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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
2,500
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.
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.
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.
Time frame: 6 months
INSTI® and TruPlex Rapid Blood Typing Test Invalid Rate
To monitor and report the rate of invalid test results for the INSTI® and TruPlex Rapid Blood Typing Tests.
Time frame: 6 months
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