"Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing"

Also a nerd alert.

This story is very technical, I just had to write it because the below announcement from the CDC raises interesting questions.

The CDC is changing their position on their own SARS-CoV-2 PCR test (“CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel”)

In their own words,

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

What diagnostic tests will be recommended after this one loses authorization?

  • Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.

Here is also a page on molecular tests on the FDA website. It contains a list of various molecular tests that currently have the Emergency Use Authorization (including the CDC’s PCR test in question). Please note that the CDC announcement seems to pertain only to their own PCR test, not the entire class of PCR tests like some tweets suggested.

It’s very interesting given the fact that there have been several lawsuits filed domestically and internationally making an argument that the SARS-CoV-2 PCR test, especially with a high cycle threshold, is a fraudulent COVID diagnostic tool. Is it related? Time will tell!

Going down the rabbit hole of tangential information, it is also interesting that the CDC has previously changed the requirement regarding the number of cycles and requested that only tests with a cycle threshold no more than 28 should be used—but only when reporting the data on breakthrough infections in the v-d. For diagnosing unv-d people, the original 35-45 cycles remained acceptable. [The PDF file on the CDC website has been edited to contain only a redirect to the latest guideline, but you can look at the archived version.]

And then in May, the CDC stopped counting breakthrough infections altogether, focusing only on the number of hospitalizations and deaths in the v-d patients, as opposed to “asymptomatic cases” or mild cases—which, by the way, would have been a sensible thing to do across the board a year and a half ago—alongside the cycle threshold requirement.

It is unclear to me as of this second how they are counting COVID hospitalizations in v-d people. (Do all v-d hospital patients get tested—regardless of the reason for hospitalization—or strictly the ones who came to the hospital with suspected COVID?)

Additionally, there has been a number of breadcrumbs potentially indicating that there is a push toward conflating the stats and diagnostics for COVID and other respiratory infections and transferring the dramatic feeling—and the resulting market capture—to other viruses and v-word medical products. An mRNA flu v-word is being worked on, after all…

Sanofi SA, GlaxoSmithKline PLC and Pfizer Inc. are all working on mRNA shots against seasonal flu, betting the technology will be more effective, and quicker and cheaper to make than traditional shots. But there are still big challenges to overcome: mRNA vaccines require ultracold storage and can cause unpleasant, and in very rare cases, dangerous, side effects.

Another thought. Does the existence of the below and other combo diagnostic tests indicate a gradual shift toward a mode in which we start treating other viruses with the COVID fervor—masking for flu and being shamed as immoral people for not desiring a flu shot?

I don’t know. But after a year and a half of untruths, I think it’s reasonable to be more than a tad suspicious.

I will end this piece with a song, for balance.

Links and references