Comparison of Dried Blood Spots and Venous Blood for the Detection of SARS-CoV-2 2 Antibodies in a Population of Nursing Home Residents.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
研究概览
简要总结
This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.
详细描述
In the current SARS-CoV-2 pandemic, testing for SARS-CoV-2 specific antibodies is paramount to monitor immune responses in post-authorization vaccination and sero-epidemiology studies. However, large scale and iterative serological testing by venipuncture in older persons can be challenging. Capillary blood sampled using a finger prick and collected on protein saver cards, i.e., dried blood spots (DBS), has already proven to be a promising alternative. However, elderly persons have a reduced cutaneous microvasculature, which may affect DBS-based antibody testing. Therefore, we aimed to evaluate the performance of DBS for the detection of SARS-CoV-2 antibodies in nursing homes residents. We collected venous blood and paired Whatman and EUROIMMUN DBS from nursing home residents, and from staff as a reference population. Venous blood samples were analyzed for the presence of SARS-CoV-2 IgG antibodies using the Abbot chemiluminescent microparticle immunoassay (CMIA). DBS were analyzed by the EUROIMMUN enzyme-linked immuno sorbent assay (ELISA) for SARS-CoV-2 IgG antibodies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nursing home staff and residents
排除标准
- •Not applicable
结局指标
主要结局
Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
时间窗: baseline (single timepoint)
Sensitivity and specificity analysis
Optimization of the cut-off for seropositivity.
时间窗: baseline (single timepoint)
Optimization of the manufacturer recommended cut-off for seropositivity in DBS.
次要结局
未报告次要终点
