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FDA must review mode of validating COVID-19 rapid test kits – GMLS

The Ghana Association of Medical Laboratory Scientists (GAMLS) is asking the Foods and Drugs Authority (FDA) to review the current criteria for validating antibody Rapid Diagnostics Test kits (RDTs) for COVID -19 testing in the country.

According to the group, the “continuous use of Real-Time Polymerase Chain Reaction (RT-PCR), the so-called gold standards, as a yardstick for antibody RDTs validation makes it almost impossible for any COVID-19 antibody RDTs to get approval from the regulator”.

“We strongly advise that the Food and Drugs Authority (FDA) and its partners review and use the appropriate method to evaluate and validate antibody RTDs for COVID-19 testing in order not deny Ghanaians the benefits of using RDTs for screening and diagnostic of the disease”, it added in a statement dated August 13, 2020.

The laboratory scientists recommended to the FDA to consider the use of a comparator gold standard; an intermediate method used to bridge the gap between RT-PCR and RDT for the validation of COVID-19 RDTs.

Ghana currently uses Polymerase Chain Reaction (PCR) tests to confirm COVID-19 cases but the laboratory scientists say, this mode of testing is not the best standard.

“There is a misleading misconception that Ghana is using the highest standards to validate COVID-19 RDTs because they are been compared to RT-PCR. This, in reality, is counterproductive and results in falsely skewed results that create the impression that the RDTs are of lower quality. The current results obtained may simply be due to the fact that the RDTs are compared to a far superior test methodology and not that the RDTs are necessarily not meeting the standard”, the argued.

GALMS has, therefore, reiterated its calls to the government, the Ministry of Health and the Ghana Health Service to speed up processes to use the 130 GeneXpert testing devices to expand testing to other parts of the country as has been previously promised.

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