en-us	Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection
zh-cn	COVID-19 病毒感染基于人群并按年龄分层的血清流行病学调查方案

en-us	Study procedures
zh-cn	研究过程

en-us	Study design
zh-cn	研究设计

en-us	Study population
zh-cn	研究人群

en-us	Eligibility criteria
zh-cn	合格标准

en-us	Data collection
zh-cn	数据收集

en-us	Specimen collection
zh-cn	标本采集

en-us	Specimen transport
zh-cn	标本运输

en-us	Ethical considerations
zh-cn	伦理问题

en-us	Laboratory evaluations
zh-cn	实验室诊断

en-us	Statistical analyses
zh-cn	统计分析

en-us	Sample size
zh-cn	样本量

en-us	Epidemiological parameters
zh-cn	流行病学参数

en-us	Reporting of findings
zh-cn	结果报告

en-us	Protocol summary
zh-cn	方案概要

en-us	Age-stratified convenience sample from general population
zh-cn	一般人群中按年龄分层的方便样本

en-us	Potential output and analysis
zh-cn	可能结果及分析

en-us	Extent of age-specific infection
zh-cn	年龄别感染程度

en-us	Cumulative incidence of infection
zh-cn	累积感染率

en-us	Infection attack rates
zh-cn	感染罹患率

en-us	Fraction of asymptomatic infection
zh-cn	无症状感染比例

en-us	Case fatality ratio
zh-cn	病死率

en-us	Prospective population-based convenience sample from the general population, stratified by age.
zh-cn	前瞻性、基于人群一般人群中按年龄分层的方便样本

en-us	WHO, in collaboration with technical partners, has developed a series of enhanced surveillance protocols, that are harmonized to help provide detailed insight into the epidemiological characteristics of COVID-19.
zh-cn	世界卫生组织（WHO）已与其技术合作伙伴共同制定了一系列强化监测方案，这些方案协调一致，有助于详细深入的了解 2019 冠状病毒病（COVID-19）的流行病学特征。

en-us	Other COVID-19 investigations and studies protocols currently available include:
zh-cn	现有的其他调查研究方案有：

en-us	Household transmission investigation protocol for COVID-19 virus infection
zh-cn	COVID-19   病毒感染家庭传播调查方案

en-us	Protocol for assessment of potential risk factors for COVID-19 infection among health care workers in a health care setting.
zh-cn	医疗环境中医护人员感染COVID-19     病毒的潜在危险因素评估方案

en-us	Surface sampling of COVID-19 virus: A practical “how to” protocol for health care and public health professionals.
zh-cn	COVID-19 病毒物体表面采样：医护人员和公共卫生专家的实用“怎样做”方案

en-us	All WHO protocols for COVID-19 are available on the WHO website together with the technical guidance documents.
zh-cn	世界卫生组织关于 2019 冠状病毒病的所有方案和技术指导文件都可以在 WHO 网站上找到。

en-us	This currently includes case definitions, laboratory guidance, infection prevention and control and travel advice.
zh-cn	现有材料的内容包括病例定义、实验室指导、感染预防与控制以及旅行建议等。

en-us	The detection and spread of an emerging respiratory pathogen are accompanied by uncertainty over the key epidemiological and serologic characteristics of the novel pathogen and particularly its ability to spread in the human population and its virulence (case-severity).
zh-cn	与新出现的呼吸道病原体的发现和传播相伴的，是对新病原体的关键流行病学和血清学特征，尤其是它在人群中的传播力和毒力（疾病严重程度）的不了解和不确定。

en-us	This is the case for the COVID-19 virus, first detected in Wuhan city, China in December 2019 (1).
zh-cn	2019年 12 月在中国武汉市首次发现的 COVID-19 病毒正是如此(1)。

en-us	To date initial surveillance has focused primarily on patients with severe disease, and, as such, the full spectrum of the disease, including the extent and fraction of mild or asymptomatic infections that do not require medical attention are not clear.
zh-cn	迄今为止，早期监测主要集中在病情严重的患者，因此，完整的疾病谱尚不明确，包括无需治疗的轻症或无症状感染的程度和比例。

en-us	Estimates of the case fatality ratio, and other epidemiological parameters, will likely be lower than current crude mortality estimates once the full spectrum of disease is able to be included in the denominator.
zh-cn	如果把整个疾病谱纳入分母，那么病死率和其他流行病学参数的估计值则可能会低于目前粗略估计的死亡数据。

en-us	In addition, the role of asymptomatic or subclinical infections in human-to-human transmission of COVID-19 virus is not well understood and it is not yet clear whether those who are reported as asymptomatic may be able to transmit the virus to other individuals.
zh-cn	此外，无症状或亚临床感染者在COVID-19 病毒的人与人之间传播中的作用尚不明确，目前还不清楚那些报告为无症状者是否能将病毒传播给其他人。

en-us	With a novel coronavirus, initial seroprevalence in the population is assumed to be negligible due to the virus being novel in origin.
zh-cn	对于一种新型冠状病毒，由于病毒的起源是全新的，其在人群中的初始血清流行率可以忽略不计。

en-us	Therefore, surveillance of antibody seropositivity in a population can allow inferences to be made about the extent of infection and about the cumulative incidence of infection in the population.
zh-cn	因此，监测人群中相关抗体的血清阳性率可以推断出人群的感染程度和累积感染率。

en-us	The following protocol has been designed to investigate the extent of infection, as determined by seropositivity in the general population, in any country in which COVID-19 virus infection has been reported.
zh-cn	以下方案适用于任何已报告COVID-19 病毒感染病例的国家，旨在通过调查一般人群的血清反应阳性情况，了解实际的感染程度。

en-us	Each country may need to tailor some aspects of this protocol to align with public health, laboratory and clinical systems, according to capacity, availability of resources and cultural appropriateness.
zh-cn	各国可能需要根据自身能力、现有资源和文化适宜性，对本方案进行适当修改，使之符合本国公共卫生、实验室和医疗体系的实际情况。

en-us	However, using a standardized protocol such as this one below, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally for timely estimates of COVID-19 virus infection severity and attack rates, as well as to inform public health responses and policy decisions.
zh-cn	然而，使用下述标准化方案，能够在全球范围内的多种环境条件下，以统一的、易于汇总、制表和分析的格式，系统收集和快速共享流行病学暴露和生物样本数据，及时评估COVID-19 病毒感染的严重程度和感染罹患率，为公共卫生响应和政策制定提供信息。

en-us	This is particularly important in the context of a novel respiratory pathogen, such as COVID-19 virus.
zh-cn	对于COVID-19 病毒这样的新发呼吸道病原体，这是尤其重要的。

en-us	Comments for the user’s consideration are provided in purple text throughout the document as the user may need to modify methods slightly because of the local context in which this study will be carried out.
zh-cn	供使用者参考的意见在整个文件中以紫色文本显示，使用者可能需要根据所研究地区的实际情况适当调整相应方法。

en-us	There are two primary objectives for this seroepidemiological investigation:
zh-cn	本血清流行病学调查的主要目标有两个：

en-us	To determine the extent of infection in the general population and age-specific infection cumulative incidence, as determined by seropositivity
zh-cn	根据血清反应阳性情况确定一般人群的感染程度和年龄别累积感染率

en-us	To determine the fraction of asymptomatic or subclinical infections
zh-cn	确定无症状或亚临床感染的比例

en-us	Seroepidemiological investigations provide the opportunity to evaluate secondary objectives, such as, but not limited to:
zh-cn	血清流行病学调查也提供了评估下列次要目标的机会，包括但不限于：

en-us	To determine risk factors for infection by comparing the exposures of infected and non-infected individuals
zh-cn	通过比较感染者和未感染者的暴露情况，确定感染的危险因素

en-us	To more accurately determine the case fatality ratio
zh-cn	更准确的确定病死率

en-us	COMMENT: Little is currently known about COVID-19 virus antibody kinetics.
zh-cn	备注：目前对 COVID-19 病毒的抗体动力学知之甚少。

en-us	Asymptomatic infected persons may clear the virus more quickly than do symptomatic patients and antibody titers in the former are likely to be lower, if they seroconvert at all, than in infected patients exhibiting symptoms.
zh-cn	无症状感染者清除病毒的速度可能比有症状的患者快，如果前者发生血清转换，那么其抗体滴度很可能比有症状的患者低。

en-us	These are considerations for the interpretation of any COVID-19 virus seroepidemiological investigation.
zh-cn	这是任何COVID-19 病毒血清流行病学调查在结果解释时均需考虑的问题。

en-us	The seroepidemiological investigation for COVID-19 virus infection is a population-based, age-stratified prospective study.
zh-cn	COVID-19 病毒感染的血清流行病学调查是一项基于人群的、按年龄分层的前瞻性研究。

en-us	It is intended to provide key epidemiological and serologic characteristics of COVID-19 virus.
zh-cn	旨在了解COVID-19 病毒的主要流行病学和血清学特征。

en-us	There are three possibilities for how this study can be implemented:
zh-cn	研究的实施方法有三种：

en-us	Cross-sectional investigation
zh-cn	横断面调查

en-us	Repeated cross-sectional investigation in the same geographic area (but not necessarily the same individuals each time).
zh-cn	同一地理区域内的重复横断面调查（但不一定每次都调查相同的个体）

en-us	Longitudinal cohort study with serial sampling of the same individuals each time
zh-cn	对相同个体进行连续采样的纵向队列研究

en-us	COMMENT: The first option will likely be the easiest to implement for countries to implement, while the third provides the most comprehensive information on extent of infection, as described below.
zh-cn	备注：如下文所述，第一种方法可能是各国最容易实施的，而第三种方法则可以提供关于感染程度的最全面的信息。

en-us	The choice as to how this study will be implemented should be determined by feasibility and available capacity.
zh-cn	应根据项目的可行性和现有能力选择研究的具体实施方法。

en-us	The timing of the study will depend on the specific public health questions that need to be addressed.
zh-cn	研究开始的时间取决于需要解答的具体的公共卫生问题。

en-us	If serial sampling is to be conducted, it is best to initiate the investigation as quickly as possible.
zh-cn	如需进行连续采样，最好尽快开始调查。

en-us	Serial sampling can then be conducted as long as possible, as determined by capacity and resources.
zh-cn	可以根据自身能力和资源情况，尽可能长时间地开展连续采样。

en-us	For one-time cross-sectional investigations, there may be an interest in completing the investigation after the peak of transmission of the epidemic wave.
zh-cn	可能有观点认为应在流行波的传播高峰之后完成一次性横断面调查。

en-us	However, a cross-sectional investigation, conducted at any time of the epidemic, will provide important information that can be used to inform public health responses.
zh-cn	其实，在疫情中的任何时段进行横断面调查，都可以为公共卫生响应提供重要信息。

en-us	For longitudinal cohort study with serial sampling, the epidemic curve from surveillance (daily number of new confirmed cases) can be used to adjust the frequency with which samples are collected to provide real-time estimates of seropositivity in the general population.
zh-cn	对于开展连续采样的纵向队列研究，可以根据监测到的流行曲线（每日新增确诊病例数）调整样本采集频率，实时估计一般人群的血清阳性率。

en-us	The geographic scope of the investigation should first be defined.
zh-cn	首先应确定调查的地理范围。

en-us	This may be limited to a local or regional investigation, or may be conducted as a national investigation.
zh-cn	调查可能局限于某个地方或某一区域，也可以是国家调查。

en-us	Within the geographic scope of the study, high incidence and low incidence areas should be identified.
zh-cn	在所研究的地理范围内，应确定发病率高和发病率低的地区。

en-us	The selection of these areas should be informed by the latest information on COVID-19 virus circulation, available on the WHO website.
zh-cn	在选择时，应参考WHO   网站上关于COVID-19 病毒的最新传播信息。

en-us	The study population should then be identified in at least one high incidence and one low incidence area through the random selection of households.
zh-cn	随后，应至少在一个高发病率和一个低发病率地区，随机选择要调查的家庭，以确定研究人群。

en-us	For the purpose of this investigation, a household is defined as a group of people (2 or more) living in the same residence.
zh-cn	根据本次调查的目的，家庭的定义是居住在同一住所的一组人（2 人及以上）。

en-us	In practice, the technical definition may vary due to social, political and cultural practices.
zh-cn	在实践中，由于社会、政治和文化习俗不同，具体的定义可能不同。

en-us	Definitions of a household which may be used (but are not limited to):
zh-cn	家庭的定义可以是（但不限于）：

en-us	Two or more people living together in a domestic residence (residential institutions, such as boarding schools, dormitories, hostels or prisons will be excluded).
zh-cn	两人及以上共同居住在一个家庭住所内（寄宿学校、宿舍、青年旅社或监狱等寄宿机构除外）。

en-us	A dwelling or group of dwellings with a shared kitchen or common opening onto a shared household space.
zh-cn	共用厨房或有开口通向其他共用居家空间的一个或一组住所。

en-us	All persons living in the household should be invited to participate in the study, including children to ensure age-specific attack rates can be calculated.
zh-cn	应请包括儿童在内的所有在家中居住的人参加研究，以确保能够计算年龄别感染罹患率。

en-us	The distribution of household compositions in the population would be needed to calculate population, age-specific infection attack rates.
zh-cn	需要整体人群中家庭构成的分布信息来计算人群和年龄别感染罹患率。

en-us	The random selection of households within a geographic area is one method of recruitment.
zh-cn	招募方法之一是在某一地理区域内随机选择家庭，

en-us	Random digit dialing1, blood donors or other ongoing longitudinal cohort studies may also be used to identify and recruit individuals to participate in the investigation.
zh-cn	也可以通过随机拨号1、献血人群或其他正在进行的纵向队列研究确定和招募个体参与调查。

en-us	The advantage of working with blood donors is that they are usually forthcoming to being contacted for future follow-up and you may be able to track long-term antibody dynamics.
zh-cn	选择献血人群的好处是，他们在日后随访时总是易于联系，可以长期追踪抗体动态。

en-us	For COVID-19, the age-specific attack rates in blood donors are likely to be similar to that in the general population except for those with substantial comorbidities or elevated exposure (e.g. healthcare workers).
zh-cn	对于 2019 冠状病毒病来说，献血者的年龄别感染罹患率可能与普通人群相似，有严重合并症或暴露风险较高者（如医护人员）除外。

en-us	Plasma may be collected from a subset of participants so that the serologic assay results of the serum and plasma could be compared.
zh-cn	可以收集部分参与者的血浆，比较血清和血浆的血清学检测结果。

en-us	This might be useful if sera and plasma give the same results as plasma are stored in many blood donor archives which could be used to retrospectively to estimate the infection attack rate.
zh-cn	如果二者相同，这一调查将十分有益，因为血站储存了很多献血者的血浆，这些血浆可用于感染罹患率的回顾性估计。

en-us	Whichever method is used to identify and recruit participants, all attempts should be made to include participants over a range of ages in order to be able to determine and compare age-specific attack rates, although crude age-specific estimates will need to be adjusted for age structures in the population.
zh-cn	虽然本调查最终会根据研究人群的年龄结构调整年龄别粗估计数，但无论采用哪种方法发现和招募参与者，都应尽一切努力将不同年龄段的参与者纳入研究，以便能够确定和比较年龄别感染罹患率。

en-us	Depending on which method of study recruitment is chosen, the group implementing the study may choose either to conduct home visits to collect data and specimens or to centralize data and specimen collection at one location, asking participants to travel to the location to participate in the study.
zh-cn	根据所选的招募方法不同，研究实施者可以通过入户访问收集数据和样本，也可以在某个地点集中收集，请参与者到该地参与研究。

en-us	Decisions as to how to implement the study should be determined by feasibility and resource (including personnel) availability.
zh-cn	应根据实际可行性和资源（包括人力资源）可用性确定如何开展研究。

en-us	Inclusion criteria: All individuals identified for recruitment into the investigation, irrespective of age.
zh-cn	纳入标准：招募过程中发现的所有被纳入调查的个体，无论年龄大小。

en-us	Exclusion criteria: Refusal to give informed consent, or contraindication to venipuncture.
zh-cn	排除标准：拒绝给予知情同意或有静脉穿刺禁忌征。

en-us	Suspected or confirmed acute or prior COVID-19 infection should not be considered as an exclusion criterion for this investigation.
zh-cn	疑似或确诊的急性期或既往 COVID-19 病毒感染不应被视为本调查的排除标准，否则会低估研究人群的感染程度。

en-us	Doing so would underestimate the extent of infection in the population. For individuals currently receiving medical care for COVID-19 infection, a family member or proxy may be used to complete the questionnaire on his/her behalf.
zh-cn	目前因 COVID-19     病毒感染而接受治疗者，可由家庭成员或代理人代其填写调查问卷。

en-us	Each participant recruited into the investigation should be asked to complete a questionnaire which covers demographic and exposure information.
zh-cn	应要求招募的每个参与者都填写一份调查问卷，内容涵盖人口统计学和暴露信息。

en-us	An example of an investigation questionnaire which may be used can be found in the Appendix A.
zh-cn	可用的调查问卷样表见附录 1。

en-us	This questionnaire is not exhaustive and may need to be adapted to the local setting and outbreak characteristics, but it provides an outline as to the data to be collected in order to calculate the epidemiological parameters (see 4.3 Epidemiological parameters).
zh-cn	该问卷并非详尽无遗，使用者可能需要根据本地的环境和疫情特点做适当修改。该表概括了为计算相关的流行病学参数（见 4.3 流行病学参数）而需要收集的数据。

en-us	A serum sample needs to be collected from each participant upon recruitment into the investigation.
zh-cn	需要在招募后采集每个参与者的血清样本。

en-us	The collection of serum samples should follow specimen collection guidance in the country.
zh-cn	样本的采集应遵循本国的标本采集指南。

en-us	Table 1 describes when data and specimens should be collected according to the study design selected.
zh-cn	表 1 描述了根据所选的研究设计而收集数据和标本的时间。

en-us	If repeated sampling is to be conducted, whether as a repeated cross-sectional investigation, or as a longitudinal investigation, specimens should be collected at least 21 days apart.
zh-cn	如需进行重复采样，无论是重复横断面调查，还是纵向调查，标本的采集时间均应至少间隔 21 天。

en-us	Other specimens (e.g. nasopharyngeal) may be collected to determine acute COVID-19 infection, as determined by the objectives of the investigation and the available resources and capacity.
zh-cn	可收集其他标本（如鼻咽部）以确定是否为 COVID-19 病毒急性感染，这取决于调查的目标以及现有的资源和能力。

en-us	Figure 1: Schedule for data and specimen collection according to study design
zh-cn	表 1：根据研究设计收集数据和标本的时间表

en-us	All those involved in the collection and transportation of specimens should be trained in safe handling practices and spill decontamination procedures.
zh-cn	所有参与标本采集和运输的人员都应接受实验室标本安全操作和标本溢洒去污染程序的培训，了解所收集样本的运输和感染控制建议的详细信息。

en-us	For details regarding the transport of samples collected and infection control advice, please refer to case management algorithm and laboratory guidance in the country or WHO laboratory guidance, available on the WHO website.
zh-cn	具体请参阅 WHO 网站上提供的所在国个案管理体系实验室指南或世界卫生组织实验室指南。

en-us	For each biological sample collected, the time of collection, the conditions for transportation and the time of arrival at the study laboratory will be recorded.
zh-cn	应记录每个生物样本的采集时间、运输条件和到达检测实验室的时间。

en-us	Specimens should reach the laboratory as soon as possible after collection.
zh-cn	标本在采集后应尽快送达实验室。

en-us	If the specimen is not likely to reach the laboratory within 72 hours, specimens should be frozen, preferably at -80°C, and shipped on dry ice.
zh-cn	如标本不可能在 72 小时内到达，则应将标本冷冻，最好在-80°C，并用干冰运输。

en-us	It is, however, important to avoid repeated freezing and thawing of specimens.
zh-cn	但是，应避免标本反复冻融，这一点十分重要。

en-us	The storage of serum specimens in domestic frost-free freezers should be avoided, owing to their wide temperature fluctuations.
zh-cn	由于家用无霜制冷设备的温度波动范围较大，应避免将血清标本存放其中。

en-us	Serum should be separated from whole blood and can be stored and shipped at 4°C or frozen to -20°C or lower and shipped on dry ice.
zh-cn	应从全血中分离出血清，在 4℃储存和运输，或冷冻至-20℃或更低温度，用干冰运输。

en-us	Transport of specimens within national borders should comply with applicable national regulations.
zh-cn	在国内运输标本应符合本国的相关条例。

en-us	International transport of specimens should follow applicable international regulations as described in the WHO Guidance on Regulations for the Transport of Infectious Substances 2019-2020.
zh-cn	标本的国际运输应遵循《世界卫生组织2019-2020    年感染性物质运输指南》中相关的国际规定。

en-us	Ethical requirements will vary by country.
zh-cn	伦理要求因国家而异。

en-us	In some countries, this investigation may fall under public health surveillance (emergency response) acts and may not require ethical approval from an Institutional Review Board.
zh-cn	在一些国家，这项调查可能属于公共卫生监测（应急响应）法案的内容，无需伦理审查委员会批准。

en-us	The purpose of the investigation will be explained to all individuals identified for recruitment into the investigation.
zh-cn	向调查招募的所有个体解释调查目的。

en-us	Informed consent will be obtained from all individuals willing to participate in the investigation before any procedure is performed as part of the investigation by a trained member of the investigation team.
zh-cn	在调查的所有程序开始之前，应由经过培训的调查小组成员，获得每个愿意参与调查者的知情同意。

en-us	Consent for children under the legal age of consent will be obtained from a parent or legal guardian.
zh-cn	对于未满法定年龄的儿童，可获得父母或法定监护人的知情同意。

en-us	Each participant must be informed that participation in the investigation is voluntary and that s/he is free to withdraw, without justification, from the investigation at any time without consequences and without affecting professional responsibilities.
zh-cn	必须告知每位参与者，参加调查是自愿的，他/她可以在任何时候毫无理由地退出调查，而不产生任何不良后果，也不会减损相关人员对他/她应负的职责。

en-us	The age of consent may vary by country.
zh-cn	知情同意的年龄限制可能因国家而异。

en-us	Check the requirements of local, regional or national authorities.
zh-cn	请查阅国家、地区和地方主管部门的相关要求。

en-us	Informed consent will seek approval to collect blood and epidemiological data for the intended purpose of this investigation, that samples may be shipped outside of the country for additional testing and that samples may be used for future research purposes.
zh-cn	知情同意的内容应包括，同意为本次调查的预期目标收集血液和流行病学数据，同意将样本运往国外做进一步检测，或用于未来的研究目的。

en-us	This investigation poses minimal risk to participants, involving the collection of a small amount of blood.
zh-cn	本调查对参与者构成的风险很小，内容涉及收集少量血液。

en-us	The primary benefit of the study is indirect in that data collected will help improve and guide efforts to understand extent of COVID-19 virus infection and may prevent further transmission of the virus.
zh-cn	研究的主要收益是间接的，收集到的数据将有助于改进和指导相关研究，以了解 COVID-19 病毒的感染程度，以阻止病毒的进一步播散。

en-us	Participant confidentiality will be maintained throughout the investigation.
zh-cn	应在整个调查过程中做好参与者的信息保密工作。

en-us	All subjects who participate in the investigation will be assigned a study identification number by the investigation team for the labelling of questionnaires and specimens.
zh-cn	调查小组应为每个调查对象分配一个研究识别号，用于标记问卷和标本。

en-us	The link of this identification number to individuals will be maintained by the investigation team and the Ministry of Health (or equivalent) and will not be disclosed elsewhere.
zh-cn	该识别号与个体的关联信息由调查小组和卫生部（或同等机构）保管，不会向外界披露。

en-us	If the data is shared by the implementing organization to WHO or any agency or institution providing support for data analysis, data shared will include only the study identification number and not any personably identifiable information.
zh-cn	如果研究的实施组织将数据共享给世界组织或为数据分析提供支持的任何部门或机构，所分享的数据应仅包含研究识别号，而不包括任何个人识别信息。

en-us	Article 45 of the IHR (2005) describes the “treatment of personal data”.
zh-cn	《国际卫生条例（2005）》第 45  条描述了“个人资料的处理”。

en-us	Person identifiable data collected under the IHR should be kept confidential and processed anonymously, as required by national law.
zh-cn	按照《条例》规定收集的身份明确或可查明身份的个人数据，应根据国家法律要求保密并匿名处理。

en-us	However, such data may be disclosed for assessments and management of public health risks, provided the data are processed fairly and lawfully.
zh-cn	但是，为了评估和管理公共卫生风险，可以披露这些个人数据，前提是数据得到公平和合法的处理。

en-us	Prevention of COVID-19 virus infection in investigation personnel
zh-cn	调查人员COVID-19   病毒感染的预防

en-us	All personnel involved in the investigation need to be trained in infection prevention and control procedures (standard contact and droplet precautions, as determined by national or local guidelines).
zh-cn	所有参加调查的工作人员都需要接受感染的预防与控制程序的培训（根据国家或地方相关指南，确定接触传播和飞沫传播的标准预防措施）。

en-us	These procedures should include proper hand hygiene and the correct use of surgical masks, if necessary, not only to minimize their own risk of infection when in close contact with individuals with COVID-19 infection, but also to minimize the risk of spread among other participants in the investigation.
zh-cn	这些措施应包括保持适当的手部卫生和正确使用外科口罩（如必要），不仅要在与 COVID-19  病毒感染者密切接触时将自身感染风险降至最低，还应将调查对象之间的传播风险降至最低。

en-us	WHO technical guidance on infection prevention and control specific to COVID-19 can be found on the WHO website.
zh-cn	世界卫生组织针对COVID-19 病毒感染的预防与控制技术的指导材料可在WHO 网站上找到。

en-us	Laboratory and biosafety guidance for COVID-19 can be found on the WHO website.
zh-cn	COVID-19     病毒相关的实验室和生物安全指南可在世界卫生组织网站上找到。

en-us	Serologic assays specific to COVID-19 are currently under development / in the process of evaluation.
zh-cn	2019  冠状病毒病的特异性血清学检测方法目前正在开发/评估中。

en-us	The protocols or SOPs will be published on the WHO website once they become available.
zh-cn	这些指南或标准操作规程一旦可以使用，就会在世界卫生组织网站上公布。

en-us	Cross reactivity to other coronaviruses may be an issue and should be considered in the interpretation of data.
zh-cn	COVID-19 病毒与其他冠状病毒的血清学交叉反应可能是个问题，应在数据解释时予以考虑。

en-us	Multiple assays may be required to confirm a seropositive for COVID-19 virus.
zh-cn	可能需要进行多次试验以确认COVID-19 病毒的血清学阳性结果。

en-us	Laboratory procedures involving sample manipulation must be carried out in a biosafety cabinet (BSC).
zh-cn	涉及标本操作的实验室程序必须在生物安全柜（BSC）中进行。

en-us	Serum samples should be screened for the presence of COVID-19 virus specific antibodies using serological testing.
zh-cn	通过血清学检测筛查血清样本是否存在COVID-19 病毒特异性抗体。

en-us	Tests for both IgM and IgG should be carried out using an enzyme linked immunosorbent assay (ELISA) or immunofluorescence.
zh-cn	IgM 和 IgG 检测应采用酶联免疫吸附试验（ELISA）或免疫荧光法。

en-us	If a sample is positive for either IgM or IgG a plaque reduction neutralization test (PRNT) should be done.
zh-cn	如果样本的IgM 或 IgG 呈阳性，则应进行空斑减少中和试验（PRNT）。

en-us	ELISA testing should be carried out in a facility with at least biosafety level 2 (BSL-2) capacity.
zh-cn	酶联免疫吸附试验应在至少符合生物安全二级（BSL-2）标准的设施中进行。

en-us	Confirmation of the presence of neutralizing antibodies
zh-cn	确认中和抗体的存在

en-us	A PRNT can be carried out on samples that were positive for COVID-19 specific IgM or IgG  antibodies to confirm the presence of neutralizing antibodies.
zh-cn	可以对COVID-19 病毒特异性IgM 或 IgG 抗体阳性的样本进行空斑减少中和试验，以确认存在中和抗体。

en-us	PRNT should be carried out in a facility with at least BSL-3 capacity.
zh-cn	空斑减少中和试验应在至少符合生物安全三级（BSL-3）标准的设施中进行。

en-us	Sample storage
zh-cn	样本储存

en-us	In the case that serum samples cannot be processed immediately, they should be stored at -80°C.
zh-cn	如果不能立即处理血清样本，应将其在-80°C 储存。

en-us	It is recommended to aliquot samples prior to freezing, to minimize freeze thaw cycles.
zh-cn	建议冷冻前对样品进行等分，以尽量减少冻融循环。

en-us	These recommendations are subject to changes as new, reliable serological assays become available.
zh-cn	随着新的、可靠的血清学检测方法的出现，这些建议可能会发生变化。

en-us	If serological testing is not available in the country in which serum samples are collected, they may be stored or shipped to an international reference laboratory. W
zh-cn	如果采集血清样本的国家无法进行血清学检测，可将其储存起来或运送至国际参考实验室。

en-us	HO is able to facilitate communication with international referral laboratories in order for samples to be shipped for further testing.
zh-cn	世界卫生组织可以帮助协调与国际参考实验室的沟通，以便各国运送样本做进一步检测。

en-us	The figure below provides estimates of margin of error as a function of seroprevalence for 100, 200 and 300 samples.
zh-cn	下图显示了一个血清流行率的函数在样本量分别为 100、200 和 300 时的误差范围估计值。

en-us	For a given seroprevalence rate p and sample size N, the expected margin of error corresponds to the expected width of the 95% confidence interval associated with the point estimate of p obtained using binomial likelihood.
zh-cn	对于给定的血清学感染率(p)和样本量(N)，其期望误差范围由二项似然函数估计出的P 值的不同 95%可信区间获得。

en-us	The table below provides an overview of the epidemiological parameters that can be measured as part of this investigation.
zh-cn	下表概括了本次调查可以估计的流行病学参数。

en-us	Form and questions where to get the data to calculate the parameters concerned
zh-cn	获得计算相关参数所需数据的表格和问题

en-us	Age-specific attack rate
zh-cn	年龄别感染罹患率

en-us	The proportion of individuals per age strata who show seropositivity for COVID-19 virus infection
zh-cn	各年龄层 COVID-19病毒血清学阳性的比例

en-us	Age-specific cumulative incidence
zh-cn	年龄别累积发病率

en-us	The proportion of individuals per age strata who show seropositivity for virus infection
zh-cn	各年龄层病毒感染血清学阳性个体的比例

en-us	Proportion should be adjusted for any difference in the age stratification of the participants and the overall population
zh-cn	如调查对象的年龄分层与人群整体不同，则应对该比例进行调整

en-us	Symptomatic proportion of cases (asymptomatic fraction)
zh-cn	有症状的病例比例（无症状感染者的比例）

en-us	The proportion of individuals who show symptoms or signs of COVID-19 infection
zh-cn	出现 COVID-19  病毒感染的症状或体征的个体的比例

en-us	The numerators of interest are the numbers of those individuals reporting various signs and symptoms of infection (e.g. fever, cough) and the number/proportion of individuals reporting no signs or symptoms (i.e. the asymptomatic fraction);
zh-cn	分子是报告了各种感染症状和体征（ 如发热、干咳）的个体的数量，或报告无相关症状或体征的个体的数量（即无症状感染者的部分）；

en-us	the denominator is the total number of individuals tested.
zh-cn	分母是接受检测的个体总数。

en-us	Serological response to infection
zh-cn	感染的血清学反应

en-us	The change in serum level of specific antibodies to COVID-19 virus (Increase in titre)
zh-cn	血清 COVID-19  病毒特异性抗体水平的变化（滴度增加）

en-us	Population groups most at risk
zh-cn	高危人群

en-us	The identification of groups who are most vulnerable to COVID-19 virus infection (e.g. age groups, gender, occupation)
zh-cn	确定最易受 COVID-19  病毒感染的人群（如年龄组、性别或职业）

en-us	May only be an early signal, a nested case- control study could be conducted to evaluate risk factors for infection
zh-cn	可能只是一个早期信号，可以通过巢式病例对照研究评估感染的危险因素

en-us	Ratio of severe disease
zh-cn	重症率

en-us	The proportion of an age group with severe infection, divided by the probability that an infection resulted in a severe case, expressed as a proportion of the total number of people in that age group
zh-cn	某年龄组严重感染的比例，即感染引起严重疾病的概率，表示为重症数除以该年龄组病例总数的比例。

en-us	The proportion of individuals with fatal outcome for COVID- 19 infection
zh-cn	COVID-19   病毒感染死亡个体的比例

en-us	May require extended follow-up to determine outcome of those with COVID-19 infection
zh-cn	可能需要延长随访时间以确定 COVID-19病毒感染者的临床结局

en-us	Any investigation of this nature should include reporting on the following information:
zh-cn	任何此类调查均应报告如下信息：

en-us	the number of households and the number of individuals included;
zh-cn	调查的家庭和个体的数量；

en-us	the age and sex of all individuals included
zh-cn	所有个体的年龄和性别；

en-us	the time in the outbreak of sample collection and the antibody titre levels of each specimen collected.
zh-cn	疫情中标本采集的时间和所采集的每个标本的抗体滴度；

en-us	the number of individuals with serologic evidence of COVID-19 virus infection.
zh-cn	有 COVID-19 病毒感染的血清学证据的个体数量。

en-us	If sample size permits, these numbers should be stratified by age.
zh-cn	如样本量允许，应把数据按年龄分层；

en-us	the number of individuals with serologic evidence of COVID-19 virus infection who have reported symptoms.
zh-cn	有COVID-19    病毒感染血清学证据者中，报告出现症状的人数。

en-us	It is also important to fully document the study design, how individuals were recruited, and the serological assay and methods used to ensure that data can be pooled to increase power in estimating epidemiological parameters.
zh-cn	同样重要的是完整的记录研究设计信息，包括如何招募个人和进行血清学试验，以及确保数据能够合并的方法，加强估计流行病学参数的能力。

en-us	Ideally, information would be collected in a standardized format according to the questionnaires and tools in this generic protocol to assist with data harmonization and comparison of results (see forms in Appendix A).
zh-cn	在理想情况下，应按照本通用方案的调查表和相关工具以标准格式收集信息，这样有助于数据协调和结果的比较（见附录 1 中的表格）。

en-us	To enable results to be aggregated across study sites and across county sites and by extension, strengthen the statistical power of the results, it is expected that they are shared with WHO by sending individual, de-identified data to EarlyInvestigations-2019-nCoV@who.int.
zh-cn	为了汇总不同项目点和不同地区的调查结果，并进一步加强结果的统计效能，世界卫生组织希望能够通过 EarlyInvestigations-2019-nCoV@WHO.int  接收和共享个体的去识别数据。

en-us	The data shared should include only the study identification number and not any personably identifiable information.
zh-cn	共享的数据应仅包含研究识别号，不包括任何个人可识别信息。