FDA warns against use of unauthorized rapid tests kits

Chief Executive Director of the FDA, Mrs Delese Darko

The Food and Drugs Authority (FDA) has warned against patronising unauthorized Rapid Diagnostic Test (RDT) kits supposedly meant for testing COVID-19.

The FDA in a statement said the test kits could provide inaccurate results.

“The public is, therefore, being cautioned against the importation or use of unauthorized antibody-based RDTs either for self-test, screening, or diagnosis. The use of unvalidated or unauthorized test kits may result in false positive or false negative.

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

According to the authority, such RDTs must be validated with its setting configured to suit targets in Ghana before they can be used.

“The Food and Drug Authority (FDA) wishes to caution the public who are using and any persons importing these test kits, that RDT Kits must be validated with the appropriate setting and target population, that is, Ghana, before they can be approved for use.”

“This validation process is guided independently evaluating the diagnostics for assurance of the quality and performance through collaboration with research laboratories and Public Health Laboratories and the expert Technical Advisory Committee for Medical Devices,” the statement said.



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