校准
参考数据
标准物质
分数(化学)
认证
参考值
样品(材料)
计算机科学
可靠性工程
可靠性(半导体)
数据挖掘
医学物理学
统计
数学
医学
工程类
色谱法
化学
法学
政治学
内科学
检出限
功率(物理)
物理
量子力学
作者
W. Greg Miller,Thomas Keller,Jeffrey R. Budd,Jesper V Johansen,Mauro Panteghini,Neil Greenberg,Vincent Delatour,Ferruccio Ceriotti,Liesbet Deprez,Robert Rej,Johanna E. Camara,Finlay MacKenzie,Alicia N. Lyle,Eline van der Hagen,Chris Burns,Pernille Fauskanger,Sverre Sandberg
出处
期刊:Clinical Chemistry
[Oxford University Press]
日期:2023-08-11
卷期号:69 (9): 966-975
被引量:1
标识
DOI:10.1093/clinchem/hvad104
摘要
Abstract A secondary higher-order calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Commutability is a property of a reference material that means results for a reference material and for clinical samples have the same numeric relationship, within specified limits, across the measurement procedures for which the reference material is intended to be used. Procedures for assessing commutability have been described in the literature. This report provides recommendations for establishing a quantitative criterion to assess the commutability of a certified reference material (CRM). The criterion is the maximum allowable noncommutability bias (MANCB) that allows a CRM to be used as a calibrator in a calibration hierarchy for an IVD-MD without exceeding the maximum allowable combined standard uncertainty for a clinical sample result (umaxCS). Consequently, the MANCB is derived as a fraction of the umaxCS for the measurand. The suitability of an MANCB for practical use in a commutability assessment is determined by estimating the number of measurements of clinical samples and CRMs required based on the precision performance and nonselectivity for the measurand of the measurement procedures in the assessment. Guidance is also provided for evaluating indeterminate commutability conclusions and how to report results of a commutability assessment.
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