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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

Title
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
Authors
Kim S.Chang J.Kim S.-K.Park S.Huh J.Jeong T.-D.
Ewha Authors
허정원정태동김수경
SCOPUS Author ID
허정원scopus
Issue Date
2021
Journal Title
Clinical Chemistry and Laboratory Medicine
ISSN
1434-6621JCR Link
Citation
Clinical Chemistry and Laboratory Medicine vol. 59, no. 1, pp. 127 - 138
Keywords
critical differenceevaluationreagent lot-to-lot variation
Publisher
De Gruyter Open Ltd
Indexed
SCIE; SCOPUS WOS scopus
Document Type
Article
Abstract
To maintain the consistency of laboratory test results, between-reagent lot variation should be verified before using new reagent lots in clinical laboratory. Although the Clinical and Laboratory Standards Institute (CLSI) document EP26-A deals with this issue, evaluation of reagent lot-to-lot difference is challenging in reality. We aim to investigate a practical way for determining between-reagent lot variation using real-world data in clinical chemistry. The CLSI EP26-A protocol was applied to 83 chemistry tests in three clinical labs. Three criteria were used to define the critical difference (CD) of each test as follows: reference change value and total allowable error, which are based on biological variation, and acceptable limits by external quality assurance agencies. The sample size and rejection limits that could detect CD between-reagent lots were determined. For more than half of chemistry tests, reagent lot-to-lot differences could be evaluated using only one patient sample per decision level. In many cases, the rejection limit that could detect reagent lot-to-lot difference with ≥90% probability was 0.6 times CD. However, the sample size and rejection limits vary depending on how the CD is defined. In some cases, impractical sample size or rejection limits were obtained. In some cases, information on sample size and rejection limit that met intended statistical power was not found in EP26-A. The CLSI EP26-A did not provide all necessary answers. Alternative practical approaches are suggested when CLSI EP26-A does not provide guidance. © 2020 2020 Walter de Gruyter GmbH, Berlin/Boston.
DOI
10.1515/cclm-2020-0454
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의과대학 > 의학과 > Journal papers
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