Dried Blood Spot Testing for At Home Health

NCT05430139 | Recruiting

• 1 other identifier: DBS-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Method Comparison Studies

  For comparisons, routine commercial diagnostic methods will be used as the predicate. The gold standard will be defined as antecubital vein venous blood collections into lithium heparin with gel separator (or serum separator tubes) for thyroid hormones, and K2-EDTA tubes for HbA1c analysis. Any commercially available clinical valid method performed in an accredited laboratory would serve as an acceptable reference method. Comparison studies will require 200 samples spanning the analytical measuring range of the assay. Paired venous collections will be required for comparison.

  Through study completion - approximately 6 months

• Precision Studies

  Precisions studies will be performed first using CLSI EP05A3 recommendations for within run, within day, between day, and total imprecision using commercial controls. This routine analysis will be augmented with repeat analysis of DBS samples to assess the stability of the matrix and the ability to extract analytes reproducibly. To assess reproducibility in patient samples, 20 sets of samples (of varying concentration) will be tested in triplicate on serial days (3x5).

  Through study completion - approximately 6 months

• Linearity Studies

  Linearity studies will be performed using known standards (e.g. NIST, assayed controls, EQA material) diluted to challenge the vendor claim. Where necessary, dilutions will be done according to the vendor instructions for users. CLSI EP06 (Evaluation of Linearity) will be followed using triple samples fit with sequential polynomials (1st, 2nd, 3rd order) to identify non-linearity. Analysis will be done with triplicate sample using the mean of each for fitting. Where significant non-linearity is identified, experiments will either be repeated, or the linearity limit truncated to include the valid linear range. This will include quadruplicate measurement of samples at 6 different concentrations (4x6)

  Through study completion - approximately 6 months

• Limit of Quantitation

  The limit of quantitation (LoQ) is defined as the lowest concentration at which results show \<=20% imprecision (CLSI EP17-A2). The LoQ will be determined as part of linearity using replicates of 4-6 to calculate the coefficient of variation at concentrations at or near the vendor claim.

  Through study completion - approximately 6 months

• Specificity

  Specificity refers to the ability of the analytical method to differentiate the analyte of interest from related or unrelated compounds. Studies typically focus on common drugs and interferences. These studies will include addition of substances known to interfere with the analyte of interest (hemolysis, icterus, lipemia, biotin, etc.). The vendor package inserts will be used to finalize the list of interferences and the CLSI EP07 guideline will be used to define the approach (recovery experiments in the presence of high concentrations of interfering substances).

  Through study completion - approximately 6 months

• Reference Intervals

  Reference intervals will either be validated against existing vendor defined cut points or established pending the findings of the method comparison studies. For either, 200 samples from healthy volunteers will be used. Depending on the distribution of the results, either parametric or non-parametric calculation of the 95% central confidence interval will be established. For HbA1c, the Canadian Diabetes Association guidelines have universally defined cut point, which requires that the assay show good agreement with the predicate method for usability

  Through study completion - approximately 6 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include 2000 participants who will be recruited when visiting Bio-Test Laboratory for routine, physician-ordered bloodwork (venous blood collection).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Switch Health Solutions Inc.: lead

Study Sites (1)

Bio-Test Laboratory Inc.

Nepean, Ontario, K2H 1A5, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Thyroid Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christopher McCudden, PhD,FCACB,FACB,NRCC-CC,DABC

  Eastern Ontario Regional Laboratory Association.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Tettman

CONTACT

1 (888) 966-6531; Kyle@switchhealth.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 24, 2022
• Study Start: October 31, 2022
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CA (1)