A multiplex diagnostic test for multi-drug/extensively drug-resistant tuberculosis

Purpose and goal

There is a considerable need to develop methods that enable rapid detection of drugresistant tuberculosis (TB). We have developed a novel proof-of-concept molecular assay aiming at identifying the causative agent of TB, Mycobacterium tuberculosis, and its drug susceptibility pattern to drugs in the definition of extensively drugresistant (XDR) TB. The objectives of the project are to fully optimize the multiplex molecular method and to evaluate it in a large scale fashion. The ultimate goal is that the method can be performed by semi-skilled personnel in regional TB laboratories.

Results and expected effects

To commercialise the first molecular method for detection of drug-resistant TB which is not based on PCR, a method which is inherently difficult to perform in a highly multiplex manner. A highly flexible and multiplexable molecular method which is easily adjusted according to different needs and demands in various settings around the world. After an initial clinical validation in India, the commercial suitability of the prototype will be further evaluated in a large scale fashion to explore its utility in peripheral TB laboratories.

Approach and implementation

Aim I - Standardization of the developed molecular method Optimization of the multiplex-array-based readout Clinical sensitivity and specificity compared with DST gold standards Aim II - In-lab validation of the test with reference clinical samples Enhancement of efficiency with clinical samples at NIRT Design for commercial prototype Aim III Validation of the developed product in the laboratories of NIRT-Chennai and XCyton Diagnostics Ltd. Evaluation of prototype in the labs Aim IV Clinical evaluation at NIRT-Chennai and optimize the testing and storage conditions