Yoo In Young, Jo Sungjin, Kwon Joo An, Han Jay Ho, Lee Hae Kyung, Park Yeon-Joon
Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Laboratory Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Ann Lab Med. 2025 Jul 21. doi: 10.3343/alm.2025.0047.
Various molecular methods are used to rapidly detect gastrointestinal pathogens, highlighting the importance of understanding the performance of the associated kits in detail. We comprehensively assessed the performance of Kogene PowerChek multiplex real-time PCR kits (PowerChek Bacterial/Viral Kits) with the FilmArray GI Panel.
Residual stool specimens (N=246), initially tested utilizing the FilmArray GI Panel (May 2023-Jan 2024), were reanalyzed using PowerChek Bacterial/Viral Kits. Discrepancies were resolved by performing additional molecular assays and reviewing culture results when available. True positives (TPs)/true negatives were defined by concordant results in at least two assays. We determined cycle threshold (Ct)/crossing point (Cp) distributions between the TP and false positive (FP) groups and analyzed melting curves for the FilmArray GI Panel FPs.
The positive-percent agreement (PPA) of the PowerChek Bacterial/Viral Kits was 50-100%, with lower values for spp., rotavirus, and astrovirus, whereas the FilmArray GI Panel showed 100% PPA across all targets. Both platforms demonstrated >99% negative-percent agreement, except for enteropathogenic (EPEC) and adenovirus (PowerChek Bacterial/Viral Kits) or EPEC, enteroaggregative , norovirus, and spp. (FilmArray GI Panel). The FPs showed higher Ct/Cp values with both kits, and these values were significantly higher for adenovirus (PowerChek Viral Kit), EPEC, and norovirus (FilmArray GI Panel). Melting curve analysis of four norovirus FPs (FilmArray GI Panel) revealed atypical patterns in three cases.
The FilmArray GI Panel demonstrated higher sensitivity than the PowerChek Kits. For norovirus, melting curve analysis will help avoid FPs.
多种分子方法用于快速检测胃肠道病原体，凸显了详细了解相关试剂盒性能的重要性。我们使用FilmArray胃肠道检测板全面评估了Kogene PowerChek多重实时PCR试剂盒（PowerChek细菌/病毒试剂盒）的性能。
对最初于2023年5月至2024年1月使用FilmArray胃肠道检测板检测的246份剩余粪便标本，使用PowerChek细菌/病毒试剂盒重新分析。通过进行额外的分子检测并在有可用培养结果时审查培养结果来解决差异。真阳性（TP）/真阴性由至少两种检测结果一致来定义。我们确定了TP组和假阳性（FP）组之间的循环阈值（Ct）/交叉点（Cp）分布，并分析了FilmArray胃肠道检测板FP的熔解曲线。
PowerChek细菌/病毒试剂盒的阳性百分比一致性（PPA）为50 - 100%，对于某些物种、轮状病毒和星状病毒的值较低，而FilmArray胃肠道检测板在所有目标上均显示100%的PPA。除了肠致病性大肠杆菌（EPEC）和腺病毒（PowerChek细菌/病毒试剂盒）或EPEC、肠聚集性大肠杆菌、诺如病毒和某些物种（FilmArray胃肠道检测板）外，两个平台的阴性百分比一致性均>99%。两种试剂盒的FP显示出较高的Ct/Cp值，对于腺病毒（PowerChek病毒试剂盒）、EPEC和诺如病毒（FilmArray胃肠道检测板），这些值显著更高。对四个诺如病毒FP（FilmArray胃肠道检测板）的熔解曲线分析显示，三例呈现非典型模式。
FilmArray胃肠道检测板显示出比PowerChek试剂盒更高的灵敏度。对于诺如病毒，熔解曲线分析将有助于避免假阳性。
