Rapid Diagnostic Test (ROT) kits not registered for diagnosing COVID-19 - FDA

Pamela Annang May - 05 - 2020 , 12:42

The Food and Drugs Authority (FDA) says it has not registered any Rapid Diagnostic Test (ROT) kits for screening and diagnosing COVID-19 in Ghana.

A statement issued by the FDA on May 4, 2020, said there are serology tests marketed globally that require a validation process due to the inaccurate results it may provide.

“There are dozens of serology tests being marketed globally that are not providing accurate information and that are not comparable to each other. Ensuring that tests are comparable and accurate requires a validation process overseen by the Food and Drug Authority (FDA).”

The statement added that “the use of such unregistered Rapid Diagnostic Test (RDT) 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 statement said information will be announced when evaluation on these kits are ready for the hospital laboratory and not home use.

The FDA urged the public to adhere to the recommended COVID-19 preventive measures announced by the Ministry of Health to help fight the coronavirus pandemic.

These include;