Tuberculosis (TB) is a major global burden that kills 1.5 million people every year. TB mostly affects developing countries, but the rise of multi-drug and extensively drug resistant strains is a global threat. In order to control and eradicate this disease, it is imperative to have adequate tools to detect active TB in limited-resource settings and point-of-care (POC) settings, which is where most TB patients are seen. However, available detection methods have poor performance and are not suited for diagnosis in limited-resource or POC settings. The most commonly used method to detect TB is smear microscopy, a procedure developed more than 100 years ago that only detects 50% of the cases. In Phase I, we developed a sample preparation and detection procedure that is rapid, robust, easy to automate, and highly sensitive and specific. The new assay is based on Single Molecule Scanning (SMS), a novel technology capable of detecting single molecules using simple equipment. Here, we will develop a fully automated next generation molecular test based on the feasibility of SMS stablished in Phase I. The goal is to replace smear-microscopy for sputum- based diagnosis of TB in high TB-burden countries and to replace PCR-based TB diagnosis in developed countries. If successful, the new assay will be more accurate than the current leader molecular assay (>95% sensitivity, >99% specificity) and its price will be affordable for limited- resource settings ($6/test, $1,200/instrument). In addition, the new assay will satisfy all the characteristics that according to a WHO report are required in a product to replace smear microscopy. The overall goal of Phase II, is to develop and to validate a disposable cartridge and a fully automated instrument for TB testing.
Aim 1 focuses on the development of the disposable cartridge, Aim 2 on the development of the portable instrument and Aim 3 on the verification and clinical validation of the final instrument and cartridge design. This evaluation together with the design documentation accumulated during the project will be combined with additional clinical evaluations to obtain CE mark, FDA approval, approval in high TB-burden countries, and the endorsement of the World Health Organization.
We propose the development of a novel technology for rapid detection of active tuberculosis without enzymatic reactions. We will develop and validate a disposable cartridge and a fully automated instrument.
