Home / HEALTH / COVID-19: Test kits must be “validated”, “approved” before “use”, “importation” – FDA

COVID-19: Test kits must be “validated”, “approved” before “use”, “importation” – FDA

By:brightwebtv.com nana Asare barimah

Mrs Delese Mimi Darko is the CEO of the FDA

The Food and Drugs Authority (FDA) has said the Rapid Diagnostic Test (RDT) kits for testing the Coronavirusmust be “validated within the appropriate settings and target population, that is, Ghana, before they can be approved for use.”A statement issued and signed by theChief Executive Officer of the FDA, Mrs Delese Mimi Darko on 1 July 2020 stated that the unregistered test kits could produce“false positive or false-negative results,” which will consequently result in “unnecessary quarantine and contact tracing or spread of infection by persons with the disease.”

Additionally,“commercially marketed test kits must pass through an evaluation/validation process and would be granted Emergency Use Authorisation (EUA).”

The FDA, therefore, cautioned the public to refrain from the use and importation of unregistered RDT kits.

“The Food and Drugs Authority (FDA) wishes to caution the public who are using and any persons importing these test kits, that RDT Kits must be validated within the appropriate settings and target population, that is, Ghana, before they can be approved for use. This validation process is guided by independently evaluating the diagnostics for assurance of quality and performance through collaboration with Research laboratories and Public Health laboratories and the expert Technical Advisory Committee for Medical Devices,” the statement said.

Read full statement below:

 

Source: Classfmonline.com

sharethis sharing button

About admin

Check Also

Three more deaths as 607 new coronavirus cases take Ghana’s case count to 27,667

By:brightwebtv.com nana Asare barimah File photo Three persons who contracted the novel COVID-19 virus have unfortunately died …

Leave a Reply

Your email address will not be published. Required fields are marked *