艾滋病初筛实验室中酶联免疫吸附试验检测HIV抗体影响因素研究

Study on Influential Factors of Enzyme linked Immunosorbent Assay for HIV Antibody Detection in AIDS Screening Laboratory

目的 探讨酶联免疫吸附试验(ELISA)检测HIV抗体过程中的影响因素。方法 选取2010年8月至2019年12月期间,在我单位参加自愿咨询检测(VCT)人群,娱乐场所人群及其他羁押人员共有8 385例接受HIV抗体检测作为研究对象。在其10年间,不同时间内采集他们静脉血样,共用过厦门新创,珠海丽珠和北京万泰的ELISA试剂盒进行检测HIV抗体,分析艾滋病初筛阳性结果与确证阳性结果,研究影响初筛结果准确性的相关因素。结果 在8 385例受检者中,艾滋病初筛结果为阳性47例,确证阳性32例,15例为阴性,准确率为68.09%。结论 酶联免疫吸附试验是HIV感染重要筛查方法,通过初筛检测试验,能够初步筛查检出HIV抗体。在检测的过程中,标本质量、试剂选取以及操作的规范性,均会对检测结果的准确性产生影响,务必严格加强实验前、中、后的质量控制。其次,由于国家HIV检测策略为了不漏检HIV抗体阳性者,酶联免疫试剂必须有较高的敏感性,使试剂的检测限度有一定的宽幅,这样HIV抗体初筛就会存在一定假阳性。所以,初筛阳性结果与确证阳性结果不相符并不存在矛盾性。

Objective To explore the influencing factors in the process of detecting HIV antibody by enzyme-linked immunosorbent assay.Methods From August 2010 to December 2019,8385 people who participated in voluntary counseling and testing(VCT)in our unit,people in entertainment places and other detainees received HIV antibody testing as the research object.In his 10 years,he collected venous blood samples from them at different times,shared ELISA kits from Xiamen Xinchuang,Zhuhai Lizhu and Beijing Wantai to detect HIV antibody by ELISA,analyzed the positive results of AIDS preliminary screening and confirmed positive results,and studied the related factors affecting the accuracy of preliminary screening results.Results Among 8385 subjects,47 were positive in the preliminary screening of AIDS,32 were confirmed positive,15 were negative,and the accuracy rate was 68.09%.Conclusion Enzyme linked immunosorbent assay is an important screening method for HIV infection.Through the preliminary screening test,HIV antibody can be preliminarily screened.In the process of detection,the quality of samples,the selection of reagents and the standardization of operation will affect the accuracy of detection results.It is necessary to strictly strengthen the quality control before,during and after the experiment.Secondly,in order not to miss HIV antibody positive persons,the national HIV testing strategy must ensure that the ELISA reagent has a high sensitivity,so that the detection limit of the reagent has a certain breadth,so that there will be some false positives in the initial screening of HIV antibodies.Therefore,there is no contradiction between the initial screening positive results and the confirmed positive results.