|本期目录/Table of Contents|

[1]施国民,徐斐.C反应蛋白快速定量检测试剂盒性能评价[J].医学研究与战创伤救治(原医学研究生学报),2014,16(04):341-342.[doi:10.3969/j.issn.1672-271X.2014.04.002]
　SHI Guo-min,XU Fei..Evaluation of the quality and performance of self-made C-reactive protein test kit[J].JOURNAL OF MEDICALRESEARCH —COMBAT TRAUMA CARE,2014,16(04):341-342.[doi:10.3969/j.issn.1672-271X.2014.04.002]
点击复制

C反应蛋白快速定量检测试剂盒性能评价()
分享到62.8K

《医学研究与战创伤救治》（原医学研究生学报）[ISSN:1672-271X/CN:32-1713/R]

卷:
第16卷
期数:
2014年04期
页码:
341-342
栏目:
出版日期:
2014-07-31

文章信息/Info

Title:
Evaluation of the quality and performance of self-made C-reactive protein test kit
作者:
施国民; 徐斐
200093 上海，上海理工大学医疗器械与食品学院
Author(s):
SHI Guo-min; XU Fei.
School of Medical Instrument and Food Engineering，University of Shanghai for Science and Technology，Shanghai 200093,China
关键词:
C反应蛋白检测试剂盒; 胶乳免疫比浊法; 性能评价
Keywords:
C-reactive protein test kit;  latex immunoturbidimetry;  performance evaluation
分类号:
R446.6
DOI:
10.3969/j.issn.1672-271X.2014.04.002
文献标志码:
A
摘要:
目的 评价以胶乳免疫比浊法原理研制的C反应蛋白快速定量检测试剂盒的方法学性能。方法 测定试剂盒的检测限、精密度、线性范围、回收率、贮存稳定性,将检测200份样本的结果与国外试剂盒比较。结果 检测限为0.72 mg/L，精密度:高、低浓度水平的样本批内变异系数分别为3.09%、6.75%,批间变异系数分别为6.47%、6.84%；线性范围为1～215 mg/L，线性相关系数为0.99；平均回收率为112.5%，系统误差＜1/2TEa。贮存有效期:18个月。200份不同浓度样本测定结果与进口试剂盒比较差异无统计学意义。结论 研制的C反应蛋白快速定量检测试剂盒符合临床检测要求。
Abstract:
Objective To evaluate the quality and performance of self-made C-reactive protein test kit (latex immunoturbidimetry).Methods The limitation of detection,precision,linearity,recovery,expiry term was measured.200 blood samples were used for the comparative study with imports.Results Limitation of detection:0.72 mg/L.Precision:the within-run relative standard deviations of two different concentration samples were 3.09% and 6.75%.The day to day relative standard deviations of two different concentration samples were 6.47% and 6.84%.Linearity:the linear range was from 1 mg/L to 215 mg/L.The correlation coefficient was 0.99.Accuracy:the average recovery was 112.5%.The system error was less than 1/2TEa.Expiry term:18 months.Contrast experiment:the results between self-made C-reactive protein test kit and imports had no significant difference.Conclusion The test kit is a valueable diagnostic tool for C-reactive protein rapid and accurate detection.

参考文献/References:

[1]税国顺，何代莉，杨晓红．C-反应蛋白的测定及临床应用[J]．现代医药卫生，2005，21(11):1365-1366．
[2]周 宓，潘柏申.C-反应蛋白在临床应用中的进展[J].国外医学:临床生物化学与检验学分册，2005，26(1):56-57.
[3]杨 朵，胡 梅,李 莉,等.C-反应蛋白及降钙素原在血流细菌感染诊断中的应用价值[J].中华医院感染学杂志,2013，23(22):5632-5633.
[4]余 丰,梁飞立,何艳英,等.C-反应蛋白水平与HIV/AIDS患者抗病毒治疗预后关系的研究[J].中华医院感染学杂志,2013，23(19):4616-4618.
[5]周志宇,韦成聪,赵冠焱,等.颅脑损伤后脑脊液C反应蛋白动态变化及临床意义[J].中华实用诊断与治疗杂志,2013,27(2):118-120.
[6]Clyne B,Olshaker JS.The C-reactive protein[J].J Emerg Med,1999,17(6):1019-1025.
[7]Nashel DJ,Petrone DL,Ulmer CC,et al.C-reactive protein:a marker for disease activity in ankylosing spondylitis and Reiter’s syndrome[J].J Rheumatol,1986,13(2):364-367
[8]叶应妩,王毓三.全国临床检验操作规程[M].3版.南京:东南大学出版社，2006:121-122.
[9]国家食品药品监督管理局医疗器械技术审评中心.体外诊断试剂分析性能评估系列指导原则(征求意见稿) [Z].2009-06-01
[10]宋 娜，张家云，余小红，等.两种检测方法测定C反应蛋白的比较[J].检验医学,2012,27(4):257-260.

相似文献/References:

备注/Memo

备注/Memo:
国家自然科学基金(31101283)
更新日期/Last Update: 2014-07-20