Will there be a “flu season” in 2021? How many positive COVID tests in 2020 were in fact positive influenza tests?
At the end of last week, the Centers for Disease Control and Prevention (CDC) issued a concerning laboratory alert.
The agency announced that after December 31, 2021, it 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 test came out in February 2020 to detect the SARS-CoV-2 (i.e., the coronavirus causing COVID019) only.
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.
At the heart of the alert is a specific CDC-developed PCR (polymerase chain reaction) test to detect genetic material from a particular organism, such as a virus. The agency is stressing the need for multiple tests, including ones recommended by the CDC, which can look for both the coronavirus and various types of influenza at the same time. This offers a chance to do influenza surveillance and identify flu strains while testing for SARS-CoV-2(the virus that causes COVID-19).
It appears if the SARS-CoV-2-only test found only that pathogen, and if that was the only test done, then flu strains went undetected. The “flu season” impact is evident to anyone interested in looking at the data (emphasis mine).
The U.S. has reported more than 34.4 million cases of the coronavirus since the pandemic began in 2020 and more than 610,000 deaths.
But while cases of COVID-19 soared nationwide, hospitalizations and deaths caused by influenza dropped.
According to data released by the CDC earlier this month, influenza mortality rates were significantly lower throughout 2020 than previous years.
There were 646 deaths relating to the flu among adults reported in 2020, whereas in 2019 the CDC estimated that between 24,000 and 62,000 people died from influenza-related illnesses.
Additionally, there have been doctors sounding the alarm about PCR testing specifically. Katy Grimes of the California Glove interviewed three of them: Dr. Michael deBoisblanc, Dr. Pete Mazolewski, and Dr. Brian Hopkins explain:
“PCR testing has proven to be seriously flawed when used to track disease prevalence, and the number of false positive tests has contributed to fear, panic and unnecessary quarantine of many. The peer review of the original Corman-Drosten PCR paper points out the serious flaws and conflicts of interest in the original article describing the PCR test (Peter Borger Et al., 11/27/2020). This paper is the basis for the PCR test used in the United States. On January 21, 2021 the World Health Organization published direction on the interpretation of a positive PCR test. They now caution about calling a test “positive” without symptoms, a confirmatory test, and physician oversight. They also cite the serious problems with high cycle thresholds leading to a high number of false positives. In short, they agree with what we argued last month.”
“With this information, your COVID positive case numbers are highly suspect and using this data to determine which tier the population falls into has been, and continues to be, completely unreliable and arbitrary. Our recommendation is to move forward quickly with rapid antigen testing. These tests are less expensive, and more appropriately sensitive to detect people with active, contagious disease.”
However, officials pulled the emergency authorization only for one type of PCR test, and other brands will remain in use.
Jim McKinney, an FDA spokesman, told us in an email that to date, “the FDA has authorized more than 380 tests and sample collection kits to diagnose COVID-19, many of which are PCR tests. PCR tests are generally considered to be the ‘gold standard’ for COVID-19 diagnosis.”
“The FDA has not issued any statement questioning the reliability of PCR test results in general and will continue to consider authorization for validated PCR tests,” he added.
Dr. Michael Mina, a Harvard University assistant professor of epidemiology, told us that the CDC’s decision regarding its test made sense, given how the landscape has changed.
“CDC is likely going to pull its own EUA for its test because hundreds of other labs now have their own EUAs and CDC no longer even needs to use its own test since many companies now have EUAs for manufactured tests,” he said in an email. “The major Companies like Roche, Hologic, Abbott all have their own test kits and instruments. Then the ThermoFishers of the world have EUAs for their PCR kits that can be run in the exact same way as the CDC assay. So there really is no reason for CDC to retain their EUA.”
It sure will be fascinating to see what the flu season looks like this year.DONATE
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