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The Reliability & Utility of Serological Antibody Tests in COVID-19

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Overall Usefulness for Clinicians

With more information gleaned from vaccine development, it may make sense to run these antibody tests as immune markers. But at the present time, these serological antibody tests, even the high-quality ones, offer little utility to clinicians. Clinicians may do well to remember the familiar adage not to test unless the results might impact medical management.

Neither Dr. Kadkhoda nor Dr. Calabrese are choosing to recommend serological antibody assays as a part of routine testing. “I don’t want to offer the test and have the healthcare provider ask me, ‘What does this result mean?’ I wouldn’t have anything helpful to tell them,” says Dr. Kadkhoda.

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If clinicians do choose to offer such antibody tests to patients, they should evaluate the regulatory status and performance characteristics of specific antibody tests used, choosing tests that have demonstrated high specificity. Clinicians must also keep in mind factors influencing the positive predictive value of the test, such as disease prevalence. Results can also be improved by focusing on people with a higher pre-test probability of having antibodies, such as people who’ve recently experienced symptoms consistent with COVID-19. Alternatively, clinicians may choose to confirm a positive result with a second test that uses different design characteristics.3

But Dr. Calabrese emphasizes that neither clinicians nor patients should overinterpret results of positive SARS-CoV-2 antibodies. “At the present time, at least until we learn more, positive serology should not cause anyone to ease up on infection prevention measures.”

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Ruth Jessen Hickman, MD, is a graduate of the Indiana University School of Medicine. She is a freelance medical and science writer living in Bloomington, Ind.

References

  1. Jacofsky D, Jacofsky EM, Jacofsky M. Understanding antibody testing for COVID-19. J Arthroplasty. 2020 Apr 27;S0883-5403(20)30442-3.
  2. Iwasaki A, Yang Y. The potential danger of suboptimal antibody responses in COVID-19. Nat Rev Immunol. 2020;20(6):339–341.
  3. Coronavirus disease 2019 (COVID-19). Interim guidelines for COVID-19 antibody testing. Centers for Disease Control and Prevention. 2020 May 23 (reviewed).
  4. Chandrashekar A, Liu J, Martinot AJ, et al. SARS-CoV-2 infection protects against rechallenge in rhesus macaques. Science. 2020 May 20;eabc4776. (Online ahead of print)
  5. IDSA COVID-19 antibody testing primer. Infectious Diseases Society of America. 2020 May 4.
  6. Abbasi J. The promise and peril of antibody testing for COVID-19. JAMA. 2020 Apr 17. doi: 10.1001/jama.2020.6170. (Online ahead of print)
  7. Kadkhoda K. COVID-19 serologic testing: FAQs and caveats. Cleve Clin J Med. 2020 Jun;87(6):329–333.
  8. Amanat F, Stadlbauer D, Strohmeier S, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 May 12. doi: 10.1038/s41591-020-0913-5. (Online ahead of print)
  9. Policy for coronavirus disease-2019 tests during the public health emergency (revised). U.S. Food & Drug Administration. 2020 May 11.
  10. Coronavirus (COVID-19) update: FDA alerts consumers about unauthorized fraudulent COVID-19 test kits. U.S. Food & Drug Administration. 2020 Mar 20.
  11. Shah A, Shuren J. Insight into FDA’s revised policy on antibody tests: Prioritizing access and accuracy. U.S. Food & Drug Administration. 2020 May 4.
  12. Coronavirus (COVID-19) update: Daily roundup. U.S. Food & Drug Administration. 2020 May 21.
  13. Emergency use authorizations. In vitro diagnostic EUAs. U.S. Food & Drug Administration. 2020 Aug 20.
  14. EUA authorized serology test performance. U.S. Food & Drug Administration. 2020 Jun 4.
  15. Independent evaluations of COVID-19 serological tests. U.S. Food & Drug Administration. (no date).
  16. ‘Immunity passports’ in the context of COVID-19. World Health Organization. 2020 Apr 24.
  17. Shen C, Wang Z, Zhao F, et al. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. JAMA. 2020 Mar 27;323(16):1582–1589. (Online ahead of print)
  18. Li L, Zhang W, Hu Y, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial. JAMA. 2020 Jun 3. doi: 10.1001/jama.2020.10044. (Online ahead of print)

About Ruth Jessen Hickman, MD

Ruth Jessen Hickman, MD, was born and raised in eastern Kentucky, where she first cultivated her love of literature, writing and personal narratives. She attended Kenyon college, where she received a Bachelor of Arts in philosophy, summa cum laude. She worked with individuals with psychiatric conditions and later in a neuroscience lab at the University of Illinois, Chicago, before graduating from Indiana University Medical School in 2011. Instead of pursuing clinical medicine, Ruth opted to build on her strength of clearly explaining medical topics though a career as a freelance medical writer, writing both for lay people and for health professionals. She writes across the biomedical sciences, but holds strong interests in rheumatology, neurology, autoimmune diseases, genetics, and the intersection of broader social, cultural and emotional contexts with biomedical topics. Ruth now lives in Bloomington, Ind., with her husband, son and cat. She can be contacted via her website at ruthjessenhickman.com.

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