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

doi:10.3969/j.issn.1673-8640.2015.01.001

Abstract

Abstract:

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 (Ⅱ)[J]. Laboratory Medicine, 2015, 30(1): 1-6.

性能确认检测	数字成像细胞定位	数字成像 CBC/Diff/Ret
精密度/可重复性	是	是
批内	是	是
批间(天间)	是	是
技术员间	是	是
准确性	是	是(参考CLSI H20-A2文件)
可比性	是	是(与CLSI H20-A2文件和指定的血液分析仪比较)
灵敏度/特异度	是	是
标本稳定性	否	是
携带污染	否	是/否(盒式系统)
线性	否	是
LoB/LoD/LoQ	否	是;可改良或修改适于分析仪的方法学
参考区间	否	是

性能确认检测	数字成像细胞定位	数字成像 CBC/Diff/Ret
精密度/可重复性	是	是
批内	是	是
批间(天间)	是	是
技术员间	是	是
准确性	是	是(参考CLSI H20-A2文件)
可比性	是	是(与CLSI H20-A2文件和指定的血液分析仪比较)
灵敏度/特异度	是	是
标本稳定性	否	是
携带污染	否	是/否(盒式系统)
线性	否	是
LoB/LoD/LoQ	否	是;可改良或修改适于分析仪的方法学
参考区间	否	是

抗体特性	荧光色素
CD16	海水蓝(Pacific Blue)
CD45	Krome橙(Krome Orange)
Syto16	异硫氰酸荧光素(FITC)
CD7	藻红蛋白(PE)
CD123	多甲藻叶绿素蛋白偶联物(PerCP-Cy5.5)
CD14	藻红蛋白偶联物(PE-Cy7)
CD3⁺	别藻青蛋白(APC)
CD11b	别藻青蛋白偶联物(APC-A750)

抗体特性	荧光色素
CD16	海水蓝(Pacific Blue)
CD45	Krome橙(Krome Orange)
Syto16	异硫氰酸荧光素(FITC)
CD7	藻红蛋白(PE)
CD123	多甲藻叶绿素蛋白偶联物(PerCP-Cy5.5)
CD14	藻红蛋白偶联物(PE-Cy7)
CD3⁺	别藻青蛋白(APC)
CD11b	别藻青蛋白偶联物(APC-A750)

有效性测量(%)	计算公式
灵敏度(异常标本中阳性检出数)	TP/(TP+FN)×100
特异度(正常标本中阴性检出数)	TN/(TN+FP)×100
阳性结果预测值	TP/(TP+FP)×100
阴性结果预测值	TN/(TN+FN)×100
总有效性	(TP+TN)/(TP+FP+TN+FN)×100

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

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参考方法	检测方法结果
参考方法	阳性(异常)	阴性(正常)
阳性(异常)	真阳性(TP)	假阴性(FN)
阴性(正常)	假阳性(FP)	真阴性(TN)

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