VIDAS HIV Duo Assay试剂的特异性及敏感性

目的评价HIV抗原/抗体联合检测快速法(VIDAS HIV Duo Quick)和超敏法(VIDAS HIV Duo Ultra)试剂的特异性及敏感性。方法用这2种试剂和HIV抗体参比试剂,分别检测287份HIV感染或疑似感染者样品、1240份非HIV感染者血清/血浆样品,对与参比试剂检测结果不一致样品,进行抗体的确认及HIV p24抗原和RNA的检测,并比较其特异性和敏感性。用这2种试剂和HIV-1p24抗原参比试剂,分别检测3株病毒培养上清的系列稀释样品,并比较其检测p24抗原敏感性的差异。结果共检测1277份HIV抗体阴性样品和250份HIV抗体阳性样品,与参比试剂相比,快速法试剂的特异性为99.45%,敏感性为100%,而超敏法试剂的特异性为99.14%,敏感性为99.20%。两种试剂检测病毒株培养上清的敏感性均不低于HIV-1p24抗原参比试剂,且能检出HIV感染窗口期样品。结论这2种试剂在增加HIV p24抗原检测的情况下,对HIV抗体检测的特异性和敏感性均没有明显降低,并且能检测出HIV感染窗口期样品。

Specificity and Sensitivity of VIDAS HIV Duo Assay Kit

Objective To evaluate the specificities and sensitivities of VIDAS HIV Duo Quick kit and VIDAS HIV Duo Ultra kit for simultaneous detection of HIV antibody and antigen.Methods A total of 287 serum samples from the patients or doubtful patients with HIV infection and 1 240 serum samples from the patients without HIV infection were tested by VIDAS HIV Duo Quick kit,VIDAS HIV Duo Ultra kit and HIV antibody reference kit,separately.The samples with inconsistent test results with that by HIV antibody reference kit were further confirmed.The specificities and sensitivities of VIDAS HIV Duo Quick kit and VIDAS HIV Duo Ultra kit were compared with that of HIV antibody reference kit.Test the serially diluted culture supernatant of three HIV strains by VIDAS HIV Duo Quick kit,VIDAS HIV Duo Ultra kit and HIV-1 p24 reference kit separately and compare the sensitivities of the three kits in test for p24 antigen.Results A total of 1 277 samples were identified as HIV antibody negative,and 250 as positive.Compared with those of HIV antibody reference kit,the specificity and sensitivity of VIDAS HIV Duo Quick were 99.45% and 100%,and those of VIDAS HIV Duo Ultra kit were 99.14% and 99.20% respectively.However,the sensitivities of VIDAS HIV Duo Quick kit and VIDAS HIV Duo Ultra kit in test for culture supernatant of HIV strain were not less than that of HIV-1 p24 antigen reference kit.The samples from patients in window period could also be confirmed by VIDAS HIV Duo Quick kit and VIDAS HIV Duo Ultra kit.Conclusion On the basis of test for HIV p24 antigen,the specificities and sensitivities of VIDAS HIV Duo Quick kit and VIDAS HIV Duo Ultra kit in test for HIV antibody showed no significant decrease.Both the kits were suitable for the samples from patients in window period.