Introduction of the ICSH guidelines for the evaluation of blood cell analyzers, 2014 edition (Ⅰ)

doi:10.3969/j.issn.1673-8640.2014.12.001

›› 2014, Vol. 29 ›› Issue (12): 1201-1206.DOI: 10.3969/j.issn.1673-8640.2014.12.001

Introduction of the ICSH guidelines for the evaluation of blood cell analyzers, 2014 edition (Ⅰ)

HU Xiaobo¹, SONG Ying², WANG Qing², JIN Daming², XIONG Lifan³

1.The Third People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 201900, China; 2. Shanghai Centre for Clinical Laboratory, Shanghai 200126, China; 3. Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China

Received:2014-11-24 Online:2014-12-30 Published:2015-01-14

Abstract

Abstract:

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.

Key words: Haematology analyzer, Evaluation, Validation, Verification, Digital imaging, Flow cytometry

CLC Number:

R446.1

HU Xiaobo, SONG Ying, WANG Qing, JIN Daming, XIONG Lifan. Introduction of the ICSH guidelines for the evaluation of blood cell analyzers, 2014 edition (Ⅰ)[J]. , 2014, 29(12): 1201-1206.

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Introduction of the ICSH guidelines for the evaluation of blood cell analyzers, 2014 edition (Ⅰ)

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