FDA declines the certification of coronavirus test kits

The Food and Drugs Authority has declined the certification of 30 coronavirus test kits for their Ghanaians market because they failed to meet standards.

The Chief Executive Officer of the FDA, Delese Mimi Darko, said none of the samples met medical requirements.

Global concerns about fake COVID-19 test kits have been rife as fraudsters as demand for testing increase across the world.

Speaking at the Ministry of Information’s weekly press briefing on COVID 19 updates, Ms Darko said, “Out of all the kits submitted, not one of them has passed the test”

She, however, stated that authority had always educated persons who submitted the kits to help them improve their kits for approval in their resubmission.

The FDA boss clarified that “there are two parts of every test, there is the sensitivity and there is flexibility, so depending on which parts have failed but you need both parts to pass before the kit has passed”.

“So depending on what it is, we will tell you to improve on that part, and the manufacturer understands what to do to improve on the kit and resubmit, so that is what we have done to all of them”.

In the early days of the COVID-19  fight, a number of European governments rejected Chinese-made equipment designed to combat the coronavirus outbreak.

Thousands of testing kits and medical masks were labelled defective, according to authorities in Spain, Turkey and the Netherlands.

The United States  FDA also reported unauthorized fraudulent test kits for COVID-19 being sold online.

In April,  a pharmacist and a surveyor were arrested on suspicion of illegally selling coronavirus testing kits in two separate investigations by the National Crime Agency (NCA).

In May, a 39-year-old woman was arrested in Santa Monica in the United States for allegedly selling COVID-19 testing kits that have not been approved by the Food and Drug Administration, police announced.





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