Interlaboratory Variability in Plasma Creatinine Measurement and the Relation with Estimated Glomerular Filtration Rate and Chronic Kidney Disease Diagnosis

Interlaboratory Variability in Plasma Creatinine Measurement and the Relation with Estimated Glomerular Filtration Rate and Chronic Kidney Disease Diagnosis
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DOI:
10.2215/cjn.05400516
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发表时间:
2017-01-01
影响因子:
9.8
通讯作者:
White, Christine A.
White, Christine A.
中科院分区:
医学1区
文献类型:
--
作者:
Lee, Elizabeth;Collier, Christine P.;White, Christine A.

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背景和目的为了减少实验室间变异性和提高测定准确度,在世界范围内实施了肌酐(Cr)参考物质与同位素稀释质谱赋值的溯源。本研究的目的是检查目前实验室间变异的程度及其对eGFR的影响。设计、设置、参与者和测量从53名具有一系列肾功能的重症监护室患者中获得连续2-3天的剩余血浆。将个体患者样本合并并分开,并送往12个不同的实验室进行Cr测量。对于每例患者,测定平均肌酐和慢性肾脏病流行病学协作组eGFR(eGFR-EPI),假设为65岁非黑人女性。通过Cr和eGFR-EPI的范围和SD评估实验室间变异性。在按检测类型和中位Cr 1.36 mg/dl分层后重复该操作。对于eGFR-EPI范围包括60 ml/min/1.73 m(2)的患者,
Background and objectives The tracing of creatinine (Cr) reference materials to isotope dilution mass spectrometry assigned values was implemented worldwide to reduce interlaboratory variability and improve assay accuracy. The aims of this study were to examine the current extent of interlaboratory variability and its effect on eGFR.Design, setting, participants, & measurements Leftover plasma from 2-3 consecutive days was obtained from 53 intensive care unit patients with a range of kidney functions. Individual patient samples were pooled and split and sent to 12 different laboratories for Cr measurement. For each patient, the mean Cr and Chronic Kidney Disease Epidemiology Collaboration eGFR (eGFR-EPI), assuming a 65-year-old nonblack woman, were determined. Interlaboratory variability was assessed by the range and SD of Cr and eGFR-EPI. This was repeated after stratifying by assay type and by the median Cr of 1.36 mg/dl. For patients whose eGFR-EPI range included 60 ml/min per 1.73 m(2), the percentage of laboratories with eGFR-EPI