Evaluation of Luminex xTAG Gastrointestinal Pathogen Analyte-Specific Reagents for High-Throughput, Simultaneous Detection of Bacteria, Viruses, and Parasites of Clinical and Public Health Importance
Evaluation of Luminex xTAG Gastrointestinal Pathogen Analyte-Specific Reagents for High-Throughput, Simultaneous Detection of Bacteria, Viruses, and Parasites of Clinical and Public Health Importance
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DOI：
10.1128/jcm.00896-13
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发表时间：
2013-09-01
影响因子：
9.4
通讯作者：
Bhattacharyya, Sanjib
中科院分区：
文献类型：
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作者：
Navidad, Jose F.;Griswold, David J.;Bhattacharyya, Sanjib
急性腹泻病（ADD）可由一系列病原体引起，包括细菌、病毒和寄生虫。传统的诊断方法，如培养，显微镜，生化测定和酶联免疫吸附测定（ELISA），是费力和耗时的，缺乏灵敏度。结合起来，对单个样品进行的一系列测试可以显着增加周转时间（达特）。我们使用Luminex xTAG分析物特异性试剂（ASR）验证了19重实验室开发的胃肠道病原体面板（GPP），以同时直接在粪便标本中筛选引起肠道疾病的病原体，包括细菌（空肠弯曲杆菌，沙门氏菌属，志贺氏菌属，产肠毒素大肠杆菌[ETEC]、产滋贺毒素大肠杆菌; coli [STEC]、E. coliO 157：H7，霍乱弧菌，小肠结肠炎耶尔森氏菌，和产毒艰难梭菌），寄生虫（贾第鞭毛虫，隐孢子虫属，和溶组织内阿米巴）和病毒（诺如病毒GI和GII、腺病毒40/41和轮状病毒A）。使用48株参考分离株和254份临床标本确定GPP ASR的性能特征。使用常规和分子方法对腹泻患者的粪便标本进行病原体检测。以预测方法为标准，GPP ASR对腺病毒40/41、诺如病毒、轮状病毒A、霍乱弧菌、小肠结肠炎耶尔森氏菌、溶组织内阿米巴、隐孢子虫属、和E.大肠杆菌O 157：H7，贾第鞭毛虫95%，ETEC和STEC 94%，志贺氏菌93%，大肠杆菌O 157：H7。沙门氏菌92%; C.为91%。艰难梭菌A/B毒素和空肠弯曲菌90%。在临床样本中，GPP ASR与传统方法的总体比较性能为94.5%（范围：90%至97%），特异性为99%（99.0%至99.9%）。GPP ASR的实施使我们的公共卫生实验室能够提供高度敏感和特异性的筛查和识别主要的ADD致病病原体。
Acute diarrheal disease (ADD) can be caused by a range of pathogens, including bacteria, viruses, and parasites. Conventional diagnostic methods, such as culture, microscopy, biochemical assays, and enzyme-linked immunosorbent assays (ELISA), are laborious and time-consuming and lack sensitivity. Combined, the array of tests performed on a single specimen can increase the turnaround time (TAT) significantly. We validated a 19plex laboratory-developed gastrointestinal pathogen panel (GPP) using Luminex xTAG analyte-specific reagents (ASRs) to simultaneously screen directly in fecal specimens for diarrhea-causing pathogens, including bacteria (Campylobacter jejuni, Salmonella spp., Shigella spp., enterotoxigenic Escherichia coli [ETEC], Shiga toxin-producing E. coli [STEC], E. coli O157:H7, Vibrio cholerae, Yersinia enterocolitica, and toxigenic Clostridium difficile), parasites (Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica), and viruses (norovirus GI and GII, adenovirus 40/41, and rotavirus A). Performance characteristics of GPP ASRs were determined using 48 reference isolates and 254 clinical specimens. Stool specimens from individuals with diarrhea were tested for pathogens using conventional and molecular methods. Using the predictive methods as standards, the sensitivities of the GPP ASRs were 100% for adenovirus 40/41, norovirus, rotavirus A, Vibrio cholerae, Yersinia enterocolitica, Entamoeba histolytica, Cryptosporidium spp., and E. coli O157: H7; 95% for Giardia lamblia; 94% for ETEC and STEC; 93% for Shigella spp.; 92% for Salmonella spp.; 91% for C. difficile A/B toxins; and 90% for Campylobacter jejuni. The overall comparative performance of the GPP ASRs with conventional methods in clinical samples was 94.5% (range, 90% to 97%), with 99% (99.0% to 99.9%) specificity. Implementation of the GPP ASRs enables our public health laboratory to offer highly sensitive and specific screening and identification of the major ADD-causing pathogens.