FDA cautions against use of unauthorized COVID-19 test kits

The Food and Drugs Authority (FDA) has advised the public to desist from the importation and use of unauthorized Rapid Diagnostic Test (RDT) Kits to test for the Coronavirus disease (COVID-19) since it may result in false results.

A statement issued on Wednesday, July 1 and signed by the Chief Executive Officer of the FDA, Mrs Delese Darko, 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,” the statement said.

In that regard, it said the currently approved method for screening and clinical diagnosis of the Coronavirus in Ghana is the Polymerase Chain Reaction (PCR) Test.

Below is the press statement

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ABOUT: Nana Kwesi Coomson

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An Entrepreneur, Corporate Social Responsibility, Corporate Communications Executive and Philanthropist. Editor-in-Chief of www.233times.com. A Senior Journalist with Ghanaian Chronicle Newspaper. An alumnus of Adisadel College where he read General Arts. His first degree is in Bachelor of Arts - Political Science (major) and History (minor) from the University of Ghana. He holds MSc in Corporate Social Responsibility (CSR) and Energy with Public Relations (PR) from the Robert Gordon University in the United Kingdom. He is a 2018 Mandela Washington Fellow who studied at Clark Atlanta University in USA on the Business and Entrepreneurship track.

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