跳至主要内容
临床试验/NCT04537572
NCT04537572Unknown不适用

A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing

Salveo Diagnostics0 个研究点目标入组 300 人开始时间: 2020年9月1日最近更新:
适应症

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

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

研究者

发起方
Salveo Diagnostics
申办方类型
Industry
责任方
Sponsor

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