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Licensed Unlicensed Requires Authentication Published by De Gruyter June 1, 2023

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

  • Hassan Bayat ORCID logo EMAIL logo , Jesper V. Johansen , Lorin Bachmann and Nils Person

Corresponding author: Dr. Hassan Bayat, Member of the CLSI Expert Panel on Evaluation Protocols, Clinical Laboratory Scientist, Sina Clinical Laboratory, Iran Mehr Complex, Telar 6 Alley, Babol Street, Qaem Shahr, Iran, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

References

1. 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.Search in Google Scholar PubMed

2. CLSI. User evaluation of between-reagent lot variation; approved guideline. CLSI document EP26-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.Search in Google Scholar

3. CLSI. User evaluation of acceptability of a reagent lot change. In: CLSI guideline EP26, 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2022.Search in Google Scholar

4. 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.Search in Google Scholar PubMed

5. 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.Search in Google Scholar PubMed

Received: 2023-04-28
Accepted: 2023-05-11
Published Online: 2023-06-01
Published in Print: 2023-10-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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