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Is there a case of COVID variant?No one is going to tell you

 


Kim Ye-hyun :: ctmirror.org

Patricia Miglowiec, a registered nurse, puts the cCOVID-19 vaccine in a syringe in the Torrington Area Health District.

Covid-19 infection with variant strains is spreading rapidly throughout the United States, but there is one major problem. Lab officials say they can’t tell patients or doctors if someone has been infected with the variant.

According to Janet, federal rules on who can be told about atypical cases are so confusing that public health officials only need to know the county where the case occurred and conduct such an investigation. Unable to send the necessary notice to delay the spread Hamilton, Secretary-General of the Council of State and Territorial Epidemiologists.

“It may or may not be relevant to people in a high-risk congregation environment, but without patient information we wouldn’t know what we wouldn’t know,” Hamilton said. The group has requested federal authorities to waive the rules. “Time is ticking.”

The problem is that the test for the problem to detect the mutation is not approved as a diagnostic tool by either the Food and Drug Administration or the federal regulations governing university laboratories. That is, the tests currently used for genome sequencing are at the same high level. Lab studies at a level where there is no contact with the patient and his doctor.

According to the Centers for Disease Control and Prevention, more than 1,900 cases of the three major mutants have been detected in 46 states in limited tests to identify different strains. It is worrisome because of early reports that some may spread faster, prove fatal, or interfere with existing treatments and vaccines.

Officials representing public health laboratories and epidemiologists say that limiting information about mutants could hinder efforts to investigate pressing questions about mutants in accordance with esoteric regulations governing clinical laboratories. I warned the federal government that there was.

Public Health Institute Association and State and Territory Epidemiologist Council earlier this month Joint press Federal authorities will “urgently” relax certain rules that apply to clinical laboratories.

Washington state officials detected the first case of a variant found in South Africa this week, but the infected did not provide the proper phone number and were unable to contact with positive results. A State Department spokesman, Teresa McCarion, sent an email saying, “Legal we are him or her, because the test has not yet been approved by the federal government, even if health authorities track the patient. I can’t tell. “

“But we are actively investigating what we can do,” she said.

Labtest experts describe the situation as Catch-22. Scientists need sufficient case data to ensure that the genomic sequencing tests used to detect variants are accurate. However, various cases are skyrocketing while waiting for results and a thorough review. Rag reminds me of some of the situation a year ago. Due to regulatory failure, approval of the covid-19 diagnostic test was delayed and the virus spread undetected.

Restrictions also detain laboratory experts and epidemiologists, as public health authorities seek to track contact with people infected with more contagious strains, and is the Chief Executive Officer of the Institute for Public Health. Scott Becker said. “You want to tell [patients] A variant has been detected, “he said.

Adhering to lab rules is “not feasible on the timeline required by rapidly evolving viruses and responsive public health systems,” the organization writes.

Hamilton also said telling patients that they have new strains could be another tool to facilitate cooperation with efforts to track and sample their contacts. She also said the notice may further encourage patients to seek advice because they remain seriously isolated.

“Would our investigation be better if we could disclose that information to patients?” She said. “I think the answer is yes.”

Public health experts predict that the first B117 mutant found in the United Kingdom could become the major variant of the coronavirus in the United States by March.

As of Tuesday, the CDC identified approximately 1,900 B117 variants in 45 states. 46 cases of B1351 first identified in South Africa, 14 states. CDC director Dr. Rochelle Walensky told reporters Wednesday about five cases of the first P.1 variant detected in four states in Brazil.

Until February 12 Note From North Carolina public health authorities to clinicians, CDC genome sequencing is for surveillance purposes and is not an approved test under the Laboratory Improvement and Modification Program supervised by the US Medicare & Medicaid Service Center. No information from result sequencing will be returned to the provider. “

Earlier this week, this topic was also covered in Illinois. According to the records obtained by the documentation, notifying patients that the covid variant is positive is “currently not allowed” because the test has not been CLIA approved, an Illinois Public Health Service infectious disease. Judy Kauerauf, chief of the program, said the COVID-19 project at Columbia University’s Institute for Brown Media Innovation.

The CDC has expanded its genomic sequencing in recent weeks, and Walensky said that when she took office as director, the agency only had 400 samples per week, compared to more than 9,000 samples for the week of February 20. He states that he was doing it.

The Biden administration has promised nearly $ 200 million to expand the federal government’s ability to sequence genomes, hoping to be able to test 25,000 samples a week.

“We are more likely to identify variants of covid and more accurately target efforts to stop its spread,” said Carol Johnson, test coordinator for President Joe Biden’s covid-19 response team. In a call with the press this month, time is important for these fast-moving variants, so we’re quickly injecting the resources of interest here.

Dr. Nick Gilpin, Head of Infection Prevention at Beaumont Health, Michigan, said the hospital has a high level of information about whether the samples submitted to sequencing are positive for the mutant. It was. Still, patients and their doctors remain in the dark as to who was exactly infected.

“This is relevant from a system-based perspective,” Gilpin said. “If you have a lot of B117s in your backyard, that would give you a slightly different way of thinking about how we do business.”

The same is true in Washington, McCarion said. Health officials may share common numbers, such as 14 of the 16 specimens generated at the facility identified as B117, but it is not known who the 14 patients are.

There are pros and cons to notifying patients. On the other hand, infection with the mutant does not affect patient care, public health officials and clinicians say. It is also recommended that individuals who test positive should take the same precautions for quarantine, masking, and hand washing, regardless of the strain they have.

Mark Pandri, director of the Nevada Institute for Public Health, said: “There is no difference in treatment with or without mutations,” he added, “in a public health emergency, it is very important for doctors to know this information.”

Pandori estimated that there could be only 10 or 20 laboratories in the United States that could validate lab-based variant tests. One of them is the University of Washington lab in Seattle.

Dr. Alex Greninger, Assistant Director, Co-created Institute for Clinical Virology One of the first tests To detect SARS-CoV-2, his lab said it began work on verifying sequence tests last fall.

He said he hopes to undergo federal-approved testing for covid’s whole-genome sequencing within the next few weeks. “So all the issues you should be aware of regarding notification and use of patients [the] The results won’t matter, “he said in an email.

Companies, including San Diego-based Illumina, have approved covid test machines that can also detect variants. However, the add-on’s sequencing feature has not been specifically approved by the FDA, so results can be shared with public health authorities, but not with patients and their physicians, said Dr. Phil Febbo, Illumina’s Chief Health Officer. I am.

He hasn’t asked the FDA for further approval, but said it would be possible if the variants began to raise greater concerns, such as avoiding vaccine protection.

“I don’t think individuals need to know their stock for now,” he said.

This story was first published on February 25, 2021 Kaiser Health News And NBC News.


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