The testing mess–UPDATE, and how government is cutting out the middleman (the healthcare system) in Covid testing and vaccinations

Let me start by explaining that an antigen test, performed by (minimally trained) personnel in a nursing home, homeless shelter, or other congregate living setting, rather than in a lab, is often the basis for a diagnosis of Covid.

The test does not need to be ordered by a doctor.  It is possible that the patient’s doctor does not even know their patient was tested, nor will they receive the results.  In most cases, there will be no billing of an insurance company.  The results are determined within the facility, and the only required reporting is to a local health authority, which forwards results to the CDC.  

Like the Covid vaccinations, these Covid tests are being handled completely outside the regular healthcare system.  No MD is responsible, nor can anyone be sued if the results are wrong and lead to a bad outcome.  Only government employees have access to the results.

States may provide test kits under federal grants to the facilities and require a certain frequency of testing.

In terms of diagnosing cases of Covid, a sole positive antigen test is defined by CDC and the Council of State and Territorial Epidemiologists as a probable Covid case, even without a single symptom. Some jurisdictions, and the CDC itself, recode probable cases as confirmed cases of Covid.  

One positive PCR result is defined as a confirmed case of Covid, even without a single symptom.

Beginning in December, a similar rapid antigen test, called a lateral flow test, was approved for home use.  It must be combined with an app, which reports your results to the government.

Both in Europe and the US, these products can be sold solely on the basis of manufacturer data, without independent evaluation by FDA or another regulatory agency. They are authorized under the minimal EUA standard. There are no standard protocols for measuring performance.  CDC pretends there are, and suggests that users keep in mind the test sensitivity when interpreting the results.  But you cannot find an accurate measure of sensitivity for Covid tests anywhere. All the numbers available are simply claims made by their manufacturers, when tests were performed under perfect conditions.

Nature magazine noted that Porton Down science park and the University of Oxford had performed some testing of rapid antigen tests; “The full results, which have not yet been peer reviewed, were posted online on 15 January. These stated that many fast antigen (or ‘lateral flow’) tests “do not perform at a level required for mass population deployment…”’

Nature also pointed out that laboratory scientists achieved nearly 79% sensitivity on all samples (including those with very low viral loads) using the Innova rapid test, but self-trained members of the public got only 58%. (Sensitivity means the chance of getting a positive result when someone has the disease.) 

Harvard School of Public Health professor Michael Mina, PhD, perhaps the most vocal proponent of these tests, admitted, “Throwing tools at people who don’t know how to use them appropriately is a terrible idea.”

Now let’s look at CDC’s January clarifications regarding these rapid antigen tests.

“As of January 7, 2021

Revised guidance on when to perform confirmatory tests. 

• In general, asymptomatic people who test antigen positive should have a confirmatory test performed. Symptomatic people who test antigen negative should have a confirmatory test performed.
• Confirmatory test should be performed with nucleic acid amplifications tests (NAAT) such as reverse transcriptase polymerase chain reaction (RT-PCR).
• Expanded the intended audience to include all long-term care facilities, including nursing homes.”