On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests.  The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.”  The interim guidelines specifically address:

  • Development of Antibodies and Immunity;
  • Current status of antibody testing in the United States;
  • Optimizing Testing Outcomes;
  • Limitations of Serologic Tests; and
  • Recommendations for Use of Serologic Tests.

Commercially marketed antibody tests are required to receive an Emergency Use Authorization from the U.S. Food and Drug Administration.  Antibody tests that have received Emergency Use Authorization may be found here.  The CDC acknowledges that it is unlikely that many individuals in the United States have developed COVID-19 antibodies, stating that “[i]n most of the country, including areas that have been heavily impacted, the prevalence of SARS-CoV-2 antibody is expected to be low, ranging from <5% to 25%, so that testing at this point might result in relatively more false positive results and fewer false-negative results”.  For individuals that test positive for COVID-19 antibodies, the CDC recommends the following:

  • Although the presence of anti-SARS-CoV-2 antibodies when detected using a testing algorithm with high positive predictive value for the context of use likely indicates at least some degree of immunity, until the durability and duration of immunity is established, it cannot be assumed that individuals with truly positive antibody test results are protected from future infection.
  • Asymptomatic persons who test positive by serologic testing and who are without recent history of a COVID-19 compatible illness have a low likelihood of active infection and should follow general recommendations to prevent infection with SARS-CoV-2 and otherwise continue with normal activities, including work.
  • Persons who have had a COVID-19-compatible or confirmed illness should follow previous guidance regarding resumption of normal activities, including work.
  • There should be no change in clinical practice or use of personal protective equipment (PPE) by health care workers and first responders who test positive for SARS-CoV-2 antibody.

There has been an increasing focus on antibody testing as businesses begin to reopen and the death toll of COVID-19 in the United States approaches 100,000.

Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.