South Africa is on track to manufacture its own Coronavirus disease 2019 (COVID-19) sample purification kits in large quantities within six months, creating a steady local supply that will speed up testing and reduce the country’s reliance on international suppliers amid intense global demand.

The CSIR’s Dr Previn Naicker says the technology being developed by his team is open source in that it would generate pure samples from nasal and throat swabs that can be tested for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA on any platform. The work is being funded by the Department of Science and Innovation, the South African Medical Research Council and the Technology Innovation Agency.

A reliable local supply of sample purification reagents also addresses the specific problem of patient swabs becoming non-viable for testing because of the lengthy backlogs caused by a lack of reagents. Not only do such long waiting periods compromise test results for individual patients, it compromises the entire disease management process that relies on quarantine along with quick contact tracing and testing.

“There are testing facilities that are not running at full capacity because there are not enough diagnostic reagents,” Naicker says. “The project will ensure that we close that gap and reduce the turnaround time of testing.”

The CSIR is working with local partners such as ReSyn Biosciences, a spin-off company of the CSIR that will produce magnetic beads for extracting viral RNA from test samples.

Magnetic beads offer the advantage that RNA extraction can be automated. “Every step of the diagnostic process that can be automated makes for better testing,” says Naicker.

As positive cases in South Africa continue to increase at an alarming rate, Naicker says the portion of positive cases in relation to the tests conducted shows that South Africa is under-testing. Experts say the virus will be with us for a long time to come, so Naicker’s team and their local partners plan to optimise the kit within the next two months so that validation (testing on real samples), licencing and regulatory approval by the South African Health Products Regulation Authority (SAHPRA) can take place as soon as possible.

“If all goes according to plan, we will have a market-ready kit within six months,” says Naicker.

“Based on the capacity of our local partners, kits for the extraction of a minimum of 5 000 samples can be assembled per day at a certified facility, and we are in discussions with two proposed facilities thus far.” In other words, this technology could support at least an additional 10 000 COVID-19 tests per day.

“As a scientist working in the health space, to be part of the COVID-19 response is both fulfilling and exciting,” he says. “We all have a desire to make a positive societal impact.”


Story by: Council of Scientific and Industrial Research