Evaluation of a Capillary Self-sampling Device for Vitamin D Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Agreement between Tasso+ capillary serum and venous serum 25(OH)D
研究概览
简要总结
This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃.
详细描述
This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃. It will compare results obtained from the routine self-collected dried blood spot (DBS) cards currently in use in our laboratory, with paired capillary and venous serum samples. This compares the collection using three approaches: finger-prick DBS, venepuncture, and the CE-marked Tasso+ upper-arm self-sampling device. The study aims to assess both quantitative agreement between sample types and user acceptability of each collection method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults aged 18 years or older.
- •Current healthcare staff or staff volunteers.
- •Already consented to use the routine dried blood spot (DBS) vitamin D service.
- •Able and willing to provide all three sample types- routine DBS finger-prick sample, a Tasso+ upper-arm self-collected capillary sample, and a venous blood sample taken by a trained Trust phlebotomist.
- •Able to give informed consent.
- •Able to complete a short questionnaire in English.
排除标准
- •• Participants will not be able to take part if any of the following apply:
- •Under 18 years of age
- •Not a member of staff or staff volunteer
- •Known difficulty with blood sampling, such as a history of fainting, severe needle phobia, or conditions that make venepuncture unsafe.
- •Skin conditions or injuries on the upper arm that would prevent safe use of the Tasso+ device.
- •Bleeding disorders or current use of anticoagulant medication that would make capillary or venous sampling unsafe.
- •Inability to give informed consent, including difficulty understanding the study information.
- •Inability to complete the short questionnaire in English, as this is needed to assess user experience.
结局指标
主要结局
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
时间窗: From Study start date for up to 12 months
Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L)
次要结局
- User acceptability(From Study start date for up to 12 months)
- User acceptability(From study start date to 12 months)
- Sample quality(From Study start date for up to 12 months)
- Laboratory workflow efficiency(From Study start date for up to 12 months)
- Turnaround time (TAT)(From Study start date for up to 12 months)
- Clinical classification agreement(From Study start date for up to 12 months)