Covid-19 infections from variant strains are quickly spreading across the
U.S., but there’s one big problem: Lab officials say they can’t tell
patients or their doctors whether someone has been infected by a variant.
Federal rules around who can be told about the variant cases are so
confusing that public health officials may merely know the county where a
case has emerged but can’t do the kind of investigation and deliver the
notifications needed to slow the spread, according to Janet Hamilton,
executive director of the Council of State and Territorial Epidemiologists.
"It could be associated with a person in a high-risk congregate setting or
it might not be, but without patient information, we don’t know what we
don’t 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 detecting variants have not
been approved as a diagnostic tool either by the Food and Drug
Administration or under federal rules governing university labs ― meaning
that the testing being used right now for genomic sequencing is being done
as high-level lab research with no communication back to patients and their
doctors.
... "legally we can’t" tell him or her about the variant because the test is not yet federally approved ...
Amid limited testing to identify different strains, more than 1,900 cases of
three key variants have been detected in 46 states, according to the Centers
for Disease Control and Prevention. That’s worrisome because of early
reports that some may spread faster, prove deadlier or potentially thwart
existing treatments and vaccines.
Officials representing public health labs and epidemiologists have warned
the federal government that limiting information about the variants ― in
accordance with arcane regulations governing clinical labs ― could hamper
efforts to investigate pressing questions about the variants.
The Association of Public Health Laboratories and the Council of State and
Territorial Epidemiologists earlier this month
jointly pressed
federal officials to "urgently" relax certain rules that apply to clinical
labs.
Washington state officials detected the first case of the variant discovered
in South Africa this week, but the infected person didn’t provide a good
phone number and could not be contacted about the positive result. Even if
health officials do track down the patient, "legally we can’t" tell him or
her about the variant because the test is not yet federally approved, Teresa
McCallion, a spokesperson for the state department of health, said in an
email.
"However, we are actively looking into what we can do," she said.
Lab testing experts describe the situation as a Catch-22: Scientists need
enough case data to make sure their genome-sequencing tests, which are used
to detect variants, are accurate. But while they wait for results to come in
and undergo thorough reviews, variant cases are surging. The lag reminds
some of the situation a year ago. Amid regulatory missteps, approval for a
covid-19 diagnostic test was delayed while the virus spread undetected.
... the B117 variant, first found in
the United Kingdom, could be the predominant variant strain of the
coronavirus in the U.S. by March.
The limitations also put lab professionals and epidemiologists in a bind as
public health officials attempt to trace contacts of those infected with
more contagious strains, said Scott Becker, CEO of the Association of Public
Health Laboratories. "You want to be able to tell [patients] a variant was
detected," he said.
Complying with the lab rules "is not feasible in the timeline that a rapidly
evolving virus and responsive public health system requires," the
organizations wrote.
Hamilton also said telling patients they have a novel strain could be
another tool to encourage cooperation ― which is waning ― with efforts to
trace and sample their contacts. She said notifications might also further
encourage patients to take the advice to remain isolated seriously.
"Can our investigations be better if we can disclose that information to the
patient?" she said. "I think the answer is yes."
Public health experts have predicted that the B117 variant, first found in
the United Kingdom, could be the predominant variant strain of the
coronavirus in the U.S. by March.
As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant
in 45 states; 46 cases of B1351, which was first identified in South Africa,
in 14 states; and five cases of the P.1 variant initially detected in Brazil
in four states, Dr. Rochelle Walensky, the CDC director, told reporters
Wednesday.
A Feb. 12 memo
from North Carolina public health officials to clinicians stated that
because genome sequencing at the CDC is done for surveillance purposes and
is not an approved test under the Clinical Laboratory Improvement Amendments
program ― which is overseen by the U.S. Centers for Medicare & Medicaid
Services ― "results from sequencing will not be communicated back to the
provider."
Earlier this week, the topic came up in Illinois as well. Notifying patients
that they are positive for a covid variant is “not allowed currently”
because the test is not CLIA-approved, said Judy Kauerauf, section chief of
the Illinois Department of Public Health communicable disease program,
according to a record obtained by the Documenting COVID-19 project of
Columbia University’s Brown Institute for Media Innovation.
The CDC has scaled up its genomic sequencing in recent weeks, with Walensky
saying the agency was conducting it on only 400 samples weekly when she
began as director compared with more than 9,000 samples the week of Feb. 20.
The Biden administration has committed nearly $200 million to expand the
federal government’s genomic sequencing capacity in hopes it will be able to
test 25,000 samples per week.
“We’ll identify covid variants sooner and better target our efforts to stop
the spread. We’re quickly infusing targeted resources here because the time
is critical when it comes to these fast-moving variants,” Carole Johnson,
testing coordinator for President Joe Biden’s covid-19 response team, said
on a call with reporters this month.
Hospitals get high-level information about whether a sample submitted for
sequencing tested 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. Yet patients and their doctors will remain
in the dark about who exactly was infected.
"It’s relevant from a systems-based perspective," Gilpin said. “If we have a
bunch of B117 in my backyard, that’s going to make me think a little
differently about how we do business.”
It’s the same in Washington state, McCallion said. Health officials may
share general numbers, such as 14 out of 16 outbreak specimens at a facility
were identified as B117 ― but not who those 14 patients were.
There are arguments for and against notifying patients. On one hand, being
infected with a variant won’t affect patient care, public health officials
and clinicians say. And individuals who test positive would still be advised
to take the same precautions of isolation, mask-wearing and hand-washing
regardless of which strain they carried.
"There wouldn’t be any difference in medical treatment whether they have the
variant," said Mark Pandori, director of the Nevada State Public Health
Laboratory. However, he added that “in a public health emergency it’s really
important for doctors to know this information.”
Pandori estimated there may be only 10 or 20 labs in the U.S. capable of
validating their laboratory-based variant tests. One of them doing so is the
lab at the University of Washington in Seattle.
Dr. Alex Greninger, assistant director of the clinical virology laboratories
there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing
tests last fall.
Within the next few weeks, he said, he anticipates having a federally
authorized test for whole-genome sequencing of covid. "So all the issues you
note on notifying patients and using [the] results will not be a problem,"
he said in an email.
Companies including San Diego-based Illumina have approved covid-testing
machines that can also detect a variant. However, since the add-on
sequencing capability wasn’t 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’s chief medical officer.
He said they haven’t asked the FDA for further approval but could if
variants start to pose greater concern, like escaping vaccine protection.
"I think right now there’s no need for individuals to know their strains,"
he said.
