New York scrambles to replace U.S. government's faulty coronavirus test
kits
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[February 29, 2020]
By Julie Steenhuysen and Jonathan Allen
NEW YORK (Reuters) - New York health
officials are trying to get their own coronavirus testing kits up and
running after getting stuck with faulty tests from the federal
government that they said left them unable to diagnose people quickly in
the nation's most populous city.
New York state's Department of Health filed an emergency application on
Friday with the U.S. Food and Drug Administration (FDA) to be allowed to
use a testing kit for the new coronavirus it has developed in-state,
according to an official involved in the process.
"Upon FDA approval, which we believe is imminent, New York State's
public health laboratory, the Wadsworth Center, can immediately begin
testing," Jonah Bruno, a spokesman for the state's Department of Health,
wrote in an email.
Public health officials say the ability to test locally and get results
within hours will be critical to a rapid response to the fast-spreading
virus that originated in China, causing a sometimes fatal respiratory
illness, and has spread to 46 countries.
The weeks-long struggle to expand local testing has been criticized as
an early misstep in the response by U.S. President Donald Trump's
administration to the outbreak.
Three weeks ago, the FDA gave the green light for state and local labs
to start using a testing kit developed by the U.S. Centers for Disease
Control and Prevention (CDC).
But most labs that received the kits complained they had faulty
components and produced inconclusive results, which the CDC later
acknowledged.
And in New York City, the kit they received was even more faulty than
most, meaning city officials could not use a workaround released by the
CDC this week. Meanwhile, it has had to courier samples to CDC's
laboratories in Atlanta, adding a day or more to the process.
There are 63 confirmed cases of the new coronavirus in the United
States, most of whom fell sick while abroad then were repatriated. No
cases have been detected in New York City, but Mayor Bill de Blasio and
health officials have said its arrival here is inevitable.
Health officials in New York, impatient with the wait for replacement
kits to be sent out, copied the CDC protocol in developing their own
test kits.
The CDC kits were meant to work by comparing a sample swabbed from a
patient's nose or mouth against three distinctive stretches of the
virus' genetic material, which are in small tubes labeled N1, N2 and N3.
Most labs only had issues with the kit's third component, N3.
After reviewing their data, the FDA and CDC told labs this week that the
tests would work fine if they only looked for the N1 and N2 bits of the
virus, ignoring the faulty N3 component.
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A woman wears a mask on Wall St. near the New York Stock Exchange
(NYSE) in New York, U.S., February 28, 2020. REUTERS/Brendan
McDermid
But in New York, both the state lab and the New York City lab said
that in their kits the N1 component was also flawed, and that the
workaround proposed by the CDC and FDA was of no use.
The CDC advised those labs also facing problems with N1 not to use
those kits.
"That was unacceptable to New York," said Scott Becker, chief
executive officer of the Association of Public Health Laboratories,
which represents state and local public health labs. "A handful of
labs had this issue. It wasn't very many. But in the case of New
York, where they were following multiple people under investigation
and with all the global air travel, they really have an urgent need
to bring up testing."
Becker said New York's was the first public health lab in the
country to seek the emergency authorization, and that the FDA said
it would act fast after the application was filed.
"They've said it's possible to do it in a day or two," he said. The
FDA declined to answer questions about the emergency approvals.
As of Wednesday, only seven state labs had the ability to test for
the coronavirus locally.
Meanwhile, the CDC has been working to manufacture new kits that
produce more reliable results.
In a hearing before the House Ways and Means Committee on Thursday,
Health and Human Services (HHS) Secretary Alex Azar said a newly
manufactured CDC test can be sent to 93 public health labs as soon
as Monday.
Jennifer Rakeman, an assistant commissioner at New York City's
health department and the director of the city's testing laboratory
in Manhattan, said that even once the replacement CDC kits arrive it
would take time to make sure they work.
"It could be a number of days, and could be on the order of a week
or weeks," she said.
(Reporting by Julie Steenhuysen in Chicago and Jonathan Allen in New
York; Additional reporting by Nathan Layne in New York; Editing by
Daniel Wallis)
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