The Food and Drugs Authority (FDA) has responded to claims by a virologist at the Noguchi Memorial Institute for Medical Research, Dr Kofi Bonney, suggesting that the COVID-19 testing device used at the Kotoka International Airport is unreliable.
In a statement issued by the FDA assured the general public that the device approved for use at the KIA is fit for purpose.
Nonetheless, the statement further added that the Authority shall continue to monitor its performance in accordance with regulatory requirements.
Dr Bonney in an interview on Accra-based Joy FM claimed that about half of the test to be conducted at the airport may be inaccurate because the test being conducted was not a PCR test but an antigen test which was less sensitive.
But the FDA in its statement signed by the Chief Executive Officer (CEO), Delese Mimi Darko, said Dr Bonney’s claims were “inaccurate and unscientific.”
“The FDA wishes to state that, testing authorized for detection of the SARS-CoV-2 Virus at KIA is not a rapid diagnostic test kit (RDT) but rather a device which detects the virus in nasopharyngeal (nasal) swabs.
“This device detects the ANTIGEN (SARS-CoV-2 Virus) by fluorescence technology. It is worth noting that other matured regulatory authorities like the Ghana FDA have approved this technology and similar products for use in detecting the SARS-CoV-2 Virus.
“The FDA in granting market authorization to this device, compared the specificity and sensitivity to the Gold Standard, PCR and it met the requirements of not less than 99.0% concordance.”
Source: Kasapafmonline.com
