A Two-Center Evaluation of the Blood Gas Immediate Response Mobile Analyzer (IRMA)

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Abstract
The Immediate Response Mobile Analyzer (IRMA) is a selective and portable point-of-care testing (POCT) blood gas, electrolyte and hematocrit (Hct) analyzer. The overall analytical performance was evaluated in a two-center study involving two Italian hospital laboratories, following the guidelines suggested by the manufacturer (based on the NCCLS protocol), after a preliminary evaluation of their formal validity. The IRMA was compared to the analyzers used in the routine laboratory as reference. The considered parameters were pH, pO2, pCO2, Na+, K+, ionized calcium and Hct. When using the aqueous quality control material provided by the manufacturer most of the parameters showed good precision, with the exception of pCO2 and pO2 that showed high CVs on two of the three levels of the aqueous control. We could demonstrate that this imprecision was material-related and was reduced when using a different material (blood equilibrated by tonometry). With tonometred blood for pO2 and pCO2 and the aqueous material for the remaining parameters the CVs were all below 5%, ranging from 0.08% to 2.8%. The IRMA results correlated adequately with the comparison instruments, with the exception of sodium and ionized calcium where contradictory results were obtained in the two centers.