Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA<sup>TM</sup> READER for detecting C-reactive protein

LINGHU Ying; HUANG Shan; TIAN He; FENG Qin-yin; CHEN Jie; XU Jian

doi:10.13406/j.cnki.cyxb.2011.05.009

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Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA^TM READER for detecting C-reactive protein

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- Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA^TM READER for detecting C-reactive protein
- Journal of Chongqing Medical University Vol. 36, Issue 5, Pages: 602-604(2011)
- 作者机构：
  
  贵州省人民医院临床检验中心
- 作者简介：
- 基金信息：
- DOI：10.13406/j.cnki.cyxb.2011.05.009
  CLC： R446.6
- Published：2011，
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[1]令狐颖,黄山,田禾,冯勤颖,陈洁,许健.i-CHROMA~(TM) READER免疫荧光分析仪检测C反应蛋白的方法学性能评价[J].重庆医科大学学报,2011,36(05):602-604.

LINGHU Ying, HUANG Shan, TIAN He, et al. Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA^TM READER for detecting C-reactive protein. [J]. Journal of Chongqing Medical University 36(5):602-604(2011)
[1]令狐颖,黄山,田禾,冯勤颖,陈洁,许健.i-CHROMA~(TM) READER免疫荧光分析仪检测C反应蛋白的方法学性能评价[J].重庆医科大学学报,2011,36(05):602-604. DOI： 10.13406/j.cnki.cyxb.2011.05.009.

LINGHU Ying, HUANG Shan, TIAN He, et al. Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA^TM READER for detecting C-reactive protein. [J]. Journal of Chongqing Medical University 36(5):602-604(2011) DOI： 10.13406/j.cnki.cyxb.2011.05.009.

摘要

目的:对i-CHROMATM READER免疫荧光分析仪检测C反应蛋白（C-reactiveprotein

CRP）进行方法学性能评价。方法:参考美国临床和实验室标准化协会（Association ofclinical and laboratorystandards

CLSI）系列文件

结合工作实际

设计验证方案

对i-CHROMATM READER免疫荧光分析仪检测血清CRP的精密度、准确度、线性、抗干扰能力等4项分析性能进行验证和评价

并将实验结果与厂商（韩国Boditech Med Inc公司）提供的分析性能或公认的质量指标进行比较。结果:CRP定量时批内、批间变异系数均符合相关要求;线性实验和准确度实验表明i-CHROMATM READER免疫荧光分析仪与日本OlympusAU2700（散射比浊法）检测结果相关性良好

线性与厂商承诺范围接近

回归方程经检验有意义;甘油三酯、胆红素对检测结果的影响在可接受的范围。结论:i-CHROMATM READER免疫荧光分析仪检测系统检测血清CRP的分析性能符合厂商提供的性能指标

同时还具有操作简便易行等优点

适合各医疗系统床旁测试检测。

Abstract

Objective:To evaluate the performance of immunofluorescence analyzer i-CHROMATM READER for detecting C-reactive protein(CRP).Methods:With reference to the series of documents by U.S.A Association of clinical and laboratory standards(CLSI)combined with actual practice

an validation program was designed to testify and evaluate the precision

accuracy

linearity

and anti-interference ability of immunofluorescence analyzer i-CHROMATM READER for detecting serum C-reactive protein.The experimental results were compared with the performance indicators provided by the manufacturer(Korea Boditech Med Inc company)or recognized quality metrics.Results:On quantifying C-reactie protein(CRP)

the variation coefficient inside batch and between batches conformed to the relevant requirements.Linear and accuracy experiments showed that the test results by immunofluorescence analyzer i-CHROMATM READER and Japan OlympusAU2700(scattering ratio turbidity method)had good correlation.The linearity was in close range with that provided by the manufacturers

Regression equations proved to be meaningful.The effect of triglycerides and bilirubin on test results was in acceptable range.Conclusion:The analyzing performance of immunofluorescence analyzer i-CHROMATM READER for detecting serum CRP meets the performance indicators provided by the manufacturers.It also has the advantage of simple operation

which can be operated at bedside in all sorts of health care organizations.

关键词

C反应蛋白方法学评价床旁检验免疫荧光分析

Keywords

C-reactive proteinevaluation methodologybedside testimmunofluorescence

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Methodological evaluation of performance of immunofluorescence analyzer i-CHROMATM READER for detecting C-reactive protein

DOI：10.13406/j.cnki.cyxb.2011.05.009

摘要

Abstract

关键词

Keywords

references

Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA^TM READER for detecting C-reactive protein