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人类感染 SARS-CoV-2 后两年的抗体反应:研究方案。

Two-years antibody responses following SARS-CoV-2 infection in humans: A study protocol.

机构信息

Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

Health and Demographic Surveillance System Sleman, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

出版信息

PLoS One. 2022 Aug 16;17(8):e0272690. doi: 10.1371/journal.pone.0272690. eCollection 2022.

Abstract

The long-term antibody response to the novel SARS-CoV-2 in infected patients and their residential neighborhood remains unknown in Indonesia. This information will provide insights into the antibody kinetics over a relatively long period as well as transmission risk factors in the community. We aim to prospectively observe and determine the kinetics of the anti-SARS-CoV-2 antibody for 2 years after infection in relation to disease severity and to determine the risk and protective factors of SARS CoV-2 infections in the community. A cohort of RT-PCR confirmed SARS-CoV-2 patients (case) will be prospectively followed for 2 years and will be compared to a control population. The control group comprises SARS-CoV-2 non-infected people who live within a one-kilometer radius from the corresponding case (location matching). This study will recruit at least 165 patients and 495 controls. Demographics, community variables, behavioral characteristics, and relevant clinical data will be collected. Serum samples taken at various time points will be tested for IgM anti-Spike protein of SARS-CoV-2 and IgG anti-Spike RBD of SARS-CoV-2 by using Chemiluminescent Microparticle Immunoassay (CMIA) method. The Kaplan-Meier method will be used to calculate cumulative seroconversion rates, and their association with disease severity will be estimated by logistic regression. The risk and protective factors associated with the SARS-CoV-2 infection will be determined using conditional (matched) logistic regression and presented as an odds ratio and 95% confidence interval.

摘要

在印度尼西亚,感染患者及其居住社区对新型 SARS-CoV-2 的长期抗体反应尚不清楚。这些信息将提供有关社区中相对较长时间内抗体动力学以及传播风险因素的深入了解。我们旨在前瞻性观察并确定感染后 2 年内与疾病严重程度相关的抗 SARS-CoV-2 抗体的动力学,并确定社区中 SARS CoV-2 感染的风险和保护因素。一组通过 RT-PCR 确诊的 SARS-CoV-2 患者(病例)将前瞻性随访 2 年,并与对照组进行比较。对照组由居住在相应病例(位置匹配)一公里范围内的未感染 SARS-CoV-2 的人组成。这项研究将招募至少 165 名患者和 495 名对照。将收集人口统计学、社区变量、行为特征和相关临床数据。将在不同时间点采集的血清样本通过化学发光微粒子免疫分析(CMIA)方法检测 SARS-CoV-2 的 IgM 抗刺突蛋白和 IgG 抗刺突 RBD。将使用 Kaplan-Meier 方法计算累积血清转化率,并通过逻辑回归估计其与疾病严重程度的相关性。使用条件(匹配)逻辑回归确定与 SARS-CoV-2 感染相关的风险和保护因素,并以比值比和 95%置信区间表示。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af2/9380924/73e652d76911/pone.0272690.g001.jpg

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