Do you want to see which COVID strain you have? The government says no

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September 14, 2021 — More than 140,000 people in the United States are diagnosed with COVID-19 every day. But no matter how curious they are about which variant they are fighting, none of them find out.

The country is littered with labs sequencing the genomes of COVID-19 cases, and the CDC is tracking those results. But federal rules don’t allow those results to be returned to patients or doctors.

According to public health and infectious disease experts, this is unlikely to change anytime soon.

“I know people want to know — I’ve had a lot of friends or family ask me how to find out,” says Aubree Gordon, PhD, an epidemiology specialist at the University of Michigan School of Public Health. “I think it’s definitely interesting to find out. And it sure would be nice to know. But because it probably isn’t necessary, there’s little motivation to change the rules.”

Because the tests used are not approved as diagnostic tools under the Clinical Laboratory Improvement Amendments program, which is overseen by the Centers for Medicare & Medicaid Services, they can only be used for research purposes.

In fact, the scientists conducting the sequencing rarely have patient information, Gordon says. For example, the Lauring Lab at the University of Michigan — run by Adam Lauring, MD — focuses on viral evolution and is currently testing for variants. But this is not done in the interest of the patient or the doctors treating the patient.

“The samples are coming in… and they’re anonymized,” Gordon says. “This is for research purposes only. Not much patient information is shared with the researchers.”

But as of now, other than out of sheer curiosity, there’s no reason to change this, says Timothy Brewer, MD, a professor of medicine and epidemiology at the UCLA Fielding School of Public Health and of Medicine.

While there are emerging variants — including the new Mu variant, also known as B.1.621 and recently classified as a “major variant” — the Delta variant accounts for approximately 99% of US cases.

In addition, Brewer says treatments are the same for all COVID-19 patients, regardless of variant.

“There should be some clinical significance to have a good reason for giving this information,” he says. “That would mean that, depending on the variant, we would do something different in terms of treatment. That is not the case at the moment.”

There is a loophole that allows labs to release variant information: they can develop their own tests. But then they have to go through a lengthy validation process that proves their tests are as effective as the gold standard, says Mark Pandori, PhD, director of the Nevada State Public Health Laboratory.

But even with validation, sequencing large numbers of cases is too time-consuming and expensive, he says.

“The reason we don’t do it routinely is that there’s no way to do the genomic analysis of all the positives,” Pandori says. “It costs about $110 dollars to do a series. It’s not like a standard PCR test.”

There’s a hypothetical situation that justifies releasing these results, Brewer says: if a variant turns up that evade vaccines.

“That would be a real public health problem,” he says. “You want to make sure that variants don’t develop somewhere that escape immunity.”

WebMD health news

sources

World Health Organisation.

Aubree Gordon, PhD, epidemiology specialist, University of Michigan School of Public Health.

Timothy Brewer, MD, professor of medicine and epidemiology, UCLA Fielding School of Public Health and of Medicine.

Mark Pandori, PhD, director, Nevada State Public Health Laboratory.


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