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P07

Validation of a novel LiquidArray based  assay for the rapid detection of tuberculous and nontuberculous mycobacteria from liquid and solid cultures

C Niccolai(1) F Corti(2) F Marcelli(2) A Andreini(2) R Mannino(2) A Antonelli(1,2)

1:Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; 2:Clinical Microbiology and Virology unit, Careggi University Hospital, Florence, Italy

M. tuberculosis complex (MTBC) is considered one of the most important public health threats for its high infection rate and mortality, specially in low-income countries. Recently, the incidence of opportunistic infections by nontuberculous mycobacteria (NTM) has steadily increased in parallel with immunocompromised population in medium- and high-income countries. Accurate diagnostic techniques to rapidly detect and differentiate Mycobacterium spp. are therefore of notable interest. Here, we evaluated The FluoroType® Mycobacteria VER 1.0 assay (Hain Lifescience GmbH, Germany – a Bruker company), for the detection of MTBC and differentiation at the species level of most clinically relevant NTM. 409 liquid (189 routine and 220 archival) cultures, 123 routine solid cultures were included in the study. Samples were extracted with the FluoroLyse kit and analyzed on the FluoroCycler® XT (interpreted by Hain Lifescience). Results were compared with those of the GenoType Micobacterium CM/AS, NTMDR assays or Sanger sequencing of specific target genes. Concordant results were obtained with 395 of 409 (96.6%) liquid cultures including 45 MTBC and 350 NTM of 24 different species. Regarding the 14 discrepant samples, the instrument reported Mycobacterium sp. in 13 cases, while in one case a different species compared to the reference method was reported. Concordant results were obtained with 122 of 123 (99.2%) solid cultures, and the only discrepant sample was reported by the instrument as Mycobacterium sp. The FluoroType® Mycobacteria VER 1.0 test showed high accuracy for detection and differentiation of NTM and MTBC and could be a valid alternative to the current standard of care.

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© 2021 The European Society of Mycobacteriology

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