Infectious Diseases Research, Abbott Diagnostics, Abbott Park, IL, USA.
J Clin Virol. 2013 Jun;57(2):169-72. doi: 10.1016/j.jcv.2013.01.017. Epub 2013 Feb 26.
HIV antigen/antibody (Ag/Ab) combination assays represent a significant advancement in assays used for diagnosing HIV infection based on their ability to detect acute and chronic infections. During acute HIV infection (AHI), detection depends on assay sensitivity for p24 Ag.
To directly compare the Ag sensitivity of the ARCHITECT(®) HIV Ag/Ab Combo assay to RNA viral load using cell culture supernatants of virus isolates. HIV-1 isolates allow correlation in the total absence of an antibody response to infection and across genetically diverse HIV-1 group M strains.
Thirty-five HIV-1 isolates comprising subtypes A-D, F and G, CRF01_AE, CRF02_AG, and unique recombinant forms were evaluated. Cell-free culture supernatant for each isolate was diluted to four levels and tested in the HIV Combo assay to determine a signal to cutoff ratio and the RealTime(®) HIV-1 assay to quantify RNA. The RNA copies/mL at the HIV Combo assay cutoff was determined.
The median RNA copies/mL at the HIV Combo assay cutoff was 57,900 for individual virus isolates (range 26,440-102,400). A single plot of all the data gave a value of 58,500RNA copies/mL. An analysis of data published for acute HIV infection in human subjects gave a similar result; HIV Combo detected 97% of AHIs with RNA copies/mL > 30,700.
Based on analysis of virus isolates, the ARCHITECT HIV Combo assay can detect p24 Ag when RNA is above approximately 58,000copies/mL. The correlation of viral load and Ag sensitivity was consistent across genetically diverse HIV-1 group M strains.
HIV 抗原/抗体（Ag/Ab）组合检测在诊断 HIV 感染方面取得了重大进展，其优势在于能够检测急性和慢性感染。在急性 HIV 感染（AHI）期间，检测取决于 p24 Ag 的检测灵敏度。
使用病毒分离株的细胞培养上清液，直接比较 ARCHITECT（®）HIV Ag/Ab Combo 检测与 RNA 病毒载量的 Ag 灵敏度。HIV-1 分离株允许在没有抗体对感染的反应的情况下进行相关性分析，并跨越遗传上多样化的 HIV-1 M 组病毒株。
评估了包括亚型 A-D、F 和 G、CRF01_AE、CRF02_AG 和独特重组形式在内的 35 个 HIV-1 分离株。将每个分离株的无细胞培养上清液稀释至四个水平，并在 HIV Combo 检测中进行测试，以确定信号与截止值的比值，并使用 RealTime（®）HIV-1 检测定量 RNA。确定 HIV Combo 检测截止值处的 RNA 拷贝/ml。
HIV Combo 检测截止值处的个体病毒分离株的 RNA 拷贝/ml 的中位数为 57900（范围为 26440-102400）。对所有数据进行单一绘图得出 58500RNA 拷贝/ml 的值。对在人类受试者中急性 HIV 感染发表的数据进行分析，得出了相似的结果；HIV Combo 检测到 97%的 RNA 拷贝/ml 大于 30700 的 AHI。
基于病毒分离株的分析，ARCHITECT HIV Combo 检测在 RNA 大于约 58000 拷贝/ml 时可以检测到 p24 Ag。病毒载量和 Ag 灵敏度的相关性在遗传上多样化的 HIV-1 M 组病毒株中是一致的。
