NHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
J Med Virol. 2020 Dec;92(12):3230-3236. doi: 10.1002/jmv.25845. Epub 2020 Jul 28.
The prevalence and incidence of human immunodeficiency viruses (HIV) infection are rapidly increasing, and novel HIV genotypes are emerging. This study evaluated the sensitivity and specificity of Elecsys HIV Duo assay in population with the epidemic of multiple genotypes of HIV-1 infection. Specificity of the Elecsys HIV Duo assay was determined using 3039 serum samples from patients receiving routine HIV-1 screening tests in China. Sensitivity was assessed with seroconversion panels. Additional 67 positive from newly diagnosed HIV-1 infected samples were also included to test assay performance on various HIV-1 genotypes. The assay performance was compared with that of the Elecsys HIV Combi PT assay. The genotypes of all HIV-1 positive samples were determined with phylogenetic analyses on the 1.1 kb Pro-RT region of pol gene for drug resistance tests. The Elecsys HIV Duo assay had a slightly higher specificity (99.93% vs 99.84%) and equivalent sensitivity to Elecsys HIV Combi PT assay. Seventy-two HIV-1 positive samples, including 12 antigens positive samples, were distinguished by Elecsys HIV Duo. Among them, 43 samples were circulating recombinant form (CRF)01_AE, followed by 13 of CRF07_BC, 10 of subtype B, 4 of URF_0107, 1 of URF_01B and 1 of CRF02_AG. The Elecsys HIV Duo assay showed good performance for the Chinese population with an epidemic of multiple HIV genotypes.
人类免疫缺陷病毒（HIV）感染的流行率和发病率正在迅速上升，新的 HIV 基因型也在不断出现。本研究评估了 Elecsys HIV Duo 检测法在 HIV-1 感染多种基因型流行人群中的灵敏度和特异性。使用中国 3039 例接受常规 HIV-1 筛查试验的患者血清样本确定 Elecsys HIV Duo 检测法的特异性。使用血清转换面板评估灵敏度。还纳入了 67 例新诊断的 HIV-1 感染阳性样本，以测试该检测法在各种 HIV-1 基因型上的性能。将该检测法的性能与 Elecsys HIV Combi PT 检测法进行比较。对所有 HIV-1 阳性样本的基因型进行了分析，对 pol 基因的 1.1kb Pro-RT 区进行了系统进化分析，以进行耐药性测试。Elecsys HIV Duo 检测法的特异性（99.93%比 99.84%）略高，灵敏度与 Elecsys HIV Combi PT 检测法相当。Elecsys HIV Duo 检测法区分了 72 例 HIV-1 阳性样本，包括 12 例抗原阳性样本。其中，43 例为流行重组型（CRF）01_AE，其次是 13 例 CRF07_BC、10 例 B 亚型、4 例 URF_0107、1 例 URF_01B 和 1 例 CRF02_AG。Elecsys HIV Duo 检测法在 HIV 多种基因型流行的中国人群中具有良好的性能。
