Audience: Clinical Laboratories

Level: Laboratory Alert

On July 21, 2021, the CDC Laboratory Outreach Communication System (LOCS) issued a Laboratory Alert to clinical laboratory professionals about CDC's decision to retire the use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel after December 31, 2021. CDC has received several questions in response to this Laboratory Alert, so this follow-up message is intended to provide further clarification and prevent potential confusion.

Why is CDC retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?

CDC is retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel because the U.S. Food and Drug Administration (FDA) has authorized hundreds of other SARS-CoV-2 diagnostic tests, many of which are now higher throughput or can test for more than one illness at a time. At the time CDC deployed the 2019-nCoV Real-Time RT-PCR Diagnostic Panel, there were no other FDA-authorized methods available within the United States.

CDC began distributing the CDC 2019 Novel Coronavirus (2019-nCOV) Real-Time RT-PCR Diagnostic Panel to fill a gap. The wide availability of other SARS-CoV-2 diagnostic tests means that the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is no longer filling an unmet need. Retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel will allow CDC to focus its resources on public health surveillance testing and other response activities.

CDC is recommending that laboratories that routinely conduct influenza testing as well as COVID-19 testing, such as public health laboratories, consider transitioning to a test that can generate a result for both influenza and SARS-CoV-2, rather than running separate tests for each virus. The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, one such assay available to public health laboratories, can simultaneously detect and differentiate SARS-CoV-2, Influenza A, and Influenza B with one test. It is a more resource-efficient way for public health laboratories to meet influenza and SARS-CoV-2 surveillance goals.