The Food and Drugs Authority (FDA) has debunked the assertion that the COVID-19 Testing regime used for passengers at the Kotoka International Airport (KIA) is unreliable.
A statement signed by the Chief Executive Officer of FDA, Mrs Delasse A. Darko, said the device at KIA “detects the ANTIGEN (SARS-CoV-2 Virus) by fluorescence technology,” adding that, “it was, therefore, not a Rapid Diagnostic Test Kit.”
The FDA statement seeks to clarify claims by Dr Kofi Bonney of the Noguchi Memorial Institute for Medical Research that the device being used for testing at the Airport was unreliable.
The statement said the FDA gave market authorisation to the device after a specificity and sensitivity comparison with the PCR tests.
It said the device met the requirements of not less than 99.0 percent concordance.
“The FDA wishes to assure the public that the device approved for use at the KIA is fit for purpose and the Authority shall continue to monitor its performance in accordance with regulatory requirements,” the statement issued on Wednesday, September 2, said.
