The US Food and Drug Administration (FDA) has warned the public against the use of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic purposes.
The agency did not authorise, clear or approve the test for commercial supply or use in the country.
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In its warning, the regulator highlighted concerns that the test’s performance had not been adequately evaluated, which could be a health risk.
The FDA noted: “In addition, labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests.”
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also available as the Innova COVID-19 Self-Test Kit, Innova SARS-CoV-2-Antigen Rapid Qualitative Test and Innova SARS-CoV-2-Antigen Rapid Qualitative Test.
In April, Innova recalled the SARS-CoV-2 Antigen Rapid Qualitative Test. The FDA classified this recall as a Class I recall, which is the most serious type of recall.
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By GlobalDataThe FDA is asking users, health care providers and testing programme organisers to destroy the tests or return them with the label included in Innova’s recall letter.
In a statement, the agency said: “Report any problems you experience with the Innova SARS-CoV-2 Antigen Rapid Test to the FDA, including suspected false results.”
Innova claims that its SARS-CoV-2 Antigen Rapid Qualitative Test identifies if an individual has had an active Covid-19 infection by using a nasal swab sample.
The test strip is said to detect antigens from the SARS-CoV-2 virus and deliver results in the form of a coloured test line.
Furthermore, the FDA stated that the false-negative and false-positive results could delay diagnosis or lead to inappropriate treatment of the disease, as well as potentially increasing the spread of the virus.
