Back in July 2021, The Centers for Disease Control and Prevention (CDC) announced that its PCR test has failed its full review and will have its Emergency Use Authorization revoked.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the CDC’s benchmark COVID diagnostic testing system, will be withdrawn for Emergency Use by the end of 2021 due to an inordinate frequency of false-positive and negative results.
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the FDA stated on its website.
“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 FDA goes on to explain the risks associated with false positives and negatives:
False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause patient harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when presumed negative patients are grouped into cohorts in health care, long-term care, and other facilities based on false test results.
