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NOT YET RECRUITING
NCT07770360
NA

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

Sponsor: bioLytical Laboratories

View on ClinicalTrials.gov

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.

Official title: Prospective, Parallel Clinical Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2026-08-31

Completion Date

2026-12-30

Last Updated

2026-08-18

Healthy Volunteers

Yes

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.