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

NCT07770360 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2026-08-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-11-26
Completion
2026-12-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770360 on ClinicalTrials.gov