Registration Background
ViralSense Diagnostics submitted the AI-enhanced dengue NS1 rapid antigen test to HSA under the revised Class C IVD framework introduced in January 2026, which for the first time permits AI-assisted reader software integrated with a point-of-care lateral flow device to be evaluated as a single system. Previous guidance required separate evaluation of hardware and software components, creating a regulatory gap for integrated AI readers.
Performance Evidence
The registration dossier included a multi-site clinical performance study conducted across three Singapore hospitals and one primary care network, enrolling 1,842 participants during the 2025 dengue season. The AI reader achieved 96.4% sensitivity and 98.1% specificity against RT-PCR reference testing, outperforming the unaided visual read of the same lateral flow strip by 4.2 percentage points in sensitivity.
Post-Market Conditions
HSA has imposed a 24-month post-market performance tracking condition requiring the manufacturer to submit quarterly real-world performance data from participating clinics. If sensitivity falls below the 93% threshold in any quarter, the manufacturer must notify HSA within 14 days and submit a Corrective and Preventive Action plan.
Regional Implications
The approval is expected to serve as a reference decision for other ASEAN national regulatory authorities evaluating similar integrated AI-IVD systems, particularly Malaysia, Thailand, and Vietnam, which have signalled intent to adopt Singapore's updated IVD classification framework under the ASEAN Medical Device Directive harmonisation roadmap.