Lot-to-lot reagent verification: challenges and possible solutions
- PMID: 35191278
- DOI: 10.1515/cclm-2022-0092
Lot-to-lot reagent verification: challenges and possible solutions
Abstract
Lot-to-lot verification is an important laboratory activity that is performed to monitor the consistency of analytical performance over time. In this opinion paper, the concept, clinical impact, challenges and potential solutions for lot-to-lot verification are exained.
Keywords: analytical variation; between-lot verification; external quality assurance; lot-to-lot verification; moving averages; patient-based quality control; quality control; reagent verification.
© 2022 Walter de Gruyter GmbH, Berlin/Boston.
Comment in
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Lot-to-lot variation: no longer a neglected issue.Clin Chem Lab Med. 2022 Feb 23;60(5):645-646. doi: 10.1515/cclm-2022-0128. Clin Chem Lab Med. 2022. PMID: 35212202 No abstract available.
References
-
- Hicks, AJ, Carwardine, ZL, Hallworth, MJ, Kilpatrick, ES. Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making. Biochem Med (Zagreb). 2021;31:010703. https://doi.org/10.11613/BM.2021.010703 . - DOI
-
- Sikaris, K, Pehm, K, Wallace, M, Picone, D, Frydenberg, M. Review of serious failures in reported test results for prostate-specific antigen (PSA) testing of patients by SA Pathology. Available from: http://www.sapathology.sa.gov.au/wps/wcm/connect/1fa1d43f-08ab-49e0-9875... [Accessed 2 Feb 2022].
-
- 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 . - DOI
-
- Chai, JH, Ma, S, Heng, D, Yoong, J, Lim, WY, Toh, SA, et al.. Impact of analytical and biological variations on classification of diabetes using fasting plasma glucose, oral glucose tolerance test and HbA1c. Sci Rep 2017;7:13721. https://doi.org/10.1038/s41598-017-14172-8 . - DOI
-
- Larsen, ML, Fraser, CG, Petersen, PH. A comparison of analytical goals for haemoglobin A1c assays derived using different strategies. Ann Clin Biochem 1991;28:272–8. https://doi.org/10.1177/000456329102800313 . - DOI
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