Centralization of multisite reagent lot-to-lot validation for Ortho Clinical Vitros chemistry instruments

Author:

To MichelleORCID,Raizman Joshua E.,Goudreau Bobbi-Lynn,Higgins Trefor,Brun Miranda,Tsui Albert K.Y.

Funder

University of Alberta

Publisher

Elsevier BV

Subject

Clinical Biochemistry,General Medicine

Reference11 articles.

1. Clinical and Laboratory Standards Institute, User Evaluation of Between-Reagent Lot Variation; Approved Guideline, CLSI Document EP26-A, 2013: Wayne, PA.

2. Evaluation of the CLSI EP26-A protocol for detection of reagent lot-to-lot differences;Katzman;Clin. Biochem.,2017

3. 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;Kim;Clin. Chem. Lab. Med.,2020

4. Validating new reagents: roadmaps through the wilderness;Martindale;Lab. Med.,2006

5. Lot change for reagents and calibrators;Don-Wauchope;Clin. Biochem.,2016

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Challenges of insulin-like growth factor-1 testing;Critical Reviews in Clinical Laboratory Sciences;2024-02-07

2. In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability;Clinical Chemistry and Laboratory Medicine (CCLM);2023-06-01

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