Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 191
- 试验地点
- 3
- 主要终点
- The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
研究概览
简要总结
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
- •Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
- •Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.
排除标准
- •Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
- •Subjects with acute decompensated heart failure currently on nesiritide therapy;
- •Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
- •Subjects unable to or refusing to provide written informed consent.
结局指标
主要结局
The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
时间窗: baseline
The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).
时间窗: baseline
Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed.
时间窗: baseline
Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay.
次要结局
- Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.(48 hours)
- The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value).(baseline)
- Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.(20 days)
- The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value).(baseline)
- Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.(baseline)
- Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.(10 days)