Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
研究概览
简要总结
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
详细描述
Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.
Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or >15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.
Treating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.
Quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high-sensitive EUA PCR results (positive result)
- •Previous diagnostic of SARS-Cov-2
- •Signed informed consent
排除标准
- •Missing PCR results
- •Results from a non-high-sensitive PCR test
- •Negative Cohort
- •Inclusion Criteria:
- •Patients with high-sensitive EUA PCR results (negative result)
- •Signed informed consent
- •Exclusion Criteria:
- •Missing PCR results
- •Results from a non-high-sensitive PCR test
- •Previous diagnostic of SARS-Cov-2
- •History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
- •Negative SARS-Cov-2 PCR result that occurred > 7 days from study visit
结局指标
主要结局
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
时间窗: 0-7 days
Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
时间窗: 15 - 90 days
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
次要结局
未报告次要终点