The Food and Drugs Authority (FDA) has dismissed claims made by Dr. Kofi Bonney of the Noguchi Memorial Institute for Medical Research saying test authorized for detection of the SARS-CoV-2 virus at the Kotoka International Airport (KIA) is not a rapid diagnostic test kit (RDT) but rather a device which detects the virus in nasophayngeal (nasal) swabs.
According to the FDA, the device detects the ANTIGEN (SARS-CoV-2 Virus) by Fluorescence technology.
In a statement released and signed by the Chief Executive Officer (CEO) of FDA, Delese Mimi Darko, she said "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 authorisation 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"
The response comes after the FDA, a statutory body mandated by Sec 118 4(b) of the Public Health Act 851, 2012 noted with concern, a media interview granted on an Accra-based television station on August 31st, 2020 by Dr. Kofi Bonney of the Noguchi Memorial Institute for Medical Research.
The statement explains that during said interview, Dr. Kofi Bonney gave inaccurate and unscientific claims about the performance of the device intended to be used for testing passengers arriving at the Kotoka International Airport (KIA).
Madam Delese Darko assured the public that the device approved for the use at the KIA is fit for purpose and the Authority shall continue to monitor its performance in accordance with regulatory requirements.
Below is a full copy of the release:
Story by: Joshua Kwabena Smith