CAJ | 학술논문

目的评价三代ELISA及四代ELISA对于HIV早期感染血样的灵敏度、窗口期和一致率.方法收集2008至2010年在沈阳市的男男同性恋人群随访中发现HIV抗体阳转及中国医科大学附属第一医院就诊患者中发现的蛋白印迹试验(WB)确认带型不全患者HIV早期感染者血浆67份,进行三代ELISA、四代ELISA、WB确认试验及HIV-1 RNA检测.比较三代ELISA、四代ELISA对阳转期标本的检测灵敏度、一致率并动态观察血清阳转过程分析窗口期.三代与四代ELISA试剂灵敏度比较卡方检验进行统计学分析.结果 67份早期HIV-1感染者血清标本中,三代ELISA检出56份阳性,11份阴性,灵敏度83.6％(95％ CI72.5％～91.5％),四代ELISA检出63份阳性,1份灰区,3份阴性,灵敏度94.0％(95％ CI 85.4％～98.3％),四代ELISA灵敏度高于三代ELISA(x2=16.1,P＜0.01).三代ELISA与四代ELISA一致率86.6％(95％ CI76.0％～93.7％).三代ELISA阳性者感染时间最早为16 d,四代ELISA阳性者感染时间最早为9d.三、四代ELISA窗口期存在明显的个体差异.结论四代ELISA对于HIV早期感染标本的检测灵敏度明显高于三代ELISA,窗口期更短.四代ELISA更适用于高危人群中的HIV早期感染的筛查.
목적 평개삼대ELISA급사대ELISA대우HIV조기감염혈양적령민도、창구기화일치솔.방법 수집2008지2010년재침양시적남남동성련인군수방중발현HIV항체양전급중국의과대학부속제일의원취진환자중발현적단백인적시험(WB)학인대형불전환자HIV조기감염자혈장67빈,진행삼대ELISA、사대ELISA、WB학인시험급HIV-1 RNA검측.비교삼대ELISA、사대ELISA대양전기표본적검측령민도、일치솔병동태관찰혈청양전과정분석창구기.삼대여사대ELISA시제령민도비교잡방검험진행통계학분석.결과 67빈조기HIV-1감염자혈청표본중,삼대ELISA검출56빈양성,11빈음성,령민도83.6％(95％ CI72.5％～91.5％),사대ELISA검출63빈양성,1빈회구,3빈음성,령민도94.0％(95％ CI 85.4％～98.3％),사대ELISA령민도고우삼대ELISA(x2=16.1,P＜0.01).삼대ELISA여사대ELISA일치솔86.6％(95％ CI76.0％～93.7％).삼대ELISA양성자감염시간최조위16 d,사대ELISA양성자감염시간최조위9d.삼、사대ELISA창구기존재명현적개체차이.결론 사대ELISA대우HIV조기감염표본적검측령민도명현고우삼대ELISA,창구기경단.사대ELISA경괄용우고위인군중적HIV조기감염적사사.
Objective To evaluate the performance of the third generation ELISA and the fourth generation ELISA for HIV-1 diagnosis assays on acute and early HIV-1 infected samples.Methods Sixtyseven acute/early HIV-1 infected samples were collected from the follow-up gays with seroconversion in Shen Yang city and from clinical patients in the First Affiliated Hospital of China Medical University with incomplete HIV-1 specific bands in western blot between 2008 and 2010.Third generation ELISA,fourth generation ELISA,western blot and HIV-1 viral load detecting were used for detecting these samples.The sensitivity,consistency were compared between third generation ELISA and fourth generation ELISA to detect the seroconversion samples and the window periods were abserved.Chi square test was used for statistical analysis.Results In the 67 acute/early HIV-1 infected samples,56 were HIV positive and 11 were HIV negative by the third generation ELISA.The sensitivity of the third generation ELISA was 83.6％ (95％ CI:72.5％ -91.5％); 63 were HIV positive,1 was at gray zone and 3 were HIV negative by the fourth generation ELISA.The sensitivity of the fourth generation ELISA was 94.0％ (95％ CI:85.4％ -98.3％),higher than the third generation ELISA(x2 =16.1,P ＜0.01).The consistency of the third generation ELISA and the fourth generation ELISA was 86.6％ ( 95％ CI:76.0％ - 93.7％).The earliest third generation ELISA positive sample was the sample collected 16 days after HIV infection and the earliest fourth generation ELISA positive sample was the sample collected 9 days after HIV infection.There was significantly different on the window periods between the third generation ELISA and the fourth generation ELLSA Conclusion The fourth generation ELISA had a higher sensitivity and shorter window period on acute/early HIV infected samples than the third generation ELISA,which is more suitable for the HIV early infection screening on high risk populations.