Clinical Evaluation of the Enterprise Point of Care for Blood Gas Electrolytes and Metabolites

Abstract

Background The Enterprise Point of Care (EPOC) Blood Analysis System is a point-of-care (POC) device designed for whole-blood testing. The purpose of this study was to evaluate and compare the performances of 2 different POC devices, EPOC and i-STAT, and to compare both POC measurements with those from the central laboratory chemistry and hematology analyzers. Methods We ran parallel measurements of blood gas, electrolytes, and other metabolites on 2 EPOC devices and 1 i-STAT device. An aliquot of the same samples was analyzed immediately on the automated chemistry and hematology analyzers in the central laboratories. We also assessed for potential interferences by bilirubin and 3 commonly used contrast agents (Conray, Omnipaque, and Visipaque) on the EPOC device. Results Within-day and between-day coefficients of variation for all measured analytes on EPOC were less than 5.0%, except those for pO2. We found EPOC measurements for all analytes to be linear (r2 = 0.9841-0.9999) over the testing ranges of 5 quality control levels, except for lactate, which was linear (r2 = 0.9990 and 0.9999) over the testing ranges of 4 quality control levels. Method comparisons between EPOC and i-STAT and the central laboratory chemistry and hematology analyzers were in good agreement, except for Na +, which showed clinically significant bias of approximately + 4 mmol/L. No significant interference was observed in the presence of bilirubin, Conray, Omnipaque, or Visipaque. Conclusions Overall, the EPOC Blood Analysis System showed good analytical performance for most of the analytes, with the exception of Na +, which showed a clinically significant bias of approximately + 4 mmol/L when compared with those of the central laboratory methods.