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

NCT07770360 | Not Yet Recruiting FDA Device

• 1 other identifier: CLS-019A
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ABO Blood Type; RhD Blood Type

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate

  6 months

Study Arms (2)

Main Cohort

OTHER

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; 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.

Diagnostic Test: INSTI® Rapid Blood Type Test; Diagnostic Test: TruPlex Rapid Blood Type Test

Interventions

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.

Main Cohort; Rare Phenotype Cohort

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.

Main Cohort; Rare Phenotype Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Subject has a previously documented rare ABO subgroup or RhD variant phenotype.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• bioLytical Laboratories: lead

Central Study Contacts

Ana Subramanian

CONTACT

604-204-6784; asubramanian@biolytical.com

Patrick Diaz

CONTACT

604-204-6784; pdiaz@biolytical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 18, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08