Rapid Diagnostic Test not registered for coronavirus – FDA alerts

The Food and Drugs Authority (FDA) on Tuesday cautioned the public against the use of Rapid Diagnostic Test (RDT) kits for screening and diagnosing COVID-19 in the country as it could lead to inaccurate results.

Any false results either negative or positive could lead to the devastating impacts on the current efforts to contain the spread of the COVID-19 pandemic.

A statement signed by Mrs Delesse A. A. Darko, the Chief Executive Officer of the FDA, and copied to the Ghana News Agency on Tuesday said the Authority had not registered any RDT kits (serology antibody assays) for screening and diagnosing COVID-19 in Ghana.

It, however, explained that the RDT test could play an important role in the management of the pandemic and complement the current recommended and approved nucleic acid PCR tests being used for diagnosing the disease.

It said while serology testing had the potential to provide valuable information to individuals and to public health authorities, there were significant areas of uncertainties that needed to be addressed as COVID-19 continued to evolve.

The statement said the first and most urgent was the serology test evaluation/validation, adding that there were dozens of serology test being marketed globally that were not providing accurate information and not comparable to each other.

It said ensuring that tests were comparable and accurate required a validation process overseen by the FDA.

The statement said as and when the test kits were evaluated, it would be made available for hospital and laboratory usage only as they were not recommended for home testing.

It urged the public to adhere to the recommended COVID-19 preventive protocols announced by the Ministry of Health to help fight the pandemic.

It said all concerns regarding the advertising, sale, supply and use of the RDT kits for coronavirus and any other FDA regulated products should be directed to the Authority through its contacts.

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