Recruiting

At Home Testing

Sponsor:

Switch Health Solutions Inc.

Code:

NCT05430139

Conditions

Diabetes

Thyroid Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Diabetes

Thyroid Diseases

Study ID

NCT05430139

Start date

Oct 31, 2022

Status verified date

Apr, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participant >=18 years old.
2. Visiting Bio-Test Laboratory for routine, physician-ordered venous blood collection.
3. Able to provide informed consent.

Exclusion Criteria:

1. Unable or unwilling to provide informed consent.
2. Pre-existing coagulopathies that might put them at risk for bleeding (e.g., hemophilia)
3. Unable to produce an adequate blood sample.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Method Comparison Studies [ Time Frame: Through study completion - approximately 6 months ]
  • Precision Studies [ Time Frame: Through study completion - approximately 6 months ]
  • Linearity Studies [ Time Frame: Through study completion - approximately 6 months ]
  • Limit of Quantitation [ Time Frame: Through study completion - approximately 6 months ]
  • Specificity [ Time Frame: Through study completion - approximately 6 months ]
  • Reference Intervals [ Time Frame: Through study completion - approximately 6 months ]

Central Contacts and Locations

Central contacts

Locations

Bio-Test Laboratory Inc.

Recruiting

Nepean, Ontario, Canada, K2H 1A5

Contacts

More Information

Sponsor

Switch Health Solutions Inc.

Last update posted

Apr 26, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Switch Health Solutions Inc. on 2024-04-26.