第四代HIV抗原抗体检测试剂在血液筛查中的应用

目的研究第四代HIV抗原抗体检测试剂在血液筛查中的应用价值。方法对第四代HIV抗原抗体检测试剂进行灵敏度和重复性实验；分别采用第三代HIV抗体检测试剂和第四代HIV抗原抗体检测试剂对血液样本进行初复检，对第三代试剂检测阴性第四代试剂检测阳性的样本采用HIV核酸检测方法进行确认。结果第四代HIV抗原抗体检测试剂最低抗原检出浓度为1．25U／mL，孔间精密度为3．2％；2009年10月~2011年3月，共筛查样本23480例，其中13例第三代试剂结果阴性而第四代试剂结果阳性，经HIV核酸检测的方法进行确认，全部结果均为阴性。结论在血液筛查中引入第四代HIV检测试剂的试剂功效尚待进一步验证，在已经广泛开展HIV抗体检测的基础上，引入第四代HIV抗原抗体检测试剂还是引入核酸检测具有更好的成本效益比，是一个值得待探讨的课题。

Application of 4th generation reagents for the detection of HIV antigen and antibody in blood screening

ABSTRACT] Objective To study the application of 4t~-generation HIV reagents for detecting HIV antigens and antibodies in blood screening. Methods The sensitivity and repeatability experiments were tested respectively. All samples were detected by 3%generation HIV reagents for only detecting HIV antibody and 4th-generation HIV reagents for detecting HIV antigens and antibodies, respectively, and the samples which were positive in 4th-generation HIV reagents detecting but negative in 3th-generation HIV reagents were confirmed by HIV nucleic acid detections. Results The minimum detectable concentration of HIV antigen was 1.25 U/mL and the precision was 3.2% for 4%generation HIV reagent. In tolal 23 480 samples had been screened from October 2009 to March 2011, 13 samples were positive in 4th-generation HIV reagent detecting but negative in HIV 3%generation HIV reagent, all of them were confired negative by HIV nucleic acid detection. Conclusion The efficacy of HIV detection attribute to applying 4th-generation HIV reagent in blood screening remains to be further verified. Applying 4th-generation HIV reagent or HIV nucleic acid detection which would have better cost-effectiveness was a problem to be researched.