US drug agency warns on COVID-19 test kits

The United States Food and Drug Administration has alerted the National Agency for Food Drugs Administration and Control on some test kits manufactured by a manufacturing company known as Ellume.

According to the US agency, the kits have the potentials of producing fake COVID-19 positive results due to manufacturing issue.

The notice was contained in a public alert by the US agency and sent on October 25, 2021 but released by NAFDAC on Sunday.

The public alert No. 0041/2021 was titled ‘Potential for false positive results with certain lots of Ellume COVID-19 tests due to a manufacturing issue: FDA safety communication.’

It read, “For these tests, a ‘false positive’ is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be detected because of the manufacturing problem.

“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age and older. The Ellume COVID-19 Home Test is for people with or without COVID-19 symptoms.

“The FDA 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.”

NAFDAC, however in its recommendation, implored importers, distributors, and consumers in possession of the recalled lots of Ellume COVID-19 Home Test to discontinue sale or use and handover remaining stock to the nearest NAFDAC office.

The agency added, “Health professionals and patients are encouraged to report adverse effects or quality problems experienced with the use of these medicines to the nearest NAFDAC office.”

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