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Dried Blood Spot Testing for At Home Health

NCT05430139 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-04-26

No results posted yet for this study

Summary

DBS (Dried blood spot) is the collection of a small volume of blood on paper cards and subsequent transport to an analytical laboratory. This method is widely used for newborn screening programs around the world to identify inborn errors of metabolism where early diagnosis and treatment can be lifesaving. The World Health Organization and World Anti-Doping Agency (WADA) have independently endorsed DBS as an alternative to conventional testing methods due to its lessened invasiveness, lower collection and transport cost, reduction in sample storage needs, and for some analytes, improved sample stability. There are hundreds of publications describing DBS testing and some commercial ventures offering direct-to-consumer testing using DBS. However, it is not clear if there have been concerted efforts to develop DBS sampling for adults for home collection in concert with high quality, accredited central clinical laboratories. The proposal herein is focused on developing and validating DBS for at home and remote sample collections for routine diagnostic testing.

Conditions

Sponsors & Collaborators

  • Switch Health Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher McCudden, PhD,FCACB,FACB,NRCC-CC,DABC · Eastern Ontario Regional Laboratory Association.

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-01-31
Completion
2025-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430139 on ClinicalTrials.gov