中国9种病毒性脑炎相关病毒分子检测的室间质量评价

External quality assessment of molecular testing of 9 viral encephalitis-related viruses in China.

作者信息

Zhang Runling, Tan Ping, Feng Lei, Li Rui, Yang Jing, Zhang Rui, Li Jinming

机构信息

National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, P. R. China; Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P. R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, P. R. China.

出版信息

Virus Res. 2021 Dec;306:198598. doi: 10.1016/j.virusres.2021.198598. Epub 2021 Oct 13.

DOI:10.1016/j.virusres.2021.198598

PMID:34653568

Abstract

BACKGROUND

Eastern equine encephalitis virus (EEEV), Western equine encephalitis virus (WEEV), Venezuelan equine encephalitis virus (VEEV), Hendra virus (HeV), Nipah virus (NiV), Yellow fever virus (YFV), West Nile virus (WNV), Saint Louis encephalitis virus (SLEV) and Tick-borne encephalitis virus (TBEV) have been detected in travelers returning to China and potentially pose a serious threat to public health. Real-time reverse transcription polymerase chain reaction (rRT-PCR) plays an important role in the detection of these viruses. Although these viruses are not mainly prevalent in China, occasionally imported cases have been reported with the increase in population mobility and entry-exit activities. Therefore, it is necessary to monitor the ability of major domestic laboratories to detect and identify exotic arbovirus infections in travelers.

METHODS

An external quality assessment program for the molecular detection of EEEV, VEEV, WEEV, SLEV, WNV, YFV, TBEV, HeV and NiV was organized. The assessment panel included 26 negative and positive samples with different concentrations of virus-like particles and distributed to 31 laboratories to evaluate the accuracy of virus detection.

RESULTS

At the laboratory level, 87.5% (7/8, EEEV), 85.7% (12/14, WEEV), 100% (13/13, VEEV), 87.5% (7/8, HeV), 76.5% (13/17, NiV), 92.6% (25/27, YFV), 81.3% (13/16, WNV), 100% (5/5, SLEV) and 75.0% (6/8, TBEV) of the participants were considered "competent". Of all the results, the false-positive and false-negative rates were 0.3% and 0.7%, respectively. The sensitivity of most detection assays (15/17, 88.2%) was more than 90%. In addition, we observed significantly different cycle threshold values when using primer-probe sets in different target regions to detect EEEV and SLEV.

CONCLUSIONS

Most laboratories have reliable virus detection capabilities. However, laboratory testing capabilities need to be improved to avoid cross-contamination and to better manage undetected false-negative samples.

摘要

背景

在返回中国的旅行者中已检测到东部马脑炎病毒（EEEV）、西部马脑炎病毒（WEEV）、委内瑞拉马脑炎病毒（VEEV）、亨德拉病毒（HeV）、尼帕病毒（NiV）、黄热病病毒（YFV）、西尼罗河病毒（WNV）、圣路易斯脑炎病毒（SLEV）和蜱传脑炎病毒（TBEV），这些病毒可能对公众健康构成严重威胁。实时逆转录聚合酶链反应（rRT-PCR）在这些病毒的检测中发挥着重要作用。尽管这些病毒在中国并非主要流行，但随着人口流动性和出入境活动的增加，偶尔也有输入性病例的报告。因此，有必要监测国内主要实验室检测和鉴定旅行者中外来虫媒病毒感染的能力。

方法

组织了一项针对EEEV、VEEV、WEEV、SLEV、WNV、YFV、TBEV、HeV和NiV分子检测的外部质量评估计划。评估小组包括26份含有不同浓度病毒样颗粒的阴性和阳性样本，并分发给31个实验室，以评估病毒检测的准确性。

结果

在实验室层面，87.5%（7/8，EEEV）、85.7%（12/14，WEEV）、100%（13/13，VEEV）、87.5%（7/8，HeV）、76.5%（13/17，NiV）、92.6%（25/27，YFV）、81.3%（13/16，WNV）、100%（5/5，SLEV）和75.0%（6/8，TBEV）的参与者被认为“合格”。在所有结果中，假阳性率和假阴性率分别为0.3%和0.7%。大多数检测方法（15/17，88.2%）的灵敏度超过90%。此外，我们观察到在使用不同靶区域的引物-探针组检测EEEV和SLEV时，循环阈值存在显著差异。