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COVID-19: FDA cautions public against use of unauthorized rapid tests kits

Ghana Ghana News

The Food and Drugs Authority (FDA) is cautioning the public to desist from patronising unauthorised Rapid Diagnostic Test (RDT) kits supposedly meant for testing COVID-19.

The Authority in a statement issued on Wednesday, July 1, 2020, said the usage of unauthorised kits could lead to inaccurate results.

“The Food and Drug Authority (FDA) wishes to caution the public who are using and any persons importing these test kits, that RDT Kits must be validated with the appropriate setting and target population, that is, Ghana, before they can be approved for use.”

“The validation process is guided independently evaluating the diagnostics for assurance of the quality and performance through collaboration with research laboratories and Public Health Laboratories and the expert Technical Advisory Committee for Medical Devices.”

According to the FDA if these inaccurate results are used for policy decision-making could undermine public confidence and hamper the national efforts in curbing the spread of the disease.

The Authority further reminded that the approved method for screening and clinical diagnosis of the disease is the Polymerase Chain Reaction (PCR).

“Currently, the Ministry of Health’s approved method for screening and clinical diagnosis of the Coronavirus in Ghana is the Polymerase Chain Reaction (PCR) Test.”

Meanwhile, the FDA also said the list of registered products including authorised test kits can be found on its website.

Below is the full FDA statement

Citi News


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