Diagnostic Test Detects Mycobacterium Tuberculosis with 96% Accuracy

A new assay is 96 % accurate in detecting rifampin-resistant Mycobacterium tuberculosis (TB). The assay is currently under development to provide rapid diagnosis and drug susceptibility information for TB.

A privately held molecular diagnostics company developing sample-to-result solutions, Great Basin Corporation (Salt Lake City, UT, USA) developed the new assay.

The technology entails an integrated disposable cartridge containing all necessary reagents and an inexpensive bench-top analyzer that executes the assay, interprets the results, and provides eye-visible detection to the clinician. The test is being automated in a manner consistent with the World Health Organization's (WHO; Geneva, Switzerland) ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, and Deliverable to end-users) goals for developing world point-of-care testing for drug-resistant TB.

More than 9.8 million cases of multidrug-resistant Mycobacterium tuberculosis (MDR TB) are reported worldwide each year, and more than half of those previously treated experience repeat infections. TB can be treated effectively if properly identified; however, mistreated or left untreated, can cause drug resistance and can be deadly. The poor sensitivity of diagnostic tests appears to be the main reason for delay of TB treatment.

A study of the new TB assay appeared in the July 2012 edition of the Journal of Clinical Microbiology. Authors of the study include scientists from Great Basin Corp. and from the Public Health Research Institute Tuberculosis Center, University of Medicine and Dentistry of New Jersey (Newark, NJ, USA).

"The need for improved point-of-care testing for drug resistance in MDR TB is acute, especially in the developing world," said Robert Jenison, CTO of Great Basin Corporation and study coauthor. "A significant advantage of the TB ID/R assay is that more information can be added to it to detect additional TB resistance mechanisms, potentially allowing for diagnosis of MDR-TB, even extremely drug-resistant TB (XDR-TB). This diagnostic capability can improve management and treatment for greater numbers of infected patients, further reducing transmission risks."

Related Links:
Great Basin Corporation
World Health Organization
Public Health Research Institute Tuberculosis Center, University of Medicine and Dentistry