Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response
Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response
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DOI：
10.1016/j.annepidem.2020.07.015
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发表时间：
2020-09-01
影响因子：
5.6
通讯作者：
Bradley, Heather
中科院分区：
文献类型：
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作者：
Siegler, Aaron J.;Sullivan, Patrick S.;Bradley, Heather
目的：美国对SARS-CoV-2流行病的反应受到早期和持续延迟感染检测的阻碍;没有关于感染发生地点和流行病规模的数据，早期公共卫生反应不是数据驱动的。了解SARS-CoV-2感染和免疫反应的流行情况对于制定和实施有效的公共卫生应对措施至关重要。大多数血清学调查仅限于选择进行调查的地点和/或以方便抽样为基础。此外，抗体检测的结果可能会受到高假阳性率的设置低流行的免疫应答和不完善的测试specificity.Methods：我们将进行一项全国性的血清学调查SARS-CoV-2 PCR阳性和免疫的经验。美国地址的概率样本将邮寄邀请函和试剂盒，用于自行采集前鼻孔拭子和手指刺干血斑标本。在每个抽样家庭中，将随机选择一名18岁或以上的成年人，并要求其填写问卷，采集生物标本并将其送回中心实验室。将通过RNA PCR检测鼻拭子样本的SARS-CoV-2 RNA;将检测干血斑样本的SARS-CoV-2抗体（即，免疫经验）。抗体筛查试验阳性将通过具有不同抗原基础的第二抗体试验确认，以提高阳性（PPV）抗体试验结果的预测值。所有在基线期返还标本的受试者将入组随访队列，并在基线后3个月邮寄额外的标本采集盒。将邀请10%的选定家庭参与全面家庭测试，并为所有年龄>= 3岁的家庭成员提供测试。主要的研究结果将是期间感染SARS-CoV-2和免疫的经验，和SARS-CoV-2感染和抗体responses.Results的发病率：功率计算表明，全国样本4000户将有利于全国SARS-CoV-2感染和抗体流行率的估计可接受的狭窄95%的置信区间，在几种可能的情况下的流行水平。在多达七个人口众多的州进行过度抽样将允许在亚人群中估计流行率。我们的抗体检测2阶段算法在患病率水平>= 1.0%时产生可接受的PPV。包括各州的过样本，我们预计将收到来自7495个美国家庭的多达9156名参与者的数据。除了对SARS-CoV-2感染和免疫经验的流行率提供可靠的估计外，我们预计这项研究将为基于家庭的SARS-CoV-2检测调查建立一种可复制的方法，解决对选择偏倚的担忧，提高血清学结果的阳性预测值。本研究产生的SARS-CoV-2感染和免疫经验的患病率估计将大大提高我们对COVID-19疾病谱的理解，其目前在各种人口统计学，地理和职业群体中的渗透率，并告知与感染相关的症状范围。这些数据将为控制当前流行病的资源需求提供信息，并促进为流行病缓解战略做出数据驱动的决策。(C)2020作者（S）爱思唯尔公司出版
Purpose: The U.S. response to the SARS-CoV-2 epidemic has been hampered by early and ongoing delays in testing for infection; without data on where infections were occurring and the magnitude of the epidemic, early public health responses were not data- driven. Understanding the prevalence of SARS-CoV-2 infections and immune response is critical to developing and implementing effective public health responses. Most serological surveys have been limited to localities that opted to conduct them and/or were based on convenience samples. Moreover, results of antibody testing might be subject to high false positive rates in the setting of low prevalence of immune response and imperfect test specificity.Methods: We will conduct a national serosurvey for SARS-CoV-2 PCR positivity and immune experience. A probability sample of U.S. addresses will be mailed invitations and kits for the self-collection of anterior nares swab and finger prick dried blood spot specimens. Within each sampled household, one adult 18 years or older will be randomly selected and asked to complete a questionnaire and to collect and return biological specimens to a central laboratory. Nasal swab specimens will be tested for SARS-CoV-2 RNA by RNA PCR; dried blood spot specimens will be tested for antibodies to SARS-CoV-2 (i.e., immune experience) by enzyme-linked immunoassays. Positive screening tests for antibodies will be confirmed by a second antibody test with different antigenic basis to improve predictive value of positive (PPV) antibody test results. All persons returning specimens in the baseline phase will be enrolled into a follow-up cohort and mailed additional specimen collection kits 3 months after baseline. A subset of 10% of selected households will be invited to participate in full household testing, with tests offered for all household members aged >= 3 years. The main study outcomes will be period prevalence of infection with SARS-CoV-2 and immune experience, and incidence of SARS-CoV-2 infection and antibody responses.Results: Power calculations indicate that a national sample of 4000 households will facilitate estimation of national SARS-CoV-2 infection and antibody prevalence with acceptably narrow 95% confidence intervals across several possible scenarios of prevalence levels. Oversampling in up to seven populous states will allow for prevalence estimation among subpopulations. Our 2-stage algorithm for antibody testing produces acceptable PPV at prevalence levels >= 1.0%. Including oversamples in states, we expect to receive data from as many as 9156 participants in 7495 U.S. households.Conclusions: In addition to providing robust estimates of prevalence of SARS-CoV-2 infection and immune experience, we anticipate this study will establish a replicable methodology for home-based SARSCoV-2 testing surveys, address concerns about selection bias, and improve positive predictive value of serology results. Prevalence estimates of SARS-CoV-2 infection and immune experience produced by this study will greatly improve our understanding of the spectrum of COVID-19 disease, its current penetration in various demographic, geographic, and occupational groups, and inform the range of symptoms associated with infection. These data will inform resource needs for control of the ongoing epidemic and facilitate data-driven decisions for epidemic mitigation strategies. (C) 2020 The Author(s). Published by Elsevier Inc.