Laboratory scientists ‘fight’ FDA over test kits validation method

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The Ghana Association of Medical Laboratory Scientists (GAMLS), has expressed concern over the Food and Drugs Authority’s (FDA) method of validating antibody Rapid Diagnostic Test kits for Covid-19 testing in the country.

GAMLS argues that the current validation method based on the use of Polymerase Chain Reaction by the Authority makes it impossible for any Covid-19 antibody RDT to be approved by the Authority.

“The methods being used amount to comparing oranges to apples instead of comparing apples to apples,” read the press statement of GAMLS.

GAMLS is, thus, calling for a review of FDA’s evaluation and validation methods of RDT for Covid-19 testing to the benefits of Ghanaians.

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