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The manufacturers tested the Covid-19 quickly responding to exceptional demand



Doctors, nursing homes and federal officials are scrambling to obtain a supply of quick-response Covid-19 antigen testing from the two companies that have secured urgent approval to manufacture them, as Cases continue to increase in the US

Rapidly reactive antigen tests make up a small but growing area of ​​the Covid-19 test in the United States and are considered to be helpful in preventing flare-ups as they give results faster than Many molecular assays have to be sent to a laboratory for processing. The tests look for the virus’s protein while the others look for the virus’s genetic material.

Quidel Group

QELEL 0.91%

and Becton Dickinson & Co., the only companies to be federally authorized to provide such diagnostic tests, also build machines to process them. Box-shaped, pre-pandemic test analyzers that handle tests for diseases such as influenza, found in physician and nursing homes, allow establishments to avoid shipping samples to Commercial laboratories for handling. They can deliver results in about 1

5 minutes and process dozens of samples per hour.

Quidel is having difficulty producing enough analyzers to meet demand, while Becton Dickinson’s challenge is to do enough of the tests, the companies said.

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In July, people waited two weeks or longer for diagnostic test results in the US. This delay underlines the importance of immediate results that people can act quickly.

CVS Health Corp.,

says they do about 5% of trials in the US, are planning to expand the so-called Covid-19 test at the point of care as it provides a solution to the delay, the company said last week. .

Some small practices reported they had struggled to get the rapid antigen tests and processing equipment they needed. Katie Schafer, a pediatrician at Bloom Pediatrics in Birmingham, Mich., Already has a Becton Dickinson analyzer this method uses 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 myself lucky because we have received whatever,” said Dr. Schafer, who tries to save tests for symptomatic patients with only about half of primary births. “There is no good news coming from the agents selling these tests,” she added.

One patient was given gauze gauze for the Covid-19 test at Glendale Urgent Care.


Image:

Hans Gutknecht / Zuma Press

Quidel and Becton Dickinson are both ramping up production to meet demand but are grappling with challenges including swab sourcing and additional factory capacity.

Quidel says it currently produces around 2,000 analyzers per month and can do up to 1.8 million tests weekly if they can secure all the supplies they need.

Quidel’s chief executive, Douglas Bryant, said a Quidel board member’s private doctor had asked for help buying one of the company’s analyzers, but Quidel declined because the plan was only Check in with five people per day.

Becton Dickinson has enough analyzers to meet the demand and is ramping up production, though it faces a shortage of test kits, a spokesman said.

The federal government has given priority to other customers for tests and analyzers that Quidel and Becton Dickinson have recently performed. Equipment is largely being deployed to nursing homes where the coronavirus has caused serious damage. Bryant said he had been informed by the US Department of Defense that they were preparing a mass order.

Public health officials have raised some concerns that rapid antigen tests give false negative results at higher rates than other tests. But federal officials have said that, as these tests become more common, they appear to have the same sensitivity as the more widely used polymerase chain reaction diagnostic tests.

A spokesperson for the Department of Health and Human Services said there are no rules as to how Covid-19 instruments or tests should be preferred, even though the agency requires test manufacturers to comply. distribution of cases in the country.

As demand for the Covid-19 test outstrips supply, some health authorities are narrowing recommendations on who should get tested. WSJ’s Stefanie Ilgenfritz explains why the message of testing has changed. Photo: Go Nakamura / Getty Images

A company spokesperson said Becton Dickinson sells most of its devices through distributors and leaves them with sales and allocation policies. It allows the buyer to purchase its machines immediately without asking them to order a minimum amount of testing to run on them.

Quidel said initially they had a process to prioritize who could buy their machines and ensure those units went primarily to medical providers capable of checking large numbers of people, he said. Bryant said. Now, he said, in addition to mass sales to government agencies, the company mainly leaves such decisions to its outside network of distributors but wants analysts to go where they can run. most tested.

“There will be people who are disappointed, and I personally feel bad about that,” said Bryant.

Quidel and its distributors either sell the analyzers for $ 1,200 each or offer the analyzer at no cost to the buyer if they agree to purchase a certain number of tests for Covid-19 and other Another disease, a deal is called a rental.

Some small practices indicate that they cannot buy Quidel machines completely and cannot afford the required amount of testing under a lease. Quidel’s distributors have sometimes directed customers to larger orders, said some primary and children’s healthcare facilities.

In a July email to Mission, the Texas-based Family Medicine Association from distributor CLIA Waived Inc. reviewed by The Wall Street Journal, an account manager said it’s customary to wait until September to buy a device right away but can get one under a lease if they commit to at least buy one. 200 flu tests and 200 streptococci a year for the next three years.

Kayla Tezcucano, director of the Family Medicine office, said the Quidel tests cost twice as much as a normal method of practice kit for those tests, and the placement will cost an additional $ 6,000.

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“I am very sad that we are in the midst of a pandemic and they can provide these tests to give us the answers we need,” said Tezcucano.

CLIA CEO Bryan Andrus said the account manager’s assertion that Quidel would lease the machine but not sell the machine based on his experience with previous orders. Quidel said Quidel does not prioritize leasing over sales but admits some distributors may direct customers to larger ticket deals.

Write letter for Sarah Krouse at sarah.krouse@wsj.com and Sharon Terlep at sharon.terlep@wsj.com

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