FDA has not registered RDT’s for screening and diagnosis for coronavirus

The Food and Drugs Authority (FDA) says it has not registered any Rapid Diagnostic Test Kits (RDTs) for screening and diagnosis of Corona Virus (SARS-Cov-2) in Ghana.

A statement signed Mrs Delese A. A. Darko, Chief Executive Officer, said the current tests for screening and diagnosis of the Coronavirus in the country, approved by the Ministry of Health is the Polymerase Chain Reaction (PCR) tests.

The statement said: “The FDA, guided by current global practices and advice from Eminent Ghanaian Scientists, is also not registering any such RDTs (Based on serology; antigen-antibody reaction) for self-test.

This process will be guided by independently evaluated diagnostics as an assurance of quality. As evidence accumulates based on rigorous data, the FDA will update and/or amend this guidance as appropriate and necessary in the interest of public health and patient protection.”

It said the FDA entreats all prospective applicants to be guided appropriately.

It appealed to the public to direct all concerns regarding the use of Rapid Test Kits for Coronavirus and other FDA regulated products to 0299802932, www.fdaghana.gov.gh, fdaghana among others.

It urged the public to comply with safety measures such as handwashing, sanitizing, social distance, avoiding handshake and touching of the face.