Completed Digestion, Kidneys & Other Organs Infection & Immunity

Novel Test for Point-of-Care Diagnosis of Tuberculosis

In plain English

AI plain-English summary

A simple urine or sputum sample could reveal whether someone has active tuberculosis within minutes, using a portable device the size of a smartphone. Tuberculosis kills over a million people each year, but current diagnostic tests are slow, expensive, or require lab equipment. Many patients in rural clinics are diagnosed too late or not at all. This project aims to close that gap by developing a test that detects an enzyme called BlaC, which is produced only by live TB bacteria. The test uses a fluorescent molecule that glows when cut by BlaC, and a cheap, off-the-shelf reader picks up the signal. If successful, this would be the first true point-of-care test for active TB. Healthcare workers in village clinics could diagnose patients in a single visit, start treatment immediately, and interrupt transmission earlier in the infection cycle. The test is designed to cost a fraction of existing lab-based methods and requires no external amplification, making it practical for low-resource settings. The company behind the work, Global BioDiagnostics Corp., plans to bring the test to global markets, potentially reshaping how TB is managed in the places that need it most.

View original technical description
One of the greatest gaps in the fight against tuberculosis (TB) is the pressing need for a low-cost, easy-to-use, point-of-care (POC) diagnostic assay. Global BioDiagnostics Corp. (GBD) is developing such an assay based on our innovative reporter enzyme fluorescence (REF) technology platform. M. Tuberculosis complex bacteria produce a ?-lactamase enzyme (BlaC) which is unique to M. TB bacteria. BlaC is outstanding as a basis for a highly specific and very sensitive, low-cost diagnostic because it is a highly conserved bio-marker that is catalytic in nature, thereby requiring no external amplification. GBD's proprietary fluorogenic substrate has a high affinity for the active site of BlaC. The company is developing a simple assay based upon cleavage of its substrate by BlaC to generate a fluorometric signal that is detectible by an off-the-shelf, low-cost, portable fluorometer. It is expected that the assay will effectively detect active TB infections in peripheral healthcare settings and accomplish diagnosis very early in and disruptive to the TB infection cycle. the first true POC capable diagnostic test to the global TB market.

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Researchers

Michael Norman (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

"MIMIC" - Multifunctional Integrated Microsystem for rapid point-of-care TB IdentifiCation
Single tube Point-Of-Care multi-drug resistant tuberculosis test
Accurate, Rapid, Robust and Economical diagnostic technoliogieS for Tuberculosis
Development and demonstration of clinical potential for a multi-biomarker-based, low-cost, point of care, lateral flow blood test for active tuberculosis.
A new approach to point of assessment diagnosis of tuberculosis

Original classification

Strategic Translation Award

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