Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting

Abstract

Abstract This study aims to evaluate the clinical performance of the EG-i30 blood gas analyzer and its test cartridge (EG10+), a maintenance-free electrochemical point-of-care blood gas analyzer system (referred to as EG), in comparison with the established ABL90 FLEX blood gas analyzer system (referred to as ABL) in the acute care setting. A total of 216 clinical residual samples from 94 patients were analyzed using both systems. Key blood gas and electrolyte parameters, including pH, pO2, pCO2, K+, Na+, iCa2+, Cl−, Lac, Glu, and Hct, were measured. Performance was assessed using statistical methods including Bland-Altman plots, Pearson’s correlation, concordance correlation coefficient (CCC), and Passing-Bablok regression. ROC curve analysis evaluated the EG’s diagnostic performance for hyperlactatemia, hypokalemia, and hyperkalemia. The EG demonstrated excellent correlation with the ABL, with r values ranging from 0.969 to 0.992 and CCC values between 0.958 and 0.991 for all parameters. Bias analysis at the medical decision levels showed that all parameters were within the allowable error limits. ROC analysis for Lac and K+ revealed high sensitivity and specificity. The EG provides reliable and accurate blood gas analysis comparable to the ABL, offering a portable, cost-effective solution for rapid diagnostics in emergency and critical care settings.