Coronavirus: Test kits must be 'validated, approved' before 'use, importation' - FDA

The Food and Drugs Authority (FDA) has said the Rapid Diagnostic Test (RDT) kits for testing the Coronavirus must be “validated within the appropriate settings and target population, that is, Ghana, before they can be approved for use.”

A statement issued and signed by the Chief Executive Officer of the FDA, Mrs Delese Mimi Darko on 1 July 2020 stated that the unregistered test kits could produce “false-positive or false-negative results,” which will consequently result in “unnecessary quarantine and contact tracing or spread of infection by persons with the disease.”

Additionally, “commercially marketed test kits must pass through an evaluation/validation process and would be granted Emergency Use Authorisation (EUA).”

The FDA, therefore, cautioned the public to refrain from the use and importation of unregistered RDT kits.

“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.

Read full statement below: