Novel Molecular Method for the Detection of Mycobacterium Tuberculosis

Unmet Need
Tuberculosis (TB) is a potentially serious infectious respiratory disease that is spread via coughs and sneezes. TB is one of the world’s deadliest diseases; one-fourth of the global population is currently infected with TB. In 2016 alone, 10.4 million people contracted TB with 1.7 million TB-related deaths. Lack of resources in developing and poor countries is one of the main reasons for high mortality rates in TB patients.
 
Since ‘standard of care’ diagnostic tests rely on serial sputum samples which require multiple patient visits and expensive equipment not necessarily available at point-of-care healthcare settings it is quite challenging for patients to receive an accurate diagnosis (most TB infections are latent and asymptomatic) and subsequent treatment. As such, there is a significant need for new diagnostic technologies that are inexpensive, time-efficient, highly selective and sensitive for M. tuberculosis, and reasonable for point-of-care use in resource-poor clinics.
 
Technology Overview
Johns Hopkins researchers have developed a molecular method towards development of point-of-care diagnosis of TB. The method detects a specific enzyme unique to M. tuberculosis which is absent in non-tubercular mycobacteria. The enzyme is detected in M. tuberculosis culture via a colorimetric assay based on the hydrolysis of a chromogenic substrate. The molecular method is highly specific for the detection of M. tuberculosis as low as 6.5x10³ CFU/ml, demonstrating diagnostic accuracy greater than methods used in resource-poor healthcare facilities. The technology has the potential to be developed into a rapid point-of-care diagnostic tool for detection of TB from sputum and body fluids. The test has the potential for development into a diagnostic tool in line with World Health Organization’s guidelines for target product profiles for high-priority diagnostic needs for TB.
 
Stage of Development
The inventors have developed a simple kit for an accurate diagnosis of TB infection using a colorimetric-based assay. This method was tested and verified to reliably detect M. tuberculosis at concentrations as low as ~10³ CFU/ml within 12 hours.
 
Publications
Manuscript in preparation,
Antimicrob. Agents Chemother. March 2017   vol. 61  no. 3  e02234-16

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