FDA Says It Has Not Approved Any Rapid Diagnostic Test Kit Yet

Food and Drugs Authority (FDA), Ghana

The Food and Drugs Authority (FDA) is cautioning the public to desist from patronizing unregistered Rapid Diagnostic Test (RDT) kits supposedly meant for testing COVID-19.

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

In a statement issued on Monday, May 4, the FDA noted that it has not registered any 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.

It added that “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 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.”

See Also:

Scientists At KNUST Develop Test Kits For COVID-19

FDA Releases List Of 10 Approved Face Masks

Here Are The FDA’s Recommendations For Homemade Face Masks

source: CNR

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