Vitamin D
Conditions
Keywords
Vitamin D Tasso
Brief summary
This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃.
Detailed description
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.
Interventions
DEVICEVit D Tasso+
Blood collected using Tasso device
Sponsors
The Royal Wolverhampton Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* • 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between Tasso+ capillary serum and venous serum 25(OH)D | From Study start date for up to 12 months | Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User acceptability | From Study start date for up to 12 months | Pain, on a scale from 1-5 1= no pain. 5= worse pain |
| Sample quality | From Study start date for up to 12 months | Volume adequacy- minimum blood vol 200uL |
| Laboratory workflow efficiency | From Study start date for up to 12 months | Hands on time (hrs/mins) |
| Turnaround time (TAT) | From Study start date for up to 12 months | Time from sample request to result authorisation |
| Clinical classification agreement | From Study start date for up to 12 months | Numerical agreement (statistically quantified by Passing and Bablok analysis) |
Outcome results
None listed