Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 719
- 试验地点
- 3
- 主要终点
- Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
研究概览
简要总结
This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Arms A - Troponin I (ACS/MI)
- •Males or Females, 18 years of age or older, of any race
- •Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- •Willing to voluntarily agree to sign a consent form (if applicable)
- •Study Arms B - Myoglobin (ACS/MI)
- •Males or Females, 18 years of age or older, of any race
- •Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- •Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.
- •Willing to voluntarily agree to sign a consent form (if applicable)
- •Study Arms C - CK-MB (ACS/MI)
- •Males or Females, 18 years of age or older, of any race
- •Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- •CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.
- •Willing to voluntarily agree to sign a consent form (if applicable)
- •Study Arm D - NT-proBNP (HF)
- •Males or Females, 18 years of age or older, of any race
- •Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines
- •Willing to voluntarily agree to sign a consent form (if applicable)
排除标准
- •Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)
- •Healthy Subjects
- •Pregnant or lactating
- •Subjects not having a cardiac marker test ordered
- •Blood sample collected >24 hours prior to screening
- •Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
- •Non-compliance to the protocol or the inclusion criteria
- •Study Arm D - NT-proBNP (HF)
- •Healthy Subjects
- •Pregnant or lactating
- •Subjects not having a cardiac marker test ordered
- •Blood sample collected >24 hours prior to screening
- •Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
- •Non-compliance to the protocol or the inclusion criteria
结局指标
主要结局
Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
时间窗: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.
The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications: * precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials; * precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and, * performance via method comparison across the reportable ranges of the RAMP® cardiac tests.
次要结局
未报告次要终点