Introduction of the ICSH guidelines for the evaluation of blood cell analyzers,2014 edition(I)
HU Xiaob · Laboratory Medicine · 2014
This article introduces the International Council for Standardization in Haematology( ICSH) guideline for the evaluation of blood cell analyzers,2014 edition. In this guideline,the performance evaluation,including sampling mode,within-run precision,between-run precision,carry-over,linearity,sample stability,reference interval,accuracy and comparability of haematology analyzers,should be conducted through validation and verification by manufacturers. The assessment of flow cytometry-based or digital imaging-based leukocyte differential count,nucleated red blood cell count and immature granulocyte count is recommended by flow cytometry immune-phenotypic counting as a reference method. A part of validation or transference of instrument should be performed by each clinical laboratory before reporting patient results.