[1]鲁燕飞,姚尧.人降钙素原定量检测方法学评价[J].现代检验医学杂志,2015,30(05):129-131.[doi:10.3969/j.issn.1671-7414.2015.05.040]
　LU Yan-fei,YAO Yao.Quantitative Detection System Performance Evaluation of Human Procalcitonin[J].Journal of Modern Laboratory Medicine,2015,30(05):129-131.[doi:10.3969/j.issn.1671-7414.2015.05.040]
点击复制

人降钙素原定量检测方法学评价()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年05期
页码:
129-131
栏目:
研究简报·实验技术
出版日期:
2015-12-10

文章信息/Info

Title:
Quantitative Detection System Performance Evaluation of Human Procalcitonin
作者:
鲁燕飞1; 姚尧2
1.湖北省黄冈市中心医院检验科，湖北黄州438000； 2.黄冈职业技术学院医药卫生学院，湖北黄州438002
Author(s):
LU Yan-fei1; YAO Yao2
1.Department of Clinical Laboratory， Central Hospital of Huanggang City，Hubei Huangzhou 438000，China； 2.Medicine and Health School，Huanggang Polytechnic College，Hubei Huangzhou 438002，China
关键词:
人降钙素原; 定量检测; 方法学评价
分类号:
R446.112
DOI:
10.3969/j.issn.1671-7414.2015.05.040
文献标志码:
A
摘要:
目的评价深圳市晋百慧生物有限公司生产的人降钙素原(PCT)定量检测系统(简称晋百慧PCT定量检测系统)的检测性能。方法以罗氏PCT检测系统为参比系统，晋百慧PCT定量检测系统为待评系统。在待评系统连续测定两浓度质控品(0.5 ng/ml，10 ng/ml)20次计算其变异系数(CV)评价其重复性，连续测定20个工作日计算其CV评价其天间不精密度；根据EP6-A文件配置不同标本浓度(0，0.5，1，2，5，10，20，50 ng/ml)计算其线性范围。收集200例患者血清标本，根据EP9-A3文件在待评系统与参比系统进行比对试验判断两者的可比性。结果待评系统重复性为不同浓度质控品的CV分别为3.59%，1.57%，天间不精密度分别为7.02%，3.82%；在0～50 ng/ml范围为线性。比对试验线性决定系数R2=0.968 6(Pearson相关分析α=0.05，P<0.001)，在有医学意义浓度0.5 ng/ml处相对偏差为9%。结论晋百慧PCT定量检测系统精密度好，检测范围宽，与参比系统具有可比性，能满足临床检测要求。
Abstract:
ObjectiveTo evaluate the quantitative detection system performance of human procalcitonin (PCT) produced by Gene Bio Health．MethodsRoche PCT detection system was used as the reference system and Gene Bio Health PCT quantitative detection system was used as evaluated system．In evaluated system，the repeatability was evaluated by continuous determination two concentration quality control (0.5，10 ng/ml) 20 times to calculate the coefficient variation (CV)．Between day imprecision was evaluated by continuous determination 20 working days to calculate the CV．The linear range was calculated according to the EP6-A file by determination different samples (0，0.5　ng/ml，concentration of 1，2，5，10，20 and 50 ng/ml)．Comparability test was done according to EP9-A3 file by determination 200 patients serum samples between both systems．ResultsThe CV of repeatability was 3.59% and 1.57%，respectively．The CV of between days imprecision was 7.02% and 3.82%，respectively．The linear was from 0 ng/ml to 50 ng/ml．Comparison test of determination R2=0.968 6 (Pearson correlation analysis，α=0.05，P<0.001)．The relative deviation was 9% in medical significance concentration of 0.5 ng/ml．ConclusionCompared with the Roche PCT，the Gene Bio Health PCT quantitative testing system had a good precision，a wide linear range，and a good comparability，which was enough to meet the clinical requirement．

参考文献/References:

［1］张婷，丁爽，李洪春，等．血清PCT，CRP及NE-U%联合检测对细菌性血流感染的早期诊断价值［J］．现代检验医学杂志，2014，29(3)：75-77． Zhang T，Ding S，Li HC，et al．Early diagnostic value of combined detection of serum PCT，CRP and NEU% in patients with bacterial bloodstream infection［J］．J Mod Lab Med，2014，29(3)：75-77．
[2]CLSI．Evaluation of the linearity of quantitative measurement procedures a statistical approach：Approved Guideline［S］．Wayne：PA，CLSI EP6-A，2003．
[3]中华人民共和国国家质量监督检验检验总局，中国国家标准化管理委员会．体外诊断检验系统自测用血糖监测系统通用技术条件(GB/T 19634-2005)［S］．北京：中国标准出版社，2005． General Administration of Quality Supervision，Inspection and Quarantine of the People’s Republic of China，Standardization Administration of the People’s Republic of China．In vitro diagnostic test systems-general technical requirements for blood-glucose monitoring systems for self-testing(GB/T 19634-2005)［S］．Beijing：China Standard Publishing House，2005．
[4]CLSI．Method Comparison and bias estimation using patient samples［S］．Wayne：PA，CLSI EP9-A3，2013．

相似文献/References:

[1]解 娟,刘文康,李 玲,等.化学发光分析法定量检测住院患者HBV血清标志物及临床意义[J].现代检验医学杂志,2017,32(03):40.[doi:10.3969/j.issn.1671-7414.2017.03.011]
　XIE Juan,LIU Wen-kang,LI Ling,et al.Clinical Implication of HBV Serum Markers Detected with Chemiluminescent Immunoassay in Inpatients of Xi’an Area[J].Journal of Modern Laboratory Medicine,2017,32(05):40.[doi:10.3969/j.issn.1671-7414.2017.03.011]

备注/Memo

备注/Memo:
作者简介：鲁燕飞(1973-)，女，主管技师，主要从事临床血液学检验工作，Tel：0713-8625077，E-mail：468929277@qq.com。
更新日期/Last Update: 1900-01-01