US FDA urges users to throw Innova rapid Covid test in trash, or return it to company
The US Food and Drug Administration (FDA) has warned against the use of a rapid antigen test to detect coronavirus disease (Covid-19) on which the United Kingdom 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 in the trash or return it to the company using the FedEx return label that was included with the recall letter that Innova sent to customers.
The FDA said it has significant concerns regarding the performance of Innova’s rapid antigen test, highlighting that the test kit does not 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 lead to delayed diagnosis or inappropriate treatment of Covid-19, which could not only aggravate the health condition, it also poses a risk of the spread of coronavirus. On the other hand, false-positive results could lead to a delay in the correct diagnosis of the disease as well as an appropriate treatment for the actual cause of the patient's illness, the FDA said.
“False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts based on false test results,” the US agency added.
On April 23, 2021, Innova Medical Group recalled their unauthorised rapid Covid test and the FDA has classified it as a Class I recall, the most serious type 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 consider retesting their patients using a different Covid diagnostic test if Innova’s rapid test was given less than two weeks ago and they suspect an inaccurate result. “If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest,” it further added.
According to the US FDA, the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also 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).