Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms

ConditionsABO Blood Type RhD Blood Type

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

INSTI® Rapid Blood Type Test
Diagnostic 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 Test
Diagnostic 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.

Treatment groups

2,500 Participants

are divided into 2 treatment groups

Group A: Main CohortOther 2 interventions

Group B: Rare Phenotype CohortOther 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Secondary outcomes

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.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

bioLytical Laboratories

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: