ABO Blood TypeNCT07770360
Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
A study testing INSTI® Rapid Blood Type Test and TruPlex Rapid Blood Type Test in people with ABO Blood Type and RhD Blood Type, run by bioLytical Laboratories.
Trial summary
CLS-019A is a prospective, multi-site, parallel clinical performance study. Each enrolled subject is tested on both investigational devices in parallel within a single study visit, yielding paired INSTI® and TruPlex results from matched capillary fingerstick and EDTA-VWB samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ABO Blood Type, RhD Blood Type
- What is being tested?
- INSTI® Rapid Blood Type Test and TruPlex Rapid Blood Type Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be enrolled in the Main Cohort if they meet all of criteria IC.1 through IC.6. Subjects will be enrolled in the Rare-Phenotype Cohort if they meet all of criteria IC.1 through IC.7:
- Subject is 18 years of age or older at the time of enrollment.
- Subject is able to provide written informed consent prior to any study-related procedures.
- Operator or study staff is able to obtain required data to complete the subject's Enrollment Questionnaire.
- Subject is able and willing to complete all required study procedures on the allocated testing day.
- Subjects is able to speak/read/write in English or Spanish.
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- Subjects is willing to provide:
- Two (2) capillary fingerstick whole blood samples, and
- Venous whole blood samples collected by venipuncture (approximately 10 mL), as required for the study. And
- If required, a maximum of two (2) further fingerstick whole blood samples in the case that the initial INSTI and/or TruPlex test results are invalid.
- Additional Inclusion Criterion for Rare-Phenotype Cohort Enrollment:
- Subject has a previously documented rare ABO subgroup or RhD variant phenotype.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Subject has known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture.
- Subject has received a blood transfusion within the past 120 days.
- Subject is currently using therapeutic anticoagulants (e.g., warfarin, heparin, or direct oral anticoagulants [DOACs]) that, in the opinion of the Investigator or Operator, may interfere with sample collection or test performance.
- Subject has any condition which, in the opinion of the Investigator or Operator, would:
- Place the participant at undue risk,
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- Interfere with completion of study procedures,
- Compromise the informed consent process, or
- Bias the interpretation of study results. Examples include, but are not limited to: intoxication, acute illness, visible distress, or inability to understand study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Parallel Clinical Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
CLS-019A is a prospective, multi-site, parallel clinical performance study. Each enrolled subject is tested on both investigational devices in parallel within a single study visit, yielding paired INSTI® and TruPlex results from matched capillary fingerstick and EDTA-VWB samples.
- Conditions
- ABO Blood Type, RhD Blood Type
- Being tested
- INSTI® Rapid Blood Type Test, TruPlex Rapid Blood Type Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTI® Rapid Blood Type TestDiagnostic test
A flow-through blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples.
TruPlex Rapid Blood Type TestDiagnostic test
A lateral-flow blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Other | Prospectively recruited subjects will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests. Receives: Diagnostic Test: INSTI® Rapid Blood Type Test; Diagnostic Test: TruPlex Rapid Blood Type Test |
| Rare Phenotype Cohort | Other | Subjects with rare blood phenotypes will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests. Receives: Diagnostic Test: INSTI® Rapid Blood Type Test; Diagnostic Test: TruPlex Rapid Blood Type Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood type detection
To evaluate the clinical performance (PPA and NPA) of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood types through detection of A, B, and RhD antigens using both capillary fingerstick and EDTA venous whole blood (VWB) samples. Performance will be determined by comparing the results of each investigational device with reference tests for ABO and RhD status.
Measured: 6 months
Secondary outcomes (1)
INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate
To monitor and report the rate of invalid test results for the INSTI® and TruPlex Rapid Blood Typing Tests.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion26 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABO Blood TypeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770360
- Sponsor's protocol ID
- CLS-019A
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Parallel Clinical Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
- ClinicalTrials.gov ID
- NCT07770360
- Acronym / sponsor ID
- CLS-019A
- Conditions
- ABO Blood Type, RhD Blood Type
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Aug 2026 (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.
CLS-019A is a prospective, multi-site, parallel clinical performance study. Each enrolled subject is tested on both investigational devices in parallel within a single study visit, yielding paired INSTI® and TruPlex results from matched capillary fingerstick and EDTA-VWB samples.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | Other | Diagnostic Test: INSTI® Rapid Blood Type Test, Diagnostic Test: TruPlex Rapid Blood Type TestProspectively recruited subjects will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests. |
| Rare Phenotype Cohort | Other | Diagnostic Test: INSTI® Rapid Blood Type Test, Diagnostic Test: TruPlex Rapid Blood Type TestSubjects with rare blood phenotypes will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects will be enrolled in the Main Cohort if they meet all of criteria IC.1 through IC.6. Subjects will be enrolled in the Rare-Phenotype Cohort if they meet all of criteria IC.1 through IC.7:
- Subject is 18 years of age or older at the time of enrollment.
- Subject is able to provide written informed consent prior to any study-related procedures.
- Operator or study staff is able to obtain required data to complete the subject's Enrollment Questionnaire.
- Subject is able and willing to complete all required study procedures on the allocated testing day.
Key exclusion criteria (9 listed)
- Subject has known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture.
- Subject has received a blood transfusion within the past 120 days.
- Subject is currently using therapeutic anticoagulants (e.g., warfarin, heparin, or direct oral anticoagulants [DOACs]) that, in the opinion of the Investigator or Operator, may interfere with sample collection or test performance.
- Subject has any condition which, in the opinion of the Investigator or Operator, would:
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 |
|---|---|---|
| INSTI® Rapid Blood Type TestA flow-through blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples. | Diagnostic test | Main Cohort, Rare Phenotype Cohort |
| TruPlex Rapid Blood Type TestA lateral-flow blood grouping reagent device intended for the determination of ABO and RhD blood group by forward typing using human whole blood samples. | Diagnostic test | Main Cohort, Rare Phenotype Cohort |
Primary outcome
Clinical performance of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood type detection
Time frame: 6 months
To evaluate the clinical performance (PPA and NPA) of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood types through detection of A, B, and RhD antigens using both capillary fingerstick and EDTA venous whole blood (VWB) samples. Performance will be determined by comparing the results of each investigational device with reference tests for ABO and RhD status.
1 secondary outcome
INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate
Time frame: 6 months
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 18 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INSTI® Rapid Blood Type Test and TruPlex Rapid Blood Type Test in people with ABO Blood Type and RhD Blood Type, run by bioLytical Laboratories.
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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ana Subramanian (604-204-6784 ext. 262, asubramanian@biolytical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of the INSTI® and TruPlex Rapid Blood Typing Tests for ABO (A, B, AB, and O) and RhD blood type detection (time frame: 6 months). 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 18 Aug 2026.