HIV区分抗原抗体检测试剂指导下的HIV确证流程优化  

Optimization of the HIV Confirmation Process Guided by HIV Test that Distinguishes Between Antigen and Antibody

作　　者：石武 杨文娟[1] 魏垠昊 王中浩 罗岚[1] 陶传敏[1] Shi Wu;Yang Wenjuan;Wei Yinhao(Department of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China)

机构地区：[1]四川大学华西医院实验医学科,四川成都610041

出　　处：《四川医学》2023年第6期585-592,共8页Sichuan Medical Journal

摘　　要：目的探讨人类免疫缺陷病毒(HIV)区分抗原抗体检测试剂对HIV确证流程的指导意义,并对现有的确证流程进行优化。方法回顾性分析2021年1至12月我院接受HIV区分抗原抗体检测试剂筛查患者数据,分析试剂的检测值和抗原抗体反应模式对HIV感染者和假阳性者的区分能力,探讨基于HIV抗原抗体反应模式优化HIV确证流程的可行性。结果2021年接受HIV区分抗原抗体检测试剂筛查的患者共225094例,其中676例筛查阳性,513例真阳,2例失访,总体阳性预测值达76.11%。区分抗原抗体检测试剂检测值可以区分真阳性者(即HIV感染者)和假阳性者,检测值越高,阳性预测值越高(Z=22.033,P<0.001),受试者工作特征曲线下面积达0.995,最佳阈值为24.90,此时方法灵敏度为96.70%,特异度为98.10%。区分抗原抗体检测试剂反应模式同样可以区分真阳性者和假阳性者,其三种反应模式中,“抗原抗体双阳性(Ag+Ab+)”阳性预测值最高(卡方检验及两两比较均P<0.05),在本研究中高达100%。此外,区分抗原抗体检测试剂反应模式对HIV确证流程具有指导意义,7例反应模式呈抗原单阳性(Ag+Ab-)患者,首次HIV-RNA定量均>5000拷贝/ml,但此时HIV抗体确证试验(免疫印迹试验,WB)均未达到阳性标准,因此这类患者应直接采用HIV-RNA定量进行确证,证实了《全国艾滋病检测技术规范》技术规范中确证流程的价值。在反应模式呈Ag+Ab+的患者中,尽管HIV-RNA定量相对于WB的诊断效能优势并不显著,但可以显著减少诊断时间(V=78,P<0.001),有助于加快患者(尤其是急性HIV感染者)启动治疗,因此我们对技术规范中的确证流程进行优化,推荐Ag+Ab+患者直接采用HIV-RNA定量进行确证。在实践中,对Ag+Ab-和Ag+Ab+患者直接进行HIV-RNA定量显著缩短了急性HIV感染者的确证耗时。结论对HIV区分抗原抗体检测试剂检测值高的患者和反应模式呈Ag+Ab-的患者,应当加强患者的管�Objective To explore significance of HIV test that distinguishes between antigen and antibody in guiding HIV confirmation process,and to optimize the existing confirmation process.Methods From January to December 2021,data were from patients screened for HIV with HIV test that distinguishes between antigen and antibodywere retrospectively analyzed.Test ability was determined to differentiate true positive patients(HIV infected patients)from false-positive patients and significance of antigen-antibody reaction pattern in guiding selection of confirmatory tests.Results Total 225,094 patients were screened with HIV test that distinguishes between antigen and antibody in 2021,of which 676 screened positive,513 true positive and 2 were lost to follow-up,giving an overall positive predictive value of 76.11%.The detected value of test could differentiate true positive patients from false-positive patients,the higher the detected value,the higher the positive predictive value(Z=22.033,P<0.001).The area under the receiver operating characteristic curve was 0.995,with an optimal threshold of 24.90,which given a method sensitivity of 96.70%and specificity of 98.10%.The reaction patterns of the test could differentiate true positive patients from false-positive patients,among three reaction patterns of the test,pattern of“positive for both antigen-antibody(Ag+Ab+)”had the highest positive predictive value(P<0.05 for both chi-square and two-way comparisons),reaching 100%in this study.In addition,reaction patterns of the test were significant in guiding the process of HIV confirmation.The national guideline for detection of HIV/AIDS suggests that patients with a reaction pattern of“positive for single antigen(Ag+Ab-)”were confirmed directly by HIV-RNA quantification test.There were 7 Ag+Ab-patients confirmed with HIV infection in this study,their HIV-RNA quantification tests were all>5000 copies/ml.However,none of them had a positive first antibody confirmatory test(western blotting,WB).This result confirmed value of c

关 键 词：HIV区分抗原抗体检测试剂 反应模式 蛋白印迹试验 HIV-RNA定量 

分 类 号：R446[医药卫生—诊断学] R512.91[医药卫生—临床医学]