FDA Focusing on Accuracy for In Vitro Diagnostics for COVID-19

FDA announces performance metrics for diagnostic test authorizations, releases performance data for authorized tests & recommends dual positive testing method

On May 6, 2020, FDA held its seventh town hall-style meeting with the in vitro diagnostics (IVD) community. This was significant because on May 4, 2020, the FDA updated the Emergency Use Authorization (EUA) guidance that governs the actions of IVD manufacturers developing COVID-19 tests.

The key takeaways from the town hall meeting on May 6, 2020, are listed below:

• FDA has updated the EUA guidance currently in effect. Manufacturers will be expected to meet the performance metrics outlined in the recently released templates. Broadly, this is a sensitivity of 90% and a specificity of 95%.
• These tests are still not to be used as the sole method of diagnosing COVID-19. As states begin to reopen, the diagnostics community is wondering whether FDA will waive the prescription requirement for testing or defer to the states for guidance. FDA maintains that a health care provider must be part of the diagnosis of this disease.
• FDA has published performance data for serological tests that have gone through the government's testing program, including sensitivity, specificity, and the 95% confidence intervals for that test's performance. Due to the accuracy of the tests available at this time, FDA is recommending that high-accuracy tests are used to gather dual positive results, meaning testing the patient a second time if the result is positive. Ideally, tests that target different antigens would be used and then both results can inform the diagnosis. Dual positive-result testing will greatly increase the positive predictive value, or the likelihood that the positive result obtained is a true positive, when the prevalence of a disease is low.
• FDA has reiterated that they are legally allowed to deem tests as appropriate for Clinical Laboratory Improvement Amendments (CLIA) high complexity, moderate complexity, or waived but that Centers for Medicare and Medicaid Services (CMS) provides the actual certification for the complexity level. CLIA waived tests are typically used in point-of-care testing scenarios.

How Exponent Can Help

Exponent's multidisciplinary team of biotechnology, medical device, and pharmaceutical industry professionals develop safety information for products and processes that comply with all pertinent standards, regulations, and best practices. With expertise in risk communication and FDA assessments, Exponent can assist in FDA label preparation and pathway B, pathway D, or Umbrella Pathway submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA, Umbrella Pathway, or pathway D submission.