What is the role of antibody detection tests in the public health response to coronavirus disease 2019 (COVID-19)?

Updated: Apr 02, 2021
  • Author: James J Dunn, PhD, D(ABMM), MT(ASCP); more...
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The overall utility of antibody testing allows for the following:

  • Diagnosis of current infection in symptomatic patients, which can improve overall sensitivity of diagnosis in conjunction with NAAT
  • Monitoring of disease course, definition of time of seroconversion, and correlation of antibody titers with clinical presentation and disease severity
  • Screening or surveillance of asymptomatic patients to help determine population prevalence of COVID-19
  • Identification of convalescent serum donors - Convalescent plasma therapy could offer “passive immunity” and has been approved by the FDA as an emergency investigational new drug or provided with EUA, for early therapy during public health emergencies. Identification of optimal donors has been challenging due to a lack of established correlation between antibody titers and clinical efficacy. The FDA, however, has published guidelines on collection, antibody titer testing, and use of convalescent plasma. [70] Guidance from August 2020 recommends testing a donor’s plasma for anti–SARS-CoV-2 antibodies using an Ortho-Clinical Diagnostics VITROS anti–SARS-CoV-2 IgG assay, in which a signal-to-cutoff ratio of 12 or greater reveals high-titer convalescent plasma. In addition, the FDA recommends testing of neutralizing antibody titers if available. [70]
  • Assessment of vaccine immunogenicity and identification of individuals with protective immune status

There is an urgent need for research providing insight into immunity against SARS-CoV-2. Appropriate, validated, and well-performing serology assays play an essential role in the public health response to the COVID-19 pandemic.

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