Test Details
Spike Antibody (SARS-CoV-2 [COVID-19])
Spike Antibody measures the presence and amount of antibodies made against the spike protein in response to either virus exposure or mRNA vaccination. The Roche Diagnostics Elecsys Anti-SARS-CoV-2 S semi-quantitative assay is authorized for use under the FDA's Emergency Use Authorization (EUA).*
EUA
Providers Fact Sheet
Patient Fact Sheet
Instructions For Use
Methodology
Electrochemiluminescent Immunoassay
Patient Preparation
None
Preferred Specimen
1.0 mL serum collected in a serum separator tube (SST / Tiger Top)
Alternate Specimen
N/A
Transport Temperature
Refrigerated (ship on frozen cold packs)
Stability
Refrigerated: 7 days
*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Lab Values
Spike Antibody (SARS-CoV-2 [COVID-19])
- Values ≥0.80 U/mL are considered positive.
Clinical Significance
Spike Antibody (SARS-CoV-2 [COVID-19])
This is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‐CoV‐2 spike (S) protein receptor binding domain (RBD) in human serum and plasma. The Elecsys Anti‐SARS‐CoV‐2 S assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‐CoV‐2, indicating recent or prior infection. The Spike antibody also measures the immune response to the Pfizer and Moderna vaccines. This assay has no cross reactivity with antibodies for other coronavirus strains or other respiratory viruses.
Reference
Roche Elecsys anti-SARS-CoV-2 S Package Insert
Treatment Options
Spike Antibody (SARS-CoV-2 [COVID-19])
Symptomatic SARS-CoV-2 (COVID-19) infections usually resolve without treatment, and vaccination is recommended for prevention. Severe cases may require hospitalization and/or medical treatment.
