Dot-ELISA法检测血液及唾液HIV抗体的应用评价

评价人类免疫缺陷病毒1+2型抗体检测试剂盒(Dot-ELISA法)检测血清和唾液样本的临床性能。采用对照试验研究,选取背景清晰的研究对象200例,采集同一研究对象的血清和唾液样本,应用万泰生物药业公司生产的人类免疫缺陷病毒1+2型抗体检测试剂盒作为考核试剂,法国生物梅里埃公司生产的人类免疫缺陷病毒抗体诊断试剂盒(ELISA法)作为参考试剂,考核试剂检测结果与参考试剂及研究对象背景进行比较分析。考核试剂检测血清HIV抗体与参考试剂相比较,阳性符合率100%,阴性符合率100%,总符合率100%,Kappa值1.00,一致性为最强;考核试剂检测唾液HIV抗体与参考试剂检测结果相比较,阳性符合率98.78%,阴性符合率100%,总符合率99.50%,Kappa值0.99,一致性为最强。Dot-ELISA法人类免疫缺陷病毒1+2型抗体检测试剂盒对血清及唾液样本检测性能优越,适合HIV抗体快速筛查。

Evaluation of Dot ELISA Assay Used for HIV Antibody Detection in Blood and Saliva

The capability of HIV antibody diagnostic kit（ Dot-ELISA） used for HIV-1 and HIV-2 antibodies detection in serum and saliva was evaluated adopting comparison method to test 200 cases enrolled with clear backgrounds,and serum and saliva samples collected from the same case,using HIV1 ＋ 2 antibody diagnostic kit produced by Wan Tai Bio-Pharmaceutical Company,at the same time,HIV antibody diagnostic kit by BioM erieux（ ELISA method） kit was also used; both detection results were compared and analyzed. The positive,negative and total accordance rates for tested serum samples were all 100% and for tested saliva samples were 98. 78%,100% and 99. 50% respectively,and the Kappa values were 1. 00 and 0. 99 respectively,showing the highest consistency. Dot-ELISA method HIV1 ＋2 antibody diagnostic kit showed excellent detection capability and adapted to the rapid screening for HIV antibodies.