Several manufacturers of the Covid-19 tests have come under increased scrutiny due to the registering of false positives and questions regarding whether the PCR test can distinguish the SARS-CoV-2 from the less deadly influenza viruses.
In June, the FDA issued a Class 1 recall of Innova SARS-CoV-2 Antigen Rapid Qualitative Test(also distributed under Innova COVID-19 Self-Test Kit). A Class 1 recall is the most severe type of recall—associated with products or devices that may cause serious injuries or death.
Most tests use a 40-cycle protocol. This means, if the virus is not detected within 40 amplification cycles, the test result is negative. If viral RNA is detected in 40 cycles or less, the PCR test shows a positive result. At the center of the debate is whether or not SARS-CoV-2 strains consistently register at cycles the test can register. The FDA has announced the coming introduction of a new test in December.
This month, Ellume, a medical tech manufacturer based in Australia, announced the recall of approximately 200,000 at-home COVID-19 tests shipped to the United States. These tests are known to produce false positive results.
In December, under the FDA emergency authorization act, Ellume was authorized to produce 19 million COVID-19 Home Test per month (almost half of which were to be shipped to the United States for non-prescription use by symptomatic and asymptomatic individuals aged two years and older). One of the hallmark advantages of this home test is that it produces results within 15 minutes.
Upon review of complaints regarding false positive readings, on October 5th, the FDA stated it was “alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.”
The FDA stated that it will continue to review the situation and “assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.”
Ellume notes in a statement on their website, that it has identified the incidence of false positives in specific lots of the tests following a thorough investigation: “We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy in all cases.”
The Ellume test kit users are encouraged to check the lot number on their home test to see if their kit is part of the recalled lot noted on the Ellume website. Users of the Ellume test kit who have received positive results in the last two weeks can confirm their status by contacting their medical provider and requesting a COVID-19 molecular diagnostic test.
Meanwhile, the FDA continues to expand vaccine test capabilities, recently authorizing ACON Laboratories’ Flowflex COVID-19 Home Test, which can be used at home without a prescription, to produce more than 100 million tests per month, with plans to produce 200 million per month by February 2022.
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