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

August 13, 2026 updated by: bioLytical Laboratories

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Main Cohort
Prospectively recruited subjects will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests.
Diagnostic test: INSTI® Rapid Blood Type 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.
Diagnostic test: TruPlex Rapid Blood Type 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.
Other: Rare Phenotype Cohort
Subjects with rare blood phenotypes will undergo testing for ABO and RhD blood type using the INSTI and TruPlex Rapid Blood Typing Tests.
Diagnostic test: INSTI® Rapid Blood Type 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.
Diagnostic test: TruPlex Rapid Blood Type 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate
Time Frame: 6 months
To monitor and report the rate of invalid test results for the INSTI® and TruPlex Rapid Blood Typing Tests.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

bioLytical Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

August 13, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CLS-019A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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