Comparison of 3 options for choosing control limits in biochemistry testing.

Background: The purpose of statistical quality control (QC) is to provide peace of mind with regard to the production of results that are suitable for analytically sound clinical interpretation and making reliable decisions about patient diagnosis, monitoring, and prognosis.

Objectives: In this study, we compared 3 options for choosing control limits for biochemistry testing. They focus on the probability of error detection (Ped) and probability of false rejection (Pfr) achievable for a veterinary biochemical analyzer using the following 3 combinations: the quality control material (QCM) manufacturer's acceptable ranges; a standard 1 rule customized for the instrument's observed performance; and candidate rules selected for the instrument's observed performance using a computerized program (EZrules).