Covid-19 infections from variant strains are spreading rapidly in the US, but there is one big problem: Laboratory officials say they cannot tell patients or their doctors if someone has been infected with a variant.
According to Janet, federal regulations about who to be notified of the variant cases are so confusing that public health officials may only know the county where a case occurred but cannot conduct the type of investigation and provide the notifications that are needed to slow the spread are Hamilton, Executive Director of the Council of State and Territorial Epidemiologists.
“It may or may not be associated with a person in a high-risk community, but without patient information, we don’t know what we don’t know,” said Hamilton. The group has asked federal officials to waive the rules. “The time is running.”
The problem is that the tests in question for detecting variants haven’t been approved as a diagnostic tool by the Food and Drug Administration or under federal regulations for university laboratories – meaning the tests currently used for genome sequencing are equally high on laboratory research Level level with no feedback to patients and their doctors.
In 46 states, more than 1,900 cases of three key variants have been detected in limited tests, according to the Centers for Disease Control and Prevention. This is worrying as early reports reported that some may spread faster, prove more deadly, or potentially thwart existing treatments and vaccines.
Public health laboratory officials and epidemiologists have warned the federal government that restricting information on the variants – under secret clinical laboratory rules – could hamper efforts to investigate urgent questions about the variants.
The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists joined forces earlier this month to urge federal officials to “urgently” relax certain rules that apply to clinical laboratories.
Washington State officials discovered the first case of the variant, which was discovered in South Africa this week, but the infected person did not provide a good phone number and could not be contacted because of the positive result. Even if health officials track down the patient, we cannot legally tell him about the variant because the test has not yet been federally approved, Teresa McCallion, a health department spokeswoman, said in an email.
“However, we are actively looking into what we can do,” she said.
Lab testing experts describe the situation as catch-22: Scientists need enough case data to ensure that their genome sequencing tests, which are used to detect variants, are correct. But as they wait for the results to come in and undergo thorough scrutiny, cases of variants are increasing. The delay is reminiscent of the situation a year ago. Amid regulatory missteps, approval of a Covid-19 diagnostic test was delayed while the virus spread undetected.
The restrictions are also causing trouble for laboratory professionals and epidemiologists as public health officials try to track down contacts from people infected with contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to say it [patients] A variant was discovered, ”he said.
Compliance with laboratory rules “is not possible in the timeline that a rapidly evolving virus and an responsive public health system require,” the organizations write.
Hamilton also said it could be another tool telling patients they have a novel tribe to foster collaboration – which is waning – to track and investigate their contacts. She said notifications could also continue to encourage patients to take seriously the advice to stay in isolation.
“Can our research be better if we can share this information with the patient?” She said. “I think the answer is yes.”
Public health experts have predicted that the B117 variant, first found in the UK, could be the predominant variant strain of the coronavirus in the US by March.
By Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, first identified in South Africa, in 14 states; and five cases of the P.1 variant originally discovered in Brazil in four states, said Dr. Rochelle Walensky, the CDC director, told reporters on Wednesday.
A February 12 memo from North Carolina public health officials to physicians stated that genome sequencing at the CDC is performed for surveillance purposes and is not an approved test under the Laboratory Clinical Improvement Modification Program established by the U.S. American Centers for Medicare & Medicaid Services – “Sequencing results are not reported back to the provider.”
Earlier this week, the issue was also raised in Illinois. Notifying patients that they are positive for a variant of Covid is “currently not allowed” because the test is not approved by the CLIA, said Judy Kauerauf, director of the communicable disease program for the Illinois Department of Public Health, according to a recording obtained in the documentation for COVID-19 project from Columbia University’s Brown Institute for Media Innovation.
The CDC has expanded its genome sequencing in recent weeks. Walensky said the agency only ran them on 400 samples a week when she started out as director, compared to more than 9,000 samples in the week of February 20.
The Biden government has allocated nearly $ 200 million to expand the federal government’s genome sequencing capacity in hopes of testing 25,000 samples per week.
“We will identify variants of Covid earlier and better target our efforts to stop the spread. We are quickly deploying targeted resources as time is of the essence for these fast-paced variants, “said Carole Johnson, test coordinator for President Joe Biden’s Covid-19 Response Team, on a call to reporters earlier this month.
Hospitals will be given full information on whether a sample submitted for sequencing tests positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Still, patients and their doctors remain in the dark about who exactly was infected.
“It’s relevant from a systems-based perspective,” said Gilpin. “If we have a couple of B117 in my back yard, I’ll be thinking a little differently about how we do business.”
It’s the same in Washington State, McCallion said. Health officials may provide general numbers, for example, 14 out of 16 outbreak samples in a facility were identified as B117 – but not who those 14 patients were.
There are arguments for and against notifying patients. On the one hand, infection with a variant won’t affect patient care, say public health officials and clinicians. Individuals who test positive are still advised to take the same precautions regarding isolation, wearing masks, and hand washing regardless of the level of exposure.
“There would be no medical treatment difference whether they had the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in the event of a public health emergency, it is really important for doctors to know this information”.
Pandori estimates that there may only be 10 or 20 laboratories in the US that are able to validate their laboratory-based variant tests. One of them is the laboratory at the University of Washington in Seattle.
Dr. Alex Greninger, deputy director of the clinical virology laboratories there, who helped develop one of the first tests to detect SARS-CoV-2, said his laboratory started validating the sequencing tests last fall.
In the next few weeks, he expects a test approved by the federal government for the sequencing of Covid in the entire genome. “So any problems you notice with patient notification and use [the] The results won’t be a problem, ”he said in an email.
Companies like Illumina from San Diego have approved Covid test devices that can also detect a variant. However, because the add-on sequencing feature has not been specifically approved by the FDA, the results can be shared with public health officials – but not patients and their doctors, said Dr. Phil Febbo, Illumina Chief Medical Officer.
He said they had not asked the FDA for further approval, but they could if variants raise major concerns, such as escaping vaccination protection.
“I think right now individuals don’t need to know their pressures,” he said.
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