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COVID-19: “Stop Using Unregistered Rapid Diagnostic Test Kits (RDT)” – FDA Warns Public


The Food and Drugs Authority (FDA) has sent a strong warning to the public to refrain from using all Unregistered Rapid Diagnostic Test Kits (RDT) which have been imported into the country adding that most of them have not been validated within the appropriate settings.

According to the FDA, there have been concerns and calls from sections of the public, complaining about the usage of the RDT kits adding that they have been made to believe it is used to test the coronavirus disease.

In a statement signed by the Chief Executive Officer (C.E.O) of the Food and Drugs Authority, Delese Darko, it said “The Food and Drugs Authority (FDA) wishes to caution the public who are using and any persons importing these tests kits, that RDT Kits must be validated within the appropriate settings and target population, that is Ghana, before they can be approved for use”

The statement further added that the 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.

Madam Delese Darko also added that the Ministry of Health’s approved method of screening and clinical diagnosis of the coronavirus in Ghana is the Polymerase Chain Reaction (PCR) Test.

Below is a copy of the press release:

Story by: Joshua Kwabena Smith

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