India’s first ICMR-recommended open RT-PCR solution that universalises affordable access to faster molecular diagnostics for TB
Problem
TB diagnostic delays and under-detection persist, especially in rural and underserved populations. Conventional diagnostic methods (culture, smear microscopy) are limited by sensitivity, while advanced molecular diagnostics (CBNAAT / TrueNat), though more accurate, are often costly and out of reach. A large segment of the population remains undiagnosed due to the limitations of closed molecular diagnostic systems, which require stable electricity, controlled environments, skilled personnel, and well-equipped labs—resources often scarce in remote and rural settings. While RT-PCR platforms are increasingly available across both government and private health systems, their full potential remains underutilized due to the lack of affordable, easy-to-use, high-quality molecular assays for TB and other infectious diseases. Centralized testing models continue to delay confirmatory results, especially for vulnerable and hard-to-reach populations. This contributes to further treatment initiation delays, poor case notifications, and persistent under-detection of TB cases.
Solution
Quantiplus® MTB Fast Detection Kit from Huwel Lifesciences is a rapid, accurate, open-system RT-PCR solution that delivers TB diagnosis in just 40 minutes without the need for complex DNA extraction. Priced at less than INR 200 per test, which is ~1/10th the current test price for closed-system cartridge-based tests, Quantiplus® offers an accessible, affordable, high-impact tool to accelerate access to molecular diagnostics. It doesn’t require complex sample preparation, expensive equipment or highly trained personnel. The test helps to reduce diagnostic delays, improve case detection in hard-to-reach populations and deliver performance comparable to high-end closed RT-PCR systems, albeit with simplified workflows that make it ideal for use in decentralized, district-level labs. The solution has the capacity to scale to 900 tests per day per lab using standard 96-well formats—enabling district-level facilities to diagnose more effectively and respond more swiftly.
IHF is supporting Huwel in conducting field feasibility studies for Quantiplus® across 10 Central TB Division-approved sites. The test has been approved by the Central Drugs Standard Control Organisation (CDSCO), validated by the Indian Council of Medical Research (ICMR), and independently benchmarked by Infexn Labs. The study will enable the generation of operational and clinical evidence for Quantiplus® in real-world settings and validate the platform’s performance across diverse geographies, specimen types, and health system levels. The expected outcome is to inform policy decisions around the inclusion of open RT-PCR solutions in national TB diagnostic frameworks, while also establishing the feasibility of decentralized, high-throughput molecular testing in district-level labs.