• Think News Online

"Rapid Diagnostic Test (RDT) Kits For Screening, Diagnosing Not Registered" - FDA


The Food and Drugs Authority (FDA) says it has not registered any Rapid Diagnostic Test (RDT) Kits (serology antibody assays) for screening and diagnosing COVID-19 in Ghana.


According to FDA, these test could play an important role in the management of the pandemic and complement the current recommended as well as approved nucleic acid PCR tests being used for diagnosis of the disease.


In a press release signed by its Chief Executive Officer (CEO), Delese Darko, it said "While serology testing has the potential to provide valuable information to individuals and to public health authorities, there are significant areas of uncertainty that will need to be addressed as COVID-19 disease continue to evolve. The first and most urgent is marketed globally that are not providing accurate information and that are not comparable to each other"


She added ensuring that tests are comparable and accurate requires a validation process overseen by the FDA.


She further added the FDA advises the public that the use of such unregistered Rapid Diagnostic Test (RDT) Kits could lead to inaccurate results which may have adverse health repercussions.


Below is a copy of the release:





0 comments