June 1, 2020
Problems with sensitivity in popular point-of-care test & new authorizations allowing collection of samples at home
On May 20, 2020, FDA held its weekly town hall-style meeting where the in vitro diagnostics (IVD) community was invited to ask clarifying questions about the guidance on IVD testing last updated on May 4, 2020, allowing emergency use authorization (EUA) for qualifying diagnostic tests for SARS-CoV-2.
The key takeaways are listed below:
- Several publications questioning the sensitivity of a popular point-of-care (POC) testing platform, particularly at the low end of the detection range, have spurred another round of IFU (Instructions for use) updates as well as multiple post-market surveillance studies. FDA is working with the developer to change the status of a negative test given by this platform to a "presumed negative" and urged healthcare practitioners to test patients showing symptoms again using a different molecular test for true confirmation of a negative result.
- FDA recognizes that POC devices often lack the high sensitivities found in central lab testing equipment but stated that POC tests still have a place in triaging patients.
- An at-home collection kit, which does not require observation by a healthcare practitioner, has been authorized. Though all authorized SARS-CoV-2 tests are prescription only as of May 20, 2020, FDA is interested in over-the-counter options. FDA urges developers interested in over-the-counter status to mitigate the risks inherent in asking the public to interpret the results, including how to respond to false positives or negatives, in the development and validation of their test kits.
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 or D submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA or pathway D submission.