人类免疫缺陷病毒抗原抗体筛查联合免疫印迹或核酸补充实验的临床应用  

Clinical application of combining human immunodeficiency virus antigen/antibody assay screening and Western blot or human immunodeficiency virus nucleic acid

作　　者：陈丽[1,2] 唐卓芸 张可依 李冬冬 罗岚[1] 敖科萍[1] 陶传敏 CHEN Li;TANG Zhuoyun;ZHANG Keyi;LI Dongdong;LUO Lan;AO Keping;TAO Chuanmin(Department of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,P.R.China;Department of Laboratory Medicine,Wenjiang Zhongyi Hospital,Chengdu,Sichuan 611130,P.R.China)

机构地区：[1]四川大学华西医院实验医学科,成都610041 [2]成都市温江区中医医院检验科,成都611130

出　　处：《华西医学》2020年第8期930-935,共6页West China Medical Journal

基　　金：四川省科学技术厅重点研发项目(2020YFS0136);四川省卫生和计划生育委员会课题(川卫办发﹝2017﹞70号)。

摘　　要：目的对第四代人类免疫缺陷病毒(human immunodeficiency virus,HIV)抗原抗体试剂筛查联合免疫印迹(Western blot,WB)或核酸补充实验的检测策略进行临床应用评价。方法回顾性分析2018年四川大学华西医院HIV抗原抗体筛查的所有样本资料,采用HIV第四代抗原抗体试剂筛查,用第三代抗体试剂对筛查阳性样本进行双份复检,复检样本均进行WB或HIV RNA的补充实验。结果HIV第四代抗原抗体试剂筛查217803例,其中筛查阳性718例,确证阳性513例,筛查阳性率为0.33%,确证阳性率为0.24%。所有筛查阳性样本经WB补充实验,确证阳性513例(71.45%)、阴性163例(22.70%)、不确定42例(5.85%);对于WB阴性和不确定的15例样本经HIV RNA检测6例阳性,随访4例患者有2例血清学转阳。第四代阳性+第三代阳性样本536例,经WB确证阳性513例(95.71%),阴性6例(1.12%),不确定17例(3.17%);第四代阳性+第三代阴性样本182例,经WB确证阳性0例(0.00%),阴性157例(86.26%),不确定25例(13.74%)。第四代阳性+第三代阳性样本的确证阳性率(95.71%,513/536)明显高于第四代阳性+第三代阴性样本(0.00%,0/182),差异有统计学意义(χ^2=610.091,P<0.001)。WB确证阳性条带以全带和次全带为主(占82.26%),条带数≥5条带组的临界值指数值更高(P<0.001)。结论第四代阳性+第三代阳性样本,确证阳性率高,需尽快做补充实验以明确诊断;第四代阳性+第三代阴性样本,确证阳性率低,但对于有高危史的患者,应尽快做HIV RNA实验进行早期诊断。Objective To evaluate the clinical significance of human immunodeficiency virus(HIV)testing algorithm combining antigen/antibody assay screening with Western Blot(WB)or HIV nucleic acid.Methods Data of HIV antigen and antibody screening samples in West China Hospital of Sichuan University in 2018 were retrospectively analyzed.The 4 th generation antigen and antibody reagents were used for initial screening,and the 3 rd generation antibody reagents were used for reexamination.WB or HIV nucleic acid detection was performed as supplementary test.Results A total of 217803 samples were initially screened,718 samples were positive in initial screening(0.33%)and 513 samples were confirmed positive(0.24%).The 718 initial positive samples were confirmed by WB,among them,513(71.45%)were positive,163(22.70%)were negative,and 42(5.85%)were indeterminate.Fifteen samples which were negative or indeterminate were detected by HIV RNA,as a result,6 were positive.Two of four patients turned into positive during follow-up.Among the 536 samples which were positive in both the 4 th and 3 rd generation assay,there were 513(95.71%)positive,6(1.12%)negative,and 17(3.17%)indeterminate confirmed by WB;among the 182 samples which were positive in the 4 th generation assay but negative in the 3 rd generation assay,there were none(0.00%)positive,157(86.26%)negative,and 25(13.74%)indeterminate confirmed by WB.The positive rate of confirmation test of samples positive in the 4 th and 3 rd generation assay(95.71%,513/536)was significantly higher than that of samples positive in the4 th generation assay but negative in the 3 rd generation assay(0%,0/182),and the difference was statistically significant(χ^2=610.091,P<0.001).WB band types for positive samples were dominated by the whole bands and sub-bands,accounting for 82.26%.The cut off index in≥5 bands group was higher than that in<4 bands group(P<0.001).Conclusions Samples with both the 4 th and 3 rd generation assay positive have a high positive rate of confirmation test,and a supplementa

关 键 词：人类免疫缺陷病毒 第四代抗原抗体试剂 第三代抗体试剂 免疫印迹试验 核酸检测 

分 类 号：R512.91[医药卫生—内科学] R446.6[医药卫生—临床医学]