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