Piralla Antonio, Lunghi Giovanna, Ardissino Gianluigi, Girello Alessia, Premoli Marta, Bava Erika, Arghittu Milena, Colombo Maria Rosaria, Cognetto Alessandra, Bono Patrizia, Campanini Giulia, Marone Piero, Baldanti Fausto
Microbiology and Virology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Microbiology and Virology Unit, Fondazione Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
BMC Microbiol. 2017 May 12;17(1):111. doi: 10.1186/s12866-017-1018-2.
Acute gastroenteritis is a common cause of morbidity and mortality in humans worldwide. The rapid and specific identification of infectious agents is crucial for correct patient management. However, diagnosis of acute gastroenteritis is usually performed with diagnostic panels that include only a few pathogens. In the present bicentric study, the diagnostic value of FilmArray™ GI panels was assessed in unformed stool samples of patients with acute gastroenteritis and in a series of samples collected from pediatric patients with heamorragic diarrhea. The clinical performance of the FilmArray™ gastrointestinal (GI) panel was assessed in 168 stool samples collected from patients with either acute gastroenteritis or hemorragic diarrhea. Samples showing discordant results between FilmArray and routine methods were further analyzed with an additional assay.
Overall, the FilmArray™ GI panel detected at least one potential pathogen in 92/168 (54.8%) specimens. In 66/92 (71.8%) samples, only one pathogen was detected, while in 26/92 (28.2%) multiple pathogens were detected. The most frequent pathogens were rotavirus 13.9% (22/168), Campylobacter 10.7% (18/168), Clostridium difficile 9.5% (16/168), and norovirus 8.9% (15/168). Clostridium difficile was identified only in patients with acute gastroenteritis (p < 0.01), while STEC was detected exclusively in patients with hemorragic diarrhea (p < 0.01). In addition, Campylobacter spp., Salmonella spp., EPEC and E. coli producing Shiga-like toxin were more frequently detected in patients with hemorragic diarrhea (p < 0.05). The overall percent agreement calculated in samples was 73.8% and 65.5%, while 34.5% were discordant. After additional confirmatory analyses, the proportion of discordant samples decreased to 7.7%. Rotavirus and astrovirus were the most frequently unconfirmed pathogens.
In conclusion, the FilmArray™ GI panel has proved to be a valuable new diagnostic tool for improving the diagnostic efficiency of GI pathogens.
急性胃肠炎是全球人类发病和死亡的常见原因。快速、特异性地鉴定感染病原体对于正确的患者管理至关重要。然而，急性胃肠炎的诊断通常使用仅包括少数病原体的诊断试剂盒。在本双中心研究中，评估了FilmArray™ GI试剂盒在急性胃肠炎患者的不成形粪便样本以及从患有出血性腹泻的儿科患者收集的一系列样本中的诊断价值。在从患有急性胃肠炎或出血性腹泻的患者收集的168份粪便样本中评估了FilmArray™胃肠道（GI）试剂盒的临床性能。对FilmArray与常规方法结果不一致的样本用另外一种检测方法进行进一步分析。
总体而言，FilmArray™ GI试剂盒在92/168（54.8%）份标本中检测到至少一种潜在病原体。在66/92（71.8%）份样本中，仅检测到一种病原体，而在26/92（28.2%）份样本中检测到多种病原体。最常见的病原体是轮状病毒13.9%（22/168）、弯曲杆菌10.7%（18/168）、艰难梭菌9.5%（16/168）和诺如病毒8.9%（15/168）。艰难梭菌仅在急性胃肠炎患者中被鉴定出（p < 0.01），而产志贺毒素大肠杆菌仅在出血性腹泻患者中被检测到（p < 0.01）。此外，弯曲杆菌属、沙门菌属、肠致病性大肠杆菌和产志贺样毒素的大肠杆菌在出血性腹泻患者中更频繁被检测到（p < 0.05）。样本中计算出的总体一致率为73.8%和65.5%，而34.5%不一致。经过额外的验证分析后，不一致样本的比例降至7.7%。轮状病毒和星状病毒是最常未被确认的病原体。
总之，FilmArray™ GI试剂盒已被证明是提高胃肠道病原体诊断效率的一种有价值的新诊断工具。
