COVID-19: 34 rapid test kits brought to us failed to meet required standards

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The Food and Drugs Authority (FDA) says it has received COVID-19 rapid diagnostic tests from 34 companies in Ghana and other countries.

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

According to the 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.

“These RDTs have come in from Ghana, China, USA, Canada, Korea, Finland, Malaysia, Singapore and the UK. Taking all of them into consideration, we have a specificity of between 85% 99% and sensitivity of between 4% and 54%,” she said.

Kwame Nkrumah University of Science and Technology (KNUST) and Incas Diagnostics announced in April that they have produced a Rapid Diagnostic Test kits to be used to test for COVID-19.

The Managing Director of Incas Diagnostics, Dr. Laud Anthony Basing said the RDT will be able to give test results in 20 minutes but Dr. Basing says they are “cautiously optimistic about” the progress made with the RDT.

FDA warns against unapproved RDT kits

The FDA had earlier warned against the use of unapproved RDT kits to test to COVID-19 in the country as it is yet to approve any such kit for use.

Ghana currently uses Polymerase Chain Reaction (PCR) tests to confirm COVID-19 cases.

 

 



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