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South Africa authorises local company to manufacture rapid COVID-19 PCR test kits

JOHANNESBURG, (The Southern African Times) – The South African Health Products Regulatory Authority (SAHPRA) has authorized local biotechnology company CapeBio to manufacture rapid COVID-19 polymerase chain reaction (PCR) test kits.

Announcing the approval of the test kits on Monday, Science, Technology and Innovation Minister, Dr. Blade Nzimande, said the COVID-19 test kits, co-developed by CapeBio and the Council for Scientific and Industrial Research (CSIR), will help to reduce South Africa’s reliance on imports, making it easier for the country and the rest of the continent to gain speedy access to test kits.

“Given Africa’s dependence on imports, the government, through the Department of Science and Innovation (DSI), the South African Medical Research Council (SAMRC) and the Technology Innovation Agency (TIA), led an initiative to respond to the local and continental demand for testing by setting up a fund to develop diagnostic tools, among other resources,” Nzimande said.

Nzimande noted that as the highly infectious Delta variant continues to drive South Africa’s third wave of COVID-19 infections, testing has become increasingly important.

“The more testing is done, the easier it is for a country to track the virus, identify clusters, and act accordingly. This latest development is part of a concerted effort by the department and its partners to build local capabilities to respond to viruses like COVID-19,” he said.

CapeBio CEO, Daniel Ndima also announced that CapeBio had commenced industrial-scale manufacturing of the test kits at its Centurion facilities, and the first batches will be available for local market uptake before the end of August 2021.

At full operational capacity, Ndima said the company will be able to produce up to 5,000 kits a day, with each kit providing for 1,000 tests.

“This will enable us to supply the local market sufficiently and effectively, confirming CapeBio’s capability to develop health-related tools to assist the government in democratising COVID-19 testing,” Ndima said.

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