Comparing Vitamin D Results and Acceptability of Sampling Obtained From Dried Blood Spot, Tasso+ Capillary Sampling, and Venous Blood. (VitD TASSO)
19 augusti 2026 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
35
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
User acceptability
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From Study start date for up to 12 months
|
Repeat samples (%)
|
From Study start date for up to 12 months
|
|
Turnaround time (TAT)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 januari 2027
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
14 juli 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
24 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2026LAB148
Läkemedels- och apparatinformation, studiedokument
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