Accuracy Issues Still Plague Developers While FDA Looks to At-Home Testing

Problems With Sensitivity in Popular Point-Of-Care Test and New Authorizations Allowing Collection of Samples at Home

June 1, 2020

On May 20, 2020, the 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. The 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.
  • The 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, the FDA is interested in over-the-counter options. The 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.

More information:

  • The FDA is routinely updating its FAQ page on diagnostic testing for SARS-CoV-2, which can be found here.
  • A full recording of the meeting can be found here.
  • Use the MedWatch system to report any suspected issues with COVID-19 IVD tests, found here.

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 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. 

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:

June 1, 2020 - FDA Publishes List of Developers Who Can No Longer Legally Market Their COVID Test

May 18, 2020 - FDA Focusing on Accuracy for In Vitro Diagnostics for COVID-19

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