Department of Laboratory Medicine, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan.
Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Ibaraki, Japan.
Sci Rep. 2021 Feb 4;11(1):3033. doi: 10.1038/s41598-021-82490-z.
We investigated the efficiency of the Verigene Enteric Pathogens Nucleic Acid Test (Verigene EP test), which is an automated microarray-based assay system that enables rapid and simultaneous genetic detection of gastrointestinal pathogens and toxins, including those in the Campylobacter Group, Salmonella species, Shigella species, the Vibrio Group, Yersinia enterocolitica, Shiga toxin 1 and 2, norovirus GI/GII, and rotavirus A. Three clinical laboratories evaluated the Verigene EP test, using 268 stool samples for bacterial and toxin genes and 167 samples for viral genes. Culture-based reference methods were used for the detection of bacteria and toxins, while a different molecular assay was used for viral detection. The overall concordance rate between the Verigene EP test and the reference methods for the 1940 assays was 99.0%. The overall sensitivity and specificity of the Verigene EP test were 97.0% and 99.3%, respectively. Of the 19 samples with discordant results, 13 samples were false positives and six were false negatives. The Verigene EP test simultaneously detected two targets in 11 samples; overall, the test demonstrated high efficiency in detecting crucial diarrheagenic pathogens, indicating its suitability for clinical practice.
我们研究了 Verigene 肠道病原体核酸检测（Verigene EP 检测）的效率，这是一种自动化的基于微阵列的检测系统，能够快速且同时检测胃肠道病原体和毒素的基因，包括弯曲菌属、沙门氏菌属、志贺氏菌属、弧菌属、耶尔森氏菌 enterocolitica、志贺毒素 1 和 2、诺如病毒 GI/GII 以及轮状病毒 A。三个临床实验室使用 268 份粪便样本进行细菌和毒素基因检测，167 份样本进行病毒基因检测，对 Verigene EP 检测进行了评估。基于培养的参考方法用于检测细菌和毒素，而不同的分子检测方法用于病毒检测。在 1940 项检测中，Verigene EP 检测与参考方法的总体符合率为 99.0%。Verigene EP 检测的总敏感性和特异性分别为 97.0%和 99.3%。在 19 份结果不一致的样本中，有 13 份为假阳性，6 份为假阴性。Verigene EP 检测在 11 份样本中同时检测了两个目标；总体而言，该检测在检测关键的致腹泻病原体方面具有高效性，表明其适用于临床实践。
