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Sahpra approves affordable, locally developed Covid-19 antigen test


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Sahpra approves affordable, locally developed Covid-19 antigen test

9th December 2021

By: Yvonne Silaule


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South Africa's fight against Covid-19 has received a boost with the approval by the South African Health Products Regulatory Authority (Sahpra) of a locally developed Covid-19 antigen detection kit.

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.

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


Medical Diagnostech founder and CEO Ashley Uys says 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 adds that the company is also 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 a year, but is also in the process of scaling up," Uys says, adding that all test kits are produced in Cape Town.

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 the Department of Science and Innovation (DSI) and the Technology Innovation Agency (TIA), 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.

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.

SAMRC executive director for grants innovation and product development Dr Michelle Mulder says the investment from the SAMRC, the DSI and the TIA had 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." she states.

DSI director-general Dr Phil Mjwara adds that the approval of this test further expands 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 polymerase chain reaction 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," he says.

"This technology not only benefits the country, but will also be made available to the rest of Africa," Mjwara adds.


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