The Global Fund to Fight AIDS, Tuberculosis and Malaria has launched a rollout of near point-of-care molecular diagnostic tests in 13 countries to address the 2.4 million tuberculosis cases that go undetected annually. This initiative, utilizing Pluslife Biotech Co. Ltd. technology, aims to close the diagnostic gap in underserved regions by providing rapid, low-cost testing that functions without the need for specialized laboratory infrastructure or stable power grids.
Why current TB diagnostic methods are failing
Standard diagnostic tools often fail to reach patients in remote or resource-limited settings. According to the World Health Organization (WHO), sputum smear microscopy remains widely used despite its well-documented lack of accuracy. While bacterial culture is considered the global gold standard, it is time-consuming and often impractical for quick clinical decisions.
Molecular diagnostics have improved speed and sensitivity, but they typically require expensive, heavy equipment and highly trained personnel. These barriers have left more than 20% of the 10.7 million annual TB cases undiagnosed, according to the WHO’s 2025 Global TB Report. The new molecular test deployed by The Global Fund addresses these limitations by using a lightweight, battery-operated device that provides results within one hour.
Tuberculosis remains the leading cause of death from a single infectious agent, with 1.23 million deaths recorded in 2024.
How the new diagnostic technology compares
The Pluslife diagnostic system utilizes proprietary RHAM technology to simplify molecular testing. By eliminating the need for complex thermal cycling and separate nucleic acid extraction, the device reduces the cost and technical expertise required for operation. Clinical data published in The New England Journal of Medicine in April 2025 validated the performance of the test, which uses a simple tongue swab.
| Feature | Standard Molecular (e.g., GeneXpert) | Pluslife System |
|---|---|---|
| Instrument Cost | ~$20,000 | ~$155 |
| Reagent Cost | $8–$10 | ~$3.60 |
While the Pluslife test shows a sensitivity of 79.6%—roughly 9 percentage points lower than the Cepheid Xpert Ultra—its portability and lower barrier to entry make it a critical tool for expanding access in high-burden countries like India, Indonesia, and the Philippines, according to data cited in the 2025 clinical study.
What happens next for global TB detection?
The Global Fund, which provides 73% of international TB financing, plans to continue supporting near point-of-care molecular testing over the next two to three years. Yang Min of the Bill & Melinda Gates Foundation, which supported the development and trials of the Pluslife technology, noted that the future path for these devices involves upgrading capabilities to detect drug-resistant strains of tuberculosis.
In addition to The Global Fund’s efforts, the Children’s Investment Fund Foundation committed $50 million in September 2025 to accelerate the deployment of innovative diagnostic tools. Health officials emphasize that these new, portable tests are designed to complement, not replace, advanced platforms like GeneXpert, which remain essential for managing complex, drug-resistant cases.
Frequently Asked Questions
- Is the new tongue swab test more accurate than a sputum smear? Yes. According to the 2025 study in The New England Journal of Medicine, the tongue swab test is approximately 18 percentage points more sensitive than traditional sputum smear microscopy.
- Will this replace existing lab equipment? No. The Global Fund states that this technology is intended to supplement existing platforms like GeneXpert, which are still required for diagnosing drug-resistant TB.
- Where are these tests being deployed first? The initial rollout includes 13 countries, with priority given to regions with high TB burdens and limited access to traditional laboratory infrastructure, such as Bangladesh, Benin, and Cameroon.
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