Coronavirus: FDA denies approving any Rapid Diagnostic Test kits

The Food and Drugs Authority (FDA) has said it is yet to approve any Rapid Diagnostic Test (RDT) kits meant for testing COVID-19.

The Authority says the usage of these kits could lead to inaccurate results which may have adverse health repercussions.

The authority is therefore cautioning the public to desist from patronizing any unregistered RDT kits.

The FDA made this known in a press statement on Monday, 4th May, 2020.

“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 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.” – it added

The FDA noted that there are different serology tests being sold in various parts of the world, however, they all provide different non-comparable results.

“Ensuring that tests are comparable and accurate requires a validation process overseen by the Food and Drug Authority,” it noted.

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.”