Shenoy Vishnu Prasad, Mukhopadhyay Chiranjay
Associate Professor, Department of Microbiology, Kasturba Medical College Manipal, Karnataka, India .
Professor and Head, Department of Microbiology, Kasturba Medical College Manipal, Karnataka, India .
J Clin Diagn Res. 2014 Apr;8(4):DC13-5. doi: 10.7860/JCDR/2014/7098.4253. Epub 2014 Apr 15.
A new rapid Immunochromatographic test (ICT) kit (SDBioline TB Ag MPT64RAPID(®)) developed by Standard Diagnostics, South Korea was evaluated for rapid differentiation of M. tuberculosis from non tuberculous mycobacteria (NTM). It detects MPT 64 antigen in M. tuberculosis isolates using mouse monoclonal MPT 64 antibody. The kit was assessed for routine identification of the Acid Fast Bacilli(AFB) isolated in our laboratory.
Two hundred eight culture isolates of Mycobacteria were tested using ICT test kit for detection of MPT 64 antigen from liquid and solid culture. H37Rv strain was employed as the positive reference control. Any negative result was referred for confirmation by Gen Probe Accu Probe assay for MTB Complex (Gen-Probe, San Diego, Calif.). Speciation of NTM was performed using genotypic Mycobacterium CM assay (Hain's life sciences, Germany).
Of the 208 culture positive isolates tested, 182 (87.5%) were found positive for Mycobacterium tuberculosis Complex and remaining 26 (12.5%) were considered as NTM. These results were further confirmed by Gen Probe Accu probe assay that served as the reference method for detection of MTBC. H37Rv reference strain was taken as a control for ICT test and molecular tests. The reference strain showed the presence of MPT64 antigen band in the ICT test. Similar bands were formed in all MTBC (182) isolates tested, proving 100 per cent sensitivity and no bands were detected in 48 (100%) NTM isolates tested, proving 100 per cent specificity of the ICT kit.
Tuberculosis is a global pandemic. Rapid identification of Mycobacteria as MTB complex or non-tuberculous Mycobacteria from culture is important for treatment of infected cases and drug susceptibility testing of the culture isolate. MPT 64 TB antgen detection using SD Bioline Immunochromatographic test is a simple and cost effective method for differentiation of Mycobacterial cultures as MTB complex from non- tuberculous Mycobacteria.
韩国标准诊断公司研发的一种新型快速免疫层析检测（ICT）试剂盒（SDBioline TB Ag MPT64RAPID(®)）用于从非结核分枝杆菌（NTM）中快速鉴别结核分枝杆菌。它使用小鼠单克隆MPT 64抗体检测结核分枝杆菌分离株中的MPT 64抗原。该试剂盒用于对我们实验室分离出的抗酸杆菌（AFB）进行常规鉴定。
使用ICT检测试剂盒对208株分枝杆菌培养分离株进行检测，以从液体和固体培养物中检测MPT 64抗原。采用H37Rv菌株作为阳性参考对照。任何阴性结果均通过结核分枝杆菌复合群的基因探针Accu Probe检测法（基因探针公司，加利福尼亚州圣地亚哥）进行确认。使用基因分型分枝杆菌CM检测法（德国海因生命科学公司）对NTM进行菌种鉴定。
在检测的208株培养阳性分离株中，182株（87.5%）被发现结核分枝杆菌复合群呈阳性，其余26株（12.5%）被视为NTM。这些结果通过基因探针Accu探针检测法进一步得到证实，该检测法作为检测结核分枝杆菌复合群的参考方法。H37Rv参考菌株用作ICT检测和分子检测的对照。参考菌株在ICT检测中显示出MPT64抗原条带。在所有检测的182株结核分枝杆菌复合群分离株中均形成了类似条带，证明敏感性为100%，在检测的48株（100%）NTM分离株中未检测到条带，证明ICT试剂盒的特异性为100%。
结核病是一种全球大流行病。从培养物中快速鉴定分枝杆菌为结核分枝杆菌复合群或非结核分枝杆菌对于感染病例的治疗和培养分离株的药敏试验很重要。使用SD Bioline免疫层析检测法检测MPT 64结核抗原是一种简单且经济有效的方法，可用于区分分枝杆菌培养物是结核分枝杆菌复合群还是非结核分枝杆菌。
