摘要
目的探讨人类免疫缺陷病毒(HIV)抗体确证试验快速检测替代策略的适用性及可行性。方法收集2019年5月至12月昆明市第三人民医院检验科艾滋病确证实验室143例HIV感染待确定样本。采用快速检测替代策略(至少2种进口快速试剂和任意2种国产试剂)进行HIV抗体确证试验,满足4种快速检测试剂强阳性,报告“HIV-1抗体阳性”;若出现其中1种快速检测试剂弱阳性或者阴性,用免疫印迹法进行抗体补充试验,按试剂盒使用说明书提供的标准判别。同时检测143例样本血清HIV抗体S/CO值,抗凝血CD4^(+)T淋巴细胞绝对计数及血浆HIV病毒载量,统计分析快速检测替代策略阳性样本和不确定进行免疫印迹法抗体补充试验阳性样本间HIV抗体S/CO值、HIV病毒载量和CD4^(+)T淋巴细胞绝对计数差异。结果143例HIV感染待确定样本中107例样本快速检测替代策略结果阳性(替代阳性组);36例出现1种或以上快速检测试剂弱阳性及阴性,其中的30例试验结果为3种快速检测试剂阳性1种弱阳性,占比高达91%(30/33),用免疫印迹法进行抗体补充试验,33例结果阳性(免疫印迹法阳性组),3例结果为不确定,快速检测替代策略不确定而免疫印迹法阳性的33例选用的4种快速检测试剂阳性率加拿大麦美华生物科技有限公司(90.91%)和日本美艾利尔医疗有限公司(87.88%)远远高于韩国标准诊断股份有限公司(57.58%)和广州万孚生物技术股份有限公司(60.61%),差异有统计学意义(χ^(2)=9.587,P<0.01;χ^(2)=8.250,P<0.01)。替代阳性组与免疫印迹法阳性组的S/CO值、HIV病毒载量和CD4^(+)T淋巴细胞绝对计数,差异均有统计学意义(Z=0.238,P<0.01;Z=0.403,P<0.01;Z=0.518,P<0.01)。结论我们的研究显示最终确诊的阳性样本中约有1/5在快速检测替代策略中检测结果不确定而二次采用免疫印迹法试验才确诊,而这1/5的样本快速检测替代策略3种阳性1种弱阳性的不确定结
Objective Discussion on the applicability and feasibility of rapid detection alternative strategies in human immunodeficiency virus(HIV)antibody confirmatory test.Methods A total of 143 patients with HIV infection to be confirmed in the HIV confirmatory laboratory of Laboratory Department of Kunming Third People′s Hospital from May to December 2019,were collected to be performed with HIV antibody confirmatory test by the rapid detection alternative strategies(including at least 2 imported rapid reagents and any 2 domestic reagents),which satisfied strong positive in 4 rapid detection reagents.The report showed"HIV-1 antibody positive";if one of the rapid detection reagents showed weak positive or negative,the antibody supple-ment test was carried out by immunoblotting(WB)and judged according to the criteria of yin and yang determi-nation provided in the instructions for the use of the kit.S/CO value of the serum HIV antibody,absolute count of anticoagulant CD4^(+)T lymphocytes and plasma HIV viral load were also detected in 143 samples.Statistical analy sis was conducted on the differences in S/CO value of HIV antibody,HIV viral load and absolute count of anticoagulant CD4^(+)T lymphocytes differences between positive samples for rapid detection alternative strategy and uncertain positive samples for WB antibody supplement tests.Results Out of 143 patients with HIV infection to be confirmed,107 patients were positive for rapid detection alternative strategy,36 patients were weak positive and negative for 1 or more rapid detection reagents,30 patients were positive for 3 rapid detection reagents and1 was weak positive,accounting for 90%(30/33),which were performed with antibody supplement test with WB,33 patients were positive(WB positive group),3 patients were uncertain.The rapid detection strategy was uncertain.The positive rate meclmira(90.91%)and selenium indication(87.88)were much higher than SD(57.58%)and wanfu(60.61%)in 4 rapid detection reagents used for 33 patients who were positive in WB,and the differ
作者
李光敏
吕松琴
徐丽萍
黄岗
张娟
段洪芬
施金丽
黄山
Li Guangmin;Lyu Songqin;Xu Liping;Huang Gang;Zhang Juan;Duan Hongfen;Shi Jinli;Huang Shan(Department of Laboratory,the Third People′s Hospital of Kunming,Yunnan 650041,China)
出处
《实用医技杂志》
2022年第3期233-236,共4页
Journal of Practical Medical Techniques
基金
云南省昆明市科技计划项目(2017-1-S-16411)。
