Real-Time PCR Detects Drug Resistant Tubercle Bacillus

A new diagnostic test identifies drug resistance genes of Mycobacterium tuberculosis (TB) in various human biological materials

The real-time polymerase chain reaction (RT-PCR) test can simultaneously detect TB and the mutations of drug resistant TB genes in sputum, aseptic and pleural fluid, blood, bone marrow aspiration, bronchial washing, fresh tissue, culture specimens (solid and liquid culture), urine and stool. The test for multi-drug resistant TB (MDR-TB) is completed within four hours.

Healthcare workers will be able to determine quickly whether or not a patient is infected with a strain of TB that is resistant to first line drugs such as isoniazid (INH) and rifampin (Rif). The Anyplex MDR-TB is a real-time detection test of M. tuberculosis that quickly and comprehensively determines the levels of targets in a patient's various sample types, and identifies mutations of drug resistant genes, which will aid physicians to make the correct diagnostic choices.

The Anyplex MDR-TB test is manufactured by Seegene (Rockville, MD, USA). The test can detect the mutations of drug resistant genes to Rif (rpoB: D516V/Y, H526D/Y, S531L) and INH (katG: S315T (2 cases); inhA promoter: -15(C/T)). The unprecedented speed and accuracy of the Anyplex MDR-TB Tests will enable doctors and clinicians to provide quickly an appropriate treatment to prevent the spread of MDR-TB.

Current TB test methods based on culture and microscopy are hindered by speed, low sensitivity, and low specificity. Furthermore, none of these approaches are able to identify rapidly and efficiently a patient's resistance to the major drugs for treating TB. Even if sequencing and Line Probe Assay are available to test drug resistance, the procedures are quite complicated and time-consuming.

The World Health Organization (WHO; Geneva, Switzerland), reported that TB strains that are resistant to all major anti-TB drugs have been documented in every country by the nongovernmental organization recent survey. A particularly dangerous form of drug-resistant TB is MDR-TB, caused by TB bacilli resistant to the most powerful anti-TB drugs. The rate for successful MDR-TB treatment is extremely low and the progress of the disease is faster than normal TB, resulting in 40% - 50% of mortality rate.

Jong-Yoon Chun, CEO of Seegene, said, "Because MDR-TB is difficult to treat, preventing its spread throughout the population is essential. The Anyplex MDR-TB Test is a powerful new tool that healthcare workers can use to rapidly determine such infections, which will both help stop it from spreading and allow health care professionals to set a course of alternative medications for infected patients."

Related Links:
Seegene
WHO