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近年来中国的艾滋病毒(HIV)感染人数以每年30％的速度增长,HIV感染者总数已超过60万人,感染者已从吸毒人员、献血员等高危人群扩展到社会各个阶层,我国已处于艾滋病泛滥前的关键时期。HIV诊断试剂盒是HIV防制工作中最重要的技术工具。用于人群筛检的HIV诊断试剂盒已历经三代,第一代试剂盒主要使用来自细胞培养的HIV病毒的裂解产物作为抗原;第二代产品使用基因工程重组抗原和/或人工合成肽作为抗原,使包被抗原中免疫优势区的比例明显增强,从而提高了试剂的灵敏度,而且标准化生产的相对更纯的抗原的使用使试剂的特异性和重复性均大为提高。前两代试剂均采用间接法原理,即先以抗原包被聚丙乙烯板,再加入待检血清,最后加入酶标记的抗人IgG
In recent years, the number of HIV infections in China has increased by 30% annually, and the total number of HIV-infected people has exceeded 600,000. The number of HIV-infected people has expanded from high-risk groups like drug users and blood donors to all sectors of society. China is already at A critical period before the AIDS pandemic. HIV diagnostic kits are the most important technical tool for HIV prevention. HIV diagnostic kits for human screening have been used for three generations. The first generation kits mainly use lysates of HIV virus derived from cell culture as antigens. The second generation uses genetically engineered recombinant antigens and / or synthetic peptides as antigens , The proportion of coated immunogen in the immunodominant region is significantly increased, thereby increasing the sensitivity of the reagent, and the use of a relatively pure antigen that is standardized to produce greatly enhances the specificity and repeatability of the reagent. The first two generations of reagents are used indirect method principle, that is coated with antigen first polypropylene plate, then added to be seized serum, and finally added enzyme-labeled anti-human IgG