Similarities and differences of limits of detection in health institutions and pharmaceutical institutions

doi:10.3969/j.issn.1673-8640.2020.08.019

Abstract

Abstract:

Clinical laboratories should complete the performance verification of the limit of detection（LoD） of qualitative test items,when the manufacturer of in vitro diagnostic reagents only declares the limit of blank（LoB） according to the standards of pharmaceutical institutions. The definitions of LoD and LoB in several medical related institution standards are analyzed,and the similarities and differences are pointed out. C50 concentration and C95 concentration in qualitative test items are correlated with LoB and LoD in quantitative test items.

Key words: Limit of detection, Limit of blank, Cut-off value

CLC Number:

R446.1

ZHU Lingfeng, GE Danhong, FANG Huiling, ZHU Yuqing. Similarities and differences of limits of detection in health institutions and pharmaceutical institutions[J]. Laboratory Medicine, 2020, 35(8): 825-828.

Figures/Tables 1

References 8

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文件	LoB	LoD
YY/T 1183-2010	检出限
WS/T 514-2017	空白限	检出限
CNAS-GL038：2019	空白限	检出限
WS/T 494/505（适用于定性项目）	C50浓度	C95浓度

文件	LoB	LoD
YY/T 1183-2010	检出限
WS/T 514-2017	空白限	检出限
CNAS-GL038：2019	空白限	检出限
WS/T 494/505（适用于定性项目）	C50浓度	C95浓度

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