In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability-Reference-Cited by-同舟云学术

In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability

Published:2023-06-01 Issue:11 Volume:61 Page:e218-e220
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Thelen Marc H.M.¹²^ORCID,van Schrojenstein Lantman Marith¹^ORCID,Boursier Guilaine³^ORCID,Vanstapel Florent⁴⁵^ORCID,Panteghini Mauro⁶

Affiliation:

1. Department of Laboratory Medicine , Radboud University Medical Centre , Nijmegen , the Netherlands

2. Foundation for Quality Assurance in Laboratory Medicine (SKML) , Nijmegen , the Netherlands

3. Department of Genetics, Rare Diseases and Personalized, Medicine Rare Diseases and Autoinflammatory Unit , CHU Montpellier, University of Montpellier , Montpellier , France

4. Laboratory Medicine , University Hospital Leuven , Leuven , Belgium

5. Department of Public Health, Laboratory Medicine, Biomedical Sciences Group , University Hospital Leuven , Leuven , Belgium

6. Department of Biomedical and Clinical Sciences “Luigi Sacco” , Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan , Milan , Italy

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2023-0516/pdf

Reference17 articles.

1. Bayat, H, Johansen Vesper, V, Bachmann, L, Person, N. Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability. Clin Chem Lab Med 2023;61:e215–7.

2. van Schrojenstein Lantman, M, Çubukçu, HC, Boursier, G, Panteghini, M, Bernabeu-Andreu, FA, Milinkovic, N, et al.. An approach for determining allowable between reagent lot variation. Clin Chem Lab Med 2022;60:681–8. https://doi.org/10.1515/cclm-2022-0083.

3. CLSI. User evaluation of between-reagent lot variation. In: Approved guideline. CLSI document EP26-A. Wayne PA: Clinical and Laboratory Standards Institute; 2013.

4. Algeciras-Schimnich, A, Bruns, DE, Boyd, JC, Bryant, SC, La Fortune, KA, Grebe, SK. Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions. Clin Chem 2013;59:1187–94. https://doi.org/10.1373/clinchem.2013.205070.

5. Katzman, BM, Ness, KM, Algeciras-Schimnich, A. Evaluation of the CLSI EP26-A protocol for detection of reagent lot-to-lot differences. Clin Biochem 2017;50:768–71. https://doi.org/10.1016/j.clinbiochem.2017.03.012.

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