CAJ | 학술논문

目的评价和反馈国产 HIV 确证试剂的临床使用情况.方法以进口 MP 试剂和国产澳亚试剂对203份 HIV 抗体初筛阳性的样本进行联合确证检测,以前者作为金标准进行比对分析;通过对 HIV PT 考核品的检测和血清库资料的比照,对国产澳亚试剂进行方法和应用评价.结果国产澳亚试剂和进口 MP 试剂检测结果的一致性为66.00%;国产澳亚试剂的检测灵敏度95.00%,特异度为37.86%,假阴性率为5.00%,假阳性率为62.14%,功效率为66.01%.5份 HIV PT 考核品检测中,国产澳亚试剂有1份考核品确证结果与国家考核结果不一致,同时,3份阳性考核品的 WB 条带均有缺失.血清库资料显示,国产澳亚试剂检测结果呈“HIV 抗体不确定”的比例明显高于相应进口 MP 试剂(p<0.01);在“HIV 抗体不确定”病例 WB 带型分布方面,进口 MP 试剂带型主要集中在核心抗体 p24和包膜抗体 gp160,国产澳亚试剂带型主要集中在包膜抗体 gp160;“包含 p24”、“包含 gp160”和“包含 p66”三种带型的率在两种试剂间有统计学差异(p<0.001,p<0.001和 p<0.01).结论与进口 MP 试剂相比,国产澳亚试剂易出现“HIV 抗体不确定”判定,试剂特异性有待提高.
목적평개화반궤국산 HIV 학증시제적림상사용정황.방법이진구 MP 시제화국산오아시제대203빈 HIV 항체초사양성적양본진행연합학증검측,이전자작위금표준진행비대분석;통과대 HIV PT 고핵품적검측화혈청고자료적비조,대국산오아시제진행방법화응용평개.결과국산오아시제화진구 MP 시제검측결과적일치성위66.00%;국산오아시제적검측령민도95.00%,특이도위37.86%,가음성솔위5.00%,가양성솔위62.14%,공효솔위66.01%.5빈 HIV PT 고핵품검측중,국산오아시제유1빈고핵품학증결과여국가고핵결과불일치,동시,3빈양성고핵품적 WB 조대균유결실.혈청고자료현시,국산오아시제검측결과정“HIV 항체불학정”적비례명현고우상응진구 MP 시제(p<0.01);재“HIV 항체불학정”병례 WB 대형분포방면,진구 MP 시제대형주요집중재핵심항체 p24화포막항체 gp160,국산오아시제대형주요집중재포막항체 gp160;“포함 p24”、“포함 gp160”화“포함 p66”삼충대형적솔재량충시제간유통계학차이(p<0.001,p<0.001화 p<0.01).결론여진구 MP 시제상비,국산오아시제역출현“HIV 항체불학정”판정,시제특이성유대제고.
Objective To evaluate and feedback the clinical application of the domestic confirmation reagent of HIV antibody. Methods The imported confirmation reagent (MP) was regarded as gold standard and 203 HIV antibody screening positive specimens were detected for the methodological evaluation of the domestic confirmation reagent, five HIV PT assessment samples and routine samples were tested for the application evaluation. Results The consistency of the imported and domestic confirmation reagent was 66.00%, the sensitivity, specificity, false negative rate, false positive rate and efficiency of the domestic confirmation reagent was 95.00%, 37.86%, 5.00%, 62.14% and 66.01% respectively. Among the five assessment samples, the result of one sample was different between the domestic and imported confirmation reagent; the WB bands of three positive samples detected by domestic confirmation reagent were incomplete. In routine test, the proportion of “indeterminate HIV WB” detected by domestic reagent was higher than that of imported reagent (p<0.01). The WB bands of the“indeterminate HIV WB”of imported reagent were focus on p24 and gp160, and WB bands of the domestic reagent were focus on gp160. The rates of the band pattern of“containing p24”, “containing gp160” and “containing p66” between the two reagents had significant differences (p<0.001, p<0.001 and p<0.01 respectively). Conclusion As compared with the imported confirmation reagent, the domestic confirmation reagent mainly demonstrated as “Indeterminate HIV WB”, the specificity of the domestic confirmation reagent should be improved.