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Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
Sponsor: bioLytical Laboratories
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
Conditions
Interventions
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.
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.