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S21: Review of Government-Sponsored Studies and Food and Drug Administration (FDA) Guidance for COVID-19 Diagnostic Testings

Poster Presenter

      Omer Baker

      • Regulatory Science Student Researcher
      • University of Southern California
        United States


To investigate the effectiveness of current federal guidance towards accelerating availability and development of COVID-19 diagnostic testing


The effectiveness of the United States (U.S.) government approach towards SARS-CoV-2 has been conducted in two ways: 1) a general review of Food and Drug Administration (FDA) Emergency Use Authorizations and 2) an examination of FDA guidance for diagnostic testing.


On February 4, 2020, an In-Effect Emergency Use Authorization Guidance (EUA) was issued by the United States Food and Drug Administration (FDA) to accelerate the development of diagnostic testings for SARS-CoV-2. On March 31, 2020, the Coronavirus Treatment Acceleration Program (CTAP) was established and was quickly followed by the launch of the Accelerating COVID-19 Therapeutics Interventions and Vaccines Partnership (ACTIV). As of February 3, 2021, the positivity rate of COVID-19 cases in the U.S. was approximately 7.7% with over 26 million confirmed cases. For the review of FDA authorizations, clinical data from diagnostic tests was measured for accuracy parameters of sensitivity, specificity, and percentage of false results. For the examination of FDA documents for diagnostic testing, FDA guidance before and after COVID-19 were comprehensively reviewed for submission requirements and approval criteria. A list of authorizations and recalls/withdrawals were compiled for COVID-19 developments. As of February 3, 2021 (to be updated), 288 active emergency use authorizations were issued following CTAP: 206 for in vitro diagnostic products and high complexity molecular-based laboratory developed tests, 69 for serology antibody tests, and 13 for antigen tests. Of the previously provided EUAs, 156 tests have now been recalled from the authorization process. The average sensitivity of IgG and IgM antibodies in serology antibody tests (n=7) was greater than 92% when tested 14 to 25 days after symptom onset.


While the extreme circumstances of the COVID-19 epidemic have challenged regulatory systems in the U.S., preliminary study results indicate that current federal guidance has failed to produce reliable diagnostic tools as seen by the inconsistent testing accuracies and high relative percentage of EUA recalls (nearly one-third). Expedited mechanisms have been implemented to approve diagnostic testing, without a reliable system to deliver diagnoses accurately and promptly. The lack of a uniform testing and qualification strategy has been a major setback in terms of holistic pandemic response. Given these fundamental failures, the reliability of subsequent data collection has been called into question. The immediate repercussions include inconclusive data on the presence of COVID-19 variants and how long they have been present in the U.S. Long-term implications are unknown and yet to be determined. As a result, the COVID-19 pandemic has and will continue to escalate.