title: Performance assessment of the CapitalBio mycobacterium identification array system for identification of mycobacteria.
abstract: The CapitalBio Mycobacterium identification microarray system is a rapid system for the detection of Mycobacterium tuberculosis. The performance of this system was assessed with 24 reference strains, 486 Mycobacterium tuberculosis clinical isolates, and 40 clinical samples and then compared to the "gold standard" of DNA sequencing. The CapitalBio Mycobacterium identification microarray system showed highly concordant identification results of 100% and 98.4% for Mycobacterium tuberculosis complex (MTC) and nontuberculous mycobacteria (NTM), respectively. The sensitivity and specificity of the CapitalBio Mycobacterium identification array for identification of Mycobacterium tuberculosis isolates were 99.6% and 100%, respectively, for direct detection and identification of clinical samples, and the overall sensitivity was 52.5%. It was 100% for sputum, 16.7% for pleural fluid, and 10% for bronchoalveolar lavage fluid, respectively. The total assay was completed in 6 h, including DNA extraction, PCR, and hybridization. The results of this study confirm the utility of this system for the rapid identification of mycobacteria and suggest that the CapitalBio Mycobacterium identification array is a molecular diagnostic technique with high sensitivity and specificity that has the capacity to quickly identify most mycobacteria.
authors.affiliation: Clinical Laboratory Department, Wuxi No. 2 People’s Hospital, Wuxi, China. yuejunnan@yahoo.com.cn
authors.forename: Jingbo
authors.initials: J
authors.lastname: Liu
authors.forename: Jun
authors.initials: J
authors.lastname: Yue
authors.forename: Zihe
authors.initials: Z
authors.lastname: Yan
authors.forename: Min
authors.initials: M
authors.lastname: Han
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Han
authors.forename: Lingjie
authors.initials: L
authors.lastname: Jin
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods*; D001992:Bronchoalveolar Lavage Fluid / Q000382:microbiology; D004269:DNA, Bacterial / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D046228:Microarray Analysis / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009161:Mycobacterium / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D009693:Nucleic Acid Hybridization / Q000379:methods; D010996:Pleural Effusion / Q000382:microbiology; D016133:Polymerase Chain Reaction / Q000379:methods; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D013997:Time Factors; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial
references.citation: J Clin Microbiol. 2002 May;40(5):1723-7
references.pmid: 11980950
references.citation: J Clin Microbiol. 2002 Nov;40(11):4138-42
references.pmid: 12409387
references.citation: AIDS. 1994 Aug;8(8):1103-8
references.pmid: 7986406
references.citation: J Clin Microbiol. 2002 Aug;40(8):3089-92
references.pmid: 12149389
references.citation: J Clin Pathol. 1999 Mar;52(3):193-7
references.pmid: 10450178
references.citation: Indian J Med Microbiol. 2010 Jan-Mar;28(1):26-9
references.pmid: 20061759
references.citation: J Clin Microbiol. 1998 Oct;36(10):2853-60
references.pmid: 9738032
references.citation: J Clin Microbiol. 1998 Dec;36(12):3601-4
references.pmid: 9817880
references.citation: J Clin Microbiol. 2003 Sep;41(9):4418-20
references.pmid: 12958281
references.citation: J Clin Microbiol. 2010 Oct;48(10):3654-60
references.pmid: 20686082
references.citation: Antimicrob Agents Chemother. 2007 Oct;51(10):3707-13
references.pmid: 17646412
references.citation: J Clin Microbiol. 1998 Jul;36(7):2023-9
references.pmid: 9650955
references.citation: JAMA. 1996 Oct 16;276(15):1223-8
references.pmid: 8849749
references.citation: J Clin Microbiol. 2003 Apr;41(4):1779-82
references.pmid: 12682186
references.citation: J Clin Microbiol. 2004 Oct;42(10):4599-603
references.pmid: 15472315
references.citation: Diagn Microbiol Infect Dis. 2003 May;46(1):29-33
references.pmid: 12742316
references.citation: J Clin Microbiol. 2001 Dec;39(12):4477-82
references.pmid: 11724865
references.citation: Syst Appl Microbiol. 2007 Sep;30(6):453-62
references.pmid: 17640840
references.citation: J Microbiol Methods. 2008 Sep;75(1):1-11
references.pmid: 18599139
references.citation: Thromb Haemost. 2005 Apr;93(4):729-34
references.pmid: 15841321
references.citation: J Formos Med Assoc. 1998 Mar;97(3):204-9
references.pmid: 9549272
references.citation: Diagn Microbiol Infect Dis. 2002 Oct;44(2):151-5
references.pmid: 12458121