| 2007: Commercial liquid culture and DST systems |
| Automated and manual commercial systems for liquid culture and DST recommended for use at central/reference laboratory level |
| Phased implementation recommended within the context of comprehensive country plans for strengthening TB laboratory capacity |
| Currently regarded as the reference standard for conventional culture and DST and recommended as a stand-alone diagnostic test for TB and drug-resistance detection |
| 2007: Rapid speciation strip technology |
| Rapid chromatographic strip speciation recommended for distinguishing Mycobacterium tuberculosis from non-tuberculous mycobacteria |
| Recommended for use in combination with conventional culture and DST systems, at central/reference laboratory level |
| Recommended as a stand-alone speciation test for Mycobacterium tuberculosis isolates |
| 2008: Molecular line probe assay for first-line anti-TB drugs |
| Commercial line probe assays recommended for rapid detection of rifampicin alone or in combination with isoniazid resistance detection in smear-positive sputum specimens and Mycobacterium tuberculosis isolates grown from culture, for use at central/reference laboratory level |
| Phased implementation recommended within the context of national plans for MDR-TB diagnosis, including development of country-specific screening/diagnostic algorithms |
| Can be used as a stand-alone diagnostic test for rifampicin resistance (but no other resistance) once laboratory proficiency and equivalence with commercial liquid culture systems have been validated |
| Need for conventional culture (for smear-negative sputum specimens and treatment monitoring) as well as phenotypic DST capacity remains |
| 2010: LED microscopy |
| Recommended as immediate replacement for conventional fluorochrome microscopy and as gradual replacement for conventional light Ziehl–Neelsen microscopy |
| Suitable for use at peripheral microscopy, as well as higher laboratory levels |
| 2010: Selected non-commercial DST methods: MODS, NRA, CRI |
| Recommended as interim solutions for rapid rifampicin testing in resource-constrained settings, at central/reference laboratory level |
| Phased implementation under strict laboratory protocols and quality assurance recommended within the context of national plans for MDR-TB diagnosis, including development of country-specific screening/diagnostic algorithms |
| Phased implementation recommended within the context of national plans for MDR-TB diagnosis, including development of country-specific screening/diagnostic algorithms |
| Can be used as stand-alone diagnostic tests for rifampicin resistance (but no other resistance) once laboratory proficiency and equivalence with conventional culture systems have been validated |
| Need for conventional culture (for smear-negative sputum specimens and treatment monitoring) as well as DST capacity remains. MODS and NRA are suitable for direct testing on smear-positive sputum specimens and indirect testing on Mycobacterium tuberculosis isolates grown from culture |
| CRI is suitable for indirect testing on Mycobacterium tuberculosis isolates only |
| 2011: Automated real-time nucleic acid amplification technology: Xpert MTB/RIF system |
| Recommended as rapid diagnostic test for TB and rifampicin resistance at peripheral microscopy, as well as higher laboratory levels |
| Can be used as stand-alone diagnostic test for TB detection in all settings (including HIV co-infected patients) and for rifampicin resistance in patients at risk of drug-resistant disease |
| Phased implementation and rapid scale-up recommended within the context of national TB and MDR-TB plans, including development of country-specific screening/diagnostic algorithms |
| Need for conventional microscopy and culture remains to monitor treatment and to conduct additional DST |
| Evaluated but not yet approved due to lack of adequate evidence |
| Sputum concentration and decontamination methods (evaluated 2008) |
| Phage-plaque technology for rapid rifampicin resistance detection (evaluated 2008) |
| Thin-layer agar methods for rapid culture and DST (evaluated 2010) |
| Molecular line probe assays for second-line anti-TB drugs (evaluated 2012) |
| Loop-mediated isothermal amplification test kit for tuberculosis (evaluated 2012) |
| Not approved for use |
| Commercial serodiagnostic tests for TB diagnosis (evaluated 2011) |
| IFN-γ release assays for detection of active TB in all settings (evaluated 2011) |
| IFN-γ release assays as replacement for TST to detect latent TB in low- and middle-income (typically high TB and/or HIV burden) settings (evaluated 2011) |
DST: drug susceptibility testing; MDR: multidrug resistant; LED: light-emitting diode; MODS: microscopic observation of drug susceptibility; NRA: nitrate reductase assay; CRI: colorimetric redox indicator; IFN: interferon; TST: tuberculin skin test.