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

• Published in: Journal of virological methods 2006-11, Vol.137 (2), p.292-297
• Main Authors: Yeom, Joon-Sup, Jun, Gyo, Chang, Young, Sohn, Mi-Jin, Yoo, Seungbum, Kim, Eunkyung, Ryu, Seung-Ho, Kang, Hee-Jung, Kim, Young-A, Ahn, Sun-Young, Cha, Je-Eun, Youn, Sung-Tae, Park, Jae-Won
• Format: Article
• Language: English
• Subjects: AIDS Serodiagnosis - methods; Biological and medical sciences; ELISA; Enzyme-Linked Immunosorbent Assay - methods; Fundamental and applied biological sciences. Psychology; HIV - immunology; HIV Antibodies - blood; HIV Core Protein p24 - blood; HIV Infections - diagnosis; HIV serodiagnosis; Human immunodeficiency virus; Humans; Microbiology; Reagent Kits, Diagnostic; Reproducibility of Results; Sensitivity; Sensitivity and Specificity; Seroconversion; Specificity; Techniques used in virology; Virology
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/j.jviromet.2006.07.002

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.