The Centers for Disease Control this week announced that it is phasing out the Real Time PCR COVID-19 test immediately. PCR tests will no longer be a valid and recognized method for determining COVID-19 infection.
“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives,” the CDC said.
In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test.
“CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing,” the CDC said.
There are several types of SARS-CoV-2 and COVID-19 related IVDs:
- Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
- Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
- Tests for Management of COVID-19 Patients: Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.
PCR tests have long been blamed for a high number of false-positive COVID-19 test results.
In New Jersey alone there have been a total of 902,870 positive PCR tests, now the CDC says the state needs to transition away from using PCR testing. 131,363 New Jerseyans have been confirmed positive with the more reliable antigen testing method.
A report published in the Journal of Occupational and Environmental Medicine looked into why the PCR tests generate more false positives and why the United States chose to use the tests.
“In the United States, because of a shortage of tests and testing facilities during the early months of the pandemic tests were primarily used for diagnoses to identify a person with an active infection associated with signs or symptoms of COVID-19 or who had definite or suspected recent exposure to the virus,” the report found. “Later, the Federal Drug Administration (FDA) approved testing to be extended to screen for infection in individuals without known or suspected exposure to SARS-CoV-2 living in congregate settings, such as long-term care facilities or prisons. Finally, periodic screening programs have been developed for educational institutions, sport teams, and the workplace to detect asymptomatic, presymptomatic, and symptomatic infected individuals early and isolate them to reduce them infecting others.”