Multi-site Performance Evaluation of pH, Blood Gas, Electrolyte, Glucose, and Lactate Determinations With the GEM Premier 3000 Critical Care Analyzer

The authors evaluated a new analyzer for measurement of pH, blood gases, sodium, potassium, ionized calcium, glucose, lactate, and hematocrit. The GEM Premier 3000 (Instrumentation Laboratory, Lexington, MA) consists of an analyzer and a multi-use disposable cartridge. Analysis takes place in the cartridge, containing electrochemical sensors, reagents, sampling stylus, and waste container. The system was evaluated for precision and accuracy versus traditional laboratory analyzers at three test sites. Day-today precision for aqueous quality control materials (SD or %CV) was pH: SD = 0.003 to 0.007; PCO2: 1.7% to 3.9%; PO2: 1.1% to 2.5%; sodium: 0.4% to 1.2%; potassium: 0 to 1.3%; ionized calcium: 0.5% to 2.5%; glucose: 1.7% to 3.7%; lactate: 1.6% to 4.0%; and hematocrit: 0 to 0.8%. Imprecision of duplicate analyses of whole blood samples showed no differences between the GEM Premier 3000 and reference instruments. Accuracy of the system was assessed by split sample comparisons and regression analysis, demonstrating clinically acceptable correlation of the GEM Premier 3000 to reference instruments. Analytical performance, ease of use, and minimal maintenance make the GEM Premier 3000 suitable for use in laboratory and nonlaboratory settings by users who are also caregivers.