p24 antigen detection assay modified with a booster step for diagnosis and monitoring of human immunodeficiency virus type 1 infection

p24 antigen detection assay modified with a booster step for diagnosis and monitoring of human immunodeficiency virus type 1 infection
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DOI:
10.1128/jcm.41.3.1016-1022.2003
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发表时间:
2003-03-01
影响因子:
9.4
通讯作者:
Chaisilwatana, P
Chaisilwatana, P
中科院分区:
医学2区
文献类型:
--
作者:
Sutthent, R;Gaudart, N;Chaisilwatana, P

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我们改良了p24抗原酶联免疫吸附试验,作为诊断和监测人类免疫缺陷病毒1型(HIV-1)E亚型感染的方法。该改良检测方法基于使用预热免疫复合物解离结合使用常规Vironostika HIV-1 p24抗原检测(bioMerieux)的加强步骤,通过新方法将p24抗原检测下限从10 pg/ml(使用常规p24抗原检测时可达到的下限)降低至0.5 pg/ml(100个病毒粒子/ml)。通过HIV-1 RNA检测获得的值之间的相关性在160份已知病毒载量的冷冻血浆样本和80份盲态新鲜血浆样本中,Amplicor HIV-1 Monitor检测试剂盒和p24抗原检测试剂盒(经加强步骤抗原检测改良)的斯皮尔曼秩相关系数为0.671(R-2 = 0.450; P < 0.01)和0.782(R-2 = 0.612; P < 0.01)。抗逆转录病毒治疗过程中,p24抗原水平的变化大于或等于0.5log与血浆中HIV-1水平相关性良好。为了提高121例HIV-1感染母亲所生婴儿HIV-1感染的早期诊断率,将经加强步骤改良的热变性血浆p24抗原检测法与DNA-PCR和HIV RNA(基于核酸序列的扩增)检测法进行了比较。对于1至2个月大的受试者,经加强步骤改良的抗原检测的灵敏度与HIV-1 RNA(NASBA QL)检测的灵敏度相似,但优于DNA-PCR检测(100 vs 61.90%)。这项研究的总体结果可能会重新引起人们对p24抗原检测的兴趣,将其作为发展中国家诊断HIV-1感染和监测疾病进展的一种经济实惠的替代方法。
We modified a p24 antigen enzyme-linked immunosorbent assay as a method for diagnosis and monitoring of human immunodeficiency virus type 1 (HIV-1) subtype E infection. This modified assay is based on the use of preheated immune complex dissociation combined with a booster step using a regular Vironostika HIV-1 p24 antigen assay (bioMerieux) to decrease the lower limit of p24 antigen detection from 10 pg/ml (lower limit achievable when using a regular p24 antigen assay) to 0.5 pg/ml (100 virions/ml) by the new method. The correlation between the values obtained by the HIV-1 RNA (Amplicor HIV-1 Monitor) assay and the p24 antigen assay modified with a booster step antigen assay in 160 frozen plasma samples with known viral load and 80 blind fresh plasma samples by Spearman rank were 0.671 (R-2 = 0.450; P < 0.01) and 0.782 (R-2 = 0.612; P < 0.01). During antiretroviral treatment, the change of p24 antigen level at greater than or equal to0.5 log correlated well with the level of HIV-1 in plasma. In order to improve the early diagnosis of HIV-1 infection in 121 infants born to HIV-1-infected mothers, a heat-denatured plasma p24 antigen assay modified with a booster step was compared with DNA-PCR and HIV RNA (nucleic acid sequence-based amplification) assays. The sensitivity of the antigen test modified with a booster step was similar to that of the HIV-1 RNA (NASBA QL) assay and better than that of the DNA-PCR assay (100 versus 61.90%) for subjects 1 to 2 months old. The overall results from this study might renew interest in p24 antigen detection as an easily affordable alternative method for diagnosis of HIV-1 infection and monitoring of disease progression in developing countries.