Bowen Zhang1,2,3,4, Qiang Ma1,2,3,4, Bin Zhao1,2,3,4, Lin Wang1,2,3,4, Cunying Pu5, Xiaoxu Han1,2,3,4. 1. NHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China. 2. National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China. 3. Key Laboratory of AIDS Immunology of Liaoning Province, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China. 4. Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, 110001, China. 5. Medical Scientific Affairs, Roche Diagnostics (Shanghai) Ltd., Shenchang Rd, Shanghai.
Abstract
BACKGROUND: The prevalence and incidence of HIV infection are rapidly increasing, and novel HIV genotypes are emerging. OBJECTIVES: This study evaluated the sensitivity and specificity of Elecsys® HIV Duo assay in population with the epidemic of multiple genotypes of HIV-1 infection. STUDY DESIGN: 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 genotype 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. RESULTS: 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 CRF01_AE, followed by 13 of CRF07_BC, 10 of subtype B, 4 of URF_0107, 1 of URF_01B and 1 of CRF02_AG. CONCLUSIONS: The Elecsys® HIV Duo assay showed good performance for Chinese population with epidemic of multiple HIV genotypes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
BACKGROUND: The prevalence and incidence of HIV infection are rapidly increasing, and novel HIV genotypes are emerging. OBJECTIVES: This study evaluated the sensitivity and specificity of Elecsys® HIV Duo assay in population with the epidemic of multiple genotypes of HIV-1 infection. STUDY DESIGN: 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 genotype 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. RESULTS: 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 CRF01_AE, followed by 13 of CRF07_BC, 10 of subtype B, 4 of URF_0107, 1 of URF_01B and 1 of CRF02_AG. CONCLUSIONS: The Elecsys® HIV Duo assay showed good performance for Chinese population with epidemic of multiple HIV genotypes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Entities:
Keywords:
China; Diagnostic performance; HIV Combi PT assay; HIV Duo assay; Human immunodeficiency virus