Abbott Laboratories received Meals and Drug Administration emergency clearance for its transportable take a look at for … [+] the coronavirus pressure Covid-19 that can promote for simply $5 and permit for “frequent mass testing” in an array of websites together with colleges and workplaces, the corporate mentioned Wednesday, Aug. 27.
Abbott Laboratories new fast take a look at for the Coronavirus pressure Covid-19 ought to broaden much-needed entry and assist fill in gaps the place U.S. testing has been gradual and nonetheless unavailable months into the pandemic.
The U.S. Meals and Drug Administration Wednesday granted an “emergency use authorization” to Abbott’s “BinaxNOW Covid-19 Ag Card” fast take a look at medical doctors and firm observers say could possibly be a “game-changer” given its $5 price tag and skill to show round outcomes inside 15 minutes, permitting it to be administered in colleges, workplaces and different websites.
“This approval could be a meaningful step forward for wide scale testing in the U.S. and could help the U.S. and later the world return to more normal daily life,” analysts at Bank of America international analysis wrote in a report Thursday evening. “This Abbott test does not require any instrument, which is probably its biggest point of differentiation versus other tests, but it also only costs $5 and it appears to be more accurate than other 15 minute turnaround antigen tests.”
Such a take a look at, which nonetheless requires a nasal swab by a well being skilled, is akin to a being pregnant take a look at in its use of “lateral flow technology” and is concerning the measurement of a bank card.
Abbott’s BinaxNow take a look at can also be completely different than the corporate’s ID NOW Covid-19 fast molecular “point-of-care” diagnostic take a look at, which the FDA granted an emergency clearance to in March that can be utilized in non permanent screening areas, physician’s workplace labs and nursing properties to detect the Coronavirus pressure COVID-19 inside a half hour. “Abbott intends on making this new antigen test available to U.S. locations that do not currently have access to Abbott’s ID NOW test or Abbotts’s lab based PCR test,” the Bank of America report mentioned.
BinaxNOW is completely different than IDNow and Becton Dickinson’s “point-of-care antigen” BD Veritor System in that it requires “no instrumentation,” Abbott mentioned. Becton Dickinson earlier this month mentioned its take a look at would value $20 on common.
“We believe this (Abbott) test is a game changer because Abbott will sell the test for $5 . . .(when) competing tests cost about $20,” Wells Fargo analyst Larry Biegelsen and colleagues wrote in a report Wednesday night. “(And) ) unlike other antigen tests, it does not require an instrument, therefore it can be administered anywhere.”
The brand new BinaxNow features a companion cell app Abbott will launch for iPhone and Android units known as NAVICATM” and can make it obtainable at no cost.
Abbott’s BinaxNow works by opening the take a look at card and laying it flat. Then, included nasal swabs are used to gather specimen from each nostrils, “rotating five times in each nostril,” the corporate mentioned.
A clinician then provides “six drops of extraction reagent” into the designated gap on the take a look at card. A swab is then inserted immediately into designated gap on take a look at card and rotated thrice earlier than the take a look at card is closed. A take a look at consequence comes inside 15 minutes, the corporate mentioned.
“The provision of fast testing for COVID- 19 will assist help overburdened laboratories, speed up turnaround instances and drastically broaden entry to individuals who want it,” mentioned Dr. Charles Chiu, professor of laboratory Medication at College of California, San Francisco.