Beaufils Quentin, Bénéjat Lucie, Ducournau Astrid, Aptel Johanna, Chevalier Alicia, Jauvain Marine, Lehours Philippe
CHU de Bordeaux, CHU Pellegrin, Laboratoire de Bactériologie, CNR des Campylobacters et des Hélicobacters, Place Amélie Raba Léon, Bordeaux, France.
LABM Cerballiance, Le Haillan, France.
BMC Microbiol. 2025 Jul 2;25(1):400. doi: 10.1186/s12866-025-04118-w.
This study assessed the clinical performance of the Biosynex AMPLIQUICK Fecal Bacteriology kit for detecting enteropathogenic bacteria in cases of acute community-acquired diarrhea. In total, 194 retrospectively collected and 207 prospectively collected stool samples were analyzed. In cases of discordant results between the AMPLIQUICK Fecal Bacteriology kit and initial status of the 401 stools, samples were reanalyzed using the Seegene Gastrointestinal Panel 1 and 2 kits or targeted PCR assays. Among the 401 samples, 190 were expected to be positive for Campylobacter spp. (C. jejuni or C. coli), 48 for Salmonella spp., 39 for Shigella spp./enteroinvasive Escherichia coli (EIEC), 21 for Yersinia enterocolitica, and 30 for enterohemorrhagic E. coli (EHEC). Additionally, 64 samples were expected to be negative. Nine other samples tested positive for either other enteropathogens (Aeromonas spp., Plesiomonas shigelloides, Vibrio spp., or Clostridioides difficile) or co-infections with two pathogens. Only three samples (four discrepancies) yielded discordant results with the AMPLIQUICK Fecal Bacteriology kit: one false positive for enterotoxigenic E. coli (ETEC), one false negative for EHEC, and one sample that was both falsely positive for Salmonella spp. and falsely negative for EHEC. The analytical performance was calculated using a composite reference standard (CRS) in the absence of a perfect gold standard. Due to the low number or absence of positive cases, the performance of the Biosynex AMPLIQUICK Fecal Bacteriology kit could not be determined for Vibrio spp., Yersinia pseudotuberculosis, hypervirulent C. difficile strains, Cholera toxin, ETEC, 0157 EHEC and P. shigelloides. Using this CRS, positive, negative and overall agreement rates ranged from 98.24 to 100% for all the other pathogens. In conclusion, the Biosynex AMPLIQUICK Fecal Bacteriology kit enables comprehensive screening for key bacterial pathogens associated with gastrointestinal infections in a single PCR assay. With excellent clinical performance, it represents a reliable tool for the rapid and accurate diagnosis of bacterial gastroenteritis in routine practice.
本研究评估了Biosynex AMPLIQUICK粪便细菌学检测试剂盒在检测急性社区获得性腹泻病例中肠道致病菌方面的临床性能。总共对194份回顾性收集和207份前瞻性收集的粪便样本进行了分析。在401份粪便样本中，若AMPLIQUICK粪便细菌学检测试剂盒的结果与初始状态不一致，则使用Seegene胃肠道检测试剂盒1和2或靶向PCR检测法对样本进行重新分析。在这401份样本中，预计空肠弯曲菌或结肠弯曲菌阳性的有190份，沙门氏菌属阳性的有48份，志贺氏菌属/肠侵袭性大肠杆菌阳性的有39份，小肠结肠炎耶尔森菌阳性的有21份，肠出血性大肠杆菌阳性的有30份。此外，预计64份样本为阴性。另外9份样本检测出其他肠道致病菌（气单胞菌属、类志贺邻单胞菌、弧菌属或艰难梭菌）呈阳性，或检测出两种病原体合并感染。只有3份样本（4处结果不一致）与AMPLIQUICK粪便细菌学检测试剂盒的结果不一致：一株产肠毒素大肠杆菌出现假阳性，一株肠出血性大肠杆菌出现假阴性，还有一份样本沙门氏菌属呈假阳性且肠出血性大肠杆菌呈假阴性。在没有完美金标准的情况下，使用综合参考标准（CRS）计算分析性能。由于阳性病例数量少或不存在，无法确定Biosynex AMPLIQUICK粪便细菌学检测试剂盒对弧菌属（菌种未提及）、假结核耶尔森菌、高毒力艰难梭菌菌株、霍乱毒素、产肠毒素大肠杆菌、0157肠出血性大肠杆菌和类志贺邻单胞菌的性能。使用该CRS时，所有其他病原体的阳性、阴性和总体一致率在98.24%至100%之间。总之，Biosynex AMPLIQUICK粪便细菌学检测试剂盒能够在一次PCR检测中对与胃肠道感染相关的关键细菌病原体进行全面筛查。凭借出色的临床性能，它是常规实践中快速准确诊断细菌性肠胃炎的可靠工具。
