Saudi research lab is on its way to developing COVID-19 test kit locally

As one of the essential factors in tackling the spread of the disease, rising global demand for testing in 2020 put significant pressure on laboratories producing reverse transcriptase, an enzyme used to generate DNA from an RNA template and polymerase. The technique known as RT-PCR can detect as little as one virus particle in one swab from the mouth or nose.

PCR tests are specific, sensitive and samples can be readily processed, providing results within hours to a day or two at most. But with increased demand, home-testing kit manufacturing is also on the rise to overcome the bottleneck to wider testing, especially given the rapid spread of the delta variant.

Since the onset of the pandemic, the number of daily PCR tests in the Kingdom has risen from a few thousand to between 75,000-110,000 a day. Demand is growing as many now recognize the symptoms of COVID-19.

Dr. Samir Hamdan, a professor of biological sciences, and his team at the King Abdullah University of Science and Technology’s (KAUST) Rapid Research Response Team, have, like many researchers around the world, recognized that diagnostic bottlenecks are one of the main obstacles to fighting the virus. The high cost of the tests and scarcity due to airport closures and shipping restrictions has left public health initiatives in many countries vulnerable.

To address this problem, Hamdan and his team decided to produce the main components of the RT-PCR test kits locally. A year since the project began, their in-house toolkit was publicized to expand testing capabilities in several Saudi cities.

To adapt its work to the new crisis, Hamdan’s group set out to develop reagents for SARS-CoV-2 virus tests for use in biomedical and clinical laboratories.

Since patents protect most of the chemicals used in the RT-PCR test kits, the researchers’ first challenge was to develop accessible and economical ways to produce custom-designed, unpatented versions of these chemicals.

Once a stable and large-scale supply of nonpatent reagents was secured, the next step was to design a virus detection kit within the university’s laboratories.

The RT-PCR test kit developed by KAUST was then subjected to rigorous testing in laboratory environments in cooperation with laboratories from the Ministry of Health and then in the testing facilities of King Faisal Specialist Hospital and Research Center and the Saudi Public Health Authority (Weqaya).

“Our virus test kit is especially important because we provide manufacturing details that are not protected by patents,” Hamdan said.

The results were promising, as the group could routinely detect at least ten copies of SARS-CoV-2 RNA structures. Most importantly, the group successfully detected COVID-19 in clinical samples of broad viral loads with similar reliability and selectivity to commercially approved groups.

Within a few months, Hamdan and his team, in cooperation with the Kingdom’s Food and Drug Authority, obtained regulatory approval from the Saudi Food and Drug Authority (SFDA).

“Now the kit is being employed for a large-scale study led by NoorDx, a KAUST-based diagnostics startup, in collaboration with US scientific instrument manufacturer Thermo Fisher, a strategic partner of the university’s core laboratories,” he said.

“The economical single-step, multi-use RT-PCR test kit is hoped to democratize diagnostics, over time, and assist in efforts to combat the spread of COVID-19,” Hamdan said.

SFDA CEO Prof. Hisham bin Saad Al-Jadhey said: “Our authority strongly supports the development of local biotechnology and innovative medical devices, including laboratory diagnostic devices such as the new COVID-19 test kit developed by national laboratories and research centers. Our support extends to all biotechnology applications developed locally and abroad, by evaluating their compliance with the safety and efficiency requirements approved by the authority.”