title: Evaluation of a new fourth generation enzyme-linked immunosorbent assay, the LG HIV Ag-Ab Plus, with a combined HIV p24 antigen and anti-HIV-1/2/O screening test.
abstract: The LG HIV Ag-Ab Plus, a new fourth generation diagnostic assay for HIV infection, was evaluated in comparison to the Enzygnost HIV Integral, an established fourth generation HIV assay. The LG assay showed 100% sensitivity with 109 samples with anti-HIV-1, anti-HIV-2 or anti-HIV-1 group O reactivity. It also detected correctly all 51 positives on three BBI performance panels, slightly outperforming the Enzygnost HIV Integral, which detected 50. The specificity of the LG HIV Ag-Ab Plus was 99.9% with 999 sera from healthy blood donors, which was slightly inferior to the performance of the Enzygnost HIV Integral, which had 100% specificity. The LG assay showed 100% specificity with 81 specimens with underlying diseases including hepatitis B, demonstrating a low risk of cross-reactivity with other infections. The reduction of the diagnostic window by the LG HIV Ag-Ab Plus, compared to a third generation HIV assay, was 6.3 days. The LG assay also showed sufficiently high intra-person and inter-person reproducibility. The overall performance of this new fourth generation HIV assay was adequate for screening and diagnosis of HIV infection.
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Joon-Sup
authors.initials: JS
authors.lastname: Yeom
authors.forename: Gyo
authors.initials: G
authors.lastname: Jun
authors.forename: Young
authors.initials: Y
authors.lastname: Chang
authors.forename: Mi-Jin
authors.initials: MJ
authors.lastname: Sohn
authors.forename: Seungbum
authors.initials: S
authors.lastname: Yoo
authors.forename: Eunkyung
authors.initials: E
authors.lastname: Kim
authors.forename: Seung-Ho
authors.initials: SH
authors.lastname: Ryu
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Kang
authors.forename: Young-A
authors.initials: YA
authors.lastname: Kim
authors.forename: Sun-Young
authors.initials: SY
authors.lastname: Ahn
authors.forename: Je-Eun
authors.initials: JE
authors.lastname: Cha
authors.forename: Sung-Tae
authors.initials: ST
authors.lastname: Youn
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Park
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006678:HIV / Q000276:immunology*; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic