Reliability Assessment of the HumaSens Plus Measurement of Uricemia in Capillary Blood
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Uricemia
研究概览
简要总结
Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of gout management success. Monitoring of uricemia in gout patients is therefore important and is presently done in the laboratory on serum samples obtained after venous puncture. This study aims at assessing the reliability of immediate uricemia measurement in a blood sample obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially available in the EU. Results obtained by the Humasens device will be compared to those of the standard measurement technique in serum and with a reference technique (liquid chromatography and mass spectroscopy). If the device appears reliable, it will allow self-measurement of uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia following a fingertip puncture. This should improve patient monitoring and management effects.
详细描述
The aim of this study is
- to assess the validity of the capillary measure of uric acid level by the HumaSens plus system by comparing the measurement of total blood uric acid level by the HumaSens plus system with the routine measurement of serum uric acid by a standard and validated automated colorimetric method (primary objective).
- to look for a systematic bias and confounding factors (secondary objectives)
Methods
Design : This is a mono-centric prospective study. Patients will be recruited from the diabetology day hospital of hospital Lariboisière, Paris
Data collection : For each patient included at the Lariboisière Diabetology day hospital and included in this study, serum uric acid levels will be measured once from venous blood samples in the biochemistry laboratory using standard automated colorimetric methods, as presently routinely done and by liquid chromatography coupled with mass spectroscopy. In, addition, uric acid levels will also be simultaneously measured from capillary blood with the HumaSensplus system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Patients seen in the diabetology day hospital
- •Patients aged at least 18 years-old
- •French-speaking patients
- •Patients able to understand the study and the information form
排除标准
- •Patients unable to understand the aim of study aind the information sheet
- •Patients not affiliated to a social security scheme (beneficiary or assignee)
结局指标
主要结局
Uricemia
时间窗: Day0
Comparison the measurement of uric acid level by the HumaSensplus system with the routine measurement of uric acid by the automated colorimetric uricase method (Abbot), and with a reference method: liquid chromatography coupled with mass spectroscopy. This will be done once for every patient.
次要结局
- Haematocrit, glucose and lipid levels, medications(Day0)
- Uricemia on capillary blood vs on serum(Day0)