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

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The Ghana Association of Medical Laboratory Scientists (GAMLS) is asking the Food 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.

Rapid test kits fail to meet standard requirement

34 companies in Ghana and other countries that presented COVID-19 rapid diagnostic tests to the FDA had them rejected because they failed to meet standard requirement.

The FDA said none of the kits passed the specificity and sensitivity tests, hence could not be adopted for use in Ghana.

Chief Executive Officer of the FDA, Delese Mimi Darko, all the companies that submitted the test kits for assessment and approval have been informed about the result of the assessments and they are expected to work to address the challenge with their kits.

“So far, all the 34 kits that have been submitted, not one of them has passed the test…So for everyone who submitted the kit, we have communicated [to them]…There are two parts, the specificity and sensitivity, depending on which part has failed, we will tell you to improve on that part and the manufacturer understands what to do before resubmitting,” she at the Ministry of Information’s bi-weekly brief briefing on COVID-19 in Ghana.

She further disclosed that the tests on the various kits show their sensitivity ranging between 4% and 54% while their specificity ranged between 85% and 99%.

Delese Mimi Darko said the FDA requires that the kits must have a sensitivity and specificity rate of at least 99% before being approved.

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