FDA Warns Against Use of Unregistered Rapid Diagnostic Test Kits

FDA Warns Against Use of Unregistered Rapid Diagnostic Test Kits

The Foods and Drugs Authority (FDA) Ghana has warned the public against the use of unregistered Rapid Diagnostic Test (RDT) kits for diagnosing coronavirus.

The Authority said it has acknowledged concerns and calls from sections of the populace demanding the use of the RDT kits to test for the coronavirus disease but these test kits were based on the detection of antibodies in blood or serum of people believed to have been infected with the virus.

A statement signed by Mrs Delese A.A. Darko, the Chief Executive Officer of FDA Ghana, and copied to the Ghana News Agency, urged the importers of the test kits to bring them for validation and approval.

It said the validation process is guided by independently evaluating the diagnostic for assurance of quality and performance through collaboration with Research laboratories, Public Health laboratories and expert Technical Advisory Committee for Medical Devices.

The statement said commercially marketed test kits that pass the evaluation/validation process, would be granted Emergency Use Authorisation (EUA) for use during the season of the pandemic, adding that the list of all registered products including authorised test kits is maintained on the FDA website.

It said currently the Ministry of Health’s approved method for screening and clinical diagnosis of the coronavirus in Ghana is the Polymerase Chain Reaction (PCR) Test.

The public is, therefore, being cautioned to desist from the importation and use of unauthorised antibody-based RDTs either for self-test, screening or diagnosis and that the use of unvalidated and unauthorised test kits may result in false positive or false negative results, the statement said.

The statement said as evidence accumulates based on rigorous data, the FDA would update and/or amend this information in the interest of public health and patient protection.

It said: “The public is assured that as and when any antibody RDTs are independently validated and authorised for use in Ghana through the FDA’s Emergency Use Authorisation process, the existing communication channels would be used to make this information public.”