SAHPRA approves affordable, locally developed COVID-19 antigen test


Cape Town | 8 December 2021 | South Africa's fight against the COVID-19 pandemic has been boosted with the latest approval by the South African Health Products Regulatory Authority (SAHPRA) of an innovative, locally developed COVID-19 antigen detection kit.


The MD SARS-nCoV-2 Antigen Device was developed by Medical Diagnostech, a local developer and manufacturer of high-quality rapid diagnostic test kits.


Ashley Uys, Founder and CEO of Medical Diagnostech, said access to cost-effective diagnostics is vital in the fight against COVID-19, especially in Africa. SAHPRA's approval of the MD SARS-nCoV-2 Antigen Device provides just such a platform.


Uys added that the company is busy developing an application for smartphones to interpret results from the device, which 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," Uys said, adding that all test kits were produced in Cape Town.


This latest approval by SAHPRA provides yet another boost to the country's efforts in developing and scaling up local reagents and point-of-care tests for self-sufficiency in relation to SARS-CoV-2. In August, the regulator 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 a 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 South African Medical Research Council (SAMRC) rallied key local partners from 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 Department of Science and Innovation (DSI) and the Technology Innovation Agency (TIA), a DSI entity, jointly ran a call 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. Three of these, including Medical Diagnostech, were aimed at direct detection of SARS-CoV-2 antigens within 15 to 30 minutes. Medical Diagnostech had already developed a prototype antigen detection test, and required support to increase its sensitivity and complete the testing and approvals for market entry.


Welcoming the latest announcement, Dr Michelle Mulder, Executive Director for Grants Innovation and Product Development at the SAMRC, said: "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 with respect to medical devices and local economic development and job creation."


Dr Phil Mjwara, Director-General at the DSI, said the latest development further expanded South Africa's ability to respond to COVID-19.


"Not only has the DSI supported the development of a capability to locally produce the reagents for PCR tests by start-up company CapeBio, but 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."


The Director-General said this vision and investment had paid off with Medical Diagnostech's COVID-19 antigen test, which lowers the cost of testing active infections. "This technology not only benefits the country, but will also be made available to the rest of Africa," Dr Mjwara added.


The head of TIA's health programme, Osmond Muroyiwa, said the organisation was living by its mantra that innovation must answer to the challenges of the day. "We are living in a moment where science has to provide answers in tracking an invisible enemy that has ravaged societies and economies globally.


"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," Muroyiwa concluded.


Issued by the South African Medical Research Council, the Department of Science and Innovation, and the Technology Innovation Agency




Medical Diagnostech (Pty) Ltd. was established in 2010 as a developer and manufacturer of lateral flow rapid diagnostic test kits.


The approved antigen detection device is a rapid visual immunoassay for the qualitative detection of the COVID-19 Nucleocapsid protein (N-protein) antigen from nasopharyngeal swabs and can diagnose acute infection, providing information on whether the patient is currently infected. This is different to antibody tests which provide information on whether the patient has previously been infected and has elicited an immune response against the virus.




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