Unique Approach to Quality Assurance in Viscoelastic Testing

Area of Science:

• Coagulation Science
• Point-of-Care Diagnostics
• Medical Device Technology

Background:

• The Quantra QPlus System is a novel viscoelastic testing (VET) device.
• It is designed for point-of-care management of coagulation function in critical care settings.
• The system is approved for use by non-laboratory personnel.

Purpose of the Study:

• To describe internal quality control (QC) checks within the Quantra system.
• To demonstrate the system's capabilities, leveraging its ultrasound core technology.
• To assess the precision of the Quantra QPlus System according to Clinical Laboratory Standards Institute guidelines.

Main Methods:

• Internal QC checks were comprehensively documented.
• Single- and multisite precision testing was conducted.
• Testing involved multiple operators, instruments, days, and cartridge lots.

Main Results:

• Total imprecision (percent CVs) ranged from 3.6% to 8.0% across all measured parameters.
• Replicate imprecision (repeatability) showed CVs from 2.7% to 7.7%.
• Replicate imprecision was the primary source of variability for most parameters.

Conclusions:

• The Quantra QPlus System is a next-generation, cartridge-based VET device.
• It enables operation with minimal central laboratory oversight.
• The system integrates seamlessly with the Individualized Quality Control Plan framework.