Elecsys HIV Duo试剂诊断效能评价研究  

Study on evaluation of diagnostic efficacy of Elecsys HIV Duo assay

作　　者：黄继德 谭明凯 黄颖 肖云菊 石亚玲 HUANG Ji-de;TAN Ming-kai;HUANG Ying;XIAO Yun-ju;SHI Ya-ling(Clinical Laboratory,the Eighth Affiliated Hospital of Guangzhou Medical University,Guangdong Province,Guangzhou 510060,China)

机构地区：[1]广州医科大学附属市八医院检验科,广东广州510060

出　　处：《中国当代医药》2021年第22期20-23,共4页China Modern Medicine

摘　　要：目的评估人类免疫缺陷病毒(HIV)检测试剂Elecsys HIV Duo的检测性能,探讨HIV Duo的临床应用价值。方法参考临床化学定量检验程序性能验证指南评价检测方法的性能。收集广州医科大学附属市八医院2020年12月的105例初筛阳性HIV感染患者血清样本,验证Elecsys HIV Duo对HIV感染不同阶段的检出能力。结果三个水平样本批内精密度分别为4.03%、0.95%、0.81%,小于6.25%(1/4 TEa),批间精密度分别为4.7%、1.23%、1.66%,小于8.33%(1/3 TEa)。使用Elecsys HIV Duo试剂检测57份含潜在干扰物质的血清样本,特异性为100%。正确度:HIV-1抗体及p24抗原阴性和阳性符合率均为100%。检测能力方面,该检测试剂针对HIV p24抗原最低检出限为0.62 U/mL,HIV-1抗体在1 NCU/mL水平下仍可检出。抗干扰能力方面,对含20 mg/L胆红素、800 mg/L血红蛋白、2000 mg/L脂肪乳剂的样本进行检测,添加干扰物质前后测定值之间符合率≥80%。对105例已知阳性样本的检测结果显示,该系统能检出不同感染时期的阳性标本。结论Elecsys HIV Duo试剂盒能够分别检测HIV-1 p24抗原和HIV抗体,在HIV抗原抗体检测中的诊断价值良好,可应用于HIV感染的早期筛查。Objective To evaluate the detection performance of human immunodeficiency virus(HIV)detection reagent Elecsys HIV Duo,and to explore the clinical application value of HIV Duo.Methods The performance of the test method was evaluated according to the performance verification guidelines of clinical chemistry quantitative test procedure.A total of 105 serum samples of HIV positive patients were collected from the Eighth Affiliated Hospital of Guangzhou Medical University in December 2020 to verify the detection ability of Elecsys HIV Duo in different stages of HIV infection.Results The intra assay precision of three concentration samples were 4.03%,0.95%and 0.81%,respectively,which were lower than 6.25%(1/4 TEa).The interbatch precision were 4.7%,1.23%,1.66%,respectively,less than 8.33%(1/3 TEa).A total of 57 samples containing potential interfering substances were detected by Elecsys HIV Duo assay,and the results showed that the specificity of the assay was 100%.The coincidence rate of p24 antigen and HIV antibody negative and positive results were both 100%.The detection limit of p24 antigen was 0.62 U/mL,while HIV-1 antibody was still detectable at the level of 1 NCU/mL.Anti-interference ability:the samples containing 20 mg/L bilirubin,800 mg/L hemoglobin,and 2000 mg/L intralipid were detected by Elecsys HIV Duo assay.The coincidence rate between measured values before and after adding interference substances was≥80%.The detection results of 105 positive samples in different infection periods showed that the system can detect effectively.Conclusion HIV-1 p24 antigen and antibodies were detected by the Elecsys HIV Duo assay separately,and the assay has a good diagnostic value in HIV antigen and antibody detection,which has a great help in the diagnosis of early HIV-infected cases.

关 键 词：Elecsys HIV Duo HIV抗原抗体检测 性能验证 

分 类 号：R446.6[医药卫生—诊断学]