This study represents a 2-year picture of the epidemiology of enteric pathogens in children suffering from gastroenteritis using the FilmArray® Gastrointestinal Panel (FA-GP), a multiplex molecular assay that allows to simultaneously detect a large panel of pathogens independently of the etiological suspicion and to evaluate its potential contribution to the diagnosis compared to the conventional methods. A total of 1716 stool samples, collected from children with clinical suspicion of bacterial and/or viral gastroenteritis attending the University Hospital of Parma, was submitted to the FA-GP and, when an adequate aliquot was available, to electron microscopy (n = 1163) for virus detection and to an enterovirus-targeting real-time PCR (n = 1703). Specimens with positive results for Salmonella, Yersinia enterocolitica, Vibrio, diarrheagenic Escherichia coli/Shigella, Campylobacter, Plesiomonas shigelloides and/or parasites by the FA-GP were also submitted to conventional diagnostic methods. The FA-GP gave positive results in 958 (55.8%) cases, 64.8% from inpatients: 647 (67.5%) contained a single agent and 311 (32.5%) multiple agents, for a total of 1374 pathogens. Enteropathogenic E. coli, rotavirus, norovirus, toxigenic Clostridioides difficile, and sapovirus were the most commonly detected pathogens. A total of 812 additional agents (344 of which as single pathogen) was detected by the FA-GP and not included in the clinical suspicion. The overall recovery rate of the conventional methods from stools that resulted positive by the FA-GP was 38.6% for bacteria, 50% and 84.2% for Giardia intestinalis and Cryptosporidium, respectively, and ranged from 3.7% to 64.6% for viruses, if excluding all electron microscopy-negative astroviruses. Enterovirus, an agent not targeted by the FA-GP, was revealed in 9.6% (164/1703) of the examined samples, and in 52 cases it was the only agent detected. The results of this study allowed to extend the range of detectable pathogens independently of the clinical suspicion, to detect co-infections in almost one third of children positive for at least one agent and to show that conventional methods would have missed more than half of the enteric agents detected by the FA-GP.

中文翻译：

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FilmArray®胃肠道面板对一群儿童胃肠炎的实验室诊断的贡献：一项为期两年的前瞻性研究。

这项研究代表了使用FilmArray®胃肠道面板（FA-GP）对患有胃肠炎的儿童进行肠道病原体流行病学研究的2年图像，该技术是一种多重分子分析方法，可独立于病因学怀疑而同时检测大量病原体并评估其对诊断的潜在贡献。从临床疑似细菌和/或病毒性肠胃炎的儿童中收集的共1716份粪便样本送至帕尔马大学医院就诊，并提交给FA-GP，并在有足够等分试样的情况下接受电子显微镜检查（n = 1163） ）进行病毒检测并进行针对肠道病毒的实时PCR（n = 1703）。沙门氏菌，小肠结肠炎耶尔森氏菌，弧菌，FA-GP引起的腹泻性大肠杆菌/志贺氏菌，弯曲杆菌，志贺氏假单胞菌和/或寄生虫也已接受常规诊断方法。FA-GP在958例病例中占55.8％的阳性结果，在住院患者中占64.8％的结果：647（67.5％）包含单一药物，311（32.5％）多种药物，共计1374种病原体。肠致病性大肠杆菌，轮状病毒，诺如病毒，产艰难梭菌和梭状病毒是最常见的病原体。FA-GP共检测到812种其他药物（其中344种为单一病原体），未纳入临床怀疑范围。由FA-GP阳性的粪便中常规方法的总回收率分别为细菌38.6％，肠贾第虫和隐孢子虫的50％和84.2％，范围为3.7％至64。如果不包括所有电子显微镜阴性星状病毒，则为病毒的6％。在9.6％（164/1703）的被检样品中发现了肠病毒，一种不是FA-GP靶向的药物，在52种情况下，它是唯一检测到的药物。这项研究的结果允许独立于临床怀疑而扩大可检测病原体的范围，在至少三分之一对至少一种药物呈阳性的儿童中检测到共感染，并表明常规方法将漏诊超过一半的FA-GP检测到的肠溶菌。