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The Food and Drug Authority (FDA) on Wednesday denied the claim that the COVID-19 testing regimen used for passengers at Kotoka International Airport (KIA) is unreliable.
A statement issued and signed by Ms. Delasse A. Darko, executive director of the FDA, and copied to the Ghana News Agency in Accra on Wednesday, said that the device at KIA “detects the ANTIGEN (SARS-CoV- 2) by fluorescence technology ”, adding that, therefore, it was 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 used for airport testing was unreliable.
The statement said the FDA granted the device market authorization after a specificity and sensitivity comparison with PCR tests.
He said the device met the requirements of no less than 99.0 percent agreement.
“The FDA wants to assure the public that the device approved for use in the KIA is fit for purpose and the Authority will continue to monitor its performance in accordance with regulatory requirements,” he said.
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