Coronavirus infections of varietal strains are spreading rapidly across the US, but there is one major problem: laboratory officials say they cannot tell patients or their doctors if someone has been infected by a variant.
Federal rules about who can be told about the various cases are so confusing that public health officials can simply know the country where a case originated, but cannot conduct the kind of investigation and give the notices needed to spread the word. to delay, Janet Hamilton said. , executive director of the Council of State and Territorial Epidemiologists.
“It can be associated with a person in a high-risk environment, or it is not, but without patient information we do not know what we do not know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”
The problem is that the tests in question for the detection of variants have not been approved as a diagnostic tool, either by the Food and Drug Administration or under federal rules for university laboratories, which means that the test now used for genomic sequencing, so done high. laboratory research without communication with patients and their physicians.
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Amid limited tests to identify different strains, more than 1,900 cases of three key variants were detected in 46 states, according to the Centers for Disease Control and Prevention. This is of concern due to early reports that some may spread faster or be more lethal or that they may interfere with existing treatments and vaccines.
Officials representing public health laboratories and epidemiologists have warned the federal government that restricting information on the variants – in line with the ominous clinical laboratory regulations – could hamper efforts to investigate urgent questions about them.
The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists this month jointly pressed federal officials to “urgently” relax certain rules applicable to clinical laboratories.
Washington officials have detected the first case of the variant discovered in South Africa this week, but the infected person did not provide a good phone number and could not be contacted about the positive result. Teresa McCallion, a spokeswoman for the health department, said Teresa McCallion, a spokeswoman for the health department, in an email.
“However, we are actively looking at what we can do,” she said.
Experts for laboratory tests describe the situation as a Catch-22: scientists need enough case data to make sure that their genome-sequence tests, which are used to detect variants, are accurate. But while they wait for the results to come in and undergo thorough reviews, the number of cases is rising.
“Can our investigations be better if we can disclose the information to the patient? I think the answer is yes.”
The backlog recalls some of the situation a year ago. Amid faulty regulations, the approval of a Covid-19 diagnostic test was delayed while the virus spread unnoticed.
The restrictions also hamper laboratory professionals and epidemiologists as public health officials try to track down those infected with more contagious strains, said Scott Becker, chief executive of the Association of Public Health Laboratories. ‘You want to be able to tell [patients] a variant has been detected, ‘he said.
Adherence to laboratory rules “is not feasible in the timeline that requires a rapidly evolving virus and a responsive public health system,” the organizations wrote.
Hamilton also said telling patients they have a new species could be another tool to encourage collaboration – which is declining – with efforts to locate their contacts. She said notices could also further encourage patients to take the advice to stay isolated.
“Can our investigations be better if we can disclose the information to the patient?” she said. “I think the answer is yes.”
Public health experts have predicted that the B.1.1.7 variant, first found in the UK, could be the predominant variant by March to March.
As of Tuesday, the CDC has identified nearly 1,900 cases of the B.1.1.7 variant in 45 states; 46 cases of B1351, first identified in South Africa, in 14 states; and five cases of the P.1 variant, which was initially detected in Brazil in four states, dr. Rochelle Walensky, the director of the CDC, told reporters on Wednesday.
A Feb. 12 memo from public caregivers in North Carolina to clinicians said that “results of sequence will not be disclosed to the provider” because genome sequencing is done at the CDC for surveillance purposes and not an approved test under clinical laboratory improvement is not. Amendment Program, or CLIA, which oversees the Centers for Medicare & Medicaid Services.
The topic was also raised in Illinois this week. Informing patients that they are positive for a coronavirus variant is currently not allowed because the test has not been approved by CLIA, Judy Kauerauf, division head of the Illinois Communicable Diseases Disease Program, according to a record of the Documenting COVID said. -19 project of the Brown Institute for Media Innovation of Columbia University.
The CDC has scaled up its genomic order in recent weeks; Walensky said the agency only did this on 400 samples per week when she started as a director, compared to more than 9,000 samples this week.
Patients and doctors in the dark
The Biden government has pledged nearly $ 200 million to increase the federal government’s genomic sequencing capacity in hopes of testing 25,000 samples a week.
“We will identify Covid variants sooner and better target our efforts to stop the spread. We are rapidly importing targeted resources here because time is critical when it comes to these fast-moving variants,” said Carole Johnson, test coordinator for President Joe. Biden’s Covid-19 response team said in a call to reporters this month.
Hospitals get high-level information on whether samples submitted for the sequence tested positive for variants, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B.1.1.7 variant detected. Yet patients and their doctors will remain in the dark about who exactly is infected.
“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B.1.1.7 in my backyard, it will make me think a little differently about how we do business.”
It’s the same in Washington state, McCallion said. Health officials can share general numbers, such as that 14 out of 16 outbreak samples at a facility were identified as B.1.1.7 – but not who the 14 patients were.
There are arguments for and against informing patients. On the one hand, caring for patients will have no effect on infecting a variant, say public health officials and clinicians. And people who test positive will still be advised to take the same precautions for insulation, mask wear and hand washing, no matter what stress they are wearing.
“There will be no difference in medical treatment if they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he said: “In an emergency for public health, it is very important that doctors know this information.”
Pandori estimated that only 10 or 20 labs in the U.S. can validate their lab-based variant tests. One is the laboratory at the University of Washington in Seattle.
Dr Alex Greninger, assistant director of the clinical virology laboratories there, who created one of the first tests to detect SARS-CoV-2, said his laboratory began validating the sequence tests last year.
Greninger said he expects to conduct a federally authorized test for sequencing of the entire genome of Covid-19 within the next few weeks.
‘So, all the problems you notice about notifying patients and using them [the] results will not be a problem, ‘he said in an email.
Illumina and other companies in San Diego have approved coronavirus testing machines that can also detect variants. Because the add-on sequence feature was not specifically approved by the FDA, the results can be shared with public health officials, but not with patients and their doctors, said Illumina medical chief Dr. Phil Febbo.
He said Illumina did not ask the FDA for further approval, but that it would be possible if variants caused greater concern, such as the release of the vaccine’s protection.
“I do not think it is necessary for individuals to know their tribes,” he said.