Informal consultation on roll-out of the xpert MTB/RIF diagnostic test and expanding laboratory services for TB control : national tuberculosis institute, Bangalore, India, 18-20 October 2011
AbstractThe Xpert MTB/RIF assay is platform technology that has the potential for being used for screening for infectious and non-infectious diseases including HIV, malaria and detection of HPV for cervical cancer. The TB platform was completed in 2009 and is considered an important breakthrough in the fight against TB. For the first time, a molecular test is simple and robust enough to be introduced outside conventional laboratory settings. The Xpert MTB/RIF assay detects M. tuberculosis as well as rifampicin resistance-conferring mutations using three specific primers and five unique molecular probes to ensure a high degree of specificity. The assay provides results directly from sputum within 100 minutes. On 8 December 2010 the World Health Organization (WHO) endorsed the Xpert MTB/RIF assay, a highly sensitive and specific, automated, real-time molecular diagnostic test which uses state-of-the-art DNA technology for rapid and simultaneous detection of tuberculosis (TB) and rifampicin resistance (a reliable proxy for multidrugresistant TB, MDR-TB), in both HIV-negative and HIV-positive individuals. The technology is suitable for use at district and subdistrict health service level, outside of conventional laboratory settings. Given its ease of use and speed of diagnosis (in 100 minutes), Xpert MTB/RIF is expected to have a major impact on patient care and disease control by reducing patient and health service diagnostic delays, decentralizing the diagnosis of MDR-TB and HIV-associated TB, and accelerating patient access to appropriate care. Although technical end-user training requirements for Xpert MTB/RIF are minimal, maximum efficiency and optimal use of the technology requires major overhaul of TB and MDR-TB diagnostic algorithms, changes in patient management approaches, and changes in case definitions and monitoring and evaluation indicators. Over the years, technical issues relating to smear microscopy, mycobacterial culture and drug susceptibility testing and quality assurance have been streamlined. Regional and national laboratory workshops have been organized and trainings conducted.
World Health Organization, Regional Office for South-East Asia. (2012). Informal consultation on roll-out of the xpert MTB/RIF diagnostic test and expanding laboratory services for TB control : national tuberculosis institute, Bangalore, India, 18-20 October 2011. WHO Regional Office for South-East Asia. http://www.who.int/iris/handle/10665/205356