scope:

The combination of traditional and newer alternative methods for the isolation and identification of mycobacteria offers opportunities to significantly impact the management of patients with mycobacterial disease and to disrupt the transmission of tuberculosis. Despite the advantages of improved sensitivity and rapidity of testing, there remain questions regarding the optimal methods and combination of methods that should be employed by clinical mycobacteriology laboratories. As a practical working document, this document is intended to provide guidance to laboratories on the total testing process for patients with suspected mycobacterial infections. Recommendations are offered for the collection, preservation, and transport of clinical specimens. Procedures for the direct detection of mycobacteria by microscopy and amplification techniques, the optimal recovery of mycobacteria from clinical specimens, and the identification of mycobacterial species by traditional (phenotypic) and alternative (phenotypic and genotypic) laboratory methods are addressed. Mycobacterial susceptibility testing is addressed in CLSI/NCCLS document M24.

Many sections of this document, especially those related to identification methods, are tailored to fullservice mycobacteriology laboratories in industrialized countries. It is recognized, however, that provision of various laboratory services is contingent upon existing local conditions and resources. For many laboratories in disease-endemic countries, implementing quality-assured direct sputum smear microscopy may be a higher priority than many of the more equipment- and reagent-dependent methods described here. Additional information for such laboratories can be found on the websites of the World Health Organization (WHO) (www.who.int) and the International Union Against Tuberculosis and Lung Disease (www.tbrieder.org). These guidelines, however, should provide useful information for the many international laboratories providing, or planning to provide, services beyond microscopy, such as solid media culture or rapid methods for M. tuberculosis complex (MTBC) detection.