Department of Molecular Microbiology, Royal Infirmary of Edinburgh, Edinburgh, UK.
Department of Molecular Microbiology, Royal Infirmary of Edinburgh, Edinburgh, UK.
J Clin Virol. 2018 Aug;105:72-76. doi: 10.1016/j.jcv.2018.06.005. Epub 2018 Jun 8.
Norovirus is a leading cause of infectious gastroenteritis, characterized by outbreaks of diarrhoea and vomiting in closed settings. Nucleic acid amplification tests allow rapid and sensitive laboratory diagnosis of norovirus, with a number of commercial platforms now available.
Evaluate the performance of the Becton Dickinson BD-MAX™System, Cepheid Xpert® Norovirus Assay, and Luminex xTAG® Gastrointestinal Pathogen Panel (GPP) for norovirus detection in stool. Assess the performance of the Xpert® Norovirus Assay and BD-MAX™ in vomit samples.
163 diarrhoeal stool samples were tested on four diagnostic systems (laboratory-defined real time RT-PCR (assigned as gold standard), BD MAX™, Xpert® Norovirus Assay, and xTAG® GPP). A further 70 vomit samples were tested on the Xpert and BD MAX platforms.
In stool, sensitivity and specificity of the BD-MAX™ was 96.8% and 100%, for Xpert® Norovirus Assay was 91.9% and 100%, and for xTAG® GPP was 79.0% and 87.1%. In vomit samples positive and negative percent agreement was 95.6% and 92.0%, between the BD-MAX™ and Xpert® Norovirus.
The BD-MAX™ System with user defined settings and the Xpert® Norovirus Assay showed acceptable sensitivity and specificity for detection of norovirus from stool and vomit. The xTAG GPP assay was less reliable for norovirus detection but can detect a number of other clinically useful enteropathogens. Clinical laboratories must consider skill mix, budget, and sample throughput to determine the best fit for their service.
诺如病毒是传染性肠胃炎的主要病因，其特征是在封闭环境中爆发腹泻和呕吐。核酸扩增检测可快速、灵敏地对诺如病毒进行实验室诊断，目前有多种商业平台可供使用。
评估 Becton Dickinson BD-MAX™系统、Cepheid Xpert®诺如病毒检测和 Luminex xTAG®胃肠道病原体检测试剂盒（GPP）对粪便中诺如病毒的检测性能。评估 Xpert®诺如病毒检测和 BD-MAX™在呕吐物样本中的性能。
对四个诊断系统（实验室定义的实时 RT-PCR（指定为金标准）、BD MAX™、Xpert®诺如病毒检测和 xTAG®GPP）检测了 163 份腹泻粪便样本。另外，对 Xpert 和 BD MAX 平台上的 70 份呕吐物样本进行了测试。
在粪便样本中，BD-MAX™的敏感性和特异性分别为 96.8%和 100%，Xpert®诺如病毒检测的敏感性和特异性分别为 91.9%和 100%，xTAG®GPP 的敏感性和特异性分别为 79.0%和 87.1%。在呕吐物样本中，BD-MAX™和 Xpert®诺如病毒的阳性和阴性符合率分别为 95.6%和 92.0%。
BD-MAX™系统和 Xpert®诺如病毒检测对粪便和呕吐物中诺如病毒的检测具有可接受的敏感性和特异性。xTAG GPP 检测在诺如病毒检测方面不太可靠，但可检测其他一些具有临床应用价值的肠道病原体。临床实验室必须考虑人员技能组合、预算和样本通量，以确定最适合其服务的检测方法。
