Unique Approach to Quality Assurance in Viscoelastic Testing.

Background: The Quantra QPlus System is a novel viscoelastic testing (VET) device designed for the management of coagulation function in critical care settings. The system is indicated and approved for use at the point-of-care and designed for use by nonlaboratory personnel.

Methods: We describe the comprehensive set of internal QC checks implemented in the Quantra and demonstrate the system's unique capabilities made possible by its ultrasound core technology. Single- and multisite precision testing were performed following Clinical Laboratory Standards Institute guidelines and included multiple days of testing, multiple instruments, multiple lots of cartridges and controls, and multiple operators.

Results: Percent CVs for total imprecision were 3.6% to 8.0% for all measured parameters. CVs for replicate imprecision ("repeatability") were 2.7% to 7.7% for all measured parameters. Replicate imprecision was the largest component of variability for most parameters.

Conclusions: The Quantra QPlus System is a new-generation cartridge-based VET device that can operate with reduced oversight from the central laboratory while easily integrating into the Individualized Quality Control Plan framework.