Analytical performance of the Gem® Premier™ 4000-a comparison study

Objective: The aim of this study was to compare a new point-of-care testing (POCT) Gem (R) Premier (TM) 4000 analyzer with reference analyzers. Special attention was given to the technology of measuring the concentration of hemoglobin and hematocrit on POCT analyzers. Materials and methods:Analytical performance of the Gem (R) Premier (TM) 4000 was compared with Ciba Corning 865, Gem (R) Premier (TM) 3000 and Dimension RxL analyzers for pH, pCO(2), pO(2), electrolytes, metabolites and for hemoglobin/hematocrit. Within-run and between-run imprecisions have been determined for the Gem (R) Premier (TM) 4000 analyzer. In the period of 30 days, 200 whole blood samples were analyzed. Results: Satisfactory results were obtained for within-run imprecision for all study analytes (CV <= 4.89%), except for pO(2) (CV = 14.66%) and for between-run imprecision for all parameters (CV <= 4.41%) except for lactate (Level I :CV = 8%, Level II :CV = 6.59%). The correlation with the comparative methods was satisfactory, correlation coefficients were between 0.9458-0.9948 for most parameters, except for sodium r = 0.8635. For hemoglobin, correlation coefficients were excellent, r = 0.9923(Gem (R) Premier (TM) 4000vs. Ciba Corning 865) and r = 0.9759 (Gem (R) Premier (TM) 4000 vs. Gem (R) Premier (TM) 3000). Passing Bablok regression analysis of analyte concentrations showed good compatibility except for sodium (Gem (R) Premier (TM) 4000 vs. Ciba Corning 865; y = 34.7500 + 0.7500x) and hemoglobin (Gem (R) Premier (TM) 4000vs. Gem (R) Premier (TM) 3000; y = 23.6923 + 0.8308x). Conclusions: Results of analyses obtained by the comparative measurement of analytes on Gem (R) Premier (TM) 4000 and reference analyzers were compatible. In determining hemoglobin concentration, Gem (R) Premier (TM) 4000 is completely comparable with Ciba Corning 865 analyzer, both analyzers using the same co-oximetry method.