SA’s first Covid-19 self-testing kit launched

The MD Covid-19 antigen self-test. Picture: Supplied

The MD Covid-19 antigen self-test. Picture: Supplied

Published May 2, 2023

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Cape Town – A Cape Town-based medical company has announced the launch of the country’s first Covid-19 antigen self-test with a companion mobile phone application, HealthPulse TestNow.

Medical Diagnostech (Pty) Ltd developed the rapid diagnostic test while the mobile application was developed by Audere, a company based in Seattle, Washington, in the US.

The application has been developed to provide detailed instructions on how to perform the self-test and assists users in interpreting the results through image capture of the rapid test.

“HealthPulse TestNow helps ensure the accurate use of rapid diagnostic tests (RDT) through easy-to-follow instructions, process control timers, and guided result interpretation.

Management and scientists who developed the Covid-19 antigen self-test. Picture: Medical Diagnostech

“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 maximize the end-to-end impact of public health programmes,” said Dr Rino Rech, CEO of Audere.

He said this AI-powered digital solution laid the foundation for a much-needed self-testing tool that facilitated improved self-diagnosis and early access to care not just for Covid-19, but for a range of medical conditions.

The MD Covid-19 antigen self-test. Photo: supplied

“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,” Rech said.

The company said with the guidance of the National Health Laboratory Service and others, the South African Medical Research Council (SAMRC), together with the 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.

It said 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 March 28, 2023, by the South African Health Products Regulatory Authority (Sahpra).

Medical Diagnostech CEO Ashley Uys.

It said the rapid test and companion application were subjected to rigorous evaluations by the National Reference Laboratory (NRL) of South Africa, the National Health Laboratory Service (NHLS).

The NHLS also conducted multi-provincial clinical trials to determine the rapid test kit’s usability among lay people.

Medical Diagnostech CEO and biotechnologist Ashley Uys, of Belhar, was proud of the company’s new product.

“We are thrilled to introduce this new product to South Africans and the rest of Africa in due course.

“South African health-care professionals and patient groups have been asking for new and innovative medical products and we believe that the MD Covid- 19 Antigen Self-test is the catalyst to more innovative biomedical and diagnostic products,” Uys said.

The MD Covid-19 antigen self-test will be available at all major pharmacies.

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