Clinical trial NCT05430139: Dried Blood Spot Testing for At Home Health
Official title: Dried Blood Spot Testing for At Home Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Thyroid Diseases
Lead sponsor: Switch Health Solutions Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

Detailed description: Remote phlebotomy services have long been an option for remote communities, yet through the pandemic there has been an apparent decline in these facilities likely driven by a lack of financial incentive for community laboratories; outpatient test volumes decreased in the early months of the pandemic and cuts commensurate with these revenue losses either reduced access or pushed the work to hospital laboratories. Sample stability and transportation for remote sites is also challenging and expensive.

Point of care (POC) testing options are an area of active research and development (R\&D) and are generally attractive for healthcare providers and patients. However, POC testing does suffer in terms of quality and accuracy, even in the hands of trained nursing professionals. Preanalytical errors, problems that occur with sample collection, device quality control and storage, still plague POC testing. In addition, POC tests tend to be more expensive than central laboratory tests and there is an underappreciation of the skill required to perform tests accuracy.

Remote self-sample collection and transport to central labs for analysis has several options, the most promising of which is dried blood spot (DBS) testing. DBS is the collection of a small volume of blood on paper cards. DBS samples are largely stable and may be collected at home or outside of the usual healthcare facilities and transported to a clinical laboratory for analysis. 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 has also endorsed DBS for testing for human immunodeficiency virus (HIV) and hepatitis B and C infection in remote and hard to reach populations. The WHO states that DBS samples are effective for measuring antibodies, serologic antigens, and nucleic acids using commonly available commercial laboratory methods. Recently the World Anti-Doping Agency (WADA) endorsed DBS testing for performance enhancing drugs. WADA cites benefits of easy sample collection, less invasive methods than current observed urine and blood collection and therefore, less expensive collection and transport of samples, 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. This partly stems from the additional effort and cost needed to process DBS samples and the need for extensive validation studies to ensure robustness, accuracy, and precision. The proposal herein is focused on developing and validating DBS for at home and remote sample collections for routine diagnostic testing.

Eligibility criteria: 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.

Primary outcomes:
measure: Method Comparison Studies
timeFrame: Through study completion - approximately 6 months
measure: Precision Studies
timeFrame: Through study completion - approximately 6 months
measure: Linearity Studies
timeFrame: Through study completion - approximately 6 months
measure: Limit of Quantitation
timeFrame: Through study completion - approximately 6 months
measure: Specificity
timeFrame: Through study completion - approximately 6 months
measure: Reference Intervals
timeFrame: Through study completion - approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nepean
country: Canada
facility: Bio-Test Laboratory Inc.
state: Ontario
Study officials:
affiliation: Eastern Ontario Regional Laboratory Association.
name: Christopher McCudden, PhD,FCACB,FACB,NRCC-CC,DABC
role: PRINCIPAL_INVESTIGATOR
References: