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Audit of HHS's Production and Distribution of COVID-19 Lab Test Kits

When a new viral disease emerges, CDC uses its expertise and biosafety laboratories to develop and distribute tests to state public health laboratories. CDC uses confirmed viral samples from initial patients to develop these tests. To ensure that it has a functioning test, CDC conducts quality assurance reviews. After validating that it has a functioning test, CDC sends the tests to state public health labs for their use. During the early phases of identification and spread of the novel coronavirus in the United States in 2020, CDC developed testing kits, called the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), and sent the kits to qualified laboratories to identify COVID-19 cases. We plan to review the controls that HHS has in place to produce and distribute the COVID-19 test kits and whether CDC has designed and implemented controls to mitigate any potential risks. The objective of our audit will be to review CDC's process of producing and distributing the COVID-19 test kits.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
April 2020 Centers for Disease Control and Prevention Audit of HHS's Production and Distribution of COVID-19 Lab Test Kits Office of Audit Services W-00-20-57303 2021