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Performance Evaluation of the i-SmartCare 10 Analyzer and Method Comparison of Six Point-of-Care Blood Gas Analyzers.

ABSTRACT: Blood gas, electrolyte, glucose, and lactate level measurement have an immediate and critical impact on patient care. We evaluated the performance of i-SmartCare 10 (i-SENS Inc., Seoul, Korea) and conducted a method comparison study of five point-of-care (POC) analyzers with i-SmartCare 10 as the comparator, according to the CLSI guidelines. Ten analytes (pH, pCO₂, pO₂, Na⁺, K⁺, Cl^-, iCa²⁺, glucose, lactate, and Hct) were tested on six analyzers: i-SmartCare 10, ABL90 FLEX PLUS (Radiometer Medical ApS, Copenhagen, Denmark), i-Stat (Abbott Point of Care Inc., Princeton, NJ, USA), RapidLab 1265 (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA), Stat Profile pHOx Ultra (Nova Biomedical, Waltham, MA, USA), and Gem Premier 5000 (Instrumentation Laboratory, Bedford, MA, USA). The total imprecision and linearity (r²>0.99) were excellent, except for a few analytes that narrowly escaped the preset criteria. Interference was noted for Na⁺ in the presence of a high K⁺ level and for iCa²⁺ in the presence of high K⁺ and Mg²⁺ levels. Forty of 48 items demonstrated either a proportional or systematic difference in regression analysis; the relative mean difference (%) of 14/48 items escaped the allowable total error in the difference plot analysis. i-SmartCare 10 shows acceptable performance, and using a single POC blood gas analyzer is recommended for monitoring.

SUBMITTER: Kim SM

PROVIDER: S-EPMC8859550 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Performance Evaluation of the i-SmartCare 10 Analyzer and Method Comparison of Six Point-of-Care Blood Gas Analyzers.

Kim Sang-Mi SM Park Hyung-Doo HD

Annals of laboratory medicine 20220701 4

Blood gas, electrolyte, glucose, and lactate level measurement have an immediate and critical impact on patient care. We evaluated the performance of i-SmartCare 10 (i-SENS Inc., Seoul, Korea) and conducted a method comparison study of five point-of-care (POC) analyzers with i-SmartCare 10 as the comparator, according to the CLSI guidelines. Ten analytes (pH, pCO2, pO2, Na+, K+, Cl-, iCa2+, glucose, lactate, and Hct) were tested o ...[more]

PMID: 35177567

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Project description:BackgroundIt is not yet clear whether the trace blood gas analyzer can be used for biochemical detection of newborns. This study aimed to evaluate the reliability of the method for the detection of bilirubin in infants.MethodsBased on the Clinical and Laboratory Standards Institute (CLSI) EP15-A2 document, the analytical performance of the blood gas analyzer method for bilirubin detection in neonates was validated. The resulting data of 363 simultaneous bilirubin detection with blood gas analyzer (optical method) and biochemical analyzer (enzymatic method) were reviewed. According to the CLSI EP9-A3 document, the relevance and consistency of the measurement results were evaluated by Pearson correlation analysis, Passing-Bablok regression, and Bland-Altman deviation analysis.ResultsThe precision and accuracy of the Werfen GEM 4000 blood gas analyzer for the detection of different levels of bilirubin samples adhered to the manufacturer's statement and industry quality standards. The bilirubin detection values of the 2 methods showed a good correlation, and both of them were significantly correlated (P<0.001). Passing-Bablok regression results showed that the regression equation of the bilirubin detection value of the 2 methods is y = -21.00 + 1.17x, with the slope as 1.17 [95% confidence interval (CI): 1.15 to 1.19], and the intercept was -21.00 (95% CI: -23.62 to -18.71), the data of the 2 sets were not consistent in each concentration range. The Bland-Altman plot demonstrated that the bilirubin detection value of 16/363 cases (4.4%) for the 2 methods exceeded the 95% limits of agreement (95% LoA); of which the maximum bias was -30.34 (95% CI: -38.48 to -22.26) and there were 5/76 cases (6.6%) outside the 95% LoA in the >300 μmol/L group.ConclusionsThe method for detecting neonatal total bilirubin by trace blood gas analyzer basically meets the clinical requirements and can be used for the preliminary screening of neonatal jaundice. However, for severe hyperbilirubinemia that requires close monitoring of dynamics, a precise enzymatic quantification is required.

Project description:The aims of this study were to: (1) determine the validity and reliability of the Nova Biomedical Lactate Plus portable analyzer, and quantify any fixed or proportional bias; (2) determine the effect of any bias on the determination of the lactate threshold and (3) determine the effect that blood sampling methods have on validity and reliability. In this method comparison study we compared blood lactate concentration measured using the Lactate Plus portable analyzer to lactate concentration measured by a reference analyzer, the YSI 2300. University campus in the USA. Fifteen active men and women performed a discontinuous graded exercise test to volitional exhaustion on a motorised treadmill. Blood samples were taken via finger prick and collected in microcapillary tubes for analysis by the reference instrument at the end of each stage. Duplicate samples for the portable analyzer were either taken directly from the finger or from the micro capillary tubes. PRIMARY OUTCOME MEASUREMENTS: Ordinary least products regressions were used to assess validity, reliability and bias in the portable analyzer. Lactate threshold was determined by visual inspection. Though measurements from both instruments were correlated (r=0.91), the differences between instruments had large variability (SD=1.45 mM/l) when blood was sampled directly from finger. This variability was reduced by ∼95% when both instruments measured blood collected in the capillary tubes. As the proportional and fixed bias between instruments was small, there was no difference in estimates of the lactate threshold between instruments. Reliability for the portable instrument was strong (r=0.99, p<0.05) with no proportional bias (slope=1.02) and small fixed bias (-0.19 mM/l). The Lactate Plus analyzer provides accurate and reproducible measurements of blood lactate concentration that can be used to estimate workloads corresponding to blood lactate transitions or any absolute lactate concentrations.

Dataset Information

Performance Evaluation of the i-SmartCare 10 Analyzer and Method Comparison of Six Point-of-Care Blood Gas Analyzers.

Publications

Performance Evaluation of the i-SmartCare 10 Analyzer and Method Comparison of Six Point-of-Care Blood Gas Analyzers.

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