HIV抗原抗体筛查结合核酸定量补充实验检测策略的临床应用评价

Clinical evaluation of HIV diagnosis strategy for the 4th generation antigen/antibody separating reagent screening combined with nucleic acid quantitative test as supplementary experiment

目的对艾滋病病毒（HIV）4代区分抗原抗体试剂筛查结合核酸定量补充实验的HIV检测策略临床应用进行评价。方法 2015年9月1日至2017年5月31日,HIV4代区分抗原抗体试剂筛查有反应的病例样本1 122例,用3代试剂双份复检、蛋白印迹法（WB）抗体确证,抗体不确定或阴性的样本采用核酸定量检测或随访检测。按2015版《全国艾滋病检测技术规范》中区分抗原抗体的抗体诊断策略对数据进行统计,分析4代试剂早期感染检出能力和HIV核酸定量检测作为补充实验的可行性。结果 1 122例样本中,非性病门诊筛查样本中,有反应的66例,均为Ag^-/Ab~＋;性病门诊筛查样本中,有反应的1 056例,其中4代试剂筛查Ag~＋/Ab~＋病例3例,Ag~＋/Ab^-32例。性病门诊的32例Ag~＋/Ab^-病例中,3代试剂Ab^-病例13例,占性病门诊初筛有反应病例的1.23%;26例进行了核酸定量检测,核酸检测率占81.3%（26/32）;抗体确证结果显示,WB阳性6例,WB阳性率为18.8%（6/32）。所有32例病例经WB抗体确证和/或核酸定量检测,结合CD4~＋T淋巴细胞和流行病史,均诊断为HIV感染。4代试剂筛查单独抗原有反应的,与HIV诊断阳性符合率为100%。按新的策略,共74例需进行核酸定量补充实验或随访检测,对补充实验选用核酸定量和随访的病例人数进行卡方检验,χ2=3.28,P=0.07,选择做核酸检测和随访检测的病例不具有统计学意义。结论 HIV区分抗原抗体试剂用作初筛结合核酸定量检测,作为补充实验的检测策略可提高HIV早期感染的检出率,在高危人群中具有推广的可行性,不同实验室宜根据检测对象的特点对HIV检测策略进行临床评估后选用。

Objective To evaluate the clinical application of the new HIV diagnostic strategy for the 4^（th） generation antigen/antibody separating reagent screening and the HIV-1 nucleic acid quantitative test（NAT）as supplementary experiment.Methods 1122 specimens with a 4 th generation antigen/antibody separating assay reactive results were collected from STD clinics and non-STD clinics of You＇an hospital during Sept 1^（st）,2015 to May 31^（st）,2017.All the cases were tested with the 3^（rd） generation reagent twice and western blot（WB）antibody confirmed assay.Uncertain or negative results were tested with NAT or follow-up detection.The data were analyzed according to 2015 edition of the national guideline for detection of HIV/AIDS.Results Among the total 1122 specimens,66 cases were from non-STD clinics and the results were all Ag^-/Ab~＋.1056 cases were from STD clinics,with 3 cases of Ag~＋/Ab~＋,32 cases of Ag~＋/Ab^-and 1021 cases of Ag^-/Ab~＋.Among the 32 cases,81.3%（26/32）were tested for NAT,and all NAT results were positive.WB results showed that 18.8%（6/32）were positive.32 cases with single antigen positive were diagnosed again by WB and/or NAT,combined with CD4 test results and clinical data.Coincidence rate was 100% between single antigen positive screened by 4 thgeneration reagent and HIV positive.According to the new strategy,a total of 74 cases should receive NAT test or follow-up detection.Among them,23 people were detected by NAT,21 people were followed up and detected by both.Chi square test was used to examine the numbers between NAT and follow-up,χ~2=3.28,and P=0.07〉0.05,with the difference not statistically significant.Conclusion The HIV diagnostic strategy of the 4^（th） generation reagent screening and NAT used as supplementary experiment can increase the detection rate of early HIV infection.It is feasible to be used widely for HIV detection among high-risk groups.