Comparing Vitamin D Results and Acceptability of Sampling Obtained From Dried Blood Spot, Tasso+ Capillary Sampling, and Venous Blood. (VitD TASSO)
19 de agosto de 2026 actualizado por: The Royal Wolverhampton Hospitals NHS Trust
Evaluation of a Capillary Self-sampling Device for Vitamin D Testing
This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
35
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Vitamin D sampling
Staff members having Vit D sampling using blood spot, venous samples, and sample collected using the device
|
Blood collected using Tasso device
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
Periodo de tiempo: From Study start date for up to 12 months
|
Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L)
|
From Study start date for up to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
User acceptability
Periodo de tiempo: From Study start date for up to 12 months
|
Pain, on a scale from 1-5 1= no pain. 5= worse pain |
From Study start date for up to 12 months
|
|
User acceptability
Periodo de tiempo: From study start date to 12 months
|
Ease of Use: how easy or difficult each method was to complete 1= Very difficult, 5=Very easy Dried Bloodspot Venepuncture Tasso+ |
From study start date to 12 months
|
|
User acceptability
Periodo de tiempo: From Study start date for up to 12 months
|
Clarity of Instructions: how clear were the instructions you were given? 1= Not clear at all, 5=Extremely clear Dried Bloodspot Venepuncture Tasso+ |
From Study start date for up to 12 months
|
|
User acceptability
Periodo de tiempo: From Study start date for up to 12 months
|
Safety: How safe did each method feel to you ? 1= Very unsafe, 5=Very safe Dried Bloodspot Venepuncture Tasso+ |
From Study start date for up to 12 months
|
|
User acceptability
Periodo de tiempo: From Study start date for up to 12 months
|
Your Preference: please rank the three collection methods 1= your favourite, 3=least preferred Dried Bloodspot Venepuncture Tasso+ |
From Study start date for up to 12 months
|
|
User acceptability
Periodo de tiempo: From Study start date for up to 12 months
|
Willingness to self-collect: how willing would you be to collect your own sample using each method in the future? 1= Very willing, 5=Very willing Dried Bloodspot Venepuncture Tasso+ |
From Study start date for up to 12 months
|
|
Sample quality
Periodo de tiempo: From Study start date for up to 12 months
|
Volume adequacy- minimum blood vol 200uL
|
From Study start date for up to 12 months
|
|
Sample quality
Periodo de tiempo: From Study start date for up to 12 months
|
Pre analytical failure- % samples unacceptable for analysis due to inadequate volume or poor quality blood spot
|
From Study start date for up to 12 months
|
|
Laboratory workflow efficiency
Periodo de tiempo: From Study start date for up to 12 months
|
Hands on time (hrs/mins)
|
From Study start date for up to 12 months
|
|
Laboratory workflow efficiency
Periodo de tiempo: From Study start date for up to 12 months
|
Batch failures based on LCMSMS batch acceptance criteria- QC with +/- 2sd of mean, cal curve R value > 0.95
|
From Study start date for up to 12 months
|
|
Laboratory workflow efficiency
Periodo de tiempo: From Study start date for up to 12 months
|
Repeat samples (%)
|
From Study start date for up to 12 months
|
|
Turnaround time (TAT)
Periodo de tiempo: From Study start date for up to 12 months
|
Time from sample request to result authorisation
|
From Study start date for up to 12 months
|
|
Clinical classification agreement
Periodo de tiempo: From Study start date for up to 12 months
|
Numerical agreement (statistically quantified by Passing and Bablok analysis)
|
From Study start date for up to 12 months
|
|
Clinical classification agreement
Periodo de tiempo: From Study start date for up to 12 months
|
Vitamin D status category agreement (deficient / insufficient / replete) quantified statistically using Cohen's kappa analysis
|
From Study start date for up to 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026LAB148
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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