新建HIV-1新发感染快速检测方法与ELISA法的比较研究

Comparison of HIV-1 recent infection measured by the dot immuno-gold silver staining filtration rapid assay and ELISA

目的初步评价艾滋病病毒Ⅰ型(HIV-1)新发感染快速检测方法,在横断面现场调查人群样本中的应用能力,并分析抗病毒治疗对该方法的影响。方法应用该研究前期构建的金标银染免疫渗滤快速检测方法(简称快速检测法),检测2014年江西省国家级哨点新报告的HIV-1感染者和抗病毒治疗者的样本。将新发感染判定的结果与限制性抗原亲和力方法(LAg Avidity EIA,简称LAg法)、BED捕获酶免疫法(BED CEIA,简称BED法)进行一致性和相关性比较,进一步分析三种方法检测抗病毒治疗者样本的差异。结果纳入研究的新发感染者样本共122份,快速检测法与LAg法、BED法判定新发感染结果的一致率分别为94.26%和88.52%。快速检测法检测探针灰度值与LAg法和BED法的ODn值具有较高的相关性。R2分别为0.947 5与0.923 4。经配对卡方检验分析,快速检测法判定新发感染的比例显著低于BED法(P<0.001),而与LAg法差异无统计学意义(P=0.257)。纳入研究的抗病毒治疗者的样本共117份,快速检测法对其误判为近期的比率为16.24%(19/117),而BED方法和LAg方法的误判比率分别为16.24%(19/117)、14.53%(17/117)。另外,快速检测法对所有样本常规HIV抗体检测结果均正确。结论金标银染免疫渗滤快速检测方法检测HIV-1新发感染具有良好的准确性和实际应用性。但抗病毒治疗对快速检测法影响较大,应在横断面人群调查时删除抗病毒治疗样本。

Objective To evaluate the applicability of the dot immuno-gold silver staining filtration rapid assay for simultaneous detection of human immunodeficiency virus type I （HIV-1） antibody and recent infection in cross- sectional specimens, and the influence of antiretroviral treatment （ART） on it. Methods The specimens from the newly reported HIV/AIDS cases and patients with ART over 12 months in 2014 in Jiangxi province were detected by rapid assay, limiting antigen avidity enzyme immunoassay（LAg） and BED capture enzyme immunoassay（BED）, re- spectively. Agreement and correlation between rapid assay and other EIAs were analyzed, and the proportion of false recent infection （PFR） was assessed among three assays. Results A total of 122 newly reported HIV-1 speci- mens were tested. The agreement of rapid assay with Lag and BED for distinguishing recent from long-term HIV in- fections were 94.26% （kappa= 0.86） and 88.52% （kappa= 0.73）, and the corresponding R2 were 0. 9475 and 0. 9234, respectively. The PFR of rapid assay had no statistical difference with Lag （P=0. 257）, but lower than BED （P 〈 0. 001） through chi-square test. Of 117 specimens with ART, PFR of rapid assay was 16.24%, while those of Lag and BED were 6. 24% and 14.53 %. In addition, all specimens were classified correctly by the diagnostic performance of rapid assay. Conclusion Rapid assay has good performance in detecting of HIV-1 recent infection, but ART specimens should he excluded in cross-sectional survey.