Qualitative detection of IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, to help identify individuals who have been exposed to the virus. Serologic results should not be used as the sole basis to diagnose or exclude recent SARS-CoV-2 infection. This test is recommended in individuals at least 10 days post symptom onset or following exposure to individuals with confirmed COVID-19.

Gold serum separator (SST) tube

Immediately following collection, mix sample by gently inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection

Gold serum separator (SST) tube

Red serum vial/tube, 5 mL

Lavender (EDTA), 4mL

Dk green Lithium heparin (Li hep), no gel

Lt green plasma separator (PST)

Immediately follow collection, mix sample by inverting 8 - 10 times to prevent clotting

Red:

1. Allow specimen to clot
2. Spin within two (2) hours of sample collection
3. Transfer serum to a Transfer vial/tube with cap - 12mL (LabCorp), labelled as serum

Lavender (EDTA):

1. Spin within two (2) hours of sample collection
2. Transfer plasma to a Transfer vial/tube with cap - 12mL (LabCorp), labelled as EDTA plasma 

Dk green Lithium heparin (Li hep), no gel:

1. Spin within two (2) hours of sample collection
2. Transfer plasma to a Transfer vial/tube with cap - 12mL (LabCorp), labelled as Li heparin plasma 

Lt green plasma separator (PST):

1. Spin within two (2) hours of sample collection

Transfer vial/tube with cap - 12mL (LabCorp)

Lt green plasma separator (PST)

Ambient (preferred) – 14 days

Refrigerated – 14 days

Frozen – 14 days

Freeze/thaw cycles - Stable x3

• Gross hemolysis
• Gross lipemia
• Visible microbial contamination

Chemiluminescent Immunoassay (CLIA)

Negative (<13.0 AU/mL)

• 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.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

The incubation period for COVID-19 ranges from 5 to 7 days. Current literature suggests that detectable IgG-class antibodies against SARS-CoV-2 develop approximately 8 to 11 days following onset of symptoms. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. A positive serological result is not diagnostic but indicates that an individual has likely been infected with SARS-CoV-2 and produced an immune response to the virus. It is not known at this time whether detectable antibody correlates with immunity. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, this could be due to testing too early in the course of infection, the absence of exposure to the virus, or the lack of adequate immune response, which can be due to conditions or treatments that suppress immune function.