FDA warns against use of unauthorized coronavirus test kits

The Food and Drugs Authority (FDA) has in a statement warned the general public to desist from the importation and use of unauthorized Rapid Diagnostic Test (RDT) Kits to test for the Coronavirus disease (COVID-19).

This may result in false results the FDA said.

It added that the currently approved method for screening and clinical diagnosis of the Coronavirus in Ghana is the Polymerase Chain Reaction (PCR) Test.

A statement issued on Wednesday, July 1 and signed by the Chief Executive Officer of the FDA, Mrs Delese Darko, said commercially marketed test kits must pass through an evaluation/validation process and would be granted Emergency Use Authorization (EUA).

“The Food and Drugs Authority (FDA) wishes to caution the public who are using and any persons importing these test kits, that RDT Kits must be validated within the appropriate settings and target population, that is, Ghana, before they can be approved for use.

This 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,” the statement said.