Abbott tests out-of-stock at Allegheny – The Campus
Company destroyed test components at Maine facility after demand slows
Starting Monday, September 13, the Allegheny College community will have their noses swabbed with kits from Inspire Diagnostics instead of Abbott Laboratories’ BinaxNOW rapid tests. Decision, announced by email on Friday, September 10, is the result of a supply shortage of the BINAX test, a shortage having origins earlier in the summer.
According to an August 20 New York Times article, Abbott ordered the destruction of 8.6 million test cards at a manufacturing facility outside of Portland, Maine. In response to the article published the same day, Abbott justified the move by citing a drop in demand for testing.
The drop is mainly due to the Center for Disease Control’s announcement in June that fully vaccinated people do not need to be tested just for being exposed to someone infected with the virus. The CDC revised its guidelines again in July, recommending this practice.
The company also cited what it believed to be sufficient reserves of its product based on market forecasts.
“At this time, Abbott had significant quantities of finished test kits in stock to meet expected demand,” the company wrote.
But the CDC’s renewed guidance, combined with the start of many academic years at many schools and universities, led Dr Sean Parsons, CEO of Australian medical society Ellume, to say in mid-August that demand for a test at home was 1,000 times what Ellume had projected. Ellume produces a rapid home test that rivals Abbott’s BinaxNOW.
To understand Abbott’s other responses to The Times article, it’s important to understand how the BinaxNOW test works. According to the FDA, the test card has two lines of antibodies suspended when positive or negative indications are given. One set of antibodies is a control set, while the other is specific for COVID-19.
Once a nasal sample is taken from a patient, it is mixed with a chemical reagent on the test card. The resulting chemical reaction displays either one line for a negative result or two lines for a positive result. So while the test card is an integral part of the test, it is not the test in its entirety, and on that technicality, Abbott again defended himself.
“We did not destroy any finished BinaxNOW product, nor any usable test components required by the market that may have been donated,” the company wrote in its statement. “In fact, since Abbott has maintained usable test components, we are now able to increase production (production). “
The Times reports also included photos of specific batch numbers of test cards that were to be destroyed. According to Abbott’s statement, these lots had “a shelf life of seven months and were disposed of in accordance with our standard inventory management process.”
However, the Times article quotes anonymous employees as saying that some of the shredded test cards had expiration dates until early February 2022, and the article includes photographs of the expiration dates during the first one. week of that month.
The Times article also quoted Amal Barakat, a virologist at the World Health Organization, regarding Abbott’s decision not to donate any of the test components and destroy them instead.
“My heart, it hurts,” Barakat said.
Barakat specifically cited Lebanon as a country under his jurisdiction that struggled to acquire tests, and said some labs import whatever they can, whether it was approved or not.
Abbott’s statement implicitly dismissed these concerns by referring to the necessary trade regulations that BinaxNOW would have to follow to be internationalized.
“It would have taken months to complete manufacturing, create individualized regulatory dossiers in countries, obtain regulatory approvals, ship the product overseas under exact specified storage conditions, and then hand it over to the people who need it -” too late for the product to be widely used. Abbott wrote.
Appearing to anticipate the company’s statement, Barakat dismissed the idea that trade regulations would prevent testing from entering the noses of Lebanese citizens.
“It’s just paperwork,” Barakat told The Times.
Either way, the shortage does not worry the Allegheny College health agency. In her announcement of the transition away from BinaxNOW, Dr Gabrielle Morrow wrote: “We will be returning to the Inspire app and website that we used so successfully last year to keep our community safe.
Inspire does not produce its own tests. Instead, the company uses AccessBio’s Carestart rapid antigen test, and there has been no indication of a shortage of AccessBio. However, the Carestart test is less accurate than the BinaxNOW test in detecting COVID-19, with Carestart detecting 88.4% of positive cases compared to 97.1% for BinaxNOW. BinaxNOW is also considered the only cheapest rapid antigen test on the market at $ 5 per unit, although Carestart’s unit cost varies and the price Allegheny pays for each test is not publicly available.
ACHA and Ellen Johnson, VP of Enrollment Management, declined to comment and referred The Campus to its September 10 announcement.