The U.S. Centers for Disease Control and Prevention (CDC) announced on July 21, 2021, that it is withdrawing the Emergency Use Authorization for detecting SARS-CoV-2. As a result, clinical labs using it should switch to a test that can distinguish the coronavirus from influenza viruses.
“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 CDC also advised clinical laboratories and testing centers to switch from RT-PCR to another FDA-authorized COVID-19 test.
“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. In addition, CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.”
Meanwhile, the FDA has revoked EUAs for Gravity Diagnostics, Curative, and BioFire Diagnostics’ SARS-CoV-2 tests.
The use of RT-PCR for SARS-COV-2 detection has been deemed unreliable and even fraudulent by numerous courts throughout the world.
According to a Portuguese court, the test’s reliability depends on the number of cycles employed and the viral load present. The court concludes, citing Jaafar et al. 2020, that “if someone is tested by PCR as positive when a threshold of 35 cycles or higher is used (as is the rule in most laboratories in Europe and the United States), the probability that said person is infected is less than 3%, and the probability that said result is a false positive is 97%.”
The court pointed out that “a PCR test is not suitable for diagnosis and therefore does not in itself say anything about the disease or infection of a person.
“However, the Minister of Health uses a completely different, much broader case definition for COVID-19 diagnosis, which cannot be used to justify the prohibition of a meeting.”
Even the World Health Organization (WHO) reversed course and revised its PCR test criteria, warning professionals not to depend only on PCR test findings to diagnose the coronavirus.
A corona test can be positive even though the infectious viruses have been dead for a long time because the PCR process replicates even a tiny fraction of the viral genetic material enough to give a false-positive result.