趋势分析方法在HIV血液筛查诊断试剂评价中应用.pdfVIP

趋势分析方法在 HIV 血液筛查诊断试剂评价中的应用  宋爱京黄维金许四宏聂建辉李秀华赵晨燕刘强王佑春* 中国食品药品检定研究院艾滋病性病病毒疫苗室 卫生部生物技术产品检定方法及其标准化重点实验室，北京 100050 摘要：目的探索趋势分析方法用于 HIV 血液筛查诊断试剂评价方法收集整理采 用同一批次国家标准品进行批批检验的 HIV 血筛试剂 A 、B 和 C 的批检测数据， 对灵敏度样品、阴性参考品符合率以及不同浓度和不同基因型的固定样品的检测 结果进行趋势分析，理论均值±2SD 为警戒线，±3SD 为行动线，观察各诊断试 剂的检测指标变化趋势。结果趋势分析表明，在观察时间内，A 试剂质量稳定， 未见超过行动线的批次，B 和 C 试剂特异性和灵敏度提高等变化均在趋势分析中 得以体现。结论我国血液筛查试剂质量稳定，趋势分析可发现试剂质量变化，从 而可尝试用于 HIV 体外诊断试剂的稳定性评价 关键词：人类免疫缺陷病毒；血液筛查；诊断试剂；趋势分析 Trends analysis was used in the evaluation of HIV blood screening diagnostic kits Song Aijing，Huang Weijin ， Xu Sihong ， Nie Jianhui ， Zhao Chenyan ， Liu Qiang ， Wang Youchun* （National Institutes for Food and Drug Control, Beijing 100050) ABSTRACT ：Objective To explore the method of trend analysis on HIV blood screening diagnostic kit. Methods The lot release data of HIV blood screening diagnostic kit was analyzed retrospectively. The detecting results were collected from three manufactures that used the same batch national standard as the lot release standard. The detecting results of sensitivity panel, the coincidence rate of negative reference and the fixed samples with different concentration or different genotypes were calculated separately. The value of mean ± 2SD was used as the warning threshold and the value of mean± 3SD was used as the action threshold. The trends of selected observation value of each batch were observed. Results Through observation and analysis of the trends of HIV blood screening diagnostic reagents, it suggests that the quality of those kits were stable during the observation period. The improvement of the sensitivity and specificity of reagent B and C were shown in the process of trends analysis. Conclusion The qualities of Chinese HIV blood screening diagnostic kit were stable. Trend analysis can be used for the stable evaluation of HIV in vitro diagnostic reagents KEY WORDS : HIV ；Blood screening ；Diagnostic kits ；Trend