By Enza Ferreri
Coronavirus RT-PCR Test Not FDA Approved but Only Authorized for Emergency Use by FDA
The recently updated document “Labcorp’s COVID-19 RT-PCR Test EUA Summary – May 11, 2021” by the US government’s Food and Drug Administration (FDA) says:
• This product has not been FDA cleared or approved, but has been authorized for
emergency use by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for the detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner [Emphasis added]
The FDA is the US government’s agency with the authority to regulate medical, health and nutrition products.
Emergency Use Authorizations (EUAs)
So what are Emergency Use Authorizations (EUAs)?
The FDA answers:
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. [Emphasis added]
FDA Has Not Approved Test Because Unreliable, Resulting in Too Many False Positives
In a post of last November we were already denouncing the high degree of unreliability of the new coronavirus tests used to detect the presence of the SARS-CoV-2, which some considered even 90% unreliable.
The high number of false positives, namely detecting a virus which is not there, or is dead, has been a primary concern for a long time, even prompting the New York Times, the staunchest defender of mainstream narrative, to publish a sceptical article headlined “Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be”, pointing out that the number of cycles used in the PCR tests for coronavirus is too high, and saying:
In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found.
In December 2020 we covered the question of covid-19 tests shambles and coronavirus overdiagnoses, observing that the creator of the gene amplification test himself, Dr. Mullis, has always maintained that it should not be used for diagnostic purposes.
The FDA admits and declares that the Covid-19 test involves a risk of false results.
World Health Organization and Fauci Caution on Use of PCR Coronavirus Test
From the website of the World Health Organization, the UN’s own medical agency, the most authoritative on the globe on matters of health:
WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology.
WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases (2). This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity.
Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information. [Emphasis added]
Basically, one positive test is not enough to confirm presence of coronavirus SARS-CoV-2 in the absence of symptoms of the disease, a second test should be performed. And not only that: testing should be accompanied by clinical evaluation of any symptoms or their absence.
“Symptom”, from the Greek, can mean “clue” or “signal”. For doctors the clinical picture, ie the symptoms of the patient, should be a primary guiding element to arrive at the diagnosis.
A Dr. Anthony Fauci’s interview from last July initially escaped attention, until it was later re-appraised.
In it Fauci seemed to acknowledge that a great number of positive Covid-19 cases may arise from oversensitive tests that detect only simple fragments of the virus and not active infections. The tests’ high number of cycles result in weaker viral samples, reducing the medical meaning of a positive test result.
At high levels, “the chances of it being [accurate] are minuscule”, Fauci said.
FDA Admits PCR Tests Give False Results
Fauci warned that widely used COVID tests may pick up ‘dead’ virus