Review of the shortcomings of CDC’s first COVID-19 test and recommendations for the policies, practices, and systems to mitigate future issues : CDC Advisory Committee to the Director (ACD) Laboratory Workgroup (LW)
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Review of the shortcomings of CDC’s first COVID-19 test and recommendations for the policies, practices, and systems to mitigate future issues : CDC Advisory Committee to the Director (ACD) Laboratory Workgroup (LW)

Filetype[PDF-449.60 KB]


  • English

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    • Description:
      ADOPTED BY ACD VOTE ON FEBURARY 7, 2023

      In January 2020, the Centers for Disease Control and Prevention (CDC) worked swiftly to develop and distribute a laboratory diagnostic test for the novel coronavirus then spreading around the globe. Unfortunately, the CDC failed at this task. The test as initially sent to state and local public health laboratories could not be used.

      For several critical weeks, CDC was the only laboratory in the nation able to perform COVID19 testing. Lacking awareness of how rapidly and widely the virus was spreading, public health agencies were slow to recommend behavior changes or implement protective measures. While peer nations dramatically increased their testing capacity, the US remained well below the testing capacity needed to understand the situation and begin to identify infected individuals to slow disease spread.

      The failure of the CDC’s diagnostic test for the virus, later named SARS-CoV-2, was far from the only significant misstep in the federal government’s overall response. But it was one of the first and most consequential.

      Publication date from document properties.

      EnhancingCDCLaboratoryPoliciesPracticesSystems.pdf

    • Content Notes:
      I. Introduction -- II. Methods -- III. What Contributed to the Shortcomings of the First COVID-19 Tests (A. Inadequate Planning; B. Ineffective Governance; C. Inadequate Quality Control, Quality Assurance and Regulatory Oversight; D. Poor Processes for Test Design) -- IV. What Policies, Practices, and Systems Should Be Established to Address These Issues? (A. Leadership and Management; B. Quality; C. Test Development; D. Electronic Laboratory Reporting) -- V. Responding to Questions -- VI. List of Workgroup Members.
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