Home Test Search Results COVID-19 Antibody, Spike (IgG) – Qualitative
COVID-19 Antibody, Spike (IgG) – Qualitative

Justification

This test detects IgG antibodies against the SARS-CoV-2 spike antigen and can be used to infer past infection or vaccination status (certain immunosuppressed individuals may fail to generate a robust antibody response). This test cannot distinguish between past infection versus vaccination. The CDC suggests antibody testing when multisystem inflammatory syndrome in children (MIS-C) is suspected and recommends testing to occur prior to IVIG or other exogenous antibody treatment.

STAT: < 24 hours (M-F)

ELISA

Draw Tube: Red Top

Sample Type: Serum

DRAW KITS AVAILABLE

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.
Yong, S. E. F. et al. Connecting clusters of COVID-19: an epidemiological and serological investigation. Lancet (2020). Available from: https://doi.org/10.1016/S1473-3099(20)30273-5.
U.S. Food and Drug Administration. Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers. FDA Website (17APR2020). Available from: https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serologicalantibody-tests-covid-19-letter-health-care-providers (accessed: 28APR2020).
Lippi, G. et al. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed (2020); Vol. 91, N. 2: 000-000. Available from: https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/9548/8756.
World Health Organization. Advice on the use of point-of-care immunodiagnostic tests for COVID-19, Scientific Brief. WHO Website (08APR2020). Available from: https://www.who.int/newsroom/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid19#.Xo_1jdsCuUE.twitter. (accessed 28APR2020).
U.S. Food and Drug Administration. Donate COVID-19 Plasma. FDA Website (22APR2020). Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid19/donate-covid-19-plasma#donate (accessed: 28APR2020).
Sethuraman, N. et al. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA (2020). Available from: https://doi:10.1001/jama.2020.8259.
Dan JM, Mateus J, Kato Y, Hastie KM, Faliti CE, Ramirez SI, et al. Immunological memory to SARS-CoV-2 assessed for greater than six months after infection. bioRxiv. 2020(10.1101/2020.11.15.383323).
Rijkers G, Murk JL, Wintermans B, van Looy B, van den Berge M, Veenemans J, et al. Differences in antibody kinetics and functionality between severe and mild severe acute respiratory syndrome coronavirus 2 infections. J Infect Dis. 2020 Sep 14;222(8):1265-9.
To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-74.
Sahin, U., Muik, A., Derhovanessian, E. et al. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature 586, 594–599 (2020). https://doi.org/10.1038/s41586-020-2814-7
U.S. Centers for Disease Control and Prevention. Information for Healthcare Providers about Multisystem Inflammatory Syndrome in Children (MIS-C). CDC Website (23MAR2021). Available from: https://www.cdc.gov/mis-c/hcp/ (accessed 23MAR2021)

SAMPLE REPORT Upon request
NEW YORK STATE APPROVED -

Test Codes

ORDER CODE P3407
CPT CODE 86769
LOINC CODE 94505-5, 94563-4