Serum AnalytesNCT07260799
Clinical Performance of Capillary Blood Samples Collected Using the Tasso+ Serum Gel Capillary Blood Collection System for Clinical Chemistry Testing of 14 Analytes on an Abbott Alinity Analyzer
An observational study of Serum Analytes, run by Tasso Inc. at 2 sites in United States.
Trial summary
The purpose of this single-visit study is to demonstrate the performance of capillary blood samples collected with the Tasso+ Serum Gel Capillary Blood Collection System compared to venous reference samples for downstream analyte testing at a clinical laboratory. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum Analytes
- What is being tested?
- Tasso+ Serum Gel Capillary Blood Collection System
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history.
Who may be able to join
- Adults aged 18-85 years with no previous experience with the Tasso+ lancet
- Willing and able to provide written informed consent prior to study entry
- Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
- Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history, in the judgement of the investigator
Who cannot join
- Present with abnormal skin integrity or atypical skin health near/on arm collection sites
- Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
- Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
- Any condition which, in the opinion of the investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celesta / American Research Labs
Atlantis, Florida, 33462
Tasso, Inc.
Seattle, Washington, 98119
About this study
The purpose of this single-visit study is to demonstrate the performance of capillary blood samples collected with the Tasso+ Serum Gel Capillary Blood Collection System compared to venous reference samples for downstream analyte testing at a clinical laboratory.
- Conditions
- Serum Analytes
- Being tested
- Tasso+ Serum Gel Capillary Blood Collection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso+ Serum Gel Capillary Blood Collection SystemDiagnostic test
Clinical evaluation of capillary blood samples collected using the Tasso+ Serum Gel Capillary Blood Collection System for downstream analyte testing.
| Study group | Role | What they receive |
|---|---|---|
| Tasso+ Serum Gel Capillary Blood Collection System | Comparison of serum analyte results from capillary blood collected using the Tasso+ Serum Gel Capillary Blood Collection System vs. venous blood obtained via traditional venipuncture. Receives: Diagnostic Test: Tasso+ Serum Gel Capillary Blood Collection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start25 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum AnalytesStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasso Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Research Labs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260799
- Sponsor's protocol ID
- T23-03
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Research results are proprietary; no sharing with other researchers is anticipated.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Capillary Blood Samples Collected Using the Tasso+ Serum Gel Capillary Blood Collection System for Clinical Chemistry Testing of 14 Analytes on an Abbott Alinity Analyzer
- ClinicalTrials.gov ID
- NCT07260799
- Acronym / sponsor ID
- T23-03
- Conditions
- Serum Analytes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tasso Inc.Industry (pharma, biotech, devices)
- Collaborators
- American Research Labs
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
The purpose of this single-visit study is to demonstrate the performance of capillary blood samples collected with the Tasso+ Serum Gel Capillary Blood Collection System compared to venous reference samples for downstream analyte testing at a clinical laboratory.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tasso+ Serum Gel Capillary Blood Collection System | – | Diagnostic Test: Tasso+ Serum Gel Capillary Blood Collection SystemComparison of serum analyte results from capillary blood collected using the Tasso+ Serum Gel Capillary Blood Collection System vs. venous blood obtained via traditional venipuncture. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history.
Key inclusion criteria (4 listed)
- Adults aged 18-85 years with no previous experience with the Tasso+ lancet
- Willing and able to provide written informed consent prior to study entry
- Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
- Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history, in the judgement of the investigator
Key exclusion criteria (4 listed)
- Present with abnormal skin integrity or atypical skin health near/on arm collection sites
- Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
- Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
- Any condition which, in the opinion of the investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasso+ Serum Gel Capillary Blood Collection SystemClinical evaluation of capillary blood samples collected using the Tasso+ Serum Gel Capillary Blood Collection System for downstream analyte testing. | Diagnostic test | Tasso+ Serum Gel Capillary Blood Collection System |
Primary outcome
Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood
Time frame: 48 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Research results are proprietary; no sharing with other researchers is anticipated.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Analytes, run by Tasso Inc. at 2 sites in United States.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood (time frame: 48 Hours). 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 20 Jul 2026.