34 COVID-19 rapid test kits fail validation test — FDA

BY: Doreen Andoh
Chief Executive Officer (CEO) of the FDA, Mrs Delese Darko
Chief Executive Officer (CEO) of the FDA, Mrs Delese Darko

The Food and Drugs Authority (FDA) says that none of the 34 Rapid Diagnosis Test kits submitted for validation has met the national COVID-19 RDT testing requirements.

There have been concerns and calls from sections of the public for the use of Rapid Diagnostic Test (RDT) kits to test for the coronavirus disease (COVID-19), particularly, when polymerase chain reaction (PCR) kits were running out.

Many members of the public, including some scientists, believe that the rapid test kits can play a significant role in the national COVID-19 response programme.

Addressing the national COVID-19 update briefings by the Ministry of Information in Accra yesterday, the Chief Executive Officer (CEO) of the FDA, Mrs Delese Darko, said based on the national validation guidelines, an RDT kit was supposed to have both sensitivity rate and specificity rate of 99 per cent.

She explained that sensitivity rate was what identified people who were positive or had ever tested positive for the virus, also known as true positives, while the specificity rate determined people who had never been exposed to the virus.

“From 16th April 2020 to 17 July, 2020, we have received 34 RDTs for validation. They have come from Ghana, China, the United Kingdom, Korea, United States of America, Canada, Finland, Singapore and Malaysia”.

“Taking all of them into consideration, we have a specificity rate of between 85 per cent and 99 per cent and a sensitivity rate of between four and 54 per cent,” she said.

Mrs Darko further explained that an RDT validation test needed to be 99 per cent accurate to ensure all positives and negatives were captured accurately.

Explaining how the RDT test kits functioned, she said they were based on the detection of antibodies, in blood or serum, in people who are believed to have been infected with the coronavirus.

She said RDTs were supposed to be used for preliminary or emergency COVID-19 screening, especially, when resources were limited.


Although a quicker method that takes at least 15 minutes, she said the results needed to be trusted, adding that “currently because majority of the cases were asymptomatic or with very little symptoms, a highly sensitive and specific RDT kit was the most appropriate.

Mrs Darko said those who submitted had been engaged to improve on them and re-submit for re-validation.

Giving more information on the need for validation, she said international best practices required that both locally made and imported RDTs should be validated on the basis of the guidelines of the country of use.

“In Ghana, they are known as class four medical equipment, the FDA has a guideline for registration of such equipment. The validation is also done by the FDA in collaboration with the Noguchi Memorial Institute for Medical Research and the Public Health Reference Laboratory of the Korle Bu Teaching Hospital,” she said.

Hydroxyl Chloroquine

On the use of hydroxyl Chloroquine for the treatment of COVID-19 patients, Mrs Darko said the FDA and the Ghana Health Service (GHS) were collecting data on its use locally to determine its efficacy with regard to treating COVID-19.

The Director-General of the GHS, Dr Patrick Kuma Aboagye, said the country now had active cases of 3,617, a reduction of 38 cases from the last announced figure of 3,655.

He said recoveries stood at 30,621 while 168 persons had died, bringing the fatality rate to 0.54 per cent as of July 26, 2020.

Dr Kuma Aboagye said cumulatively 34,406 cases had been confirmed out of 382,752 tests conducted so far, indicating a positivity rate of 8.9 per cent.

"The active cases continue to stay quite low; now we are doing 11 per cent of our cases which are active, the rest have all recovered”.

"We need to focus on active cases because that is where we need to respond with our healthcare services, with our beds, our contract tracing and we are lucky that the numbers seem to be going low," he said.

Dr Kuma Aboagye appealed to the public to continue in earnest adherence to the preventive protocols to help sustain and improve on gains.

Public transport easing

On whether the easing of the restrictions on public transport would not cause a surge in cases, he explained that the rate of transmission in a vehicle was relatively low because activities that facilitated the spread of the virus such as talking and singing, apart from coughing and sneezing, were relatively low in public transport.

“And so if all passengers wear the mask, transfer of the virus will be limited,” he said.

 He, however, recommended frequent cleaning by vehicle owners and passengers while adhering to all the other safety protocols.


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