The FDA said it's significant concerns regarding the performance of Innova’s rapid antigen test, highlighting that the test kit doesn't have authorisation from the US regulator.
The US Food and Drug Administration (FDA) has warned against the utilization of a rapid antigen test to detect coronavirus disease (Covid-19) on which the uk government has based its mass-testing programme.
In a blistering review of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the US FDA advised healthcare providers and test users to either destroy the lateral flow Covid tests by throwing them away within the trash or return it to the corporate using the FedEx return label that was included with the recall letter that Innova sent to customers.
The FDA said it's significant concerns regarding the performance of Innova’s rapid antigen test, highlighting that the test kit doesn't have authorisation, clearance, or approval from the US regulator.
The FDA further added that the performance of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test device has not been adequately established, which presents a risk of false results.
The US regulator warned that false-negative results may cause delayed diagnosis or inappropriate treatment of Covid-19, which couldn't only aggravate the health condition, it also poses a risk of the spread of coronavirus.
On the opposite hand, false-positive results could lead on to a delay within the correct diagnosis of the disease also as an appropriate treatment for the particular explanation for the patient's illness, the FDA said.“False-positive results could also cause further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts supported false test results,” the US agency added.
On April 23, 2021, Innova Medical Group recalled their unauthorised rapid Covid test and therefore the FDA has classified it as a category I recall, the foremost serious sort of recall. The FDA announced that the agency has also issued a warning letter to Innova Medical Group, Inc.
The FDA has advised healthcare providers to think about retesting their patients employing a different Covid diagnostic assay if Innova’s rapid test was given but fortnight ago and that they suspect an inaccurate result. “If testing was performed quite fortnight ago and there's no reason to suspect current SARS-CoV-2 infection, it's not necessary to retest,” it further added.
According to the US FDA, the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is additionally distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).
