08/02/2021: Lab Alert: Clarifications about the Retirement of the CDC 2019 Novel Coronavirus (2019-nCov) Real-Time RT-PCR Diagnostic Panel
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.
Does the retirement of this test apply to all RT-PCR-based tests or all SARS-CoV-2 tests that have received Emergency Use Authorization from FDA?
No. The discontinuation of Emergency Use Authorization (EUA) only applies to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel test. It does not affect any other SARS-CoV-2 test that has received EUA from FDA.
Does the retirement of this test affect any other CDC tests for SARS-CoV-2?
No. The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay received EUA from FDA in July 2020, and its status is not impacted by the decision to retire the CDC 2019 Novel Coronavirus Real-Time RT-PCR Diagnostic Panel. CDC and public health laboratories continue to use the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
Was the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel revoked because it failed its review by FDA?
No. The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel did not fail a full review and was not revoked by the FDA.
Is CDC retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel because it has produced inaccurate results?
No. There are no performance concerns with this test. The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is a highly accurate test. It has been used to successfully detect SARS-CoV-2 since February 2020.
Since the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel continues to perform well, CDC will continue to make the design of the primers and probes used in the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel publicly available on the CDC website. Laboratories and test developers are free to use the design in their own research or diagnostic test.
CDC will also continue to extend Right of Reference to anyone who wishes to reference the data in CDC’s Emergency Use Authorization (EUA 200001) to support their own regulatory submission to FDA. The retirement of the test and the discontinuation of the associated EUA will have no impact on the availability of the design or Right of Reference. The CDC submission will remain on file at FDA.
Does the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel detect both SARS-CoV-2 (the virus that causes COVID-19) and influenza (flu)?
No. The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel was specifically designed to only detect SARS-CoV-2 viral genetic material. It does not detect influenza or differentiate between influenza and SARS-CoV-2. The presence of influenza viral genetic material within a specimen will not cause a false positive result.
There are other multianalyte tests available, including the CDC Influenza SARS-CoV-2 Multiplex Assay, that can simultaneously detect and differentiate Influenza A, Influenza B, and SARS-CoV-2.
Does the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel confuse influenza with SARS-CoV-2?
No. The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel does not confuse influenza with SARS-CoV-2. It is a highly accurate test that detects the presence or absence of SARS-CoV-2 viral genetic material within a patient specimen.
Does the retirement of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time PCR Diagnostic Panel mean that the previous results from this test are invalid?
No. Results from this test are reliable, valid, and specific to SARS-CoV-2.
Are RT-PCR-based tests valid for the detection of SARS-CoV-2?
Yes. RT-PCR-based tests are one type of laboratory-based nucleic acid amplification test (NAAT), which continue to be the “gold standard” of diagnostic testing for COVID-19. Many diagnostic tests for SARS-CoV-2 that have received EUA from FDA use RT-PCR-based tests, including both the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
What tests can laboratories and testing sites use instead of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?
CDC encourages public health laboratories to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for the simultaneous surveillance testing of both SARS-CoV-2 and influenza. The test specifies whether a patient specimen is positive for SARS-CoV-2, influenza, or both.
Clinical laboratories that use a SARS-CoV-2 diagnostic test based on the CDC EUA of February 2020 should visit the FDA website for a list of authorized COVID-19 diagnostic molecular methods.
What if a laboratory or testing site is using a test with Right of Reference to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?
Tests that use the Right of Reference to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and that have received their own EUA from FDA are not affected by the retirement of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. CDC will continue to extend Right of Reference to anyone who wishes to reference CDC’s EUA for the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel in their own regulatory submission. Even after the CDC requests that the authorization for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel be discontinued, the submission will remain on file at FDA.
Can laboratories and testing sites continue to use the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?
Yes. Because there are no performance concerns with the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, laboratories and testing sites may continue to use this test until it is retired at the end of December 2021. CDC is making this announcement now to give laboratories and testing sites time to select and shift to one of the many other FDA-authorized tests.
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Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)