The Food and Drugs Authority (FDA) has cautioned the public to desist from importing and using unauthorised Rapid Diagnostic Test (RDT) kits to test for coronavirus.
According to a statement from the FDA, the 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 read.
According to the FDA, the Ministry of Health’s approved method for screening and clinical diagnosis of coronavirus in Ghana is the Polymerase Chain Reaction (PCR).
The FDA further stated that the use of the unauthorised RDTs may result in false positive or false negative results.
The FDA also indicated that the list of registered and approved products including authorised test kits can be found on its website.
The FDA, however, assured the public that: “as and when any antibody RDTs are independently validated and authorised for use in Ghana through the FDA’s Emergency Use Authorisation Process, the existing communication channels would be used to make this information public.”
Below is the full statement:
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