ABL90 Flex Plus血气分析仪尿素和肌酐的分析评价

Cristina Pizarro Sánchez, P. O. Sáez, P. Fernández-Calle, Marta Suescun Giménez, Ricardo Miguel Alonso Díaz, Erika Perez Zafra, Núria Estañ Capell, A. Buño Soto
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引用次数: 0

摘要

背景急性肾损伤是住院患者常见的并发症。肌酸酐和尿素测量作为护理点检测的可用性提供了监测肾功能和制定预防策略的替代策略,特别是在紧急服务中,可能需要减少等待时间和快速临床决策。目的:本研究的目的是评估ABL90 Flex Plus和三种常见的中心实验室方法之间的肌酐和尿素测量是否可互换。方法采用多中心设计,首先采用ABL90 Flex Plus检测肌酐和尿素,然后采用实验室方法:Dimension Vista 1500、Cobas c702和Architect c16000,按照临床与实验室标准协会EP09-A3方案进行检测。所有测量都是重复进行的。采用Passing-Bablok回归和Bland-Altman比较对结果进行评价。在不同的临床决策水平上验证了患者结果的互换性。结果3种中心实验室方法与ABL90 Flex Plus之间的passin - bablok回归显示肌酐和尿素的相关系数超过0.998和0.994,尽管在研究中观察到比例和/或恒定偏差,但在所有病例的临床决策水平上,估计差异低于允许差异(尿素±15.6%和肌酐±8.9%)。结论与3种中心实验室方法相比,ABL90 Flex Plus血气分析仪测定肌酐和尿素的方法具有可互换性,不影响患者的护理。
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Analytical Evaluation of ABL90 Flex Plus Blood Gas Analyzer for Urea and Creatinine
Background Acute kidney injury is a common complication among hospitalized patients. The availability of creatinine and urea measurements as point-of-care testing provides an alternative strategy to monitor renal function and develop prevention strategies, especially in the emergency services, where reducing waiting times and rapid clinical decisions may be required. Objective The aim of this study was to evaluate if creatinine and urea measurements are interchangeable between ABL90 Flex Plus and three common central laboratory methods. Methods With a multicenter design, creatinine and urea were first analyzed by ABL90 Flex Plus and then by laboratory method: Dimension Vista 1500, Cobas c702, and Architect c16000 according to Clinical and Laboratory Standards Institute EP09-A3 protocol. All measurements were performed in duplicate. Results were evaluated using Passing-Bablok regression and Bland-Altman comparison. Interchangeability of patient results was verified at different clinical decision levels. Results Passing-Bablok regression between the 3 central laboratory methods and ABL90 Flex Plus showed correlation coefficients over 0.998 for creatinine and 0.994 for urea, and despite the presence of proportional and/or constant bias observed in the study, estimated difference was lower than the allowable difference (±15.6% for urea and ±8.9% for creatinine) at clinical decision levels in all cases. Conclusion Creatinine and urea measurements are interchangeable using ABL90 Flex Plus blood gas analyzer compared with 3 central laboratory methods, ensuring no impact on patient care using indistinctly any analyzer.
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