FDA warns against unauthorized test kits for Coronavirus

The Food and Drugs Authority (FDA) has warned persons importing rapid diagnostic test (RDT) kits to the country to go through the necessary procedure, specifically being validated within the appropriate setting and target population, before use.

According to the FDA, the concerns and calls from a section of the public for the use of RDT kits for coronavirus tests must be with caution.

Ghana’s testing laboratories are said to be overwhelmed with calls made for the importation of more RDT kits to meet the demand.

The Authority said each test kit must be independently evaluated for quality assurance and performance through collaboration with research and public health laboratories and the expert Technical Advisory Committee for Medical Devices.

A statement issued by the Chief Executive Officer (CEO) of the Authority, Delese A. A. Darko, on Friday said each commercially marketed test kit that passes evaluation process will be granted Emergency Use Authorisation (EUA) for use in the fight against the pandemic.

And so far, the statement continues, Ghana uses the Polymerase Chain Reaction (PCR) tests for the screening and clinical diagnosis of coronavirus.

It, therefore, warned that those using unauthorized antibody-based RDTs for self-test, screening or diagnosis may have false positives or even false negatives.

“The consequence of unnecessary quarantine and contact tracing or spread of infection by persons with the disease…if used for policy decision-making could undermine public confidence and hamper national efforts being put in place to control the disease.”

The Authority assured that any RDT authorized will be announced to the public.