KNUST-Incas RDT for COVID-19 pending FDA’s validation

Dr. (Mrs.) Augustina Sylverken,

The ground-breaking COVID-19 test kit developed by the Kwame Nkrumah University of Science and Technology (KNUST) and Incas Diagnostics, is awaiting approval for use from the Food and Drugs Authority (FDA), Dr. (Mrs.) Augustina Sylverken, a Virologist at the Kumasi Center for Collaborative Research (KCCR), has said.

She said the Rapid Diagnostic Tests (RDT) for COVID-19 testing, which when finalised is expected to augment the current COVID-19 testing regime in the country, will have to undergo evaluation by the FDA before being authorised for use.

She explained that patients who are tested for COVID-19 are put through counselling before samples are taken for further laboratory analysis. As a result, she said among other things that the FDA is, therefore, mandated to thoroughly scrutinize the RDT, which also involves the specificity and sensitivity tests, before issuing any clearance.

She said samples have been made available to the FDA for the processes to commence, but notwithstanding the huge progress made, she cautiously said the FDA will have to be given the room to do its work.

According to the research scientist, Incas Diagnostics can produce 10,000 pieces in a week and scale it up to 60,000 per week, when mass production takes off upon the approval of the regulatory authorities.

As noted, the development of this product locally marks a significant contribution to the country’s fight against the COVID-19 pandemic.

This trailblazing work comes at the back of the work of scientists at the University of Ghana who has also successfully sequenced the genome of SARS-CoV-2 to help track mutations, trace community infections of the disease among others.

The development of the RDT is in line with two of the country’s objectives in the fight against COVID-19; to contain the spread of the virus, inspire the expansion of domestic capability and deepen self-reliance.

The KNUST have said these serological tests which use finger-prick blood and in lateral flow format, similar to blood glucose test or home pregnancy test, detects two different types of antibodies produced by the body to fight off the COVID-19 infection about 7 days after infection and also in those who have been exposed to the virus but not showing any symptoms (asymptomatic) or recovered from the infection.

“Current molecular diagnostics; Polymerase Chain Reaction (PCR) which is being used in the country detects parts of the viral genome very early in infection and takes at least 48 hours from testing to results; potentially delaying contact tracing and other efforts.”

The PCR tests are also, unable to identify people who have been infected (symptomatic or asymptomatic) and recovered. However, KNUST/Incas RDT detects asymptomatic cases, enables decentralised testing to be done anywhere without requiring any equipment.

The device also requires little technical training for those performing the test. The test which takes 15-20 minutes to perform, would enable those tested to know their results in a shorter time to enable decision making in real-time by health authorities.

A key use of this RDT would be for mass testing of the population to identify all those who have been exposed to the virus and thus provide key data for efforts to model the course of the pandemic and also, enhance contact tracing efforts.

By indicating how much of the population is already likely immune because of mild infections, antibody data can offer a key to how fast the virus will continue to spread.

In the future, it could also, help identify recovered patients who could then donate their SARS-CoV-2 antibody-rich serum to help treat critically ill patients as is being done in some countries.

Another key application would be to identify frontline health workers who have been infected and developed likely immunity to the virus.

They would then be able to return to work early and treat patients safely. For researchers in the country, the antibody tests would enable the study of the dynamics of immune responses of infected people.

As the country intends partnering and supporting COVID-19 vaccine development, the antibody tests would be invaluable in determining individual and community responses to the vaccine.

These and more  were contained in the statement issued and signed by the University. The statement said KNUST and Incas Diagnostics throughout the development have been in touch with the Ministry of Health and the National Covid-19 Response Team.

Dr. (Mrs.) Augustina Sylverken, Virologist,  Kumasi Center for Collaborative Research (KCCR),

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