超敏C反应蛋白即时检验方法性能评价
Performance evaluation of a point-of-care testing method for high sensitive C-reactive protein measurement
胡金川 1李岩 1张立敏 1董红芳 1菅强 1蒋玥1
作者信息
- 1. 解放军第281医院检验科,河北秦皇岛066100
- 折叠
摘要
目的 评价深圳国赛NEPHSTAR PLUS特定蛋白分析仪检测超敏C反应蛋白(hs-CRP)的性能.方法 评估深圳国赛NEPHSTAR PLUS特定蛋白分析仪测定hs-CRP的准确度、精密度、线性范围,及其与奥林巴斯AU640生化分析仪检测结果的可比性.结果 其测定偏倚为3.6％;正常值、病理值标本测定批内变异百分率分别为7.61％和4.91％,批间变异百分率分别为6.88％和5.73％;该方法在0 mg/L-300 mg/L范围内呈线性.采用该仪器分析全血样本与AU640生化仪分析血清样本结果间的相关性具有非常显著的统计学意义(r =0.980,P=1e-006).结论 深圳国赛NEPHSTAR PLUS特定蛋白分析仪检测hs-CRP准确度高,精密度好,线性范围宽,与生化仪分析结果相关性好.
Abstract
Objective To evaluate the performance of the Goldsite NEPHSTAR PLUS specific protein analyzer for high sensitive C-reactive protein(hs-CRP) measurement.Methods The accuracy,precision and linearity of the Goldsite NEPHSTAR PLUS specific protein analyzer in hs-CRP measurement were evaluated and the result was compared with that of the Olympus AU640 automatic biochemical analyzer.Results It showed that the bias of three test results of control serum was 3.6％ ; and the intra-assay coefficient of variation (CV) of normal and pathological blood sample were 7.61％ and 4.91％ respectively,while the inter-assay CV of them were 6.88％ and 5.73％,respectively.This point-of-care testing (POCT) method was linear in the range of 0 mg/L ～300 mg/L.There was significant statistical correlation between the Goldsite NEPHSTAR PLUS specific protein analyzer and the Olympus AU640 automatic biochemical analyzer in the hs-CRP measurement values (r =0.980,P =1 e-006).Conclusion The Goldsite NEPHSTAR PLUS specific protein analyzer has good accuracy,precision and wide linear range in hs-CRP measurement,and it also has good correlation with the Olympus AU640 automatic biochemical analyzer.
关键词
超敏C反应蛋白/即时检验/性能评价/对比实验Key words
High sensitive C-reactive protein/Point-of-care testing/Performance evaluation/Comparison test引用本文复制引用
出版年
2013
NETL
NSTL
维普
万方数据