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某国产人类免疫缺陷病毒1型核酸定量检测试剂的临床试验研究
引用本文:周全华,王越,刘华,廖莉,陈玲,张媛媛,张敏. 某国产人类免疫缺陷病毒1型核酸定量检测试剂的临床试验研究[J]. 检验医学与临床, 2021, 18(5): 585-588. DOI: 10.3969/j.issn.1672-9455.2021.05.003
作者姓名:周全华  王越  刘华  廖莉  陈玲  张媛媛  张敏
作者单位:重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042;重庆市疾病预防控制中心微生物检测所,重庆 400042
基金项目:重庆市卫生和计划生育委员会医学科研项目;重庆市技术创新与应用发展专项面上项目
摘    要:目的 评价某国产人类免疫缺陷病毒1型(HIV-1)核酸定量检测试剂(考核试剂)和对比试剂的相关性及一致性.方法 采用国产HIV-1考核试剂和对比试剂,对197例标本进行平行检测.采用相关性分析、Bland-Altman模型等统计方法分析2种检测试剂之间的相关性和一致性.结果 197例标本中该国产HIV-1考核试剂与对比...

关 键 词:人类免疫缺陷病毒1型  病毒载量  相关性  一致性

A clinical trial study of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection reagent
ZHOU Quanhua,WANG Yue,LIU Hua,LIAO Li,CHEN Ling,ZHANG Yuanyuan,ZHANG Min. A clinical trial study of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection reagent[J]. Laboratory Medicine and Clinic, 2021, 18(5): 585-588. DOI: 10.3969/j.issn.1672-9455.2021.05.003
Authors:ZHOU Quanhua  WANG Yue  LIU Hua  LIAO Li  CHEN Ling  ZHANG Yuanyuan  ZHANG Min
Affiliation:(Department of Microbiology Laboratory,Chongqing Center for Disease Control and Prevention,Chongqing 400042,China)
Abstract:Objective To evaluate the correlation and consistency between a domestic human immunodeficiency virus type 1(HIV-1)nucleic acid quantitative detection reagent(assessment reagent)and contrast reagent.Methods The domestic HIV-1 assessment reagent and contrast reagent were used to parallel test the viral load of 197 samples.Correlation analysis,Bland-Altman model and other statistical methods were used to analyze the correlation and consistency between the two detection reagents.Results In 197 samples,the positive coincidence rate of the domestic HIV-1 assessment reagent and the comparison reagent was 98.94%,the negative coincidence rate was 100.00%,and the total coincidence rate was 98.98%.The linear regression equation was Y=0.98 X-0.04,and the correlation coefficient was r=0.968(R 2=0.937).The two reagents had a high consistency.Conclusion The domestic HIV-1 assessment reagent and the contrast reagent have good correlation and consistency.
Keywords:human immunodeficiency virus type 1  viral load  correlation  consistency
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