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One strip – one test for the detection of the genus Mycobacterium and 16 mycobacterial species.

INNO-LiPA® MYCOBACTERIA v2 is a line probe assay for the simultaneous detection and identification of the genus Mycobacterium and 16 different mycobacterial species. The test is based on the nucleotide differences in the 16S-23S rRNA spacer region and can be performed starting from either liquid or solid culture.

The following Mycobacterium species can be detected simultaneously: M. tuberculosis complex, M. kansasii, M. xenopi, M. gordonae, M. genavense, M. simiae, M. marinum and M. ulcerans, M. celatum, MAIS, M. avium, M. intracellulare, M. scrofulaceum, M. malmoense, M. haemophilum, M. chelonae complex, M. fortuitum complex, and M. smegmatis.

Art. no. 80346 (20T - CE) - Please contact your local Fujirebio representative for the availability of this product in your country.

Features & Benefits

  • One strip replaces multiple testing
  • The 16S - 23S rRNA spacer region brings the precision of molecular testing to species differentiation
  • Mixed populations easily identified
  • Discriminates subgroups within M. kansasii and M. chelonae
  • Easy to perform
  • Quick visual interpretation
  • Applicable on early liquid culture - no need for colony morphology
  • Quick screening of major species
  • Fully automated processing of the strips possible using TENDIGO and Auto-LiPA 48


Strip design




Although more than 70 Mycobacterium species are currently described, relatively few are strictly pathogenic for men or animals. Most are harmless saprophytic bacteria; some are occasionally pathogenic (1-3).

M. tuberculosis complex strains are still responsible for the majority of Mycobacterium infections worldwide. However, opportunistic infections due to non-tuberculous mycobacteria (NTM) [also called mycobacteria other than tuberculosis (MOTT) or atypical mycobacteria] are on the increase, as a consequence of the AIDS pandemic (3-5).

Among the Mycobacterium species often implicated in NTM infections, M. avium complex (MAC), M. avium, M. intracellulare, M. chelonae, M. kansasii and M. xenopi figure prominently (1, 4, 6).

M. gordonae does not usually cause human infections, but it is often encountered as a contaminant in clinical samples. Discrimination of M. gordonae from pathogenic species is a relevant diagnostic issue (7).

In general, the epidemiology of NTM infections is poorly understood (8). In clinical mycobacteriology laboratories identification of mycobacterial cultures is predominantly achieved by biochemical methods. Recently developed molecular methods, such as DNA probe tests, may simplify identification and may eventually lead to a better understanding of this complex group of organisms and their relevance in human disease (9-11).


  1. Nolte FS, Metchock B. Mycobacterium. In: Murray PR, Baron EJ, Pfaller MA, et al., editors. Manual of Clinical Microbiology. 6th ed. Washington DC: ASM Press;1995. p. 400-437.
  2. Pitchenik AE, Fertel D. Tuberculosis and nontuberculosis mycobacterial disease. Med Clin North Am 1992;76:121-171.
  3. Portaels F. Epidemiology of mycobacterial diseases. Clin Dermatol 1995;1:207-222.
  4. Falkinham III JO. Epidemiology of infection by nontuberculosis mycobacteria. Clin Microbiol Rev 1996;9:177-215.
  5. Pozniak AL, Uttley AHC Kent RJ. Mycobacterium avium complex in AIDS: who, when, where, why and how? Soc Appl Bacteriol Symp Ser 1996;25:40S-46S.
  6. Benson CA, Ellner JJ. Mycobacterium avium complex infection and AIDS: advances in theory and practice. Clin Infect Dis 1993;17:7-20.
  7. Wayne LG, Good RC, Böttger EC, et al. Semantide- and chemotaxonomy-based analyses of some problematic phenotypic clusters of slowly growing mycobacteria, a cooperative study of International Working Group on Mycobacterial Taxonomy. Int J Syst Bacteriol 1996;41:280-297.
  8. Doern GV. Diagnostic mycobacteriology: where are we today? J Clin Microbiol 1996;34:1873-1876.
  9. Rogall T, Wolters J, Flohr T, Böttger EC. Towards a phylogeny and definition of species at the molecular level within the genus Mycobacterium. Int J Syst Bacteriol 1990;40:323-330.
  10. Miller N, Infante S, Clearly T. Evaluation of the LiPA MYCOBACTERIA assay for identification of Mycobacterial species from BACTEC 12B bottles. J Clin Microbiol 2000;38:1915-1919.
  11. Tortoli E, Nanetti A, Piersimoni C, Cichero P, Farina C, Mucignat G, et al. Performance assessment of new multiplex probe assay for identification of Mycobacteria. J Clin Microbiol 2001;39:1079-1084.

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