Evaluation of the GEM® Premier™ 4000: a compact blood gas CO-Oximeter and electrolyte analyzer for point-of-care and laboratory testing

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Abstract
GEM Premier 4000 (Instrumentation Laboratory), a new blood gas/CO-Oximeter/hematocrit/electrolyte/glucose/lactate analyzer was evaluated. The only reagents required were disposable cartridges (GEM Premier 4000 PAK comprise all components necessary for analysis, including quality controls). The evaluation was performed in two laboratories according to the Valtec protocol guidelines. Analytical performances (imprecision at three levels, linearity, inaccuracy by method comparison using patient samples, interferences) and instrument practicability were compared with three routinely used laboratory blood gas analyzers (ABL 835 and 725, Radiometer; OMNI S, Roche Diagnostics) and the centrifuged microhematocrit method. Within-run and between-run imprecision yielded good coefficients of variation values for all parameters. Linearity was satisfactory and within the expected ranges provided by the manufacturer. Method comparisons demonstrated close agreement (Deming's regression correlation coefficients 0.92-1.00). No interferences of lipemia, hyperbilirubinemia and hemolysis were found on CO-Oximetry parameters. Fetal hemoglobin >35% overestimated carboxyhemoglobin measurements, but the magnitude of error was reduced with the fetal hemoglobin correction analysis mode. The GEM Premier 4000 analytical performance was validated for all parameters with the accuracy and the reliability of traditional systems. This blood gas analyzer fulfills most of the requirements for both point-of-care and laboratory use.