Qualitative detection of high affinity antibodies to SARS-CoV-2 nucleocapsid (N) protein, the virus that causes COVID-19, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2 N protein. While this assay in principle can detect high affinity antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies since these are more likely to evolve to become high affinity. Serologic results should not be used as the sole basis to diagnosis or exclude recent SARS-CoV-2 infection. This test is recommended for individuals at greater than or equal to 14 days post-symptom onset or following exposure to individuals with confirmed COVID-19.The incubation period for COVID-19 ranges from 5 to 7 days.

This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines.

Serum separator (Gold SST) tube

Immediately following collection, mix sample by gently inverting 5 times

Allow sample to clot for a minimum of 30 minutes

Spin within two (2) hours of sample collection

Red serum vial/tube - 5 mL

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

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

Ambient (preferred) - 14 days

Refrigerated - 14 days

Frozen - 14 days

Freeze/thaw cycles: stable x3

Electrochemiluminescence immunoassay (ECLIA)

Negative