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Performance Evaluation of the i-SmartCare 10 Analyzer and Method Comparison of Six Point-of-Care Blood Gas Analyzers.
Annals of Laboratory Medicine ( IF 4.0 ) Pub Date : 2022-2-19 , DOI: 10.3343/alm.2022.42.4.467
Sang-Mi Kim 1 , Hyung-Doo Park 1
Affiliation  

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.

中文翻译:

i-SmartCare 10 分析仪的性能评估和六个护理点血气分析仪的方法比较。

血气、电解质、葡萄糖和乳酸水平测量对患者护理具有直接和关键的影响。根据 CLSI,我们评估了 i-SmartCare 10(i-SENS Inc.,首尔,韩国)的性能,并以 i-SmartCare 10 作为比较器对五台即时 (POC) 分析仪进行了方法比较研究指导方针。十种分析物(pH、pCO 2、pO 2、Na +、K +、Cl -、iCa 2+、葡萄糖、乳酸和 Hct)在六台分析仪上进行测试:i-SmartCare 10、ABL90 FLEX PLUS(Radiometer Medical ApS,哥本哈根,丹麦)、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)和 Gem Premier 5000(Instrumentation Laboratory,Bedford,MA,USA)。总体不精密度和线性 (r 2 >0.99) 非常出色,除了少数分析物勉强超出预设标准。注意到存在高 K +水平时 Na +和高 K +和 Mg 2+存在时iCa 2+的干扰水平。48 项中有 40 项在回归分析中显示出比例或系统差异;14/48 个项目的相对平均差 (%) 超出了差异图分析中允许的总误差。i-SmartCare 10 表现出可接受的性能,建议使用单个 POC 血气分析仪进行监测。
更新日期:2022-02-19
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