South Africa’s Health Products Regulatory Authority (Sahpra) has approved the first locally developed antigen test that can offer a result for Covid-19 inside 15 minutes and will cost just over a thousand naira.
Ashley Uys, founder, and CEO of Medical Diagnostech, a local developer and manufacturer of high-quality rapid diagnostic test kits, developed the test with funding from various government agencies including South Africa’s Medical Research Council (SAMRC), the department of science & technology and the Technology Innovation Agency (TIA).
Rapid antigen tests are less accurate than PCR tests — which are considered the gold standard — and are best at identifying people when they are at their most infectious.
The more widely recommended PCR test costs N22,100 in South Africa and can take days to deliver a result.
By contrast, antigen tests are far cheaper and results are obtained within minutes, which means they can play a valuable role in managing the Covid-19 pandemic.
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Uys told BusinessDay South Africa the cost for a test could be just N1,000. “It’s way cheaper. That’s the reason we’re so excited.”
His company already produces rapid pregnancy, ovulation, malaria, drug, HIV, and syphilis tests.
He said Africans needed cost-effective solutions and shouldn’t have to rely solely on imports from the developed world when SA had its own world-class scientists.
In 2020, the SAMRC worked with government bodies, academia, and industry to set up a programme to help reduce the country’s reliance on international test kit supplies.
It asked local test makers to submit applications for funding for the development of antigen tests.
Medical Diagnostech was one of three companies that received funding to develop the test and had already started working on production when the company was granted the support.
Uys said it had since been tested in a clinical trial in a Cape Town hospital with samples from Covid-19-positive patients and the study was verified by the National Health Laboratory Service’s national reference laboratory.
Dr Michelle Mulder, executive director for grants, innovation and product development at the SAMRC, said investment from the government agencies “enabled the final product development steps” to ensure the test met global standards.
“The local ownership and manufacture of these test kits will not only increase South Africa’s self-sufficiency in a time of high demand but also contribute to reducing the trade imbalance with respect to medical devices.”
Uys said a version of the home kit is ready and an app that would interpret the test for consumers is being developed.
The home kit will be available once the government approves its use.
Home testing for Covid-19 is not permitted in South Africa despite being used in European countries including France, Germany and Switzerland.
Scientists and doctors have been calling on the government to permit the use of the home test kits as they are cheap and would make testing for Covid-19 more frequent and widespread.
Uys said this would help to control the pandemic.
“If you can test yourself at home and if you find out you are positive and isolate immediately, of course, it’s going to stop the spread.”
The head of TIA’s health programme, Osmond Muroyiwa, welcomed the approval of the rapid antigen test.
“The ability to produce test kits locally is testimony to the great scientists and innovators we have who, with the right support, can help save lives, reduce imports, create jobs and ultimately improve the quality of life of all South Africans.”
