Laboratory of Clinical Microbiology, AP-HM Timone, Université de la Méditerranée, Marseille, France.
Clin Microbiol Infect. 2011 Dec;17(12):1890-4. doi: 10.1111/j.1469-0691.2011.03487.x. Epub 2011 Aug 16.
Enteroviruses (EVs) constitute the most common cause of aseptic meningitis in both children and adults. Molecular techniques have now been recognized as the reference standard for the diagnosis of EV infections, and the rapidity of the molecular diagnosis of EV meningitis has been shown to be a determining factor in the management of patients. The rapid documentation of EV RNA in cerebrospinal fluid (CSF) is key to adapting patient management and the therapeutic regimen. To shorten the time needed for virological documentation, we implemented EV RNA detection in two point-of-care (POC) laboratories. Here, we present the results of the POC detection of EV RNA with the Xpert EV kit on the GeneXpert integrated system, and a comparison with the real-time RT-PCR (rtRT-PCR) assay routinely used in the core virology laboratory. From January to September 2009, a total of 310 CSF samples were tested. The rtRT-PCR gave 81 positive, 225 negative and four 'indeterminate' results. POC results were concordant in 81.6% (253/310). Most of the discrepancies consisted of 'indeterminate' results at the POC level (16%). Calculated performances (excluding the indeterminate results) of the Xpert EV kit on the GeneXpert system in POC settings were 100%, 98.9%, 97.6% and 100% for Sensibility, Specificity, positive predictive value and negative predictive value, respectively. Taken together, these results indicate that the implementation of POC detection of EV RNA can provide robust results in <4 h, and may have a significant impact on patient management, therapeutic attitude, and hospitalization costs.
肠道病毒(EV)是儿童和成人无菌性脑膜炎的最常见病因。分子技术现已被确认为 EV 感染诊断的参考标准,并且 EV 脑膜炎的分子诊断速度已被证明是患者管理的决定性因素。快速记录脑脊液(CSF)中的 EV RNA 是调整患者管理和治疗方案的关键。为了缩短病毒学记录所需的时间,我们在两个即时检测(POC)实验室中实施了 EV RNA 检测。在这里,我们介绍了 GeneXpert 集成系统上 Xpert EV 试剂盒对 EV RNA 的 POC 检测结果,并与核心病毒学实验室常规使用的实时 RT-PCR(rtRT-PCR)检测进行了比较。从 2009 年 1 月到 9 月,共检测了 310 份 CSF 样本。rtRT-PCR 给出了 81 个阳性、225 个阴性和 4 个“不确定”结果。POC 结果在 81.6%(253/310)的情况下是一致的。大多数差异包括 POC 水平的“不确定”结果(16%)。在 POC 环境下,GeneXpert 系统上 Xpert EV 试剂盒的计算性能(不包括不确定结果)分别为 100%、98.9%、97.6%和 100%,用于敏感性、特异性、阳性预测值和阴性预测值。总的来说,这些结果表明,POC 检测 EV RNA 的实施可以在<4 小时内提供可靠的结果,可能对患者管理、治疗态度和住院费用产生重大影响。