IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design

被引：111

作者：

Miller, W. Greg ^{[1
]}

Schimmel, Heinz ^{[2
]}

Rej, Robert ^{[3
,4
]}

Greenberg, Neil ^{[5
]}

Ceriotti, Ferruccio ^{[6
]}

Burns, Chris ^{[7
]}

Budd, Jeffrey R. ^{[8
]}

Weykamp, Cas ^{[9
]}

Delatour, Vincent ^{[10
]}

Nilsson, Goeran

MacKenzie, Finlay ^{[11
]}

Panteghini, Mauro ^{[12
]}

Keller, Thomas ^{[13
]}

Camara, Johanna E. ^{[14
]}

Zegers, Ingrid ^{[2
]}

Vesper, Hubert W. ^{[15
]}

机构：

[1] Virginia Commonwealth Univ, Dept Pathol, Richmond, VA USA

[2] European Commiss, Joint Res Ctr, Directorate F, Geel, Belgium

[3] New York State Dept Hlth, Wadsworth Ctr Labs & Res, Albany, NY USA

[4] SUNY Albany, Sch Publ Hlth, Albany, NY USA

[5] Neil Greenberg Consulting LLC, Rochester, NY USA

[6] Fdn IRCCS CaGranda Osped Maggiore Policlin, Milan, Italy

[7] Natl Inst Biol Stand & Controls, Westminster, Herts, England

[8] Beckman Coulter, Chaska, MN USA

[9] Queen Beatrix Hosp, Winterswijk, Netherlands

[10] Lab Natl Metrol & Essais LNE, Paris, France

[11] Univ Hosp Birmingham NHS Fdn Trust, Birmingham Qual UK NEQAS, Birmingham, W Midlands, England

[12] Univ Milan, Res Ctr Metrol Traceabil Lab Med CIRME, Milan, Italy

[13] ACOMED Stat, Leipzig, Germany

[14] NIST, Gaithersburg, MD 20899 USA

[15] Ctr Dis Control & Prevent, Atlanta, GA USA

来源：

CLINICAL CHEMISTRY | 2018年 / 64卷 / 03期

关键词：

D O I：

10.1373/clinchem.2017.277525

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and results for clinical samples (CSs) when measured by >= 2 measurement procedures (MPs). Commutability of RMs used in a calibration traceability scheme is an essential property for them to be fit for purpose. Similarly, commutability of trueness controls or external quality assessment samples is essential when those materials are used to assess trueness of results for CSs. This report is part 1 of a 3-part series describing how to assess commutability of RMs. Part 1 defines commutability and addresses critical components of the experimental design for commutability assessment, including selection of individual CSs, use of pooled CSs, qualification of MPs for inclusion, establishing criteria for the determination that anRMis commutable, generalization of commutability conclusions to future measurements made with the MPs included in the assessment, and information regarding commutability to be included in the certificate for an RM. Parts 2 and 3 in the series present 2 different statistical approaches to commutability assessment that use fixed criteria related to the medical decisions that will be made using the laboratory test results. (c) 2017 American Association for Clinical Chemistry.

引用

页码：447 / 454

页数：8

共 12 条

[1]

[Anonymous], 2013, MEAS PROC COMP BIAS

[2]

[Anonymous], INT VOC METR BAS GEN

[3]

[Anonymous], 2003, 175112003 ISO

[4] Performance criteria for combined uncertainty budget in the implementation of metrological traceability [J].

Braga, Federica ;

Infusino, Ilenia ;

Panteghini, Mauro .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2015, 53 (06) :905-912

[5] IFCC Working Group Recommendations for Assessing Commutability Part 3: Using the Calibration Effectiveness of a Reference Material [J].

Budd, Jeffrey R. ;

Weykamp, Cas ;

Rej, Robert ;

MacKenzie, Finlay ;

Ceriotti, Ferruccio ;

Greenberg, Neil ;

Camara, Johanna E. ;

Schimmel, Heinz ;

Vesper, Hubert W. ;

Keller, Thomas ;

Delatour, Vincent ;

Panteghini, Mauro ;

Burns, Chris ;

Miller, W. Greg .

CLINICAL CHEMISTRY, 2018, 64 (03) :465-474

[6]

Clinical and Laboratory Standards Institute, 2010, EP30A CLSI

[7]

Clinical Laboratory Standards Institute, 1999, C37A CLSI

[8]

Clinical Laboratory Standards Institute (CLSI), 2014, Evaluation of Commutability of Processed Samples Approved Guideline CLSI Document EP14-A3 CLSI

[9] Commutability Assessment of External Quality Assessment Materials with the Difference in Bias Approach: Are Acceptance Criteria Based on Medical Requirements too Strict? [J].

Delatour, Vincent ;

Liu, Qinde ;

Vesper, Hubert W. .

CLINICAL CHEMISTRY, 2016, 62 (12) :1670-1671

[10] Difference in Bias Approach for Commutability Assessment: Application to Frozen Pools of Human Serum Measured by 8 Direct Methods for HDL and LDL Cholesterol [J].

Korzun, William J. ;

Nilsson, Goeran ;

Bachmann, Lorin M. ;

Myers, Gary L. ;

Sakurabayashi, Ikunosuke ;

Nakajima, Katsuyuki ;

Nakamura, Masakazu ;

Shamburek, Robert D. ;

Remaley, Alan T. ;

Miller, W. Greg .

CLINICAL CHEMISTRY, 2015, 61 (08) :1107-1113

← 1 2 →