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A biotechnology company has been given the go-ahead to produce locally developed ‘one-step’ COVID-19 test kits in South Africa.

CapeBio collaborated with the Council for Scientific and Industrial Research (CSIR) to develop the rapid polymerase chain reaction (PCR) test kits whose manufacture has now been authorised by the South African Health Products Regulatory Authority. According to the CSIR, the ‘one-step diagnostic’ test resulted from a ‘combination of the CSIR’s research and development infrastructure and expertise, coupled with CapeBio’s capability’.

A PCR test involves the collection of respiratory material via nasal swabs, from which genetic material is extracted and processed using chemicals and a PCR machine to detect the COVID-19 virus.

CapeBio has already commenced industrial-scale manufacturing of the test kits at its facility in Centurion, Gauteng, and the first batches will be available for the local market before the end of August 2021.

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

‘We will be able to assist the nation and Africa by alleviating our reliance on imports that are normally associated with high costs and long lead times,’ says Daniel Ndima, CEO of CapeBio.

The CSIR also provided its expertise in areas such as enzyme biomanufacture during development.