The Food and Drugs Authority (FDA) has assured that the device approved for use at the Kotoka International Airport (KIA) is fit for purpose and the Authority shall continue to monitor its performance in accordance with regulatory requirements.
The FDA’s statement comes after Dr. Kofi Bonney of the Noguchi Memorial Institute for Medical Research raised issues with the device being used for the testing at the airport.
The FDA described his clams as “inaccurate and unscientific”, adding that the device detects the ANTIGEN (SARS-CoV-2 Virus) by fluorescence technology.
According to the FDA, it gave market authorization to the device after a specificity and sensitivity comparison with the PCR tests.
The Authority further has outlined what it claimed were inaccurate statements made by Dr. Bonney and corrected them as follows:
- The sensitivity of the device, being not less than 99.0% makes it statistically improbable for the claim that more than half of the test results will come out as false negative (people who are carrying the virus and are falsely reported not to be).
- The specificity of the device, being also not less than 99.0% makes it highly improbable for test results to come out as false positive (people who are carrying other viruses to be classified as SARS-CoV-2) as being claimed. • The nasal specimens are not placed on paper but rather onto cartridges which are inserted into the device and the results displayed electronically on an LCD, which can be printed out from a computer.
- The allusion to “tests done over the years” and all statistics given with reference to performance of RDTs in response to the accuracy of the Antigen test cannot be true for SARS-CoV-2, as the disease has not been around for that long for such data to have been gathered on RDT antigen.
- Data available to the FDA on Antibody and Antigen RDTs from March 2020 to date shows that their sensitivity ranges from 4% – 62% and not 34%-80%. This is the reason why the FDA has not authorised any Antibody or Antigen RDT kits to date.
5.The misleading statement alleging that The WHO requires confirmation of a negative RDT test by a PCR test is inaccurate. This has also no relevance with respect to the specific antigen testing being done at the KIA as this uses a device which has been validated against PCR and found to be comparable and is not an RDT kit.
By Laud Nartey|3news.com|Ghana