A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)
研究概览
简要总结
The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
- •>17 years old
排除标准
- •Refusal or inability to provide informed consent
结局指标
主要结局
Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)
时间窗: testing will be performed within 2 days of collection
次要结局
未报告次要终点
