THE LAST COUPLE of weeks, customers at Skenderian Apothecary in Cambridge have been asking for at-home COVID tests. But owner Joseph Skenderian hasn’t been able to stock them.
“I can’t get a steady line,” Skenderian said. “When I go to order, I might get a couple, then they’re unavailable. They go very quickly.”
As COVID-19 rates are rising again amid a surge in Delta variant cases, people are flocking to buy a relatively new product: at-home, rapid COVID tests. The high demand nationwide is creating a shortage of the products. And their availability also poses new questions about the accuracy of state-related COVID case counts, since if someone tests positive at home, their illness may never be reported to public health officials.
Since November 2020, the US Food and Drug Administration has approved for emergency use several COVID tests where specimens can be collected at home.
Some, like QuestDirect, mail consumers a kit. The consumer takes a nasal swab and mails the kit back. According to Quest, the test is processed in the lab just as if it were collected in a doctor’s office, and results are reported to public health authorities as required by law.
But other tests can be done without a lab. Abbot BinaxNOW is a rapid test that is done at home and delivers results in 15 minutes. There is another rapid at-home test manufactured by Ellume, and one by Quidel called QuickVue. The tests are generally less reliable than the traditional PCR tests, but they still have relatively high accuracy and allow for faster results. While PCR tests are often covered by insurance or government programs, the rapid tests cost money – between $24 and $39 for one or two tests, depending on the brand.
Demand for the tests appears to be surging. CVS said last week that it was limiting the number of at-home tests each customer could purchase due to increased demand and limited supply.
“We’re experiencing high demand for over-the-counter testing products and are working with our suppliers to meet that demand,” CVS spokesperson Matt Blanchette said in an email. “In the event that any of our stores experience a temporary shortage, we will re-supply them as quickly as possible.”
On Wednesday, Quidel announced that it had reached a deal with CVS to sell the QuickVue tests, after Quidel experienced a surge in demand.
John Koval, a spokesperson for Abbott, said his company is seeing “unprecedented demand” as case rates rise, and it has been scaling up manufacturing since Delta became the dominant strain and the CDC called for a reprioritization of testing. “Today, there are tens of millions of BinaxNOW tests in various settings and supply chains,” Koval said in an email. “We’re hiring people and turning on parts of our manufacturing network that were idled or slowed when guidance changed and demand plunged – and we’re working with our customers to ensure tests get to where they’re most needed and we’re ramping back up, as we did last year.”
Smaller pharmacies cannot even get the tests. Gail Bray, the manager at Gary Drug Co. in Boston, takes multiple phone calls a day from people seeking at-home COVID tests. “Unfortunately, I do not carry them because they’re in such high demand they’re unavailable,” Bray said. When she calls her distributer, Bray said, “They’re constantly out of stock.”
If stores are selling out of tests, that raises the question of how many cases are out there and whether they are all getting reported.
The Massachusetts Department of Public Health’s data includes positives reported from both molecular and antigen tests – the PCR tests and the rapid tests. But, according to the department, rapid tests are not meant to be a substitute for molecular tests. it is recommended that any individual who tests positive with a BinaxNOW test consult their health care provider. They may need a confirmatory PCR test because molecular tests are considered the standard for reporting positivity rates and accurately measuring transmission.
The department notes that at-home tests can be paired with mobile apps, which are set up to report results to the Department of Public Health. But not every positive result is necessarily reported.
The Ellume test was approved with a mobile application, which requires users to input their zip code and birth date (names are optional), then reports the results to public health authorities. The Abbot BinaxNOW test recently paired with a mobile app, which is set up to report data to public health authorities, but use of the app is optional. The QuickVue test says in its instructions that someone who tests positive should follow up with their doctor “as additional testing may be necessary and for public health reporting.”
Dr. Michael Mina, assistant professor of epidemiology at Harvard’s T.H. Chan School of Public Health and a strong proponent of at-home rapid COVID-19 tests, could not be reached this week, but he told Bloomberg that the US should be doing a better job of tracking the results of at-home COVID tests. Now, he said, when a person tests positive at home, their family members are buying the same at-home tests “and nobody knows that there’s a little cluster of people that are infected right here.”