A drop of blood, a Minute's wait: rapid blood typing put to the test
NCT ID NCT07770360
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This study evaluates two rapid blood typing devices, INSTI® and TruPlex, to see how accurately they determine ABO and RhD blood types compared to standard reference tests. About 2,500 adults will provide both a fingerstick and a venous blood sample, which will be tested on both devices in parallel. The goal is to measure the tests' clinical performance and how often they produce invalid results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INSTI® Rapid Blood Type Test and TruPlex Rapid Blood Type Test (diagnostic devices)
- What this could lead to
- If successful, these rapid tests could provide quick, accurate blood typing at the point of care, potentially improving emergency transfusions and access in remote settings.
- What could go wrong
- This is a performance study, not a treatment trial. The tests may not be as accurate as standard lab methods, and results depend on sample type and operator skill.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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: 1. Subject is 18 years of age or older at the time of enrollment. 2. Subject is able to provide written informed consent prior to any study-related procedures. 3. Operator or study staff is able to obtain required data to complete the subject's Enrollment Questionnaire. 4. Subject is able and willing to complete all required study procedures on the allocated testing day. 5. Subjects is able to speak/read/write in English or Spanish. 6. 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: 7. Subject has a previously documented rare ABO subgroup or RhD variant phenotype. Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria: 1. Subject has known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture. 2. Subject has received a blood transfusion within the past 120 days. 3. 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. 4. Subject has any condition which, in the opinion of the Investigator or Operator, would: * Place the participant at undue risk, * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.