Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorbioLytical Laboratories
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Place the participant at undue risk,
Trial design
Treatments tested in this trial
- INSTI® Rapid Blood Type Test
- TruPlex Rapid Blood Type Test
Treatment groups
2,500 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov