Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and manufacturers offering COVID-19 tests and test validation on its FAQs on Testing for SARS-CoV-2 webpage. Updated questions included in the FAQ and brief summaries of the responses are below.

Regarding laboratories and manufacturers offering tests for COVID-19:

• What laboratories are offering diagnostic tests? (Updated 23 June 2020)
  FDA’s response lists those laboratories that have validated their own COVID-19 test and begun patient testing. The response further notes that FDA does not intend to object to CLIA lab use of validated tests for detection of COVID-19 while an emergency use authorization (EUA) request is being prepared, but that FDA intends to remove laboratories from the list that fail to submit an EUA in a timely manner (15 days is indicated as a reasonable timeframe to prepare the submission). Tests that have been issued an EUA can be found on the EUA page.

• What laboratories are offering serology tests? (Updated 25 June 2020)
  FDA’s response lists those laboratories that have validated their own COVID-19 serology test. The agency’s response also notes that, exclusive of at-home testing and at-home specimen collection, the agency does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by CLIA laboratories that are certified to perform high-complexity testing, where the test has been validated, notification provided to FDA, and the noted caveats to the use of test report information are provided.

• What commercial manufacturers are distributing serology kits? (Updated 25 June 2020)
  Similar to other FAQ responses, FDA’s response lists those commercial manufacturers that have validated their own serology test for COVID-19 and notified FDA of their intent to distribute it. The agency’s response further notes that, exclusive of at-home testing and at-home specimen collection, the agency does not intend to object to the development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time while an EUA request is being prepared, provided the test has been validated, notification provided to FDA, and appropriate information included in the test instructions for use. Distinct from the above described FAQ response pertaining to laboratories offering COVID-19 diagnostic tests, here FDA notes that 10 business days (rather than 15) is deemed a reasonable time to prepare the submission. Tests that have been issued an EUA can be found on the EUA page. If an EUA request is not submitted within the required timeframe, or if other problems with the test arise, FDA will remove the manufacturer and test from the notification list and expects the manufacturer to suspend distribution of the test.

• What commercial manufacturers of serological tests have been removed from FDA’s notification list? (Updated 24 June 2020)
  As referenced in the FAQ response above, commercial manufacturers that notify FDA of an intent to distribute their own validated serology test for COVID-19 but fail to submit an EUA request to FDA in a timely manner (10 business days), or whose test experiences other problems, are removed from FDA’s notification list and are expected to cease distribution of the test until an EUA is issued. As of this writing, 50 manufacturers had been removed from the FDA notification list, of which 13 were voluntarily withdrawn by the manufacturer.

Regarding test validation:

• What are the current validation study recommendations for a new COVID-19 assay? (Updated 24 June 2020)
  FDA’s response references Section V of the Policy for Coronavirus Disease-2019 Tests where recommendations for testing to validate the underlying technological principles of the SARS-CoV-2 test can be found. Additionally, the FAQ response includes links to current EUA templates, which incorporate FDAs current thinking on data and information developers should submit in the EUA process. Currently, because the pandemic progression has increased access to positive disease samples, the agency recommends that tests be validated with positive clinical samples and test performance confirmed with a minimum of 30 positive and negative specimens, each. Test developers may take alternative approaches to those suggested by the agency but FDA recommends discussing them with FDA by sending a message to CDRH-EUA-templates@FDA.HHS.GOV.

• Does a high-complexity CLIA-certified laboratory developing a COVID-19 assay that is a modification of a previously EUA authorized COVID-19 assay need to start its validation from scratch or can it validate with a bridging study? (Updated 24 June 2020)
  FDA’s response explains that this depends upon the type of modification under consideration. A modification to a new specimen type must have been validated and authorized for another test of the same technology. All other modifications may be validated with a bridging study. The agency notes that, among other ways, a bridge to a new test component may be established through parallel testing of the same specimens with the new and original components. FDA also requests the opportunity to review the validation data through an email to CDRH-EUA-templates@FDA.HHS.GOV to determine if the bridge validation data could be applicable to modifications of other tests or to other laboratories modifying the same authorized tests. If so, and if the laboratory agrees, FDA intends to share the validation information on its website. This data sharing is not considered to be a notification, a pre-EUA submission or EUA request by FDA.

[View source.]