Single-tube high-multiplex molecular assay for differentiation of 32 clinically relevant nontuberculous mycobacteria and detection of M. tuberculosis complex from cultivated samples.
Nontuberculous mycobacteria (NTM) are a group of ubiquitous bacteria commonly found in soil and water, which can cause opportunistic infections. Since treatment depends on the species causing the infection, identification of mycobacteria at the species level is of great clinical relevance. Consequently, rapid and reliable differentiation between clinically significant NTM species is essential for effective disease management.
Differentiation between NTM species
FluoroType
® Mycobacteria VER 1.0 is a molecular genetic assay powered by the innovative LiquidArray
® technology. It allows detection of the
Mycobacterium tuberculosis complex as well as differentiation of 32 clinically relevant NTM species, such as
M. avium, M. kansasii, M. fortuitum and the
M. abscessus complex in a single reaction. The
M. abscessus complex can be further subcategorized. Moreover, detection of additional nontuberculous mycobacteria on the genus level is facilitated due to a genus-specific target. Starting from a positive culture, automatically evaluated results are available within just 2.5 hours.
The Assay allows the detection of these NTMs in one well:
• Mycobacterium abscessus subsp. abscessus
• Mycobacterium abscessus subsp. bolletii
• Mycobacterium abscessus subsp. massiliense
• Mycobacterium asiaticum
• Mycobacterium avium
• Mycobacterium celatum
• Mycobacterium chelonae
• Mycobacterium chimaera
• Mycobacterium fortuitum
• Mycobacterium gastri
• Mycobacterium genavense
• Mycobacterium goodii
• Mycobacterium gordonae
• Mycobacterium haemophilum
• Mycobacterium heckeshornense/Mycobacterium xenopi*
• Mycobacterium intermedium
• Mycobacterium interjectum
• Mycobacterium intracellulare
• Mycobacterium kansasii
• Mycobacterium lentiflavum
• Mycobacterium malmoense
• Mycobacterium marinum
• Mycobacterium mucogenicum
• Mycobacterium peregrinum
• Mycobacterium phlei
• Mycobacterium scrofulaceum
• Mycobacterium shimoidei
• Mycobacterium simiae
• Mycobacterium smegmatis
• Mycobacterium szulgai
• Mycobacterium ulcerans
• Mycobacterium xenopi
* Detection signature for M. heckeshornense is similar to that of M. xenopi. While M. xenopi can be reliably identified, specific determination of M. heckeshornense is not possible.
Results at a glance in combination with FluoroCycler® XT
Following DNA extraction with FluoroLyse and PCR set-up, the plate can be directly placed into the FluoroCycler® XT for amplification and detection. The wizard-based software guides users easily through setup and results evaluation. An Internal Control ensures the correct test procedure and validity of results. FluoroSoftware® XT-IVD generates results in an easy to use, easy to interpret test report. The FluoroType® Mycobacteria is a powerful tool for the detection of the M. tuberculosis complex and differentiation of clinically relevant NTMs directly from cultured material. FluoroType® Mycobacteria VER 1.0 harnesses the LiquidArray® technology to provide a high level of multiplex analysis.