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GREEN OAKS, IL — Abbott Laboratories accustomed emergency use allotment from the U.S. Food and Drug Administration Wednesday for a accelerated coronavirus analysis that it affairs to advertise for $5 each. The new analysis is about the admeasurement of a acclaim card, requires no added equipment, and will accommodate after-effects aural 15 minutes, aggregation admiral announced.

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Abbott Labs will be able to address tens of millions of the new tests — alleged the BinaxNow COVID-19 Ag Agenda — abutting ages with a ambition of bearing 50 actor tests a ages by the alpha of October, according to aggregation officials. They said Abbott has spent hundreds of millions of dollars back April to accomplish new tests at a massive scale.

"This new COVID-19 antigen analysis is an important accession to attainable tests because the after-effects can be apprehend in minutes, appropriate off the testing card," said Dr. Jeff Shuren, administrator of the FDA's Center for Accessories and Radiological Health, in a account afterward Wednesday's emergency use authorization. "This agency bodies will apperceive if they acquire the virus in about real-time. Due to its simpler architecture and the ample cardinal of tests the aggregation anticipates authoritative in the advancing months, this new antigen analysis is an important advance in our action adjoin the pandemic."

The analysis is conducted application nasal swabs. It functions agnate to a abundance analysis — an added band appears on the agenda back a sample tests absolute for the COVID-19 virus.

Under its use authorization, the agenda is advised for use by healthcare professionals in able settings. With basal training and a prescription, the analysis can be performed by academy nurses, medical administration and technicians, pharmacists and anatomic bloom specialists, according to the company.

"Our nation's frontline healthcare workers and analytic class cadre acquire been beneath annoy back the admission of this pandemic," Dr. Charles Chiu, assistant of Class Medicine at University of California, San Francisco, said in a account from Abbott announcement the authorization. "The availability of accelerated testing for COVID-19 will advice abutment overburdened laboratories, advance turnaround times and abundantly aggrandize admission to bodies who charge it."

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Antigen tests are cheaper to aftermath and bear after-effects faster than atomic analytic tests performed in labs, but they acquire additionally been begin to be beneath accurate. FDA admiral said their bargain acuteness agency abrogating tests may charge to be accepted with added atomic tests afore analysis decisions are made.

"Negative after-effects from an antigen analysis should be advised in the ambience of analytic observations, accommodating history and epidemiological information," according to the FDA statement.

According to Abbott officials, the new analysis is 97.1 percent authentic in anecdotic absolute after-effects and 98.5 percent authentic in anecdotic abrogating after-effects back administered to bodies with doubtable cases of COVID-19 aural a anniversary of their aboriginal symptoms.

"The massive calibration of this analysis and app will acquiesce tens of millions of bodies to acquire admission to accelerated and reliable testing," said Joseph Petrosino, a virologist alive on COVID-19 testing at Baylor College of Medicine.

"With lab-based tests, you get accomplished acuteness but ability acquire to delay canicule or best to get the results," he said. "With a accelerated antigen test, you get a aftereffect appropriate away, accepting communicable bodies off the streets and into apprehension so they don't advance the virus."

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Related:Abbott Labs Ships Over 1 Actor Accelerated Coronavirus Tests To Every StateAbbott Labs Gets Emergency Approval For Accelerated Coronavirus Test2nd Abbott Labs Coronavirus Antibiotic Analysis Gets Emergency ApprovalCoronavirus Analysis Fabricated By Abbott Labs Wins Emergency FDA Approval

Abbott admiral said BinaxNOW tests can be acclimated to analysis ample groups of bodies at workplaces, schools and added gatherings. To accompany the new tests, the aggregation additionally appear a downloadable adaptable app advised to accommodate affidavit of contempo abrogating analysis results. It's the aboriginal such app in the United States, although agnate measures acquire been adopted in China in an accomplishment to axis the advance of the coronavirus.

The app, dubbed Navica, is chargeless and not mandatory, according to Abbott. The alternative apparatus works with both Apple and Android agenda wallets.

People who analysis abrogating for the virus can affectation a QR cipher on their phones, like with a boarding canyon for a plane. The "digital bloom pass" is stored briefly and is alone accurate for as continued as the organizations that acquire the app after-effects choose.

Robert Ford, Abbott's admiral and CEO, said the new analysis and accompanying app action the adventitious for bodies to acquire "a bit added normalcy" in their circadian lives.

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"We carefully advised the BinaxNOW analysis and NAVICA app so we could action a absolute testing band-aid to advice Americans feel added assured about their bloom and lives," Ford said.

The app is not acclimated for acquaintance archetype and alone collects a person's name, age, ZIP code, acquaintance advice and analysis results, according to the company.

"While BinaxNOW is the accouterments that makes alive your COVID-19 cachet possible, the NAVICA app is the agenda arrangement that allows bodies to allotment that advice with those who charge to know," he added. "We're demography our ability from our digitally-connected medical accessories and applying it to our affection at a time back bodies apprehend their bloom advice to be agenda and readily accessible."

Shares in Abbott Labs were up by added than 9 percent Thursday, a new high, according to Bloomberg News. As of the afternoon, the company's banal had risen by about 30 percent so far in 2020 as of the afternoon. A agent told the Chicago Tribune the aggregation affairs to appoint 2,000 acting workers at a new ability in Gurnee to advice aftermath the tests.

The testing agenda is sixth coronavirus analysis developed by the arctic burghal company. The aggregation has produced added than 27 actor coronavirus tests in the U.S. to date. Of those, about 14 actor were analytic tests to ascertain alive COVID-19 cases and 13 actor were antibiotic tests, which ascertain beforehand infections.

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