Editorial & Opinion
Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability.
| العنوان: | Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability. |
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| المؤلفون: | Bayat H; Clinical Laboratory Science, Sina Clinical Laboratory, Qaem Shahr, Iran., Johansen JV; Department of Metrology, Radiometer Medical ApS, Copenhagen, Denmark., Bachmann L; Department of Pathology, Virginia Commonwealth University, Richmond, USA., Person N; Siemens Healthineers USA, Chester Springs, USA. |
| المصدر: | Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2023 Jun 01; Vol. 61 (11), pp. e215-e217. Date of Electronic Publication: 2023 Jun 01 (Print Publication: 2023). |
| نوع المنشور: | Letter; Comment |
| اللغة: | English |
| بيانات الدورية: | Publisher: Walter De Gruyter Country of Publication: Germany NLM ID: 9806306 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1437-4331 (Electronic) Linking ISSN: 14346621 NLM ISO Abbreviation: Clin Chem Lab Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Berlin ; New York : Walter De Gruyter, c1998- |
| مواضيع طبية MeSH: | Indicators and Reagents*/standards , Reagent Kits, Diagnostic*, Quality Control |
| التعليقات: | Comment on: Clin Chem Lab Med. 2022 Feb 16;60(5):681-688. (PMID: 35172415) Comment in: Clin Chem Lab Med. 2023 Jun 01;61(11):e218-e220. (PMID: 37261942) |
| References: | van Schrojenstein Lantman, M, Çubukçu, HC, Boursier, G, Panteghini, M, Bernabeu-Andreu, FA, Milinkovic, N, et al.. on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN Standards WG-A/ISO . 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 . (PMID: 10.1515/cclm-2022-0083) CLSI . User evaluation of between-reagent lot variation; approved guideline . CLSI document EP26-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2013. CLSI . User evaluation of acceptability of a reagent lot change . In: CLSI guideline EP26 , 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2022. Miller, WG, Erek, A, Cunningham, TD, Oladipo, O, Scott, MG, Johnson, RE. Commutability limitations influence quality control results with different reagent lots. Clin Chem 2011;57:76–83. https://doi.org/10.1373/clinchem.2010.148106 . (PMID: 10.1373/clinchem.2010.148106) Kim, S, Chang, J, Kim, SK, Park, S, Huh, J, Jeong, TD. Sample size and rejection limits for detecting reagent lot variability: analysis of the applicability of the Clinical and Laboratory Standards Institute (CLSI) EP26-A protocol to real-world clinical chemistry data. Clin Chem Lab Med 2020;59:127–38. https://doi.org/10.1515/cclm-2020-0454 . (PMID: 10.1515/cclm-2020-0454) |
| فهرسة مساهمة: | Keywords: CLSI EP26; lot-to-lot variation; measurement procedures; reagent-lot |
| المشرفين على المادة: | 0 (Indicators and Reagents) 0 (Reagent Kits, Diagnostic) |
| تواريخ الأحداث: | Date Created: 20230531 Date Completed: 20231004 Latest Revision: 20231004 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1515/cclm-2023-0430 |
| PMID: | 37255006 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1437-4331 |
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| DOI: | 10.1515/cclm-2023-0430 |