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.
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.
The 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.