Desist from importing & using unauthorised test kits-FDA cautions
The Food and Drugs Authority (FDA) has cautioned the public against the use of unauthorized Rapid Diagnostic Test (RDT) Kits to test for the Coronavirus disease (COVID-19).
The FDA in a statement explained the caution was necessary because the test might result in false results.
The Chief Executive Officer of the FDA, Mrs Delese Darko, who signed the statement 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,” it added.
Read the full statement below