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一种新型快速试剂盒——BD MGIT结核杆菌鉴定试验用于复杂情况确认的评估。

Evaluation of a new rapid kit, BD MGIT TBc identification test for confirmation of complex.

作者信息

Kandhakumari Gandhi, Stephen Selvaraj

机构信息

Department of Microbiology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.

出版信息

Indian J Pathol Microbiol. 2017 Apr-Jun;60(2):243-246. doi: 10.4103/IJPM.IJPM_695_15.

Abstract

At present, three rapid kits are available globally for the confirmation of Mycobacterium tuberculosis complex (MTBC) in cultures by MPT64 antigen (MPT64 Ag) detection. These include Capilia TB, SD Bioline, and BD MGIT TBc Identification (TBcID). The third kit is yet to be validated in India. We have tested this kit and compared with SD Bioline using conventional tests as gold standard. Seventy-one MTBC (70 M. tuberculosis and one Mycobacterium bovis) and four nontuberculous mycobacteria (NTM) were isolated from 649 clinical specimens in MGIT 960 and/or Lowenstein-Jensen slants (LJ). MPT64 Ag was detected by both TBcID and SD Bioline kits in all the 71 clinical isolates and the reference strain M. tuberculosis H37Rv. All NTM species tested were negative by the two different kits. Thus, TBcID kit showed 100% concordance in terms of sensitivity and specificity. Rapid kits confirm MTBC cultures within 15 min in contrast to several weeks' time required by conventional techniques.

摘要

目前,全球有三种快速检测试剂盒可通过检测MPT64抗原(MPT64 Ag)来确认培养物中的结核分枝杆菌复合群(MTBC)。这些试剂盒包括Capilia TB、SD Bioline和BD MGIT TBc鉴定试剂盒(TBcID)。第三种试剂盒尚未在印度进行验证。我们对该试剂盒进行了测试,并以传统检测作为金标准与SD Bioline进行了比较。从MGIT 960和/或罗-琴斜面(LJ)上的649份临床标本中分离出71株MTBC(70株结核分枝杆菌和1株牛分枝杆菌)和4株非结核分枝杆菌(NTM)。TBcID试剂盒和SD Bioline试剂盒在所有71株临床分离株以及结核分枝杆菌参考菌株H37Rv中均检测到MPT64 Ag。两种试剂盒对所有测试的NTM菌株检测结果均为阴性。因此,TBcID试剂盒在敏感性和特异性方面显示出100%的一致性。与传统技术需要数周时间相比,快速检测试剂盒可在15分钟内确认MTBC培养物。

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