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Health News of Thursday, 5 August 2021


We have not approved any RDT kits for coronavirus - FDA warns

The FDA said it has not approved any  Rapid Diagnostic Test (RDT) kits The FDA said it has not approved any Rapid Diagnostic Test (RDT) kits

The Food and Drugs Authority (FDA) says the Authority has not approved any RDT kits, therefore urging the public to desist from relying on any.

This was after some persons who travelled into the country from the USA, and the UK claimed they tested negative in the country they were coming from and did not accept results that they had tested positive for covid-19 when they arrived in Ghana.

The FDA described as erroneous, claims that the COVID-19 testing of passengers at the Kotoka International Airport (KIA) is not reliable.

It said the "detection of the SARS-CoV 2 virus at the airport is not a rapid diagnostic test (RDT) kit but rather a device which detects the virus in nasopharyngeal (nasal) swabs."

The clarification by the Authority follows what it says are "inaccurate and unscientific" claims by one Dr Kofi Bonney of the Noguchi Memorial Institute for Medical Research about the device being used for the testing at the airport.

In a statement, the FDA indicated 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.

It said the device met the requirements of not less than 99.0% concordance.

Speaking on ATinka TV's morning show, Ghana Nie with Ekourba Gyasi Simpremu, the Head of Communication and Public Education Department at the FDA, Ms Rodha Ewuraabena Appiah said, "Some people have brought in the RDT kits and are using it for their own rapid test. The FDA has been given the mandate to research and approve all medical devices, and so far, we have not approved of any RDT kits for covid-19. We have not approved of any of them, and so if people have it and they are using it, then they are using it for their personal purposes and cannot be used as the required test results."

According to her, the Authority received a number of medical devices and RDT kits for covid-19, but none of them reached its requirements and therefore did not approve of any.

"The ISO has accepted our operations, and so before we come out, we have a lot of things we do, so we wish people will understand us and cooperate with our measures. If you want to use the RDT for your personal use, it is okay but using the rapid test to challenge the ANTIGEN test is not a step in the right direction," she added.

Meanwhile, Ms Rodha said the tests conducted at KIA is very sophisticated and intensive, and so it cannot be contested with a test by a rapid result test kit because of how both tests are conducted.

"We are there to serve the country, and so we will plead with the public to listen to us when we explain things to them," she added.