- In the United States, most people with COVID-19 cannot legally know which variant has infected them.
- This is because the sequencing test has been approved by the federal government to disclose the results to doctors or patients.
- Laboratory scientists say the process of verifying tests for approval is too costly 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. Despite being fully vaccinated, Reider recently tested positive for COVID-19 after teaching music at a summer camp. The health department asked him to conduct a second test at the local Kaiser Permanente.
Reid believed this was because the authorities wanted to find out if he was infected with the delta virus. He was also curious-but when he got the test results, he was surprised to find that the doctor could not give him any information about his mutation.
“When I got follow-up from Kaiser, they said it was positive, but they didn’t have any sequencing information,” Reider told Insider. This “makes me feel very strange,” he said.
Some legal obstacles prevented Reider and his doctors — and almost all Americans who tested positive for the coronavirus — from knowing which mutation to blame.
The Centers for Medical Insurance and Medicaid Services (CMS), which oversees the regulatory process for laboratories in the United States, requires that genome sequencing tests must be approved by the federal government before the results are disclosed to doctors or patients. These are tests to detect variants, but nowadays, laboratories have little incentive to do the work of verifying these tests.
Kelly Wroblewki, Director of Infectious Diseases of the Public Health Laboratory Association, told Insider: “To be honest, I don’t think there is much motivation to get this job done.”
However, some patients believe that they are denied access to their health information.
In some cases, knowing which variants are involved in the infection can inform patients how to conduct their own contact tracing, because it can tell them how likely they are to spread the virus to other people. (For example, if it is a Delta infection, they may want to notify a wider circle of family and friends.)
Other patients, such as Ryan Forrest, 30, of Midland Park, New Jersey, just want to know how they got infected.
Forrest tested positive for COVID-19 after attending an indoor wedding in July. He said he did not have any personal interactions with the “patient zero” at the wedding, so he still wants to know how he got sick-especially after he was vaccinated in March. He said that knowing that the Delta variant is infected with him can eliminate the confusion.
He said: “It would be great to know that this matter is more important than anything just out of curiosity.”
Wroblewki said she “fully understands” this feeling.
“I will be curious. I think anyone will be curious,” she said. “The important thing to realize is that the release of information by the laboratory is a responsibility.”
Validation sequencing test is laborious and time-consuming
Wroblewki said that so far, more than 50 public laboratories in the United States are able to sequence coronavirus samples to detect mutations. But she is not aware of any laboratory that has completed the verification process to obtain federal approval.
“The process of verifying next-generation sequencing tests is onerous,” Wroblewki said. “It takes a lot of time. It requires a lot of data. It requires a lot of resources. The thing about variants is that the attention and interest are constantly changing, so you have to do a complete verification every time. It’s time you have a variant. .”
In order to validate the sequencing test, the manufacturer needs to collect data to prove that the test does a good job of detecting specific variants, and then apply for emergency authorization from the Food and Drug Administration. Alternatively, laboratories can validate their sequencing tests “internally,” which means they collect the same data so that CMS can approve their tests.
“CMS law stipulates that if you do not pass this complete verification process, you cannot publish results with patient identification information,” Wroblewki said. She pointed out that a major exception is whether epidemiologists need to disclose a person’s mutation information during the contact tracing process.
She added that testing to validate a single variant can take weeks to months.
Wroblewki said: “Keep up with it in real time. It is not very useful when it does not affect your decision on how you will treat the patient.” “Rather than benefit the patient, it is better to say that it satisfies curiosity.”
A more worrying variant may prompt scientists to disclose information to patients
Wroblewki said the main purpose of sequencing is to detect new variants and understand whether they will challenge the effectiveness of vaccines, treatments, or diagnostic tests. She said that next, the laboratory also hopes to better understand whether certain variants will cause more serious consequences in certain populations, such as pregnant women or the elderly.
But now, variants have not fundamentally changed the way people protect themselves from COVID-19. Although the Delta variant is the most contagious version of the virus to date, wearing a mask and maintaining social distancing can still reduce its spread. And the COVID-19 vaccine continues to provide good protection against serious illness and death.
Wroblewki said: “At this point, unless we see something that will really guide your treatment choices at the individual patient level, knowing that you have Delta will not do much for the doctor or the patient.” “The doctor’s approach to that patient. no difference.”
She added that this makes it difficult to justify the time and cost of verification tests—especially when these resources are available for more sequencing.
“If we later see a real impact on therapies used to treat SARS-CoV-2, then yes, we are likely to change our approach,” Wroblewki said. “But at this moment, we are not there yet.”