DiabetesNCT05430139
Dried Blood Spot Testing for At Home Health
An observational study of Diabetes and Thyroid Diseases, run by Switch Health Solutions Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes, Thyroid Diseases
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Participant >=18 years old.
- Visiting Bio-Test Laboratory for routine, physician-ordered venous blood collection.
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Bio-Test Laboratory Inc.
Nepean, Ontario, K2H 1A5
Nick Bailargeon, 613-789-4242, tbaillargeon@switchhealth.ca
About this study
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.
Read the 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.
- Conditions
- Diabetes, Thyroid Diseases
- Medical subject headings
- Diabetes Mellitus, Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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
Measured: Through study completion - approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start31 Oct 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Switch Health Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher McCudden, PhD,FCACB,FACB,NRCC-CC,DABC, Principal investigator, Eastern Ontario Regional Laboratory Association.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430139
- Sponsor's protocol ID
- DBS-01
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dried Blood Spot Testing for At Home Health
- ClinicalTrials.gov ID
- NCT05430139
- Acronym / sponsor ID
- DBS-01
- Conditions
- Diabetes, Thyroid Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Switch Health Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Participant >=18 years old.
- Visiting Bio-Test Laboratory for routine, physician-ordered venous blood collection.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Method Comparison Studies
Time frame: Through study completion - approximately 6 months
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.
Precision Studies
Time frame: Through study completion - approximately 6 months
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).
Linearity Studies
Time frame: Through study completion - approximately 6 months
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)
Limit of Quantitation
Time frame: Through study completion - approximately 6 months
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.
Specificity
Time frame: Through study completion - approximately 6 months
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).
Reference Intervals
Time frame: Through study completion - approximately 6 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher McCudden, PhD,FCACB,FACB,NRCC-CC,DABC principal investigator
Eastern Ontario Regional Laboratory Association.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Thyroid Diseases, run by Switch Health Solutions Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyle Tettman (1 (888) 966-6531, Kyle@switchhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method Comparison Studies (time frame: Through study completion - approximately 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.