FDA advises Public to Avoid Covid-19 Self-Testing Kits

the FDA says it has not registered any Rapid Diagnose Test (RDT) kits for Covid-19

FDA advises Public to Avoid Covid-19 Self-Testing Kits

The Food and Drugs Authority (FDA) has admonished the public against procuring self-testing kits on covid-19, as any such item is yet to be recognized by the body.

The FDA says, it has neither registered nor recognized any rapid diagnoses test (RDT) kits for self-testing in the country.

According to the FDA, the World Health Organization (WHO) had not even approved any RDT for use and, therefore, cautioned the public to be wary of any RDT kits.

Speaking in an interview in Accra today, the Head of Medical Devices Department of the FDA, Mr Joseph Yaw-Bernie Bennie, said for now, only the Polymerase Chain Reaction (PCR) test was the recommended one and that was what the Noguchi Memorial Institute for Medical Research in Accra and the Kumasi Centre for Collaborative Research in Kumasi were using.

He disclosed that over 100 companies and institutions had approached the FDA to allow them to bring in RDTs from China, South Korea and other places with one of them requesting to be allowed for local mass production of the RDT kits in partnership with a foreign partner.

 

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“Since the outbreak of the pandemic in the country, a lot of people have made enquiries and the possibility of bringing in the RDT kits for testing on the COVID-19. Ordinarily, it is a good thing because the WHO is recommending that we should do mass testing.

“But we do not want to do test and give false positives and false negatives. So, there is the need to make sure that the tool you are using for testing is correct,” Mr Bennie explained.

Mr Bennie said the RDT kits were available, but explained that they had limitations and that it was not advisable to patronize them because even after using it, “you still have to go for a confirmation test using the PCR, which gives precise results as to whether the person has it or not.”

He said while the PCR gave accurate information of the presence of the virus in a person, the current RDT kits available gave an indication and, therefore, required a confirmation test as to whether the person had it or not.