We’ve not approved any Rapid Diagnostic Test kit for COVID-19 – FDA

• Posted on May 5, 2020May 5, 2020
• by Nana Kwesi Coomson
• Comment

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.”

KNUST-Incase RDT Test kit 

The only RDT kit that is advanced in its work to come onstream for tackling COVID-19 is the one developed by the Kwame Nkrumah University of Science and Technology (KNUST) and Incas Diagnostics.

According to a statement signed by the Public Relations Officer of KNUST, Dr. Daniel Norris Bekoe, the creation of the test kit is in line with Ghana’s objectives in the fight against the coronavirus, specifically to “contain the spread of the virus, inspire the expansion of domestic capability and deepen self-reliance”.

The Noguchi Memorial Institute for Medical Research and the FDA are expected to complete work on RDT kits for COVID-19 to confirm their appropriateness for use.

The KNUST/Incas RDT kit detects asymptomatic cases and enables decentralised testing to be done anywhere without requiring any equipment.

The device also requires little technical training for those performing the test.

The test which takes 15-20 minutes to perform, would enable those tested to know their results in a shorter time to enable decision making in real-time by health authorities.