Cape Town – Incomplete paperwork has frozen an application for a licence to manufacture 5000 Covid-19 test kits a day, which would have plugged South Africa’s shortfall in testing capacity, according to the SA Health Products Regulation Authority (Sahpra).
The privately-owned CapeBio Technologies, a spin-off from the CSIR, will have to hold off making the kits, which are said to produce results within two hours, down from the three to four hours taken by the imported kits available in the market.
Sahpra spokesperson Yuven Gounden said yesterday: “CapeBio applied to Sahpra for a licence to manufacture medical devices. The application was evaluated. However, it could not be processed further as the applicant did not submit a complete application.”
Gounden added: “On July 24, Sahpra sent correspondence requesting the applicant to submit the outstanding documentation, but to date Sahpra has not received a response from the applicant. Sahpra will only be able to proceed with the licence application once the applicant has provided the necessary documentation.”
According to Sahpra regulations: “Covid-19 molecular test kits may only be manufactured, imported, exported or distributed/sold at wholesale level by medical device establishments that hold a valid medical device establishment licence issued by Sahpra, in terms of the Medicines Act.”
The kits were set to be manufactured in response to a call by the Department of Science and Innovation in collaboration with the SA Medical Research Council and the Technology Innovation Agency to ramp up the country’s ability to produce locally developed reagents and test kits for Covid-19.
Senior CSIR researcher Dr Lusisizwe Kwezi said: “We can make enough enzyme for one billion chemical reactions that can be applied in Covid-19 testing, and we hope to begin supplying reagents for a faster, one-step test by the end of the year.
“This enzyme is known as DNA Taq polymerase, and just 3g of the protein, produced in E coli bacteria in as little as three days, is enough for a billion PCR reactions.”
Kwezi said the CSIR delivered a 3g batch to CapeBio Technologies, which had licensed and commercialised the technology. Once all the approvals are in, the kits will be rolled out to support the national testing effort. At 5000 tests kits per day, the company could meet approximately a tenth of the country’s current daily testing capacity.