The Centers for Disease Control and Prevention (CDC) urged labs this week to stock clinics with kits that can test for both the coronavirus and the flu as the "influenza season" draws near.
The CDC said Wednesday it will withdraw its request for the "Emergency Use Authorization" of real-time diagnostic testing kits, which were used starting in February 2020 to detect signs of the coronavirus, by the end of the year.
"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 agency said.
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 in 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.
The CDC urged laboratories to "save both time and resources" by introducing kits that can determine and distinguish a positive test for the coronavirus and flu.
"CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses," the agency said Wednesday.
Laboratories will have until the close of 2021 before the CDC officially withdrawals its Emergency Use Authorization of the Real-Time RT-PCR Diagnostic Panel.
A source from Gov. Newsom’s $100 million labs explained to the Globe in February about the high number of false-positive PCR tests:
“Results from a positive PCR test should be considered as a preliminary result only and doesn’t determine an active infection or hospitalization rates. Doctors typically order these tests when a patient shows symptoms and the doctor suspects the patient has a high probability of having the disease. Once a result comes back positive, it must be confirmed with another test in order to be considered definitive.
The concern with Covid screening is that none of these steps are taken. A positive PCR has little clinical significance and increases our case numbers without confirming the presence of an active infection. Without the expertise of a physician and a confirmatory assay, there is no way to determine if this is a true positive result.”
The Globe also reported on three doctors in Contra Costa County who were concerned with the excessive COVID PCR testing leading to high numbers of false-positive results. 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 directions 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.”
Six months later, the CDC pulls the PCR tests.
