ADELINE ANTHONY ALPHONSO – 19 Oct 2025
Source: The HEALTH September-October 2025, Page 18-19
HIV remains one of the world’s most persistent health challenges, with stigma and late testing continuing to hinder prevention efforts. Malaysia has taken a bold step forward by approving HIV self-testing (HIVST) kits, allowing individuals to privately test themselves at home.
At the forefront is SURE CHECK® HIV SELF-TEST distributed by Reszon Diagnostics International Sdn. Bhd. (Reszon) — recently recognised with the prestigious FDA Breakthrough Device designation. For Reszon, the award is more than a regulatory milestone. It marks a turning point in expanding access to discreet and accurate testing in Malaysia and beyond.
“The FDA designation affirms the scientific robustness of SURE CHECK® HIV Self-Test and builds confidence among healthcare professionals, NGOs, and distribution partners.
“Trust is essential for expanding access to quality testing, enabling wider adoption, and supporting public health efforts to improve early detection and treatment,” said Reszon Sales Director Katherine Koay.
TACKLING STIGMA AND BARRIERS
While the FDA designation boosts international standing, Reszon’s work at home is deeply rooted in partnerships. HIV self-testing is still a relatively new concept in Malaysia, and reaching the right people requires more than simply putting kits on pharmacy shelves.
To bridge that gap, Reszon collaborates with community-based organisations and NGOs such as the PT Foundation and the Malaysian AIDS Council. These groups are already embedded in communities most affected by HIV.
Koay explained: “NGOs are essential partners because they provide outreach, education, and support in spaces where stigma remains a barrier.”
Distribution is also expanding beyond hospitals and clinics. Reszon has partnered with local distributors to bring the test to major pharmacy chains, including Alpro Pharmacy and Mega Kulim Pharmacy.
Recognising that privacy is critical, the company is also preparing to work with telehealth providers, enabling discreet purchases through online and e-commerce platforms.
Despite these efforts, Koay acknowledges that challenges remain.
“The primary challenges are awareness, stigma, and education,” she explained. “Some individuals may still be hesitant to self-test due to lack of familiarity or concerns about accuracy and privacy.”
Reszon’s approach is to break down these barriers through collaborative education campaigns and professional training. By working closely with NGOs, pharmacists, and healthcare providers, the company aims to normalise self-testing and reassure the public that support is available after results. This ensures that HIV self-testing is not seen as an isolated act, but as the first step in a continuum of care.
Instead of relying on broad advertising, Reszon’s strategy to raise awareness lies in blending public health education with community engagement. Social media campaigns, educational videos, and targeted online outreach are being deployed to reach diverse audiences, especially higher-risk groups.
Koay added: “Our goal is to make HIV self-testing a familiar and trusted option.
“By working with advocacy groups and healthcare partners, we ensure the message resonates at the community level — that early, accessible HIV testing saves lives and supports better health outcomes.”
TECHNOLOGY THAT SIMPLIFIES TESTING
What sets SURE CHECK® apart from other HIV rapid tests is its patented barrel design, which integrates blood collection and testing into a single sealed device. Unlike conventional tests that often require 50μL (microlitres) of blood and multiple handling steps, SURE CHECK® requires just one small drop — 2.5 μL. The direct transfer system reduces the risk of error and makes the process more approachable for non-professionals.
This simplicity, however, does not compromise accuracy. WHO prequalification studies reported 99.7 per cent sensitivity and 99.9 per cent specificity in professional-use settings. Field evaluations further demonstrated that untrained laypersons could achieve results comparable to those of trained professionals, with 97 per cent sensitivity and 100 per cent specificity. Results are available within 15 minutes, striking a balance between speed and reliability.
Koay emphasised that the device was designed with ordinary users in mind. “The test is purposefully intuitive and accessible,” she said. “With fewer steps and lower hands on time (no bottles, no mixing, no pouring), there are fewer chances of mistakes, preventing accidental spilling.
Users can perform the test confidently without medical training.”
To ensure accessibility, the Malaysian market kit includes QR codes that link directly to video tutorials and product information pages. A separate QR code connects users to the TESTNOW platform, where they can report results and receive guidance on next steps. This integration not only empowers individuals but also helps public health authorities strengthen interventions through real-time data.
SILENT EPIDEMIC NO MORE
By combining robust science with human-centred design, SURE CHECK® HIV Self-Test is an innovative tool that lowers the threshold for testing by public while reinforcing the importance of follow-up care.
Reszon is not only strengthening its business but also contributing to the broader public health agenda by making testing private, accurate, and accessible.
“HIV self-testing empowers individuals to take control of their health. It’s about giving people the confidence to know their status and take action early, without fear or stigma. That is how we create healthier communities,” Koay noted.
– The HEALTH
