By Sarah Krouse and Sharon Terlep
Doctors, nursing homes and federal officials are scrambling to
get rapid-response Covid-19 antigen testing supplies from the two
companies that secured emergency approval to produce them, as cases
continue to rise in the U.S.
Rapid-response antigen tests make up a small but growing area of
Covid-19 testing in the U.S. and are seen as helpful in tamping
down outbreaks because they offer faster results than many
molecular tests that must be sent to labs for processing. The tests
search for virus proteins while other tests look for the virus's
Quidel Corp. and Becton Dickinson & Co., the only companies
that so far have federal emergency authorization to supply such
diagnostic tests, also make machines that process them. The boxlike
test-analyzers, which before the pandemic processed tests for
ailments such as the flu, are found in doctors' offices and nursing
homes, allowing facilities to avoid shipping samples to commercial
labs for processing. They can deliver results in about 15 minutes
and process dozens of samples an hour.
Quidel is struggling to produce enough analyzers to meet demand,
while Becton Dickinson's challenge is making enough tests, the
In July, people waited two weeks or longer for results of
diagnostic tests in the U.S. The delays underscored the importance
of immediate results that individuals can quickly act on.
CVS Health Corp., which says it performs about 5% of U.S.
testing, is planning to expand so-called point-of-care Covid-19
testing because it offers a solution to delays, the company said
Some small practices say they have struggled to obtain the rapid
antigen tests and processing equipment they need. Katie Schafer, a
pediatrician at Bloom Pediatrics in Birmingham, Mich., had a Becton
Dickinson analyzer that the practice used for flu tests. Last
month, she ordered 1,000 Covid-19 tests to run on the machine. So
far, only 120 tests have arrived.
"I consider ourselves lucky that we got any at all," said Dr.
Schafer, who tries to save the tests for patients with symptoms and
has about half of the initial delivery left. "There's no good news
coming out of the reps that sell these tests," she added.
Quidel and Becton Dickinson are each ramping up production to
meet demand but are grappling with challenges including sourcing
sample-collection swabs and additional manufacturing plant
Quidel said it currently makes about 2,000 analyzers a month and
can make up to 1.8 million tests weekly if it is able to secure all
the supplies it needs.
A Quidel board member's personal physician asked for help
acquiring one of the company's analyzers, but Quidel refused
because the practice planned to test only five people a day, said
Douglas Bryant, Quidel's chief executive.
Becton Dickinson has enough analyzers to meet demand and is
ramping up production, though it faces a shortage of testing kits,
a spokeswoman said.
The federal government has been given priority over other
customers for the tests and analyzers Quidel and Becton Dickinson
have made recently. The equipment is largely being deployed to
nursing homes where the coronavirus has taken a severe toll. Mr.
Bryant said he was told by the U.S. Defense Department that it was
preparing a mass order.
Public health officials have raised some concerns that rapid
antigen tests deliver false-negative results at a higher rate than
other tests. But federal officials have said that, as these tests
become more widespread, they appear equal in sensitivity to the
more broadly used polymerase chain reaction diagnostic tests.
There are no rules on how Covid-19 testing instruments or tests
should be prioritized, said a spokeswoman for the Department of
Health and Human Services, though the agency asks that test makers
follow the distribution of cases in the country.
Becton Dickinson sells most of its devices through distributors
and leaves sales policies and allocation to their discretion, the
company spokeswoman said. It allows buyers to purchase its machines
outright without also requiring them to order a minimum number of
tests to run on them.
Quidel said it initially had a process for prioritizing who was
able to buy its machines and ensured the units went mostly to
health providers capable of testing large numbers of people, Mr.
Bryant said. Now, he said, aside from mass sales to government
entities, the company mostly leaves such decisions to its network
of external distributors but wants analyzers to go to places that
can run the most tests.
"There are going to be people who are disappointed, and I
personally feel bad about that," Mr. Bryant said.
Quidel and its distributors either sell the analyzers for $1,200
each or give the analyzer free to a buyer if they agree to purchase
a certain number of tests for Covid-19 and other illnesses, an
arrangement referred to as leasing.
Some small practices say they haven't been able to buy a Quidel
machine outright and can't afford the number of tests required
under the lease arrangement. Quidel distributors have at times
steered customers toward larger orders, some primary care and
pediatric practices said.
In a July email to Mission, Texas-based Family Medicine
Associates from distributor CLIA Waived Inc. that was reviewed by
The Wall Street Journal, an account manager said the practice would
have to wait until September to buy a device outright but could get
one under a lease if it committed to buying at least 200 flu and
200 strep tests a year for the next three years.
The Quidel tests cost roughly twice as much as the practice's
normal kits for those tests, and the arrangement would cost it an
additional $6,000, said Kayla Tezcucano, Family Medicine's office
"I get upset because we are in the middle of a pandemic and they
are able to supply these tests that give us answers we need," Ms.
CLIA Waived operating chief Bryan Andrus said the account
manager's assertion that Quidel would lease but not sell a machine
was based on his experience with past orders. Mr. Bryant said
Quidel doesn't prioritize leases over sales but acknowledged some
distributors may steer clients toward larger-ticket deals.
Write to Sarah Krouse at firstname.lastname@example.org and Sharon Terlep
(END) Dow Jones Newswires
August 12, 2020 07:38 ET (11:38 GMT)
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