What is it about?
The EFLM WG-A/ISO has proposed a new approach for assessment of new reagent lots promising to address shortcomings the authors attribute to CLSI EP26 guidance. We argue that the purported shortcomings are already addressed in the EP26 guideline making it an appropriate tool to evaluate new reagent lots. Further, conceptual and statistical defects with the EFLM proposed approach make it of limited utility for the purpose.
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This page is a summary of: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability, Clinical Chemistry and Laboratory Medicine (CCLM), June 2023, De Gruyter,
DOI: 10.1515/cclm-2023-0430.
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