Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
This week the FDA recalled at-home rapid antigen COVID-19 test kits manufactured by Ellume. It is estimated that over 2 million test kits are a part of the recall due to inaccurate test results, which could result in a delay of care or incorrect treatment of patients.
The FDA reported there have been at least 35 cases of false-positive test results from the kits and has designated the voluntary recall as a Class I event, which is the most serious recall. The rapid tests received emergency use authorization from the FDA in December of 2020 and was distributed by Amazon, Target, CVS and the Department of Defense.
The test kits include a nasal swab, processing fluid, and an analyzer. The user collects a nasal swab sample and dilutes it in the processing fluid, which is then placed on the analyzer. The results are sent to the user’s smart phone within 15 minutes. The main issue with Ellume’s test kits have been false positive results. There have been no reports of false negative test results.
This is not the first time that the FDA has recalled a rapid antigen test. In June the FDA recalled test kits manufactured by Innova Medical Group. The SARS-CoV-2 Antigen Rapid Qualitative Test was also a Class I recall. The recall notice issued by the FDA stated that “the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests” and that the use of the tests presented “risk of false results.” The test kits were distributed between November 2020 and March 2021 and were used by health care providers and “organizers of large testing programs, such as on college campuses.”
Even though these rapid kits have been recalled in the United States, the UK has no plans to stop using the kits.
According the AACC, rapid antigen tests do not always perform well in clinical trials, however diagnostic accuracy may depend on the brand of test being used.
A study from March of 2021 evaluated the accuracy of multiple rapid antigen tests. The study results revealed that the test can be used if PCR tests are not available. The accuracy of identifying individuals with symptomatic COVID-19 through thes rapid tests proved to be anywhere between 72% and 58% for asymptomatic individuals, but early testing resulted in more accurate test results.
Knowing that multiple test kits have been recalled by the FDA for being inaccurate, it raises questions about the ability of test kits to accurately identify infection or if faulty kits have over inflated COVID-19 case numbers. Making rapid testing widely available was one of President Biden’s points in his Sept. 9 speech detailing his plan to further curb the spread of COVID-19.