SOUTH AFRICA – Medical Diagnostech, a manufacturer of lateral flow rapid diagnostic test kits, has launched South Africa’s first Covid-19 antigen self-test with companion mobile phone application, HealthPulse TestNow.
The company 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 supports self-testers with the administration and interpretation of rapid diagnostic tests (RDT). It 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.
“We are proud to announce the first deployment of HealthPulse TestNow in South Africa,” says Dr Dino Rech, CEO of Audere.
“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.
“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.”
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, the National Health Laboratory Service (NHLS).
The NHLS also conducted multi-provincial clinical trials to determine the rapid test kit’s usability amongst lay persons.
“We are thrilled to introduce this new product to South Africans and the rest of Africa in due course,” says Ashley Uys, CEO of Medical Diagnostech.
“South African healthcare 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.”
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