The Food and Drugs Authority (FDA) has clarified that no Rapid Diagnostic Test (RDT) kits supposedly meant for testing COVID-19 has been approved by the authority.
In a statement issued on Monday, May 4, 2020 the FDA asked the public to stop patronizing such unregistered Rapid Diagnostic Test kits for screening and diagnosing coronavirus in the country.
“The Food and Drugs Authority (FDA) wishes to inform the general public that it has NOT registered any Rapid Diagnostic Test (RDT) kits (serology antibody assays) for screening and diagnosing COVID-19 in Ghana. These tests could play an important role in the management of the pandemic and complement the current recommended and approved nucleic acid PCR tests being used for diagnosis of the disease,” the FDA said in a statement.
The Authority emphasized that usage of these kits will bring inaccurate results which may have adverse health repercussions.
“the use of such unregistered Rapid Diagnostic Test kits could lead to inaccurate results which may have adverse health repercussions. False positive or negative results can have devastating impacts on the current efforts to contain the COVID-19 outbreak and spread.”
The FDA said it will make public announcements when it evaluates any such test kits which should be used in only hospitals and laboratories.
“As and when these test kits are evaluated, the information will be publicly available for hospital and laboratory use only as home testing is not recommended.”
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