Performance of Gem Premier blood gas/electrolyte analyzer evaluated

Abstract

Abstract We evaluated a new analyzer designed for point-of-care testing of blood gases, sodium, potassium, ionized calcium, and hematocrit. The Gem Premier (Mallinckrodt) system has two components: the analyzer and a disposable cartridge. Analysis takes place in the cartridge, which contains the electrochemical sensors, the calibrants, the reagents, the sampling stylus, and the waste container. The system was evaluated for imprecision and accuracy. With aqueous control materials, total imprecision (CV) was: pH, 0.10-0.18%; PCO2, 3.16-5.78%; PO2, 2.92-4.85%; sodium, 0.82-1.44%; potassium, 1.35-1.48%; ionized calcium, 0.75-1.45%; and hematocrit, 1.13-1.83%. Accuracy of the system was assessed by split-sample comparison with the Radiometer ABL 330 blood gas analyzer for pH and blood gases, the Nova Stat Profile 5 for whole-blood electrolyte and hematocrit analysis, and the IL Phoenix for plasma electrolyte analysis. After outlier correction, regression statistics were excellent for all analytes except sodium, which demonstrated Sy[x values between 1.80 and 2.30 mmol/L and 0.85 < or = r < 0.90.