|
COVID-19 Antibody Testing
Blood samples are drawn from the patient and shipped to our CLIA certified, CAP accredited, High Complexity lab in Richmond, Virginia.
|
What Are Antibodies?Antibodies, also known as immunoglobulins, are proteins that are produced by the immune system to help stop intruders (like viruses) from causing bodily harm. If you have been Infected by the SARS-CoV-2 virus, you will begin to develop antibodies 7-14 days after contracting the virus. SARS-CoV-2 IgG/IgM antibodies can be detected in your blood.
Why Are Antibody Tests Important?
Antibody tests may assist in understanding a patients previous COVID-19 infection status. Emerging evidence indicates that patients who have contracted the virus may develop immunity for a period of time. Tracking people who showed minor or no symptoms will provide additional data as to how far the virus has spread. |
Monitoring Active & Previous Infections
A Systematic Approach to Antibody Testing for COVID-19
|
Stage Zero's COVID-19 Antibody Testing Program tests for both IgM and IgG antibodies. IgM antibodies indicates recent infection, while IgG antibodies gradually appear and increase in the later stage of infection.
An Initial test is run to help detect both SARS-CoV-2 IgM and SARS-CoV-2 Antibodies.
Based on recommendations from the FDA(1), StageZero Life Sciences offers a two test approach for detecting SARS-CoV-2 IgG antibodies.
Why This Approach? This approach is based on evidence that a single test cannot accurately predict the presence of antibodies to SARS-CoV-2 in a population with a 5% point prevalence of the virus. When a positive test is reflexed to a confirmatory test, we can validate the presence of antibodies with a Positive Predictive Value of 99%. Positive predictive value (PPV) is the probability that subjects with a positive screening test truly have the antibodies. 1. FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID19) Diagnostic Tests. Moderator: Irene Aihie April 22, 2020 1:15 pm ET |
|
About the Tests
The Rapid Response™ COVID-19 IgG/IgM Test
StageZero Life Sciences offers The COVID-19 IgG/IgM Antibody Test, an in-vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum, plasma or venipuncture whole blood to aid in the diagnosis of COVID-19 in conjunction with clinical presentation and results of other laboratory tests. Detection of IgM antibodies indicates recent infection, while IgG antibodies gradually appear and increase in the late stage of infection. It is not known how long these antibodies persist in the blood after infection. This test is for professional in-vitro diagnostic use only.
The Access SARS-CoV-2 IgG Antibody Test
The Access SARS-CoV-2 IgG Antibody Test features market-leading sensitivity and specificity.
Sensitivity and specificity matter because tests without extremely high accuracy could lead to large numbers of incorrect results, potentially resulting in dangerous consequences.
The Access SARS-CoV-2 IgG Antibody Test features market-leading sensitivity and specificity.
Sensitivity and specificity matter because tests without extremely high accuracy could lead to large numbers of incorrect results, potentially resulting in dangerous consequences.
- The Access SARS-CoV-2 IgG assay is being validated against over 1,000 negative broad population-based samples—significantly more than the number of samples required by the FDA for Emergency Use Authorization
- 100% sensitivity and 99.8% specificity—one of the highest dual rates for SARS-CoV-2 antibody tests in the market
The Access SARS-CoV-2 IgG Antibody Test
This test has been authorized by FDA under an EUA for use by authorized laboratories; · This test has been authorized only for the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and This test has not been FDA cleared or approved; and 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)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This test has been authorized by FDA under an EUA for use by authorized laboratories; · This test has been authorized only for the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and This test has not been FDA cleared or approved; and 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)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
COV-13C25 Rapid Response™ COVID-19 IgG/IgM Test /The Access SARS-CoV-2 IgG Antibody Test
Disclaimer: Available in U.S. to healthcare professionals under FDA's emergency guidance policy. This test has not been reviewed by the FDA.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.
References for The Rapid Response™ COVID-19 IgG/IgM Test
1. Masters, P. S. & Perlman, S. in Fields Virology Vol. 2 (eds Knipe, D. M. & Howley, P. M.) 825–858 (Lippincott Williams & Wilkins, 2013).
2. Su, S. et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol. 24, 490–502 (2016).
3. Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus genomes. Trends Microbiol. 25, 35–48 (2017).
4. Kan, B. et al. Molecular evolution analysis and geographic investigation of severe acute respiratory syndrome coronavirus-like virus in palm civets at an animal market and on farms. J. Virol. 79, 11892–11900 (2005).
5. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat, South Africa. Emerg. Infect. Dis. 19, 1697–1699 (2013).
6. “Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)” https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html.
7. “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”. Issued March 16, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policydiagnostic-tests-coronavirus-disease-2019-during-public-health-emergenc
References for The Rapid Response™ COVID-19 IgG/IgM Test
1. Masters, P. S. & Perlman, S. in Fields Virology Vol. 2 (eds Knipe, D. M. & Howley, P. M.) 825–858 (Lippincott Williams & Wilkins, 2013).
2. Su, S. et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol. 24, 490–502 (2016).
3. Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus genomes. Trends Microbiol. 25, 35–48 (2017).
4. Kan, B. et al. Molecular evolution analysis and geographic investigation of severe acute respiratory syndrome coronavirus-like virus in palm civets at an animal market and on farms. J. Virol. 79, 11892–11900 (2005).
5. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat, South Africa. Emerg. Infect. Dis. 19, 1697–1699 (2013).
6. “Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)” https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html.
7. “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”. Issued March 16, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policydiagnostic-tests-coronavirus-disease-2019-during-public-health-emergenc
