CAPE TOWN – A locally produced COVID-19 rapid antigen test that was recently approved by South Africa’s medicines regulator is able to detect Omicron, according to its developer.
This follows some controversy about whether antigen tests were able to detect Omicron, and suggestions that throat swabs might be more effective than nasal swabs as Omicron affects the upper respiratory tract rather than the lungs.
But Dr Lyndon Mungur, COO of Medical Diagnostech, said that his company’s antigen test has been able to detect every COVID-19 variant, including Omicron.
“Most antigen tests detect the nucleoprotein and not the spike protein. There are only two mutations on the nucleoprotein for the Omicron variant, and both mutations are embedded in the centre of the protein, and not on the antigenic sites,” explained Mungur, a biotechnologist who helped with the research and development of the local antigen test.
“We have an ongoing clinical study program so that we can be abreast of new variants as they become evident. Our antigen tests were able to detect every one, and we also compare results to PCR tests on the same specimens,” said Mungur, adding that the Medical Diagnostech test used nasal swabs.

Cheaper than imported tests

“If current tests were able to detect at a lower sensitivity, this would only affect the very beginning and very end stages of infection. There is a very small window at the start and at the end in terms of low viral load.”
The Medical Diagnostech test is likely to be around 35% cheaper than imported tests, and it was approved by the South African Health Products Regulatory Authority (SAHPRA) in December.
Company CEO Ashley Uys said that his company “has a production capacity of 20 million units per annum”.
The company received funding from the South African Medical Research Council (SAMRC) to develop its test.
Medical Diagnostech had already developed a prototype antigen detection test, but required support to increase its sensitivity and complete the testing and approvals for market entry, according to SAMRC official Dr Michelle Mulder,
“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,” added Mulder.
“This [antigen test] not only benefits the country but will also be made available to the rest of Africa,” said Dr Phil Mjwara, Director-General of the Department of Science and Innovation.

A few months earlier, the country’s regulator approved a locally produced PCR test.

Image Credits: MedicalDiagnostic.