Unique Approach to Quality Assurance in Viscoelastic Testing.

Abstract

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. 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. 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. 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.