FDA Rejects 34 Covid-19 RDT Kits For Failing Tests
Some 34 Rapid Diagnostic Test (RDT) kits submitted to the Food and Drugs Authority for approval have failed to meet the required specificity and sensitivity tests.
As a result, the FDA has declined in granting the required approvals for their importation and use in the country.
The Chief Executive Officer (CEO) of the FDA, Delese Mimi Darko, made this known as she addressed the media at the Information Ministry yesterday.
According to her, the 34 RDT kits were submitted between April 16 and June 17 to FDA by manufacturers from countries such as China, UK, USA, Finland, Malaysia and Finland.
According to her, the acceptance criterion for validating RDTs is a 99 per cent sensitivity and specificity and stated that all the 34 RDT kits submitted had a specificity of between 85 and 99 per cent and sensitivity of between 4 and 54 per cent.
“The sensitivity is what identifies people who have tested positive for a disease. When an RDT is highly sensitive, it means it can expose people who tested positive for the disease before and when it is highly specific, it shows the true negatives,” she explained.
RDTs are supposed to be registered by the FDA before they can be used in the country.
According to her, per international best practice, all RDT kits must be validated in the country in which they are going to be used.
FDA has guidelines for the registration of the RDT kits and an import permit is required before bringing RDT kits into the country even if they are for personal use.
She said normally an international reference standard is required for validating RDTs.