Analytical properties of the GEM Premier 3000 analyzer evaluated

Introduction: The development of sensor technology has led to the advent of analyzers for fast and simple determination of analyte concentration in whole blood samples that can be performed in a laboratory and as point of care testing (POCT). POCT analyzers are generally put in at intensive care units to enable rapid test results and earliest possible therapy introduction. Aim: To evaluate analytical properties of the GEM Premier 3000 analyzer and compatibility of the results obtained by use of this analyzer with those reported from analyzers used in central laboratory before the GEM Premier 3000 POCT analyzer fitting and placing in operation at Intensive Care Unit, University Department of Surgery. Material and methods: Analytical properties of the analyzer were evaluated by determination of within-run imprecision, between-run imprecision, inaccuracy, and comparative determination of analyte concentrations in patient samples on the study analyzer and the analyzers used for the respective analytes at central laboratory as reference analyzers. The study was performed in accordance with ECCLS recommendations. Results: Satisfactory results were recorded on within-run imprecision for all study analytes (CV:<= 3.46%), and on between-run imprecision for all analytes (CV <= 4.65%) except for lactate (Level 2, CV = 9.35%; Level 3, CV =5.55%). Inaccuracy evaluation yielded satisfactory results for all study analytes (R <= 4.53%) except for lactate (Level 1, R = 13.59%; Level 2, R = -11.00%; Level 3, R = 10.00%). Correlation coefficients were within range 0.9727-0.9920, except for sodium (r = 0.9207) and showed high correlation of all analyte concentrations determined in patient samples on the study analyzerand reference analyzers. Passing Bablok regression analysis also indicated a very high compatibility of analyte concentrations measured in patient samples by use of the study analyzer and reference analyzers. Conclusion: Results of analyte concentration determination in patient samples obtained by use of the study analyzer were compatible with those produced by reference analyzers at central laboratory. The GEM Premier 3000 analyzer has proved to be simple to operate, while automated and independent quality control performed after each individual sample and automated error elimination ensures safe work and reliable test results.d