Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Point of care ferritin detection accuracy
研究概览
简要总结
Measurement of iron is important for identifying both low and high iron levels in the body. Measuring a protein in the blood called ferritin is currently the easiest way to determine a patient's iron status. However, the test requires a blood sample that is be sent to the laboratory for measurement, which can cause delays in obtaining the result. The investigators are testing whether a point of care device that measures ferritin levels using a capillary blood sample is accurate compared to current methods of testing. This could allow measurement of ferritin immediately in the clinic with only a drop of blood, and enable treatment decisions based on these results.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to read and understand English (the consent form is in English)
- •attending ambulatory hematology clinic and/or outpatient medical care
排除标准
- 未提供
研究组 & 干预措施
Intervention
All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).
干预措施: Point of care ferritin test (Diagnostic Test)
结局指标
主要结局
Point of care ferritin detection accuracy
时间窗: Within 12 hours of standard testing
The proportion of subjects where the difference between the two different methods is less than 15; this will be measured by calculating the difference between the two results. The proportion for the absolute difference between the two measurement methods on the same subject that is less than 15 ng/mL will be calculated. Non-inferiority test for one proportion will be performed to examine, if, the proportion is greater than 95%, where the test p value and the one-sided 97.5% confidence interval will be reported. An interim analysis will be performed after the first 50 subjects are enrolled to test the assumptions made.
次要结局
- Diagnostic accuracy of the new measurement method(Within 12 hours of standard testing)
- Distribution of the differences between ferritin level as measured by the standard test and POC test(Within 12 hours of standard testing)
- Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design(Within 12 hours of standard testing)
- Agreement between testing methods in patients who have been assessed at least twice(Within 12 hours of standard testing)
研究者
Michelle Zeller
Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program
McMaster University