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

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 (refe...

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Main Authors: Lixia Yang, Dazhi Chi, Cuixiang Zhen, Wenjie Zhang, Junhua Yang, Jinlian Shao, Hua Xie
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-025-06710-6
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author Lixia Yang
Dazhi Chi
Cuixiang Zhen
Wenjie Zhang
Junhua Yang
Jinlian Shao
Hua Xie
author_facet Lixia Yang
Dazhi Chi
Cuixiang Zhen
Wenjie Zhang
Junhua Yang
Jinlian Shao
Hua Xie
author_sort Lixia Yang
collection DOAJ
description 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.
format Article
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institution Kabale University
issn 2045-2322
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publisher Nature Portfolio
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spelling doaj-art-dacb0665a6cb4635830ee024e151cbcd2025-08-20T03:45:28ZengNature PortfolioScientific Reports2045-23222025-07-0115111010.1038/s41598-025-06710-6Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care settingLixia Yang0Dazhi Chi1Cuixiang Zhen2Wenjie Zhang3Junhua Yang4Jinlian Shao5Hua Xie6Obstetrics and Gynecology Medical Center, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityEmergency Department, Zhujiang Hospital, Southern Medical UniversityAbstract 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.https://doi.org/10.1038/s41598-025-06710-6
spellingShingle Lixia Yang
Dazhi Chi
Cuixiang Zhen
Wenjie Zhang
Junhua Yang
Jinlian Shao
Hua Xie
Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
Scientific Reports
title Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
title_full Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
title_fullStr Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
title_full_unstemmed Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
title_short Clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
title_sort clinical performance validation of an integrated cartridge based bedside blood gas analyzer system in the acute care setting
url https://doi.org/10.1038/s41598-025-06710-6
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