Test Directory
Justification
STAT: < 24 hours (M-F)
ELISA
Draw Tube: Red Top
Sample Type: Serum
Specimen Requirements
Sample Type | Volume Required | Minimum Volume | Stability | |
---|---|---|---|---|
PREFERRED | Serum | 1mL | 0.5mL | Room Temp.: 4 days
Refrigerated: 4 days Frozen (-20C): 1 month Frozen (-80C): 6 months |
ALTERNATIVE | - | - | - | - |
REJECTION CRITERIA | Sample contamination; sample compromised |
SPECIAL INSTRUCTIONS | - |
General Information
METHODOLOGY | ELISA |
STAT TAT | < 24 hours (M-F) |
STAT TAT Performance | > 90% of results released in 24 hours |
ROUTINE TAT | < 1 week |
ALTERNATIVE NAMES | COVID-19 Serology, Coronavirus Antibody, SARS-CoV-2 Antibody |
DESCRIPTION | This is a qualitative ELISA-based test for COVID-19-associated antibodies. This test detects IgG antibodies against the SARS-CoV-2 spike antigen and can be used to infer past infection or vaccination. This test cannot distinguish between past infection versus vaccination. Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19 (SARS-CoV-2) infection or to inform infection status. Higher antibody levels and longer persistence were correlated to individuals with more severe disease while seroreversion was seen in some individuals with mild disease. While reinfection is possible, studies show individuals with anti-SARS-CoV-2 antibodies are less likely to become infected. Individuals who have received a vaccine derived from the spike gene should have a detectable antibody response against the spike antigen. Clinical trial data has shown that fully vaccinated individuals typically have higher antibody levels than those seen after natural infection. The current vaccines from Pfizer-BioNtech, Moderna, Oxford-AstraZeneca, Johnson & Johnson, and Novavax are all based on the spike protein. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA) and is only authorized for the duration of the emergency for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b) (1). |
LIMITATIONS | This test cannot distinguish between past infection versus vaccination. |
NORMAL RANGE | Negative |
ASSOCIATED TESTING | - |
REFERENCES | Wolfel, R., Corman, V.M., Guggemos, W. et al. Virological assessment of hospitalized patients with COVID-2019. Nature (2020). Available from: https://doi.org/10.1038/s41586-020-2196-x. |
SAMPLE REPORT | Upon request |
NEW YORK STATE APPROVED | - |
Test Codes
ORDER CODE | P3407 |
CPT CODE | 86769 |
LOINC CODE | 94505-5, 94563-4 |