Regulator approves locally-developed Covid-19 test for South Africa


The South African Health Products Regulatory Authority (Sahpra) has approved an innovative, locally developed Covid-19 antigen detection kit.

According to the South African Medical Research Council (SAMRC), this development by Medical Diagnostech will boost the fight against the Covid-19 pandemic.

In August, the SAMRC authorised the manufacture of rapid Covid-19 polymerase chain reaction (PCR) test kits by local biotech company CapeBio.

“These developments could not have come at a better time in South Africa, where the fourth wave of Covid-19 infections, and the discovery of the apparently highly infectious Omicron variant, have made widespread testing increasingly important.”

In mid-2020, the SAMRC rallied government, academia and industry to help reduce the country’s reliance on international test kit supplies through the local development and manufacture of robust alternatives capable of producing results before patients leave the testing site.

With the guidance of the National Health Laboratory Service and others, the SAMRC, together with the Department of Science and Innovation (DSI) and the Technology Innovation Agency (TIA), jointly called for applications to identify suitable projects for funding.

Following the peer review, selection and approval processes, Medical Diagnostech, along with two other local companies and a science council, received funding to develop rapid point-of-care tests for Covid-19.

However, Medical Diagnostech already had a prototype antigen detection test and needed support to increase its sensitivity and complete the testing and approvals for market entry.

SAMRC executive director for Grants Innovation and Product Development, Dr Michelle Mulder, welcomed the announcement.

“This investment from the SAMRC, DSI and TIA has enabled the final product development steps required to deliver an approved antigen detection test for COVID-19 that meets the minimum globally accepted performance criteria for such tests.

“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 concerning medical devices and local economic development and job creation,” said Mulder.

DSI director-general, Dr Phil Mjwara, said the development further expanded South Africa’s ability to respond to COVID-19.

“The department, together with the SAMRC, believed that with the necessary funding it was possible to locally develop rapid tests for the detection of active COVID-19.”

He believes that the investment had paid off with Medical Diagnostech’s COVID-19 antigen test, which will lower the cost of testing active infections.

“This technology not only benefits the country but will also be made available to the rest of Africa,” he added.

TIA’s Health Programme head, Osmond Muroyiwa, said the organisation was living by its mantra that innovation must answer to the challenges of the day.

According to the Medical Diagnostech Founder and CEO, Ashley Uys, the company was busy developing an application for smartphones to interpret results from the device.

This, he said, will reduce subjectivity while creating a portal for data generation, interpretation and management, as well as statistical analysis, in compliance with the Protection of Personal Information Act.

“Medical Diagnostech has already produced initial commercial batches, and has a production capacity of 20 million units per annum, but is also in the process of scaling up,” he said, adding that all test kits were produced in Cape Town.

Read: South Africa approves Pfizer booster shot for people over 18 – here’s when you should take it


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