Health regulatory body gives the nod to Cape Town company to produce rapid Covid-19 antigen test kits
A new rapid Covid-19 antigen test, developed in South Africa, has been approved by the South African Health Products Regulatory Authority.
The South African Health Products Regulatory Authority (Sahpra) on Wednesday approved a locally developed Covid-19 antigen test that is produced in Cape Town.
The MD SARS-nCoV-2 Antigen Device was developed by Medical Diagnostech, a local developer and manufacturer of rapid diagnostic test kits.
While a PCR test remains the gold standard for Covid-19 testing, as it is the most sensitive, results can take up to 48 hours or longer when there are a lot of people testing.
Antigen tests are often used to test in congregate settings. It takes 15 to 30 minutes to produce a result. This rapid test detects a specific protein on the surface of the virus.
In both cases, the swabs used in the testing must still be taken through the nose by a trained health professional. Rapid antigen tests are more reliable when they are done on patients who have symptoms of Covid-19 and are likely to have a high viral load.
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.
Uys said the company is busy developing an app for smartphones to interpret results from the testing device and create 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.
In August, Sahpra authorised the manufacture of rapid Covid-19 PCR test kits by local biotech company, CapeBio.
Welcoming the latest announcement, Dr Michelle Mulder, executive director for Grants Innovation and Product Development at the SA Medical Research Council (SAMRC), said: “This investment from the SAMRC, the Department of Science and Innovation and the Technology Innovation Agency (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,” she said.
Dr Phil Mjwara, director-general of the Department of Science and Innovation (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.”
Mjwara said this investment had paid off with Medical Diagnostech’s Covid-19 antigen test, which lowered the cost of testing active infections.
“This technology not only benefits the country, but will also be made available to the rest of Africa,” Mjwara added.
The head of TIA’s health programme, Osmond Muroyiwa, said the organisation was living according to its mantra that innovation must answer to the challenges of the day.
“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.” DM
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