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CDC Diagnostic Tests for COVID-19

The CDC has developed two laboratory tests that identify SARS-CoV-2, the virus that causes COVID-19. The first COVID-19 diagnostic test distributed by the CDC, released in February 2020, is the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, a test that accurately detects SARS. -CoV-2 in the respiratory tract. specimens The CDC launched a second assay in July 2020, the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which allows public health laboratories to perform three tests on a single reaction well.

The Flu SC2 Multiplex is more efficient in the use of test reagents, enables higher throughput, and at the same time provides accurate results on the presence of SARS-CoV-2, influenza A, and influenza B nucleic acid in a sample of patients. Symptoms of COVID-19 and the flu can be similar, so testing for all three viruses at the same time will provide public health officials with the information they need to help reduce the spread of these viruses in the community while they conserve resources that are scarce.

CDC 2019-nCoV RT-PCR Diagnostic Panel

On February 3, 2020, the CDC introduced a US package to accelerate the FDA-permitted use of CDC’s 2019-nCoV real-time RT-PCR diagnostic panel in the United States. The FDA issued the EUA the next day, and the CDC shipped the test kits to state and local public health laboratories.

CDC developed and distributed the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel to fill a gap at a time when there were no other FDA-approved or authorized COVID-19 diagnostics. Since the first CDC test was developed, many commercially available options for testing for SARS-CoV-2 have been licensed.

While the CDC 2019 nCoV Real-Time RT-PCR Diagnostic Panel filled a significant unmet need when it was developed and deployed in early 2020, demand for this test has declined due to the authorization of higher-throughput alternatives. and multiplexed assays that detect both SARS-CoV-2 and other common respiratory pathogens simultaneously. For this reason, CDC will discontinue the 2019 nCoV Real-time RT-PCR Diagnostic Panel after December 31, 2021.

As the test continues to perform very well, CDC will continue to make the design of the primers and probes used in the CDC 2019-nCoV Real-time RT-PCR Diagnostic Panel available on the CDC website. for others to use in their own research activities. or development of diagnostic tests. CDC will also continue to offer a general CDC EUA reference right for the diagnostic panel (EUA200001) to anyone who wishes to reference CDC data in their own FDA regulatory submission.

The CDC’s decision to discontinue the Diagnostic Panel and the subsequent withdrawal of the EUA for the Diagnostic Panel will have no impact on those tests that have referenced CDC’s USA data in their US submission or those that they plan to do so in the future. The data and submission will remain on file with the FDA and will be available for reference.

CDC is encouraging public health laboratories (PHLs) to adopt the multiplexed CDC Influenza SARS-CoV-2 (Flu SC2) assay to enable efficient surveillance of both influenza and SARS-CoV- 2, which will save time and resources for PHLs. Clinical laboratories that have been conducting testing under the CDC EUA using CDC-qualified materials purchased from IDT or BioSearch are encouraged to transition to another FDA-cleared test. If the clinical laboratory performs influenza diagnoses, the CDC recommends that the clinical laboratory consider one of the FDA-authorized tests that can provide results for SARS-CoV-2 and influenza A and B.