Test Directory

This assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Specimen Type: Serum

Alternate Specimen Type: Plasma

Collection Container: Gold Top, Serum Separator

Alternate Collection Container: Red Top (Plain), Green Top (Lithium Heparin), or Lavender Top (EDTA)

Desired Specimen Volume: 0.5 mL

**FOR STEM CELL TRANSPLANT ORDERS ONLY**

1. Collect a gold top, serum separator tube via venipuncture

1. Separate serum from cells.
2. Transfer 0.5 mL of serum to a clear aliquot tube (screw cap).

Samples should only be tested from individuals that are 15 days or more post symptom onset.

Transport to the laboratory refrigerated. 

• Grossly hemolyzed
• Lipemic
• Samples containing particulate matter or exhibiting obvious microbial contamination

See patient report.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b) of the Act, 21 U.S.C. 360bbb-3(b), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.

• SARS-CoV-2 Semi-Quantitative IgG Antibody, Spike
• COVID-19
• S protein
• Severe Acute Respiratory Syndrome (SARS)
• Spike