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在英国哨兵网络中进行流感血清学监测:初步研究方案。

Serological surveillance of influenza in an English sentinel network: pilot study protocol.

机构信息

Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK.

Clinical Innovation and Research Centre (CIRC), Royal College of General Practitioners, London, UK.

出版信息

BMJ Open. 2019 Mar 8;9(3):e024285. doi: 10.1136/bmjopen-2018-024285.

Abstract

BACKGROUND

Rapidly undertaken age-stratified serology studies can produce valuable data about a new emerging infection including background population immunity and seroincidence during an influenza pandemic. Traditionally seroepidemiology studies have used surplus laboratory sera with little or no clinical information or have been expensive detailed population based studies. We propose collecting population based sera from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), a sentinel network with extensive clinical data.

AIM

To pilot a mechanism to undertake population based surveys that collect serological specimens and associated patient data to measure seropositivity and seroincidence due to seasonal influenza, and create a population based serology bank. METHODS AND ANALYSIS: We will recruit 6 RCGP RSC practices already taking nasopharyngeal virology swabs. Patients who attend a scheduled blood test will be consented to donate additional blood samples. Approximately 100-150 blood samples will be collected from each of the following age bands - 18- 29, 30- 39, 40- 49, 50- 59, 60- 69 and 70+ years.

METHODS

We will send the samples to the Public Health England (PHE) Seroepidemiology Unit for processing and storage. These samples will be tested for influenza antibodies, using haemagglutination inhibition assays. Serology results will be pseudonymised, sent to the RCGP RSC and combined using existing processes at the RCGP RSC secure hub. The influenza seroprevalence results from the RCGP cohort will be compared against those from the annual PHE influenza residual serosurvey.

ETHICS AND DISSEMINATION

Ethical approval was granted by the Proportionate Review Sub- Committee of the London - Camden & Kings Cross on 6 February 2018. This study received approval from Health Research Authority on 7 February 2018. On completion the results will be made available via peer-reviewed journals.

摘要

背景

分层年龄的血清学研究可以快速提供有关新出现感染的有价值的数据,包括大流行期间背景人群的免疫和血清发生率。传统的血清流行病学研究使用剩余的实验室血清,这些血清几乎没有或没有临床信息,或者是昂贵的详细人群为基础的研究。我们建议从皇家全科医师学院(RCGP)研究和监测中心(RSC)收集基于人群的血清,这是一个具有广泛临床数据的监测网络。

目的

试点一种机制,开展基于人群的调查,收集血清标本和相关患者数据,以衡量季节性流感引起的血清阳性率和血清发生率,并建立基于人群的血清库。

方法和分析

我们将招募 6 家已经采集鼻咽病毒拭子的 RCGP RSC 实践。参加定期血液检查的患者将被同意捐献额外的血液样本。每个年龄组(18-29、30-39、40-49、50-59、60-69 和 70+岁)将从以下人群中采集 100-150 份左右的血液样本。

方法

我们将把样本送到英国公共卫生署(PHE)血清流行病学部门进行处理和储存。这些样本将使用血凝抑制试验进行流感抗体检测。血清学结果将被匿名化,发送到 RCGP RSC,并使用 RCGP RSC 安全中心现有的流程进行组合。RCGP 队列的流感血清流行率结果将与 PHE 年度流感剩余血清调查的结果进行比较。

伦理和传播

2018 年 2 月 6 日,伦敦卡姆登和国王十字区比例审查小组委员会批准了伦理审查。本研究于 2018 年 2 月 7 日获得了英国健康研究管理局的批准。研究完成后,结果将通过同行评审期刊公布。

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