Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation

被引：9

作者：

Roelofsen-de Beer, Roseri ^{[4
]}

Wielders, Jos ^{[5
]}

Boursier, Guilaine ^{[6
]}

Vodnik, Tatjana ^{[7
]}

Vanstapel, Florent ^{[8
]}

Huisman, Willem ^{[9
]}

Vukasovic, Ines ^{[10
]}

Vaubourdolle, Michel ^{[11
]}

Sonmez, Cigdem ^{[12
]}

Linko, Solveig ^{[13
]}

Brugnoni, Duilio ^{[14
]}

Kroupis, Christos ^{[15
]}

Lohmander, Maria ^{[16
]}

Sprongl, Ludek ^{[17
]}

Bernabeu-Andreu, Francisco ^{[18
]}

Brguljan, Pika Mesko ^{[19
]}

Thelen, Marc ^{[1
,2
,3
]}

机构：

[1] Radboud Univ Nijmegen, Med Lab Care, Nijmegen, Netherlands

[2] Amphia, Lab Clin Chem & Haematol, POB 90158, NL-4800 RK Breda, Netherlands

[3] Radboud Univ Nijmegen, Nijmegen, Netherlands

[4] Rivierenland Hosp, Lab Med Diagnost, Tiel, Netherlands

[5] Clin Chem & Lab Med, Amersfoort, Netherlands

[6] Univ Montpellier, Dept Genet Rare Dis & Personalized Med, CHU Montpellier, Montpellier, France

[7] Ctr Med Biochem, Clin Ctr Serbia, Belgrade, Serbia

[8] Katholieke Univ Leuven, Dept Publ Hlth, Lab Med, Biomed Sci Grp,Univ Hosp Leuven, Leuven, Belgium

[9] Clin Chem & Lab Med, The Hague, Netherlands

[10] Sestre Milosrdnice Univ Hosp Ctr, Dept Clin Chem, Zagreb, Croatia

[11] Hop St Antoine, AH HP, Dept Biochim, Paris, France

[12] Oncol Educ & Res Hosp, Cent Lab, Ankara, Turkey

[13] Univ Helsinki, Fac Med, Helsinki, Finland

[14] Spedali Civil Brescia, Clin Chem Lab, Brescia, Italy

[15] Natl & Kapodistrian Univ Athens, Attikon Univ Gen Hosp, Med Sch, Dept Clin Biochem, Haidari, Greece

[16] Lab Med NU Sjukvarden, Trollhattan, Sweden

[17] Hosp Kladno, Clin Lab, Kladno, Czech Republic

[18] HU Puerta Hierro Majadahonda, Serv Anal Clin, Madrid, Spain

[19] Univ Clin Resp & Allerg Dis, Golnik, Slovenia

来源：

CLINICAL CHEMISTRY AND LABORATORY MEDICINE | 2020年 / 58卷 / 03期

关键词：

EFLM; examination procedure; ISO; 15189; opinion paper; validation; verification;

D O I：

10.1515/cclm-2019-1053

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：

This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.

引用

页码：361 / 367

页数：7

共 6 条

[1] [Anonymous], 2017, VALIDATION VERIFICAT, DOI [10.13140/ RG. 2.2.18137.72809, DOI 10.13140/RG.2.2.18137.72809]
[2] [Anonymous], 20914 ISODTS
[3] Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach
Antonelli, Giorgia
Padoan, Andrea
Aita, Ada
Sciacovelli, Laura
Plebani, Mario
[J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2017, 55 (10) : 1501 - 1508
[4] Validation of quantitative analytical procedures in laboratory medicine
Haeckel, Rainer
Sonntag, Oswald
[J]. LABORATORIUMSMEDIZIN-JOURNAL OF LABORATORY MEDICINE, 2012, 36 (02): : 111 - 118
[5] ISO, 151892012 ISO
[6] Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine
Sandberg, Sverre
Fraser, Callum G.
Horvath, Andrea Rita
Jansen, Rob
Jones, Graham
Oosterhuis, Wytze
Petersen, Per Hyltoft
Schimmel, Heinz
Sikaris, Ken
Panteghini, Mauro
[J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2015, 53 (06) : 833 - 835

← 1 →