CDC Diagnostic Test for COVID-19
CDC developed a laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019 Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)–PCR Diagnostic Panel.” CDC’s test kit is intended for use by laboratories designated by CDC as qualified and, in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests. It is intended for use on upper and lower respiratory specimens with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software.
The U.S. Secretary of Health and Human Services declared the SARS-CoV-2 virus to be a U.S. public health emergency on January 31, 2020. On February 3, 2020, CDC submitted an Emergency Use Authorization
(EUA) package to the U.S. Food and Drug Administration (FDA) to expedite FDA-permitted use of the CDC diagnostic panel in the United States. The EUA process enables FDA to consider and authorize the use of unapproved, but potentially life-saving medical or diagnostic products during a public health emergency. FDA issued the EUA on February 4, 2020. The International Reagent Resource (IRR) began distributing the test kits to states, but shortly thereafter performance issues were identified related to a problem in the manufacturing of one of the reagents, which led to laboratories being unable to verify the test performance. CDC remanufactured the reagents with more robust quality control measures. New tests were distributed to states and are in use.
Since distribution of CDC test kits began, high demand for the extraction reagents needed for testing has resulted in global shortages; some public health laboratories have been unable to obtain testing reagents to support their testing volumes, resulting in testing delays. Therefore, on June 12, 2020, FDA approved an amendment
to the test’s EUA to allow state public health laboratories and others the flexibility to use alternatives
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