摘要
目的:评价威高AutolumiS3000型全自动免疫分析仪对丙肝抗体(抗-HCV)的分析性能评价。方法:收集住院及门诊患者的血清标本119份,其中无反应性样本40份、有反应性样本59份以及确诊样本20份,依据国家卫生行业标准《临床定性免疫检验重要常规项目分析质量要求》(WST494-2017)的要求,采用AutolumiS3000型全自动免疫分析仪,以丙型肝炎为检测项目,对检测抗-HCV的精密度、检出限、阴阳性符合率等性能以雅培i2000型全自动化学发光仪为参照进行验证试验。结果:AutolumiS3000型全自动免疫分析仪检测抗-HCV的批内及批间精密度(CV%)均符合要求;室间质量评价(EQA)留样再检测符合率为100%;检出限为0.15 NCU/ml;阴阳性符合率为100%;检测抗-HCV无反应性、吸光度与临界值之比(S/CO)≥8.0时样本结果与i2000的符合率均为100%,S/CO为1.01～4.0和4.01～8.0时,样本结果的符合率为13.3%和55.6%;22例抗-HCV反应性标本重组免疫印迹试验(RIBA)确证结果:确认阳性3例,不确定8例,其余为阴性。结论:AutolumiS3000型全自动免疫分析仪检测抗-HCV的分析性能良好,能满足临床需求,适用于临床标本的常规检测,对于弱阳性样本,建议进行补充实验来明确诊断。
Objective: To evaluate the analysis performance of full-autoimmune analyzer of AutolumiS 3000 for antibody of hepatitis C virus (HCV). Methods: 119 serum samples of patients in hospital and outpatient were selected, which included 40 patients without reaction, 59 patients with reaction and 20 confirmed patients. According to the requirements of national hygiene industrial standard (WST494-2017), the HCV was used as detection item, and the verification tests of precision, detection limit, masculine coincidence rate and other performance of detecting antibody of HCV were implemented. Results: The intra-batch and inter-batch precision (CV %) of detecting antibody of HCV of AutolumiS 3000 met the requirements. The conformance rate of retested retention sample of equipment quality assessment (EQA) of inter-laboratory was 100%. The detection limit was 0.15 NCU/ml, and the positive and negative coincidence rate was 100%. The coincidence rate between results and i2000 was 100% when there was reaction in detecting antibody of HCV and when the ratio of absorbance and cutoff value (S/CO) was larger than or equal to 8.0. And it was 13.3% and 55.6% when S/CO was 1.01-4.0 and 4.01-8.0, respectively. And the results of recombinant immunoblotting assay (RIBA) of 22 reactive samples for antibody of HCV indicated that 3 cases were positive, 8 cases were uncertainty, and others were negative. Conclusion: The analysis performance of AutolumiS 3000 analysis system is good in detecting antibody of HCV, and it can meet the clinical requirements. And it is suitable for routine detection of clinical specimens. For samples with weak positivity, it is suggested to conduct supplementary experiments to make a clear diagnosis.
作者
孙梅
耿建利
曲业敏
王晓伟
姚继承
邵淑丽
孙胜波
王明义
SUN Mei;GENG Jianli;QU Ye-min(Central Laboratory,Weihai Municipal Hospital Affiliated to Dalian Medical University,Weihai 264200,China)
出处
《中国医学装备》
2019年第4期42-45,共4页
China Medical Equipment
基金
国家科技重大专项艾滋病和病毒性肝炎等重大传染病防治科技重大专项(2009ZX10004-719)"全自动粒子化学发光法测定艾滋病和病毒性肝炎等重大传染病研发技术平台的建设"
关键词
丙型肝炎抗体
化学发光免疫分析
性能评价
Antibody of hepatitis C
Chemiluminescence immunoassay
Performance evaluation
