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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07770360
Lead Sponsor bioLytical Laboratories
Conditions
(from sponsor)		 ABO Blood Type, RhD Blood Type
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov