High:        > 4.0 ng/mL

Clinical Significance

Serum total PSA levels 4.0 ng/mL are associated with an increased risk of prostate cancer, but may also be seen in subjects with benign prostatic hypertrophy. PSA levels can also be used to monitor patients.

This test is performed using the Roche Diagnostics chemiluminescent method. Values obtained from different assay methods cannot be used interchangeably. PSA levels, regardless of value, should not be interpreted as absolute evidence of the presence or absence of disease.

Treatment Options

Patients with serum total PSA levels > 4.0 ng/mL are at increased risk of having prostate cancer.

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Coenzyme Q10 (CoQ10)

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Test Code

606

Description

Coenzyme Q10 (CoQ10), also known as ubiquinone, is an endogenously produced lipid-soluble cofactor that has a significant role in the formation of energy within cells. It also serves as a potent antioxidant and is very effective in inhibiting the oxidation and modification of low density lipoproteins (LDLs).  In addition to endogenous production, dietary sources and/or supplements provide CoQ10. Reflects the amount of CoQ10 present in serum.

Methodology

Ultra-high sensitivity liquid pressure chromatography (UPLC)

Patient Preparation

8 hour fast prior to collection, includes refraining from CoQ10 supplementation.  Patient may drink water, black coffee or tea (no milk, cream or sugar).

Preferred Specimen

300 µL (min.) collected in serum separator tube (SST/Tiger Top).

Alternate Specimen

None

Transport Temperature

Refrigerate immediately (ship on frozen cold packs).

Stability

Refrigerated: 2 days

Lab Values

  • Optimal: >1.40
  • Borderline: 0.70-1.40
  • High Risk: <0.70

Clinical Significance

Studies have shown that statins reduce serum CoQ10 levels. Low CoQ10 levels are associated with increased risk of statin associated muscle pain and heart failure. Supplementation decreases muscle symptoms related to statins and mortality in patients with heart failure. Early recognition of CoQ10 deficiency is essential to institute appropriate and timely treatment for cardiovascular disease.

Significant CoQ10 deficiency has been associated with:

  • Cardiovascular disease
  • Congestive heart failure
  • Significant muscle disorders
  • Significant neurological disorders
  • Liver disease
  • Chronic kidney failure

Treatment Options

Treatment Consideration for Low levels of CoQ10

  • CoQ10 supplementation
  • Encourage intake of dietary sources rich in CoQ10 like fish, avocados, vegetable oils (canola, soybean, olive)
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