A Pilot Study Investigating the Clinical Performance of a Novel, Point-of-care, Semi-quantitative Test for SARS-CoV-2 Antibodies in Patients Vaccinated Against COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical Performance
研究概览
简要总结
This study aims to investigate the clinical performance characteristics of the novel point-of-care, semi-quantitative test for SARS-CoV-2 in the Emergency Department compared to the gold standard (ELISA).
详细描述
A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland.
Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information and past medical history. Upon enrollment into the study, a study team member will obtain a fingerstick blood sample and a sample of blood obtained during usual care venipuncture. Both fingerstick blood and blood from venipuncture will be run on the point-of-care, semi-quantitative test. The test should be expected to result within minutes after the blood sample is added to the agglutinin. An additional tube of blood will be obtained and sent to the local central laboratory for quantitative serum SARS-CoV-2 antibody testing.
Additional data will be collected on the reported or documented COVID-19 immunization status and reported or documented history of prior COVID-19 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult (age > 18 years) emergency department patients
- •ED workup includes blood testing
- •Confirmed history of vaccination against SARS-CoV-2
排除标准
- •Known to be pregnant at the time of evaluation
- •Incarcerated at the time of evaluation
- •Requires the use of an interpreter
- •Patient is considered immunocompromised or has any other condition that the investigator feels makes the patient unsuitable for study inclusion.
- •Has any other condition that the investigator feels makes the patient unsuitable for study inclusion
结局指标
主要结局
Clinical Performance
时间窗: 6 months
To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test.
次要结局
- Past Medical Conditions(6 months)
- Inter-Rater Reliability(6 months)
- Time Since Vaccination(6 months)
- Type of Blood(6 months)
研究者
Richard Gentry Wilkerson
Associate Professor
University of Maryland, Baltimore