You are not legally allowed to know which variant gave you COVID-19 in the United States, even if it is Delta

• Most people with COVID-19 in the United States are legally prevented from knowing which variant infected them.

• That’s because sequencing tests need to be federally approved for results to be released to doctors or patients, and most are not yet.

• Scientists at the lab say the process of validating tests for approval is too expensive and time-consuming.

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Sam Reider, a musician from San Francisco, received a call from the California Department of Public Health in June. Although fully vaccinated, Reider had recently tested positive for COVID-19 after teaching music at a summer camp. The health department asked her to take a second test at a local Kaiser Permanente.

Reider speculated it was because authorities wanted to know if he had a Delta infection. He, too, was curious – but when he got the test results he was surprised to learn that doctors couldn’t give him any information about his variant.

“When I got the follow-up from Kaiser, they said it was positive, but they had no sequencing information,” Reider told Insider. It “seemed strange to me,” he said.

Several legal barriers have prevented Reider and his doctors – as well as nearly all Americans who have tested positive for the coronavirus – from knowing which variant was to blame.

The Centers for Medicare and Medicaid Service (CMS), which oversees the regulatory process for U.S. labs, requires genome sequencing tests to be approved by the federal government before their results can be released to doctors or patients. These are the tests that detect the variants, but right now there is little incentive for labs to do the work to validate these tests.

“I don’t think there’s a lot of motivation, quite frankly, to do this,” Kelly Wroblewki, director of infectious diseases at the Association of Public Health Laboratories, told Insider.

Some patients, however, feel that they are being denied access to their own health information.

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In some cases, knowing which variant is involved in an infection could indicate how patients conduct their own contact tracing, as it indicates the likelihood that they have spread the virus to others. (If it’s a Delta infection, for example, they might want to tell a much larger circle of family and friends.)

Other patients, like Ryan Forrest, 30 in Midland Park, New Jersey, are just curious how they got infected.

Forrest tested positive for COVID-19 after attending an indoor wedding in July. He said he hasn’t had any personal interaction with the marriage’s “patient zero”, so he’s still wondering how he got sick – especially since being vaccinated in March. Knowing that the Delta variant infected him could clear up the confusion, he said.

“It would have been nice to know just out of curiosity more than anything else,” he said.

Wroblewki said she “totally understood” this feeling.

“I would be curious. I think anyone would be curious,” she said. “The important thing to recognize is that it is a responsibility of the laboratories to disclose the information.”

Validating a sequencing test is arduous and time consuming

So far, Wroblewki said, more than 50 public labs in the United States are able to sequence coronavirus samples to detect variants. But she is unaware of any labs that have completed the validation process for federal approval.

“The process of validating a next-generation sequencing assay is tedious,” said Wroblewki. ” This takes lots of time. It takes a lot of data. It takes a lot of resources. And the problem with variations is that the worrisome and interesting variations are constantly changing, so you will have to do a full validation every time you have a variation. “

For a sequencing test to be validated, a manufacturer must collect data to show that the test does detect a specific variant, and then seek emergency clearance from the Food and Drug Administration. Alternatively, labs can validate their sequencing assays “in-house”, which means they collect the same data so CMS can approve their assay.

“The letter of the law from CMS is that if you don’t go through this full validation process, you can’t publish the results with the patient’s identifying information,” Wroblewki said. One major exception, she noted, is that epidemiologists must disclose information about a person’s variants during contact tracing.

Validating a test for a single variant can take weeks or even months, she added.

“To track this in real time, when it doesn’t influence a decision you’re going to make about how you treat a patient, just isn’t very helpful,” Wroblewki said. “It satisfies curiosity more than it actually benefits a patient.”

More worrying variant could push scientists to release information to patients

The main goal of sequencing, said Wroblewki, is to detect new variants and understand whether they call into question the effectiveness of vaccines, treatments or diagnostic tests. Ultimately, she said, labs are also hoping to gain a better understanding of whether certain variants cause more serious results in certain populations, such as pregnant women or the elderly.

But as of yet, the variants haven’t fundamentally changed the way people protect themselves from COVID-19. Although the Delta variant is the most contagious version of the virus to date, masks and social distancing still reduce its spread. And COVID-19 vaccines continue to offer good protection against serious illness and death.

“At this point, unless we see something that is really going to guide your therapeutic choice on an individual patient level, there isn’t much benefit to a doctor or patient from knowing that you have Delta. “said Wroblewki. “There is nothing different that a doctor is going to do to treat this patient.”

This makes it difficult to justify the time and expense required to validate a test, she added, especially when those resources could be used to do more sequencing.

“If we see later that there will be a real impact on a therapy used to treat SARS-CoV-2, then yes, we will most likely change our approach,” Wroblewki said. “But right now, we’re not there yet.”

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