Analytical and clinical performance of three hand-held point-of-care creatinine analyzers for renal function measurements prior to contrast-enhanced imaging
Analytical and clinical performance of three hand-held point-of-care creatinine analyzers for renal function measurements prior to contrast-enhanced imaging
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DOI：
10.1016/j.cca.2019.06.025
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发表时间：
2019-10-01
影响因子：
5
通讯作者：
Peeters, Bart
中科院分区：
文献类型：
--
作者：
van der Heijden, Catharina;Roosens, Laurence;Peeters, Bart
背景资料：由于碘基造影剂可导致肾功能受损患者的肾功能恶化，指南建议在给药前测量肌酐并计算估计的肾小球滤过率（eGFR）。床旁监护（POC）设备似乎是一个有吸引力的替代中心实验室检测，但不确定性分析和临床comparatively remains.Methods：本研究比较了三个POC设备，i-STAT（雅培），StatSensor（新星）和epoc（西门子）与中心实验室的方法（酶肌酐，西门子Vista 1500平台）。纳入120例患者，并在StatSensor上同时进行手指针刺毛细血管血分析和在StatSensor、i-STAT和epoc上进行肝素全血分析。所有POC器械生成的结果均显示参考标准的肌酸酐值周围存在相当大的变异性，StatSensor具有最宽的变异性。（-1，12-1，11 mg/dL）和epoc最严格（-0，49-0，49 mg/dL）95%一致性限值。I-STAT显示与参比标准品的临床一致性最高（Kappa：0.94），与参比标准品相比，肌酐和eGFR的平均分析误差最小（6%），分别符合8.87%和10%的预定义标准。Epoc仅符合eGFR标准。StatSensor不符合任何标准。结论：I-STAT和epoc，分析和临床上，在这项研究中包括的性能最好的POC设备，但显示出用户友好性较差。StatSensor不符合任何错误标准，无论是肌酐还是eGFR测量，并且给出了更多的临床主要分类错误。然而，与其他POC设备相比，它被证明更加用户友好。
Background: As iodine-based contrast can cause deterioration of renal function in patients with impaired kidney function, guidelines advise to measure creatinine and calculate estimated glomerular filtration (eGFR) prior to administration. Point-of-care (POC) devices seem an attractive alternative to central laboratory testing but uncertainty regarding analytical and clinical comparability remains.Methods: This study compared three POC devices, i-STAT (Abbott), StatSensor (Nova) and epoc (Siemens) with a central laboratory method (enzymatic creatinine, Siemens Vista 1500 platform). 120 patients were included and underwent simultaneous finger prick capillary blood analysis on the StatSensor and heparine whole blood analysis on StatSensor, i-STAT and epoc.Results: All POC devices generated results which showed considerable variability around the creatinine value of the reference standard, with StatSensor having the widest ( -1,12-1,11 mg/dL) and epoc the tightest ( - 0,49-0,49 mg/dL) 95% limits of agreement. I-STAT showed the highest clinical concordance with the reference standard (Kappa: 0,94) and had the smallest average analytical error (6%) for creatinine and eGFR compared to the reference standard, meeting the predefined criteria of 8,87% and 10%, respectively. Epoc only met criteria for eGFR. StatSensor did not meet any of the criteria.Conclusions: I-STAT and epoc were, analytically and clinically, the most performant POC devices included in this study but showed to be less user-friendly. StatSensor did not meet any of the error criteria, neither for creatinine nor for eGFR measurements, and gave more clinical major classification errors. However, it proved to be more user-friendly compared to the other POC devices.