FDA cautions against import, use of COVID-19 RDT kits

The Food and Drugs Authority (FDA) has cautioned the public against the importation and use of unauthorised antibody-based Rapid Diagnostic Test (RDT) kits to test for coronavirus disease (COVID-19).

A statement signed and issued by Delese A.A Darko, Chief Executive Officer, FDA, in Accra, said the use of invalidated and unauthorised test kits may result in false positive or false negative results.

These results, if used for policy decision, it said, could undermine public confidence and hamper national efforts being put in place to control the disease.

The statement noted that the RDT kits must be validated within the appropriate settings and target population before they could be approved for use.

“The validation process is guided by independently, evaluating the diagnostics for assurance of quality and performance through collaboration with research laboratories and public health laboratories and the expert Technical Advisory Committee for medical devices,” it added.

Commercially marketed test kits that pass the evaluation/validation process, the statement said, would be granted Emergency Use Authorisation (EUA) for use during the COVID-19 pandemic.

It said, currently, the method for screening and clinical diagnosis of the disease approved by the Ministry of Health is the Polymerase Chain Reaction (PCR) Test.

As evidence accumulate based on rigorous data, the FDA said it would announce necessary amendment to the use of test kits to promote public health and patient protection.

“As and when any antibody RDT’s are independently validated and authorised for use in Ghana through the FDA’s EUA process, the information would be made public,” the statement added.


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