On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: (1) testing for people who do not have COVID-19 symptoms or who have no reason to suspect infection and (2) testing pooled samples containing up to 5 individual specimens, with a matrix approach using multiple pools to reduce the need for retesting of positive pools.

Organizations may want to conduct broad screening of asymptomatic people as part of a strategy to help ensure the safety of their employees, patients, students, etc. LabCorp’s test was shown to be as accurate in the broader asymptomatic population as it is for people suspected of having COVID-19 based on a clinical concordance validation study 133 samples (20 positive and 113 negative) including a combination of self-reported asymptomatic patient samples and employee screening samples. Additionally, sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker. LabCorp’s test is authorized for specimen collection either at home or by a health care provider, but only health care provider-collected samples may be pooled.

FDA previously updated its FAQs on Testing for SARS-CoV-2 with templates and recommendations for developers on how to validate a diagnostic test for screening asymptomatic individuals. Finally, FDA is providing regulatory flexibility for developers that offer validated diagnostic tests, including screening of asymptomatic individuals, while developers pursue an EUA.

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