Khare Reeti, Espy Mark J, Cebelinski Elizabeth, Boxrud David, Sloan Lynne M, Cunningham Scott A, Pritt Bobbi S, Patel Robin, Binnicker Matthew J
Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Minnesota Department of Health, St. Paul, Minnesota, USA.
J Clin Microbiol. 2014 Oct;52(10):3667-73. doi: 10.1128/JCM.01637-14. Epub 2014 Aug 6.
The detection of pathogens associated with gastrointestinal disease may be important in certain patient populations, such as immunocompromised hosts, the critically ill, or individuals with prolonged disease that is refractory to treatment. In this study, we evaluated two commercially available multiplex panels (the FilmArray gastrointestinal [GI] panel [BioFire Diagnostics, Salt Lake City, UT] and the Luminex xTag gastrointestinal pathogen panel [GPP] [Luminex Corporation, Toronto, Canada]) using Cary-Blair stool samples (n = 500) submitted to our laboratory for routine GI testing (e.g., culture, antigen testing, microscopy, and individual real-time PCR). At the time of this study, the prototype (non-FDA-cleared) FilmArray GI panel targeted 23 pathogens (14 bacterial, 5 viral, and 4 parasitic), and testing of 200 μl of Cary-Blair stool was recommended. In contrast, the Luminex GPP assay was FDA cleared for the detection of 11 pathogens (7 bacterial, 2 viral, and 2 parasitic), but had the capacity to identify 4 additional pathogens using a research-use-only protocol. Importantly, the Luminex assay was FDA cleared for 100 μl raw stool; however, 100 μl Cary-Blair stool was tested by the Luminex assay in this study. Among 230 prospectively collected samples, routine testing was positive for one or more GI pathogens in 19 (8.3%) samples, compared to 76 (33.0%) by the FilmArray and 69 (30.3%) by the Luminex assay. Clostridium difficile (12.6 to 13.9% prevalence) and norovirus genogroup I (GI)/GII (5.7 to 13.9% prevalence) were two of the pathogens most commonly detected by both assays among prospective samples. Sapovirus was also commonly detected (5.7% positive rate) by the FilmArray assay. Among 270 additional previously characterized samples, both multiplex panels demonstrated high sensitivity (>90%) for the majority of targets, with the exception of several pathogens, notably Aeromonas sp. (23.8%) by FilmArray and Yersinia enterocolitica (48.1%) by the Luminex assay. Interestingly, the FilmArray and Luminex panels identified mixed infections in 21.1% and 13.0% of positive prospective samples, respectively, compared to only 8.3% by routine methods.
在某些患者群体中,检测与胃肠道疾病相关的病原体可能很重要,比如免疫功能低下的宿主、危重症患者或患有难治性长期疾病的个体。在本研究中,我们使用提交至我们实验室进行常规胃肠道检测(如培养、抗原检测、显微镜检查和个体实时聚合酶链反应)的 Cary-Blair 粪便样本(n = 500),评估了两种市售多重检测试剂盒(FilmArray 胃肠道 [GI] 检测试剂盒 [BioFire Diagnostics,美国犹他州盐湖城] 和 Luminex xTag 胃肠道病原体检测试剂盒 [GPP] [Luminex Corporation,加拿大多伦多])。在本研究开展时,原型(未获美国食品药品监督管理局批准)FilmArray GI 检测试剂盒针对 23 种病原体(14 种细菌、5 种病毒和 4 种寄生虫),建议对 200 μl Cary-Blair 粪便进行检测。相比之下,Luminex GPP 检测经美国食品药品监督管理局批准可检测 11 种病原体(7 种细菌、2 种病毒和 2 种寄生虫),但使用仅供研究使用的方案有能力鉴定另外 4 种病原体。重要的是,Luminex 检测经美国食品药品监督管理局批准可用于 100 μl 原始粪便;然而,在本研究中 Luminex 检测对 100 μl Cary-Blair 粪便进行了检测。在 230 份前瞻性收集的样本中,常规检测显示 19 份(8.3%)样本中一种或多种胃肠道病原体呈阳性,相比之下,FilmArray 检测为 76 份(33.0%),Luminex 检测为 69 份(30.3%)。艰难梭菌(患病率为 12.6% 至 13.9%)和诺如病毒基因组 I(GI)/GII(患病率为 5.7% 至 13.9%)是两种在两种检测中在前瞻性样本中最常检测到的病原体。札幌病毒在 FilmArray 检测中也常被检测到(阳性率为 5.7%)。在另外 270 份先前已鉴定特征的样本中,两种多重检测试剂盒对大多数靶点均显示出高灵敏度(>90%),但有几种病原体除外,特别是 FilmArray 检测的嗜水气单胞菌(23.8%)和 Luminex 检测的小肠结肠炎耶尔森菌(48.1%)。有趣的是,FilmArray 和 Luminex 检测试剂盒分别在 21.1% 和 13.0% 的阳性前瞻性样本中鉴定出混合感染,而常规方法仅为 8.3%。