Infectious Disease

*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 IgM 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.

• Values ≥1.00 AU/mL are considered positive.

A positive antibody test indicates prior exposure. Serum IgM indicates recent infection, and is typically positive within 3 to 10 days of symptom onset, while serum IgG antibodies (Spike or Neutralizing Antibodies) are often present within 1-2 weeks from symptom onset and can remain positive for several months.

• A positive PCR test for SARS-CoV-2 indicates active infection.
• A negative PCR with a positive IgM indicates recent infection.
• A negative PCR with negative IgM and positive Spike or Neutralizing antibody indicates past infection, or vaccination and presumed immunity.
• This assay has no cross reactivity with antibodies for other coronavirus strains or other respiratory viruses.
• The sensitivity and specificity of our COVID-19 antibody tests are >95%, with CVs of <4%.

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.