Popular COVID-19 home test kits are producing false positives due to manufacturing error, FDA says

Video above: What does a false positive coronavirus test result mean? Due to a recently identified manufacturing issue, the U.S. Food and Drug Administration (FDA) is warning the public of the potential for false-positive results with Ellume COVID-19 Home Test kits.A “false positive” is a test result that indicates that a person has the virus when they do not actually have it. At this point, negative results do not appear to be affected by the manufacturing defect.The Australian company has said the tests were shipped to U.S. retailers and other distributors from April through August. It published a list on its website of the lot numbers on test packages affected by the recall.The company said about 427,000 tests are in the lots identified in the recall, and nearly 200,000 are unused. Ellume said tests from those lots may provide false-positive results at a rate higher than researchers saw during clinical testing.Ellume said it will email customers who used one of those test kits and received a positive result in the last two weeks. It recommended that people who have not scheduled another test to confirm the result should immediately do so.The FDA says it is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.A complete list of affected Ellume COVID-19 Home Tests can be found on Ellume’s websiteExternal Link Disclaimer.Recommendations for Test Users and CaregiversCheck if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to the lot numbers on Ellume’s websiteExternal Link Disclaimer.Contact your health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID-19 Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result.Contact your health care provider, urgent care facility or other COVID-19 testing site if:You received a positive test result using one of the affected lots of the Ellume COVID-19 Home Test more than two weeks ago, andYou did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result. A health care provider can help you decide what next steps you should take. You should not assume that you had COVID-19 or have immunity to COVID-19. You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention’s guidelines.If you have an unused Ellume COVID-19 Home Test from an affected lot, use the Ellume COVID-19 Home Test App or follow the directions on Ellume’s websiteExternal Link Disclaimer to request a product replacement. Test DescriptionThe Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people 2 years of age and older. The Ellume COVID-19 Home Test is for people with or without COVID-19 symptoms.The FDA issued an Emergency Use Authorization (EUA) to permit emergency use of the Ellume COVID-19 Home Test on Dec. 15, 2020, and granted a revision to the EUA on Feb. 11, 2021.FDA ActionsThe FDA says it regularly monitors the post-authorization use of tests, including reports of problems with test performance or results, and is providing this information to help educate patients, caregivers, and health care providers.Moreover, the administration is continuing to work with Ellume to assess the company’s additional manufacturing checks and other corrective steps to address the reason for the manufacturing issue and help ensure that it is resolved.The FDA added that it will keep the public informed if significant new information becomes available.Reporting Problems with Your DeviceIf you think you had a problem with the Ellume COVID-19 Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.Generally, as specified in a test’s EUA, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations. Questions?If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.