Lisa Song, reporting for ProPublica, revealed that the U.S. Department of Health and Human Services (HHS) purchased more than 150 million rapid COVID-19 antigen tests for nursing homes and schools, spending more than $760 million. Song explained, though, that there is a problem with those rapid COVID-19 antigen tests.
[A]ntigen tests are less sensitive because they can only detect samples with a higher viral load. The tests were prone to more false negatives and false positives.
But the federal government is on board with the antigen tests and is using its money and its force to push it out to the public. It has come down hard on state officials who object to the inaccuracy of the antigen tests. Song explains:
When health care workers in Nevada and Vermont reported false positives, HHS defended the tests and threatened Nevada with unspecified sanctions until state officials agreed to continue using them in nursing homes. It took several more weeks for the U.S. Food and Drug Administration to issue an alert on Nov. 3 that confirmed what Nevada had experienced: Antigen tests were prone to giving false positives, the FDA warned.
Indeed, the FDA warning states unequivocally that the antigen tests are inaccurate and give false positives. “The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests.”
But what Song overlooked in her article is the bombshell admission by the FDA that all tests, whether they be antigen or PCR are inaccurate. The FDA states:
The FDA reminds clinical laboratory staff and health care providers about the risk of false positive results with all laboratory tests. Laboratories should expect some false positive results to occur even when very accurate tests are used for screening large populations with a low prevalence of infection.
That astounding admission by the FDA has gone unreported by the major media outlets, even as many states are issuing more draconian social distancing, masking, and lock-down orders based on those inaccurate false-positive COVID-19 test results.
How did this situation arise? The FDA has allowed the drug companies to tout their antigen tests as being accurate when there is insufficient testing data to support their claims. Song reports:
FDA gave the first authorization to Quidel on May 8 based on data from 209 positive and negative samples. BD got its permit July 2 with a total of 226 samples and Abbott in late August with 102. Outside of a pandemic, the agency might otherwise have required hundreds more samples; in 2018, BD’s antigen test for the flu provided data on 736 samples.
There’s no excuse for the small pool of data, particularly for Abbott … said [Matthew Pettengill, scientific director of clinical microbiology at Thomas Jefferson University]. At the start of the pandemic, the FDA authorized PCR tests based on as few as 60 samples because it was difficult to find confirmed cases. By the time Abbott got its authorization in August, it was “a completely different ballgame.” Abbott’s validation document states the company collected swabs from patients at seven sites. Given the case counts over the summer, it should have only taken a few days to collect many hundreds of samples, Pettengill said.
Song reported that “[t]he day after the Abbott test was authorized, HHS placed a huge bet on it, buying 150 million tests.”
The tests are wreaking havoc on patients. For example, Song reveals that “[i]n July, an urgent care clinic in Manchester, Vermont, discovered that, of 64 patients (mostly asymptomatic) who the Quidel test said were positive, only four, all symptomatic, got a positive PCR result.” When one realizes that the PCR test itself is prone to false-positive results, one can see just how the inaccurate COVID-19 PCR and antigen tests are fanning the flames of hysteria. Song gives more examples:
The federal government defended Quidel again in early October. The Times reported that Nevada’s Health Department ordered nursing homes to stop using all antigen tests after reviewing results from 3,725 tests. Nursing homes had double-checked 39 samples the BD and Quidel tests flagged as positive, but 23 of them tested negative via PCR. Nevada’s letter noted that it only learned about the problem because the state chose to go above and beyond federal guidelines: The FDA had said there was no need to double-check positive results.
Please note that the FDA acknowledges that the antigen test is not accurate and yet it specifically states that “there was no need to double-check positive results.” It goes further than just guidance. It is putting economic and political pressure on state officials to continue to use the inaccurate antigen tests. The FDA is running a scam on the public. It is knowingly pressuring states to report false-positive results.
This could have deadly results. Song explains:
If someone tests positive on an antigen test, the nursing home may sequester the patient with other residents who are truly infected, the Nevada official, Bradley Waples, wrote. If that person later has a negative PCR test, then the faulty diagnosis will have placed them “in danger of contracting the virus by introducing them to a room full of actual positive residents.”
Song quantified the false-positive reporting:
One paper from August found that if a quarter of American school kids were tested three times a week with an antigen test that’s 98% specific, it would produce 800,000 false positives a week that need to be double checked by PCR tests. (For reference, the U.S. is processing an average of 1.4 million tests per day, nearly all of them PCR).
Lisa Song, Rapid Testing Is Less Accurate Than the Government Wants to Admit, Propublica, November 16, 2020, https://www.propublica.org/article/rapid-testing-is-less-accurate-than-the-government-wants-to-admit?utm_source=sailthru&utm_medium=email&utm_campaign=majorinvestigations&utm_content=river