FDA Expands Recall of Ellume COVID-19 Home Test Kits

During the early days of the COVID-19 public health emergency, most of the COVID-19 tests that received emergency use authorization (EUA) from the FDA were designed for diagnosis. But before long, the agency also began clearing a new breed of COVID-19 tests designed for screening on a rapid and scalable basis at the point of care. At-home versions of rapid test kits began receiving EUA late last year. But now accuracy concerns have prompted a series of recalls of these tests. On Oct. 15, the FDA issued a Class 1 recall for a pair of high throughput tests from Abbott Laboratories; and on Nov. 9, the agency expanded its current recall of home test kits from Ellume.

Recalls Raise Doubts at the Worst Possible Time

The stakes are incredibly high. As the pandemic has drawn on, the focus of diagnostic testing has shifted to rapid point-of-care and over-the-counter, at-home products allowing for screening the asymptomatic population. Many of these tests are sold over the counter by retail giants like Amazon, CVS, Walmart and Target. In September, the Biden administration unveiled a plan calling for the federal government to spend $2 billion to make these tests more widely available to the public.

But while they offer scalability and speed, questions remain about whether rapid at-home and high throughput COVID-19 screening tests are accurate enough to provide a reliable solution. And the recent recalls threaten to undermine public faith in these tests at a time when they are being counted on the most.

The Ellume Recall

On Dec. 15, 2020, the Ellume COVID-19 Home Test became the first fully at-home SARS-CoV-2 testing kit to receive EUA for over-the-counter sale. In studies, the 20-minute antigen test registered an overall sensitivity of 96 percent and specificity of 100 percent. In February, the Australian test maker cut a $231.8 million deal with the Departments of Defense and Health and Human Services to establish a US production facility and crank out 8.5 million of the tests for distribution across the country.

On Oct. 5, Ellume recalled 200,000 of the test kits shipped to US retailers from April through August due to concerns that they were reporting a higher than expected rate of false positive results. The recalled lots also included 227,000 kits that had already been used. Ellume said it plans to email customers who used the kit over the previous two weeks that if they tested positive, they should immediately schedule another test to confirm the results. The FDA issued a statement of its own recommending that those individuals immediately get a molecular test. The manufacturing issue causing the false positives  apparently did not apply to the negative test results.

On Nov. 9, the FDA expanded the scope of the Class I recall to cover more than 2 million tests manufactured by Ellume that were distributed between April 13, 2021, and Aug. 26, 2021. The Class I label indicates that the agency considers the issue serious, involving a high risk of causing serious adverse events or death. Some potential risks of false positives include unnecessary treatments or isolation, delayed diagnosis of the actual cause of a test-taker’s illness and the continued spread of the virus if people with seemingly positive results are quarantined together, the agency notes.

Ellume says it has corrected the manufacturing problem and federal regulators are monitoring the situation. The company has posted an apology from founder and CEO Dr. Sean Parsons on its website. “[W]e understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,” the statement says.

The Abbott Recall

Abbott Laboratories has also been among the leaders in developing tests to meet the demand for high throughput COVID-19 test products. In addition to its BinaxNOW rapid, point-of-care test, Abbott’s COVID-19 products suite includes tests run on its Alinity system, including the Alinity m SARS-CoV-2 AMP Kit, a real-time reverse transcription (RT) polymerase chain reaction (PCR) kit for qualitative detection of nucleic acid from the virus, which originally received EUA in May 2020 and has since been granted multiple revisions, including for use on asymptomatic screening and in pooled samples. In December, Abbott also received EUA for the Alinity m Resp-4-Plex AMP Kit, a multiplex respiratory test which detects SARS-CoV-2, influenza A and B and respiratory syncytial virus.

But problems with the Alinity products have recently begun to surface. In early September, one month before the Ellume recall, Abbott notified its customers that it had detected an issue with the software used by special laboratory processing equipment to prepare swab samples and mix the chemicals for the assays. The problem was that too much liquid might have been getting added to samples under certain mixing parameters, resulting in overflow into the neighboring process tray. False positives may occur when a positive sample overflows into a nearby negative one.

Upon receiving notification of the problem from Abbott, the FDA posted an alert on its website warning testing laboratories, providers and patients of the potential for false positive tests from the Alinity kits. In October, the agency upped the ante by issuing a Class 1 recall for the products.

According to the FDA recall notice, 187 software installations are undergoing corrections. Altogether, those programs are responsible for analyzing the results of more than 10 million already distributed tests: more than 9.9 million Alinity m SARS-CoV-2 tests and just over 48,000 of the Resp-4-Plex assays.

The FDA is not actually recalling the Abbott tests; for now, it’s just warning customers to be wary of the results. Like Abbott’s previous note did, FDA has advised laboratories and providers to treat all positive results from the two affected assays as “presumptive.”

The FDA recommends retesting positive patient specimens with an alternate authorized test and notifying patients who have receive positive results from the kits since June that they may have had false positive test results and that since they might not have actually had COVID-19, they may not be carrying antibodies against the virus.

Meanwhile, the agency said it is working with Abbott to resolve the issues. The update for the SARS-CoV-2 test is nearly complete, while the update for the 4-plex test is expected to be finished in the next few weeks.

Takeaway

The Ellume and Abbott recalls aren’t the first affecting a COVID-19 test that has received EUA clearance. In July, the agency issued a Class I recall of one of the first COVID-19 tests to receive EUA, the Quidel Lyra PCR assay for COVID-19. However, the issue with the Lyra test was not false positives but false negatives. More significantly, the most recent recalls target the rapid, high throughput test products that have become integral to widespread screening necessary to keep society open while the virus remains unconquered.