Served Its Purpose? CDC and FDA Recall Faulty COVID Test
Last week, big media was salivating over the COVID Delta variant and recommendations for indoor masking, even for the vaccinated, masking young children, and the possibility of a return to last year, with social distancing, capacity limits, and business closures.
There were also news stories that the media dutifully ignored, like ongoing election audits, Hunter Biden’s laptop, his father’s growing inability to think and speak coherently, and growing inflation and unemployment.
Also somehow missed by the investigative sleuths at CNN and MSNBC was the recall of a COVID rapid antigen test last month. This wasn’t just any recall but according to the FDA a serious one, “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.” That’s an understatement.
Specifically, this is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test using a nasal swab and test strip, with a colored line appearing if the person has the Chinese coronavirus. None of these tests are FDA-approved, only being used under emergency use authorization, like the COVID vaccines.
Who used these tests? According to the FDA, these were used by health care providers and large testing programs such as on college campuses. The faulty test provided both false-negative and false-positive results, each problematic but in different ways.
This test was introduced in February 2020, when COVID was barely a blip on the radar. This was the same time as when Dr. Anthony Fauci was becoming a media celebrity and told a USA Today reporter at the time, “The risk of coronavirus in USA is 'minuscule'; skip mask and wash hands.” Why would such a test even be developed for this Fauci-predicted non-event? Unless more was known or planned than Dr. Fauci admitted at the time.
YouTube screen grab
At least 77,339 devices were recalled in the U.S., but perhaps far more were used and unaccounted for. A false-negative test might mean a sick patient was sent home to worsen and spread the virus rather than beginning treatment or being admitted to the hospital.
A false-positive might prevent someone from working, traveling, or competing in sport, as recently happened to professional golfer and 2021 U.S. Open winner Jon Rahm, who was scratched from the Olympic games due to a positive test, despite having antibodies from prior COVID infection and being vaccinated.
Who makes this recalled test? Innova Medical Group, headquartered in Pasadena, Calfornia, is a wholly-owned subsidiary of Pasaca Capital, Inc. Pasaca is a private equity firm, also headquartered in Pasadena, whose founder and CEO, Charles Huang, Ph.D., received his undergraduate degree in economics from Wuhan University, China, where he grew up. All roads in the COVID story seem to lead to Wuhan.
While the FDA stopped the Innova PCR test in the U.S., across the pond in the U.K., they are doubling down by clearing its use and extending its authorization. What do they know that our FDA does not?
Dr. Huang received a Ph.D. in marketing and an MBA from the University of Strathclyde in Scotland. Named “Scottish university of the year” in 2020, it is likely a good place to make connections with future Downing Street power brokers. Very convenient.
Will other emergency use COVID tests be similarly canceled by FDA and CDC? Why isn’t this a story since these tests have guided policy not only in America but around the world, everything from stay-at-home orders to school and business closures, and masking and distancing requirements?
There have been other faulty tests, as NPR reported. CDC lab officials decided to release a coronavirus test kit despite a quality control test suggesting a 33 percent failure rate. How and why was such a decision made?
The PCR test was never designed for mass infectious disease screening, according to Kary Mullis, inventor of the PCR test. He said, “With PCR if you do it well you can find almost anything in anybody.” But “it doesn’t tell you that you are sick.” Yet these are the same tests that have been relied on for shaping public health policy.
Even that bastion of right-wing propaganda, the New York Times, recognized last year the folly of PCR testing with a high cycle threshold used to determine who is sick rather than who has a few viral fragments in their nose.
Tests with thresholds so high may detect not just live virus but also genetic fragments, leftovers from infection that pose no particular risk — akin to finding a hair in a room long after a person has left.
The standard tests are diagnosing huge numbers of people who may be carrying relatively insignificant amounts of the virus.
Most of these people are not likely to be contagious.
The other major problem is that these tests do not differentiate between COVID and influenza. From the CDC website, “CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.”
How many who tested positive, were hospitalized, or died from COVID actually had the flu, if the test is unable to distinguish between the two? Would this explain the absence of influenza, or seasonal flu this past year? Did we destroy the world’s economies over a bad flu season?
Was this incompetence or deliberate? Was there a concerted plan to drive up case numbers during the Trump presidency to damage him and influence the upcoming election? Only to reverse course now that Biden is in charge, dropping case numbers to reflect the brilliance of Biden’s policies and the wonders of the vaccines?
Is this why the vaunted PCR test that we have been using and relying on for a year and a half has been quietly shelved after it produced the desired results? Was it ever about the virus? Or was it just to further a political agenda?
UPDATE: The word "PCR" has been removed from this article's title in the interests of greater accuracy.
Brian C. Joondeph, M.D., is a physician and writer.
To comment, you can find the MeWe post for this article here.