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, and Recommends Dual Positive Testing Method

May 18, 2020

On May 6, 2020, the 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:

  • The 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 the FDA will waive the prescription requirement for testing or defer to the states for guidance. The FDA maintains that a health care provider must be part of the diagnosis of this disease.

  • The 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, the 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.

  • The FDA has reiterated that they are legally allowed to deem tests as appropriate for CLIA high complexity, moderate complexity, or waived but that CMS provides the actual certification for the complexity level. CLIA waived tests are typically used in point-of-care testing scenarios.

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How Exponent Can Help

Exponent’s multi-disciplinary 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. 

The FDA held town hall-style meetings for the in vitro diagnostics community can ask questions to clarify the FDA's recently issued guidance for developing diagnostic tests for SAR-CoV-2. To read more on the key takeaways from each meeting and how Exponent can help, please see the links below:

May 5, 2020 - FDA Holds Third Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 30, 2020 - FDA Discusses First Authorized Home Collection Kit

April 17, 2020 - FDA Holds Second Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Holds Town Meetings to Clarify Recent COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Releases Updated Guidance on Diagnostics Testing as Response to COVID-19 Crisis