The Centers for Disease Control and Prevention (CDC) will no longer recommend its first generation PCR diagnosis test to detect the CCP virus, saying that it will withdraw the test’s emergency use authorization (EUA), and instead encourage labs to use newer FDA-authorized multiplex assay that can detect and differentiate both the virus and the flu.
“Given the availability of commercial options, CDC intends to discontinue support for 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,” Jasmine Reed, public affairs specialist at the CDC, told The Epoch Times via email.
She added that “the demand for this test has declined with the emergence of other higher-throughput and multiplexed assays. CDC is encouraging public health laboratories (PHL) to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to enable continued surveillance for both influenza and SARS-CoV-2, which will save both time and resources for PHL.”
SARS-CoV-2 is the scientific name for the CCP (Chinese Communist Party) virus, also known as the novel coronavirus that causes COVID-19.
In a lab alert published on July 21, the CDC said it will withdraw its EUA request for the polymerase chain reaction (PCR) test after Dec. 31, 2021, to allow labs to “begin their transition to another FDA-authorized COVID-19 test.”
The CDC’s testing tool, the 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, was developed and made available in the early stages of the pandemic and is only able to detect the presence of SARS-CoV-2 and not other disease agents.
The new multiplex PCR test the CDC now recommends was granted emergency use authorization in July last year and allows multiple targets to be simultaneously amplified in a single tube, making it ideal for high-volume analyses of multiple indicators of disease at the same time.
The public health agency said its multiplex assay is a “real-time reverse-transcription polymerase chain reaction (RT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens” from individuals in the acute phase of infection.
Currently, none of the authorized diagnostic tests used to determine if an individual is infected with the CCP virus are approved by the FDA.
Reed did not reply to an inquiry on whether testing for the flu had stopped last year and is the reason why the CDC now encourages labs to adopt the multiplex tests. Nor did the health agency reply to an inquiry on what the cutoff cycle threshold value should be, considering that every manufacturer has its own cutoff value, many at 40 or more cycles.
The CDC’s PCR test uses a cutoff threshold value of 40 cycles, a number experts say is too high and likely to detect dead-virus fragments only.
The cycle threshold value is determined by the number of cycles it takes for the PCR test machine to detect a fragment of the CCP virus. It informs an infected person of how much virus is in their system.
The higher the threshold value, the less the viral load, indicating that the person is less likely to be infectious. In comparison, a person with a lower cycle threshold value will have a higher viral load or is more infectious.
In addition, many people are not aware that they may request the cycle threshold value of their test result, as the standard practice of reporting is to only state negative or positive. Except in Florida, cycle threshold reporting is not part of the diagnosis unless requested by the patient.
The CDC itself says that the cycle threshold value “should not be used to determine a patient’s viral load, how infectious a person may be, or when a person can be released from isolation or quarantine” in its updated frequently asked questions about the CCP virus for labs in November 2020, months after concerns were raised by the scientific community that there was an over-reliance on and a misuse of the PCR test as a diagnostic tool.
Any positive PCR test during the pandemic, with or without clinical symptoms, is counted as part of the daily CCP virus cases and is one of the metrics that impacts public health policies.
The World Health Organization (WHO) issued guidance on Jan. 20, 2021, informing lab experts and health care practitioners that they should also consider the patient’s history and epidemiological risk factors alongside the PCR test in diagnosing the CCP virus, saying that “most PCR assays are indicated as an aid for diagnosis.”
In addition, the WHO advised that a positive PCR test that isn’t consistent with the clinical presentation should be verified by taking “a new specimen” and retesting it.
The day after the guidance was published, Dr. Anthony Fauci attended the WHO executive board meeting and said that the United States would rejoin the organization and fulfill its financial obligations after the Trump administration pulled out of the United Nations body in July 2020 over its inability to attain information about the disease outbreak from the Chinese communist regime, which had covered up the severity of its CCP virus epidemic.
Fauci, the long-time director of the National Institute of Allergy and Infectious Diseases (NIAID), said in July of last year that detection of virus at a cycle threshold of 35 cycles or more was likely to mean that a fragment of dead virus had been detected.
“What is now sort of evolving into a bit of a standard, that if you get a cycle threshold of 35 or more [cycles] that the chances of it being replication-competent are minuscule,” Fauci said in an interview with This Week in Virology.
“So I think if somebody does come in with 37, 38, even 36, you got to say, you know it’s just dead nucleotides, period.”
A study published in the Clinical Infectious Diseases journal last month found that with the increase in the cycle threshold value, the percent of viruses that can be cultured decreases.
The authors said that at a cycle threshold of 25, “up to 70 percent of patients remain positive in culture and that at [cycle threshold] 30, this value drops to 20 percent.”
However, at a cycle threshold of 35, the value cutoff used to report a positive result for PCR, “<3 [percent] of cultures are positive.”
A day after the CDC published its lab alert, the Health and Human Services (HHS) announced that the Biden administration would invest more than 1.6 billion “to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.”
Of the 1.6 billion of investments, $100 million will be used to expand mitigation resources and testing for people with substance use and mental health disorders; $80 million will support state and local testing and mitigation resources among individuals experiencing homelessness, in group homes, and encampments; $169 million will support testing and mitigation efforts in “federal congregate settings”; $700 million will go “to 64 state and local jurisdictions to help prevent the spread of COVID-19 in confinement facilities, including prisons, jails, and juvenile confinement facilities”; and $550 million will support mitigation efforts and testing in “adults, children, and youth experiencing domestic violence and dating violence.”
However, there was still one million of the $1.6 billion that was unaccounted for. The HHS did not reply to The Epoch Times’ email inquiring about the one million and why the Biden administration is only now testing these high-risk communities.
Correction: The headline has been updated to clarify the actions taken by the CDC.