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Summary

As the Coronavirus Disease 2019 (COVID-19), caused by the novel SARS-CoV-2 virus, rapidly spreads through the US, media and public scrutiny over the current diagnostic testing landscape has increased, given that the US lags behind other countries in the number of tests performed and turnaround time for results reported.

Diagnostic Oversight Updates in Response to COVID-19

FDA’s policy around ensuring safe and effective COVID-19 diagnostics has been evolving over the past  several weeks. Initially, CDC developed a COVID-19 diagnostic test that was granted an Emergency Use Authorization (EUA) by the FDA. On February 29, the FDA issued guidance that allowed certain Clinical Laboratory Improvement Amendments (CLIA) certified laboratories to use validated tests prior to submission of EUA.  Later, the FDA granted the NY State Department of Health the authority to oversee testing approval. On March 16, FDA updated its oversight policy to allow all states to authorize protocols for the approval of COVID-19 testing kits and for commercial manufacturers to distribute validated diagnostic kits prior to EUA submission.  This new policy is intended to allow for the rapid deployment of tests and accommodate the needs of the public. Deferring development and approval oversight to more regionally localized offices is hoped to speed access to patients.

Shifting aspects of COVID-19 diagnostics oversight to the states could reduce turnaround time for test results, which currently takes several days in most cases, if proper procedures are able to be put in place including chains of communication, adequate personnel, and proper equipment. However, concerns exist that lack of federal oversight may present a variety of unexpected challenges and responsibilities at the state level.

COVID-19 Diagnostic Testing via State Regulation

States will have full control over laboratory operations related to COVID-19 diagnostic tests within their state in response to the “Memorandum on Expanding State-Approved Diagnostic Tests” issued by the White House. Additionally, the FDA will not require test validation documentation nor the submission of EUA for these diagnostic kits if the state or territory takes responsibility for COVID-19 testing by laboratories within its jurisdiction. The FDA requests the state or territory notify the FDA if they decide to use this flexibility to expedite COVID-19 testing.

COVID-19 Diagnostic Testing via FDA’s Emergency Authorization

Laboratories that have already been certified under CLIA are now able to perform tests to detect the SARS-CoV-2 virus, and kit manufacturers can distribute test kits prior to submission of an EUA request. The FDA expects that laboratories and manufacturers will complete an EUA submission within 15 business days of notifying the FDA of assay validation.

Necessary Precautions to Ensure Valid Diagnostics

With the rapid developments surrounding COVID-19, the FDA urges state authorities and commercial developers to take all necessary precautions to ensure tests are properly validated in order to avoid and minimize any faulty testing results. Laboratories should immediately notify appropriate federal, state, and local public health agencies of all positive results.

As the development of diagnostics continues to increase across the country, the FDA requests the following actions take place to ensure validation of all tests and support agency decision making:

  • The FDA recommends manufacturers post instructions for use and assay performance summaries on their website in a publicly available format.
  • Laboratories and manufacturers should notify the FDA via email once diagnostic assays have been validated and informally share validation data (CDRH-EUA-Templates@FDA.HHS.GOV).
  • While awaiting EUA designation, the FDA recommends that clinical laboratories obtain confirmation of the first five positive and the first five negative clinical specimens using an EUA-authorized assay. This includes sending these ten specimens to a second laboratory for confirmation.
  • The FDA requests that all labs conducting diagnostic testing report their diagnostic capacity to the agency.

Due to the challenges of ramping up production and distribution of testing in response to the COVID-19 outbreak, the FDA policy expansion indicates the agency is aware of the risks associated with the lack of testing and is poised to continue working to enact polices aimed at improving testing availability. As COVID-19 continues to spread across the country, testing rates and results will drive our understanding of and response to the scale of the problem we are facing.

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