Comparing Vitamin D Results and Acceptability of Sampling Obtained From Dried Blood Spot, Tasso+ Capillary Sampling, and Venous Blood. (VitD TASSO)
19. august 2026 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
35
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
User acceptability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Study start date for up to 12 months
|
Repeat samples (%)
|
From Study start date for up to 12 months
|
|
Turnaround time (TAT)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2027
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
14. juli 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
24. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026LAB148
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