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SA launches first Covid-19 antigen self-test kit

South Africa is home to the first deployment of a Covid-19 antigen self-test kit with companion mobile-phone application, HealthPulse TestNow.
Source: Pexels

Medical Diagnostech developed the rapid diagnostic test, while the application was developed by the Seattle-based company, Audere.

The application provides detailed instructions on how to perform the self-test and assists in interpreting the results through image capture of the rapid test device.

HealthPulse TestNow is the first Covid-19 app deployed in South Africa that supports self-testers with the administration and interpretation of rapid diagnostic tests (RDT).

HealthPulse TestNow helps ensure the accurate use of RDTs through easy-to-follow instructions, process control timers, and guided result interpretation. The solution seamlessly integrates with public health reporting systems and ensures that self-testing data is reported, providing a more comprehensive understanding of disease prevalence.

Self-testing is an important component of public health strategies worldwide, however, challenges exist with accurate and reliable test administration, interpretation, and collection of data that can compromise the benefits of these efforts.

HealthPulse TestNow is designed to improve an individual’s self-testing aptitude while seamlessly connecting ministries of health with test data in an effort to maximise the end-to-end impact of public health programmes.

“While the current state of Covid-19 testing varies across communities, this AI-powered digital solution lays the foundation for a much-needed self-testing tool that facilitates improved self-diagnosis and early access to care not just for Covid-19, but for a range of medical conditions,” says Dino Rech, chief executive officer of Audere.

“We are actively expanding HealthPulse TestNow's coverage to include new conditions across a broader set of geographies in Africa. Our mission is to empower early diagnosis and expedite access to care.”

Driving local manufacturing

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. The development of the first Medical Diagnostech Covid-19 antigen test was co-funded through this mechanism.

The current announcement comes on the heels of the approval of the company’s rapid diagnostic test on 28 March 2023 by the South African Health Products Authority (Sahpra).

The rapid test and companion application were subject to rigorous evaluations by the National Reference Laboratory (NRL) of South Africa, and the National Health Laboratory Service (NHLS). The NHLS also conducted multi-provincial clinical trials to determine the rapid test kit’s usability among lay persons.

“We are thrilled to introduce this new product to South Africans and the rest of Africa in due course,” said chief executive officer of Medical Diagnostech, Ashley Uys. “South African healthcare professionals and patient groups have been asking for new and innovative medical products and we believe that the Medical Diagnostech Covid-19 antigen self-test is the catalyst to more innovative biomedical and diagnostic products”.

This is just one of many products in Medical Diagnostech’s wide range of diagnostic products and the company plans to continue pushing the envelope within the health market with future releases.

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