@article{oai:nagasaki-u.repo.nii.ac.jp:00005219, author = {Chikamatsu, Kinuyo and Aono, Akio and Yamada, Hiroyuki and Sugamoto, Tetsuhiro and Kato, Tomoko and Kazumi, Yuko and Tamai, Kiyoko and Yanagisawa, Hideji and Mitarai, Satoshi}, issue = {1}, journal = {BMC Infectious Diseases}, month = {Feb}, note = {Background: The rapid identification of acid-fast bacilli recovered from patient specimens as Mycobacterium tuberculosis complex (MTC) is critically important for accurate diagnosis and treatment. A thin-layer immunochromatographic (TLC) assay using anti-MPB64 or anti-MPT64 monoclonal antibodies was developed to discriminate between MTC and non-tuberculosis mycobacteria (NTM). Capilia TB-Neo, which is the improved version of Capilia TB, is recently developed and needs to be evaluated.Methods: Capilia TB-Neo was evaluated by using reference strains including 96 Mycobacterium species (4 MTC and 92 NTM) and 3 other bacterial genera, and clinical isolates (500 MTC and 90 NTM isolates). M. tuberculosis isolates tested negative by Capilia TB-Neo were sequenced for mpt64 gene.Results: Capilia TB-Neo showed 100% agreement to a subset of reference strains. Non-specific reaction to M. marinum was not observed. The sensitivity and specificity of Capilia TB-Neo to the clinical isolates were 99.4% (99.6% for M. tuberculosis, excluding M. bovis BCG) for clinical MTC isolates and 100% for NTM isolates tested, respectively. Two M. tuberculosis isolates tested negative by Capilia TB-Neo: one harbored a 63-bp deletion in the mpt64 gene and the other possessed a 3,659-bp deletion from Rv1977 to Rv1981c, a region including the entire mpt64 gene.Conclusions: Capilia TB-Neo is a simple, rapid and highly sensitive test for identifying MTC, and showed better specificity than Capilia TB. However, Capilia TB-Neo still showed false-negative results with mpt64 mutations. The limitation should be recognized for clinical use., BMC Infectious Diseases, 14(1), 54; 2014}, title = {Comparative evaluation of three immunochromatographic identification tests for culture confirmation of Mycobacterium tuberculosis complex}, volume = {14}, year = {2014} }