摘要
目的探讨人类免疫缺陷病毒(human immunodeficiency virus,HIV)抗体ELISA检测S/CO比值、核酸定量检测结果与确证检测阳性结果的相关性。方法应用2种国产[北京万泰生物药业股份有限公司(以下简称万泰)和上海科华生物工程股份有限公司(以下简称科华)]抗-HIV诊断试剂(ELISA法)、1种进口(美国Bio-Rad公司,以下简称Bio-Rad)HIV抗原抗体诊断试剂(ELISA法)、1种核酸检测试剂(RT-PCR-荧光探针法)及WB确证试剂(Western blot法)对86份抗-HIV初筛阳性血浆样本进行检测,并进行相关性分析。结果 86份样本中,3种ELISA试剂检出的53份共同阳性样本WB确证结果均为阳性;25份共同阴性样本WB确证结果 20份为阴性,5份为不确定;检测结果不一致的8份样本WB确证结果 3份为不确定,5份为阴性。万泰和科华试剂检测样本S/CO比值≥10时,96.30%和100%的样本为WB确证阳性,1≤S/CO比值<10时,均有20%的样本为WB确证阳性;Bio-Rad试剂检测样本S/CO比值≥5时,100%的样本为WB确证阳性。核酸检测病毒载量≥103IU/ml时,97.87%的样本为WB确证阳性;0 IU/ml<病毒载量<103IU/ml时,53.85%的样本为WB确证阳性。86份样本中有15份ELISA检测、核酸检测及确证检测结果不完全一致,其中4份样本为核酸检测阳性,确证试剂检测结果为不确定,疑似HIV-1感染者样本。结论抗-HIV ELISA S/CO比值及核酸定量检测结果与确证检测阳性结果有一定相关性,S/CO比值及病毒载量对确证检测阳性结果的判定具有一定参考价值。
Objective To investigate the correlation of S/CO value in ELISA and RNA level with the positive result of human immunodeficiency virus （HIV） in confirmatory test. Methods A total of 86 preliminarily screened anti-HIV pos- itive samples were analyzed by ELISA using two domestic （Wantai and Kehua） and one imported （Bio-Rad） kits for HIV antigen and antibody, by RT-PCR-fluorescent probe method using one RNA determination kit, and by Western blot using WB confirmatory kit, and the relationship of result was analyzed. Results Of the 86 samples, 53 anti-HIV positive ones judged by three ELISA kits were confirmed as positive by Western blot. However, of the 25 negative samples judged by three ELISA kits, 20 were confirmed as negative by Western blot, while 5 as uncertain. Of the 8 samples with inconsistent ELISA results, 3 were confirmed as uncertain, while 5 as negative, by Western blot. Of the samples with S / CO values of not less than 10 judged by Wantai and Kehua kits, 96. 30% and 100% were confirmed as positive by Western blot. How- ever, of the samples with S / CO values of not less than 1 but less than 10, 20% were confirmed as positive by Western blot. All the samples with S / CO value of not less than 5 judged by Bio-Rad kit were confirmed as positive by Western blot. Of the samples with RNA level of not less than l03 IU / ml, 97. 87% were confirmed as positive by Western blot. However, of the samples with RNA level of less than 103 IU / ml, only 53. 85% were confirmed as positive by Western blot. Of the 15 samples with incomplete results in ELISA and RNA quantitation test, 4 were judged as positive by RNA quantitation test and confirmed as uncertain by Western blot, which were defined as suspected HIV-1 infection. Conclu-sion The S/CO value in ELISA and RNA level of anti-HIV showed a certain correlation with positive results in confirma- tory test, which provided a certain reference for judgment of positive result in confirmatory test.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第9期1300-1303,共4页
Chinese Journal of Biologicals
基金
国家卫生公益性行业科研专项(201002005)
关键词
人类免疫缺陷病毒
酶联免疫吸附试验
核酸
免疫印迹法
Human immunodeficiency virus （HIV）
Enzyme-linked immonosorbent assay （ELISA）
Nucleic acid
Western blot
