There are numerous tests to help detect the virus that causes COVID-19 (SARS-CoV-2) or antibodies to the virus. Only a few are highly accurate.
Why Antibody Tests?*
Highly accurate antibody tests are critical to help inform clinical and public health decisions as we look towards safely opening our communities.
Clinical Use Summarized
- Determine immune response to the virus, indicating some potential level of immunity1,2
- Some tests detect antibodies that may be associated with neutralizing the virus1,2
- When swab sample collection is compromised, thus affecting PCR test results (antigen or PCR testing should be performed as soon as possible afterwards)
- Testing as an adjunct to PCR tests to aid in clinical assessment, including when viral load is low 3,4
- Potentially verifying effectiveness of vaccines when they become available1,2
Antibody Tests Complement PCR Tests By:
- Supporting the clinical assessment of COVID-19 illness as an adjunct to PCR in patients that test negative while presenting with COVID-19 signs and symptoms3
- Providing an alternative when swab sample collection is compromised, which may affect PCR test results (antigen or PCR testing should be performed as soon as possible afterwards)
- Supporting the assessment of recent or prior infection as an adjunct to PCR testing, including, for example patients in clinical settings (e.g. Pre-op, ED, acute hospitalized)4
Antibody Tests Help Improve Public Health and Safety By:
- Informing infection prevalence and the COVID-19 related death rate
- Allowing testing following outbreaks in high density work settings (i.e. food processing industry) and communal living (college dorms)—where prevalence may be higher†
- Enabling testing of healthcare and elder care workers and first responders–serving high-risk populations†
- Testing workforce to return and stay safe in the workplace—when social distancing is a challenge† (e.g. manufacturing, correctional facilities, military, transportation, childcare, teachers)
†Combined with PCR testing for active infection.
Quality and Accuracy are Paramount
A good antibody test is one that has a high degree of sensitivity and specificity.
- Test sensitivity indicates the ability of the test to correctly identify patients that have the disease (true positives).
- Test specificity indicates the ability of the test to correctly identify patients that do not have the disease (true negatives).
The CDC guidelines indicate a specificity of >99.5% for antibody tests is desirable.4
What tests should you be given and how should you interpret the results?
How business leaders can help bring people back to work
Leaders can use this knowledge to help build programs that more safely and efficiently reopen communities, businesses and schools. As a leader of one of the world’s largest laboratory diagnostics businesses Deepak Nath, PhD, President of Siemens Healthineers Laboratory Diagnostics has proposed a framework for such a plan.
*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. 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. Product availability may vary from country to country and is subject to varying regulatory requirements.
**Depending on healthcare provider
1. Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. Posted 2020 May 1. https://doi.org/10.1101/2020.03.13.990226
2. Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Pinto, D. et al. Nature https://doi.org/10.1038/s41586-020-2349-y (2020).
3. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf Accessed June 21, 2020
4. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html Accessed June 21, 2020
5. https://www.ama-assn.org/delivering-care/public-health/serological-testing-sars-cov-2-antibodies. Accessed June 21, 2020.