September 14, 2021 – Every day, more than 140,000 people in the United States are diagnosed with COVID-19. But no matter how curious they are as to which variant they are fighting, none of them will.
The country is dotted with labs that sequence the genomes of COVID-19 cases, and the CDC is tracking those findings. But federal rules state that these results are not allowed to be returned to patients or doctors.
Public health and infectious disease experts say that is unlikely to change anytime soon.
“I know people want to know – I’ve had a lot of friends or family who have asked me how they can find out,” says Aubree Gordon, PhD, epidemiology specialist at the School of Health of the University of Michigan. “I think that’s an interesting thing to find out for sure. And it would certainly be nice to know. But because it’s probably not necessary, there’s little incentive to change the rules.
Because the tests used have not been approved as diagnostic tools under the Clinical Laboratory Improvement Amendments program, which is overseen by the Centers for Medicare & Medicaid Services, they may only be used for research purposes. .
In fact, the scientists who do the sequencing rarely have information about the patients, Gordon says. For example, the Lauring Lab at the University of Michigan – led by Adam Lauring, MD – focuses on viral evolution and is currently testing variants. But this is not done for the good of the patient or the doctors treating the patient.
“The samples are coming in… and they’ve been anonymized,” says Gordon. “It’s just for research purposes. Little patient information is shared with researchers.
But for now, other than sheer curiosity, there’s no reason to change that, says Timothy Brewer, MD, professor of medicine and epidemiology at 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 “variant of interest” – the Delta variant accounts for about 99% of cases in the United States.
Plus, Brewer says, the treatments are the same for all COVID-19 patients, regardless of the variant.
“There would have to be clinical significance for there to be a good reason for giving this information,” he says. “It would mean that we would do something different in terms of treatment depending on the variant. For now, this is not the case. “
There is a flaw that allows labs to publish information about variants: 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, it is too long and expensive to sequence a large number of cases, he says.
“The reason we don’t do it systematically is that there is no way to do genomic analysis on all the positives,” Pandori explains. “It’s about $ 110 to do a streak. It is not like a standard PCR test.
There is a hypothetical situation that may justify the publication of these results, says Brewer: if a variant emerges that eludes vaccines.
“It would be a real public health problem,” he says. “You want to make sure there aren’t any variants emerging somewhere that escape immunity.”