On the 27th of April 2020, the Kwame Nkrumah University of Science and Technology (KNUST), in partnership with Incas Diagnostics, a diagnostic company in Kumasi, developed an optimized Rapid Diagnostic Test (RDT) for the testing of COVID-19.
The development of the kit attracted praises from Ghanaians while the developers enjoyed free publications in the media home and abroad. Diplomatic missions like the United States Embassy in Ghana also congratulated KNUST and Incas Diagnostics for the step taken to assist Ghana’s effort in combating the novel coronavirus.
According to a statement issued by Dr. Daniel Norris, the University’s Relations Officer, the test kit was aimed at complementing the current COVID-19 testing regime in the country.
According to the statement, the RDT’s advantage over the Polymerase Chain Reaction (PCR) which is currently being used for the testing is that the RDT, unlike the PCR, is able to identify people who have been infected (symptomatic or asymptomatic) as well as those who have recovered.
“However, KNUST/ Incas RDT detects asymptomatic cases, enables decentralized testing to be done anywhere without requiring any equipment”, portions of the statement said.
The statement also averred that the RDT required little technical training for those performing the test and took within 1-20 minutes to perform and will also enable those tested to know their results within a shorter time as compared to the PCR.
The statement also had it that in the future, the RDT could also help identify recovered patients who could then donate their SARS-CoV-2 antibody-rich serum to help treat critically ill patients as being done in some countries.
However, on the 4th May 2020, the Food and Drugs Authority (FDA) released a statement which said that they have not registered any RDT (including the one manufactured by KNUST/Incas) for the screening and diagnosing of COVID-19 in Ghana.
The decision according to the FDA was premised on “significant areas of uncertainty that will need to be addressed as the COVID-19 disease continues to evolve”.
“The first and most urgent is serology test evaluation/validation. There are dozens of serology tests being marketed globally that are not providing accurate information and that are not comparable to each other. Ensuring that tests are comparable and accurate requires a validation process overseen by the Food and Drug Authority (FDA). Consequently, the FDA advises the general public that the use of such unregistered Rapid Diagnostic Test (RDT) Kits could lead to inaccurate results which may have adverse health repercussions”, portions of the FDA’s statement read.
More so, speaking at the Ministry of Information’s COVID-19 press briefing on 5th May 2020, Professor William Ampofo revealed that Noguchi is still going through the processes in evaluating the COVID-19 RDT.
On KNUST’s RDT, Professor William emphatically stated that “there has been a local development where KNUST has developed an RDT which is being submitted through the FDA. As soon as results are available, KNUST will be notified through the FDA and we will decide on how we proceed further with locally available RDTs”.
The whole point is that KNUST/Incas really manufactured a Rapid Diagnostic Test Kit but for it to be used, it has to be approved by the FDA which hasn’t yet done so, hence the wait for approval continues!
So what really is keeping us waiting? Is there something that the FDA is not telling us?
It is evident that the FDA gives priority to inventions aimed at aiding the fight against coronavirus. Nose Masks, Personal Protective Equipments have their evaluations and approvals fast-tracked by the FDA and one would wonder why the delay in approving the kits developed by KNUST and Incas.
One can only guess that there is a problem somewhere that is hindering the licensing of the RDT kits by FDA hence the silence since news on the kit hit the media.
The government of Ghana has been doing everything within its means to conduct as many tests as possible. The RDT kits would make it possible for Ghana to test 10,000s of samples daily which will, in turn, put us in ahead in the fight against the pandemic. The continued silence from KNUST, Incas and the FDA is sending us a message that the kits are not as envisaged and as such, the FDA has been left with no choice than to delay its licensing.
Nothing would have kept the FDA waiting this long if the sampled kits efficiently tested COVID-19. Have the developers thrown dust into our eyes?
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