Evaluation of the CLSI EP26-A protocol for detection of reagent lot-to-lot differences
| Autor: | Karl M. Ness, Alicia Algeciras-Schimnich, Brooke M. Katzman |
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| Rok vydání: | 2017 |
| Předmět: |
Quality Control
medicine.medical_specialty Pathology Time Factors Minnesota Clinical Biochemistry Thyrotropin Guidelines as Topic 030204 cardiovascular system & hematology Autoantigens Iodide Peroxidase Thyroglobulin 03 medical and health sciences 0302 clinical medicine Thyroid-stimulating hormone Thyroid peroxidase Iron-Binding Proteins Medicine Humans Medical physics Autoantibodies Protocol (science) Immunoassay Academic Medical Centers biology business.industry Critical factors International Agencies Reproducibility of Results General Medicine Reagent Lot Decision points Thyroxine Solubility Sample size determination 030220 oncology & carcinogenesis biology.protein Regression Analysis Triiodothyronine Test performance Indicators and Reagents business |
| Zdroj: | Clinical biochemistry. 50(13-14) |
| ISSN: | 1873-2933 |
| Popis: | Background Verification of new reagent lots is a required laboratory task. The Clinical and Laboratory Standards Institute (CLSI) EP26-A guideline provides a lot-to-lot verification protocol to detect significant changes in test performance. The aim of this study was to compare the performance of EP26-A with our laboratory reagent lot verification protocol. Methods Prospective evaluations for two reagent lots each for thyroid stimulating hormone (TSH), thyroglobulin (Tg), thyroxine (T4), triiodothyronine (T3), free triiodothyronine (fT3), and thyroid peroxidase antibody (TPOAb) were performed. The laboratory's lot verification process included evaluation of 20 patient samples with the current and new lots and acceptability based on a predefined criteria. For EP26-A, method imprecision data and critical differences based on previously defined lot-to-lot consistency goals were used to define sample size requirements and rejection limits. Results EP26-A required the following number of samples: 23 for TSH, 17 for Tg, 33 for T4, 31 for T3, 48 for fT3, and 1 for TPOAb. Our current protocol and EP26-A were in agreement in 9 of the 12 (75%) paired verifications. Of the 3 discrepant verifications, Tg and TSH reagent lots were rejected by EP26-A due to significant differences at medical decision points; whereas TPOAb was rejected by the current laboratory protocol. Conclusions The EP26-A protocol arrived at the same conclusions as our protocol in 75% of the evaluations and required more samples for 4 of the 6 analytes tested. Challenges associated with determining rejection limits and the need for increased sample sizes may be critical factors that limit the utility of EP26-A. |
| Databáze: | OpenAIRE |
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