国产第4代人类免疫缺陷病毒化学发光试剂在血液筛查中的应用

Application of Domestic 4th Generation Human Immunodeficiency Virus Chemiluminescent Reagent in Blood Screening

目的通过与酶联免疫吸附试验(ELISA)试剂对比,探讨国产第4代人类免疫缺陷病毒(HIV)化学发光(CLIA)试剂的检测性能及其在血液筛查中的应用价值。方法分别使用国产第3代ELISA试剂、进口第4代ELISA试剂、国产第3代和第4代CLIA试剂对330份血清盘标本进行HIV检测,对检测结果进行对比分析。结果ELISA试剂的批内精密度较好,而批间精密度不如CLIA试剂,第4代CLIA试剂的批内和批间精密度均好于第3代。2种第4代试剂的阳性符合率最高(98.68%),但阴性符合率最低(92.11%)。第4代CLIA试剂与其他3种试剂均具有极好的一致性(K>0.8),且检测结果比较,差异无统计学意义(P>0.05)。2种ELISA试剂和第4代CLIA试剂均能检测出2个1∶800的强阳性稀释样本。所有试剂中第4代CLIA试剂的评价指标总体最好,检测灵敏度、特异度和准确度分别为100%、97.44%和99.12%。结论国产第4代CLIA试剂与其他3种试剂具有良好的一致性,且检测性能更加优秀,值得在血液筛查中推广使用。

Objective To explore the detection performance and application value of domestic 4th-generation human immunodeficiency virus(HIV)chemiluminescence reagent in blood screening by comparing with enzyme linked immunosorbent assay(ELISA).Methods A total of 330 serum panel samples were tested by domestic 3rd-generation ELISA reagent,imported 4th-generation ELISA reagent,domestic 3rd-generation and 4th-generation chemiluminescence analysis(CLIA)reagent respectively,and the results were comparatively analyzed.Results ELISA reagents had better within-run precisions,but the between-run precisions were not as good as CLIA reagents.The within-run and between-run precisions of 4th-generation CLIA reagent were better than those of 3rd-generation.The positive agreement of two 4th-generation reagents was the highest(98.68%),but the negative agreement was the lowest(92.11%).The 4th-generation CLIA reagent had excellent consistency with the other three reagents(K>0.8),and the results had no statistical difference(P>0.05).Except for 3rd-generation CLIA,all reagents could detect the two samples with 1∶800 dilution rate.The 4th-generation CLIA reagent had the best performance,and the sensitivity,specificity and accuracy were 100%,97.44%and 99.12%respectively.Conclusion The domestic 4th-generation CLIA reagent has good consistency with other three reagents,and the detection performance is more excellent.