摘要
目的通过对比分析3种进口第四代人类免疫缺陷病毒(HIV)抗原抗体诊断试剂检测HIV抗体和P24抗原的特异性及敏感性,评价这3种HIV检测试剂在临床实际应用中的意义。方法用HIV抗体阴性样品1 075份、HIV抗体阳性样品164份、BBI阳转血清盘(PRB92901-07)和7种不同稀释度的P24抗原阳性对照血清等,对3种进口第四代HIV检测试剂的敏感性和特异性进行分析。结果方法1、2、3检测HIV抗体特异性分别为92.9%、99.4%和99.3%,经统计处理,方法2特异性高于方法1,差异有统计学意义(χ2=59.7,P<0.01),方法3特异性高于方法1,差异有统计学意义(χ2=57.3,P<0.01),方法2和方法3特异性差异无统计学意义;3种试剂检测HIV抗体的敏感性一致,皆为100.0%;但其检测P24抗原的敏感性不同,方法3检测P24抗原的敏感性最高,可检出最高稀释度为1∶32的P24抗原阳性对照血清;而方法1和方法2检测P24抗原敏感性较低,只能检出最高稀释度为1∶16的P24抗原阳性对照血清;3种试剂检测BBI阳转血清盘AD第18天的HIV抗体检测结果为阳性,而第三代HIV抗体检测试剂检测血清盘第21天的HIV抗体检测结果为阳性。结论 3种进口第四代抗原抗体检测试剂敏感性均高于第三代检测试剂,能检出HIV感染窗口期的样品;3种试剂检测HIV抗体的敏感性一致,但检测P24抗原的敏感性和HIV抗体的特异性不一致,方法1检测HIV抗体的特异性较低,而方法3检测P24抗原的敏感性最高。
OBJECTIVE To compare and analyze the specificity and sensitivity of three imported fourth generation HIV antigen-antibody diagnostic reagents in detection of HIV antibodies and p24 antigen and evaluate the values of the three HIV detection reagents in clinical practice. METHODS By means of 1 075 negative HIV antibody samples, 164 positive HIV antibody samples, BBI seroconversion serum plate（PRB92901-07）, and 7 different dilutions of p^24 antigen-positive control serum, the sensitivity and specificity of the three imported fourth generation HIV reagents were analyzed. RESULTS The specificity of NO. I reagent in the detection of HIV antibody was 92.9%, NO. 2 reagent 99.4%, NO. 3 reagent 99.3%; the statistical analysis showed that the specificity of the NO. 2 reagent was higher than that of the NO. 1 reagent, the difference was significant（x^2=59.7,P〈0. 01） ; the specificity of the NO. 3 reagent was higher than that of the NO. 1 reagent, the difference was significant （X^2 =57.3 ,P〈0.01） ; the difference in the specificity between the NO. 2 reagent and the NO. 3 reagent was not significant. The sensitivity of all the three reagents in detection of HIV antibody was 100.0% but differed in detection of p^24 antigen, the sensitivity of the NO. 3 reagent in detection of p^24 antigen was the highest, and it could detect the highest dilution of 1 ： 32 p^24 antigen positive control serum; while the NO. 1 reagent and the NO. 2 reagent had low sensitivity in detection of p^24 antigen and could only detect the highest dilution of 1 ： 16 p^24 antigen positive control serum. The HIV antibody was tested positive for BBI seroconversion serum plate AD on the 18th day withthe three reagents but was tested positive on the 21st day with the third generation HIV reagents. CONCLUSION The sensitivities of the three imported fourth generation HIV reagents are higher than those of the third generation HIV reagents in detection in antigen and antibody and can detect the samples in window period of HIV infection. The three reagents have the similar sensitivity in detection of the HIV antibody but vary in the sensitivity in detection of p^24 antigen as well as in the specificity in detection of HIV antibody; the specificity of the NO. 1 reagent is low in detection of the HIV antibody, while the sensitivity of the NO. 3 reagent is the highest in detection of the p^24 antigen.
出处
《中华医院感染学杂志》
CAS
CSCD
北大核心
2014年第17期4412-4414,共3页
Chinese Journal of Nosocomiology
基金
国家质量监督检验检疫总局科研基金项目(2012IK248)
