HIV抗体诊断试剂特异性样品库的建立

Establishment of Sample Bank for Evaluating Specificity of HIV Antibody Diagnostic Assays

目的建立评价HIV抗体诊断试剂特异性的样品库。方法从不同地区收集献血者样品990份,采用HIV抗体检测试剂和HIV抗原抗体联合检测试剂进行筛选,对结果不一致样品采用HIV抗体确认试剂和HIV核酸检测试剂进行检测。结果筛选出985份样品组成样品库,各试剂检测样品库的特异性为97.77%~99.90%,其“δ”为-1.774^-4.690,且两者具有较好的相关性。结论该样品库样品能够反映试剂特异性的差异,可用于对试剂特异性的分析。

Objective To establish sample bank for evaluating specificity of HIV antibody diagnostic assays. Methods 990 plasma samples were collected from blood donors in different regions of China and tested for HIV antibody and HIV antigen/antibody with HIV antibody diagnostic assays and HIV antigen/antibody diagnostic assays. All the samples with discrepancy results would be tested for HIV RNA and confirmed with HIV blot. Results 985 samples were selected to comprise sample bank. The specificity and δ value were at ranges of 97.77%～99.90% and -1. 774～-4. 690 respectively for different diagnostic assays when they were used to test this sample bank. The specificity and δ value were showed to be closely relevant. Conclusion The samples in this bank can differentiate specificity of different HIV antibody diagnostic assays and can be used to evaluate specificity of assays.