The Chief Executive Officer (CEO) of the Food and Drugs Authority (FDA), Madam Delese Mimi Darko has disclosed that the device used for the testing of the coronavirus disease at the Kotoka International Airpot has met the specifications of the Authority.
Madam Delese Darko made this known at a press briefing held in Accra on Wednesday, August 4, 2021, following reports that some travelers after arriving in the country complained of changed COVID-19 test results.
She indicated that 100 samples of positive and negative PCR test results were used to test the system at the airport which produced the same results.
”In evaluating this device, we took 100 samples that have been determined as positive and 100 samples that have been determined as negative using PCR and the machine at the KIA was used to determine if it was positive for PCR, it should remain positive and if negative, should remain negative.”
We then realized that this device meets our specifications of not less than 99% sensitive and not less than 99% specific, which means, when we say specificity if it is positive, it must remain positive and if it is negative, it must remain negative, that was how the device was registered.”, she said.
Madam Darko added that the device, among others things, was able to register very low viral loads.
”There is something we call cycle threshold. The device was able to detect even very low viral loads, that was one of the basis on which we registered that device and also because it had full authorization.”
Madam Darko further indicated that the test kits that are commonly used cannot detect the strains of the Delta, Gamma, and other variants of the coronavirus disease.
”I can assure you that all the test kits people are using cannot detect the circulating strains, Delta, Gamma and all the others, those test kits cannot detect them.”.
However, as a standard practice, when a device is registered, and for that matter the device at the airport, we demand that if there is any circulating strain, the manufacturer of the device has to test the device with the circulating strain and let us know whether it can or cannot detect the strain and we go to the site to verify.”, she added.
Madam Delese Mimi Darko however assured Ghanaians that the device at the airport can detect all the circulating strains of the virus.