By skyforbes 
According to a Yahoo news article, “the Centers for Medicare and Medicaid Service (CMS), which oversees the regulatory process for US labs, requires genome-sequencing tests to be federally approved before their results can be disclosed to doctors or patients.” The article goes on to say that the “letter of the law from [The Centers for Medicare and Medicaid Service] is that if you don’t go through [a] full validation process, you cannot release the results with patient identifying information.” So, if you get a Covid-19 test, even if it involves gene sequencing to determine a variant, you are not entitled to the results because theses 50 labs are not using a federally approved gene sequence test. This is not to say that these labs are not actually gene sequencing for the variants. Or that they have not independently devised methods to do so. They may be testing regularly for the variants, but if they are they, they are doing so without the use of a federally approved test. Why is this the case? Kelly Wroblewki, director of infectious diseases at the Association of Public Health Laboratories is quoted in the Yahoo article as follows:
“It takes a lot of time. It takes a lot of data. It takes a lot of resources. And the thing about the variants is that variants of concern and of interest are constantly changing, so you would have to do a whole validation every time you have a variant.”
The Yahoo article goes on to say that “laboratories can validate their sequencing tests ‘in house,’ meaning they collect the same data so CMS can approve their test.” Which, I think, is another way of saying that federal approval is as easy as collecting and submitting data. None of this, neither the data collection nor the time it takes, would seem to be insurmountable in the case of obtaining a federally approved delta variance sequencing test. The delta variant was identified in India in December of 2020. It’s been over 8 months. So, in my opinion, it’s rather astounding that the U.S. may not (and it’s not entirely clear from the Yahoo article if we do) have a single lab that has a federally approved gene sequence test for the delta variant.
The use of “more than” followed by the number “50” indicates it’s around 50 total U.S. labs that can gene sequence for a variant. Other sources set it exactly at 50. So, it’s probably “only 50.” Only 50 labs in a country with 331 million people. The question remains, how many of those 50 labs are actually running gene sequencing for the delta variant, and what percentage of all cases are actually being sequenced? Is it 1 lab? 2 labs? 20 labs? 1 person? 2 people? 20 people? In either case, it could be rather low, especially since the Yahoo article indicates that, from a treatment perspective, it’s not beneficial to do so. The treatment protocol for Covid-19 is the same no matter which variant is found.
Someone could argue that a statistical sampling would be a fair measure of prevalence. This would be true if the tests were actually federally approved, meaning they have been investigated and found to be accurate, and if we also had an adequate sample size. In the first instance, it seems they are not approved. And therefore subject to potentially being unreliable. As far as a sample size, Dr. John Sanders, chief of infectious diseases at Atrium Health Wake Forest Baptist said, “only a small number of tests get sent to labs for genome sequencing” (source: How do scientists test for the delta variant). Which means, statistically speaking, the sample size used to determine the prevalence of the delta variant is likely very small.
Moreover, since they can’t disclose positive or negative delta variant test results to patients and doctors (which would include hospitals), who can they disclose them to? It’s entirely unclear from the Yahoo article. I suppose they are submitting that information to the CDC. Which would form the basis of an opinion of prevalence. Nevertheless, it seems that those opinions would be based upon a sub-set of data of potentially questionable reliability — simply given the lack of federal approval in regard to sequencing methodology and the limited sample size.
I’ve used the word “ potentially” here a number of times to indicate a lack of positive confirmation. In reverse, can we state for a “scientific” or statistical certainty that we know the actual prevalence of the delta variant? I don’t think do.
So, these are just the facts: 50 labs, no clear indication that any of them has a single federally approved test, and a small number of actual gene sequencing tests being performed. Remember “science” requires positive confirmation, and not guess work. As in, “maybe our gene sequencing test works but it’s not been verified as such by a independent third-party.” That whole “peer review” argument is here somewhere lurking in the shadows. And yet, the media and health profession narrative seems to defy these facts. Yale Medicine:
“[The delta variant] swept rapidly through [India] and Great Britain before reaching the U.S., where it is now the predominant variant.”
Again how do we know that it is the “predominant variant”?
Similarly, here is an NBC news article that seems to contradict itself on the issue of prevalence:
“The delta variant is fueling a devastating new surge of infections, but experts say declines in testing and a lack of granular data about hospitalizations make it difficult to know just how much the virus is circulating in communities — and who remains most vulnerable.”
So, exactly how is NBC concluding the “delta variant is fueling a devastating surge” if we have a decline in testing and no way of knowing “how much is circulating in communities”? Not to mention that there are only 50 sequencing labs in the U.S. and limited sequencing at that.
Clearly, some of the media and health profession narrative seems to indicate that it’s a certainty that the delta variant is “overrunning” the county. Doesn’t seem right to me. Doesn’t seem we would have the kind of “scientific” or statistical information needed to reach such an affirmative (this is true) conclusion. To me, it seems like that’s more of a narrative than the “science” of it all. Censorship disclaimer: of course, this is just a layman’s opinion.