title: Evaluation of the Bio-Rad Geenius HIV 1/2 Confirmation Assay as an Alternative to Western Blot in the Korean Population: A Multi-Center Study.
abstract: Recently updated recommendations for diagnosis of HIV infection suggest a new diagnostic algorithm including HIV-1/HIV-2 antibody differentiation immunoassay instead of western blot (WB) as a confirmatory testing. We evaluated Bio-Rad Geenius HIV1/2 confirmation assay as a simple and reliable alternative to WB in the Korean population with low HIV prevalence. The Geenius HIV1/2 was performed in a total of 192 serum specimens (140 reactive and 52 nonreactive specimens by ARCHITECT HIV Ag/Ab Combo assay) that were prospectively collected from five institutions. HIV-1 nucleic acid amplification test (NAT) was performed in negative or indeterminate specimens by Geenius HIV1/2 or WB. Among 140 reactive specimens by HIV Ag/Ab assay, 82 (58.6%) were positive for HIV-1 Ab by Geenius HIV1/2. Among 58 negative or indeterminate specimens by Geenius HIV1/2, four specimens (6.9%) were positive by HIV-1 NAT. The sensitivity and specificity of Geenius HIV1/2 were 95.3% and 100.0%, respectively. When we considered only WB, the sensitivity and specificity of Geenius HIV1/2 were 100.0% and 99.1%, respectively. Agreement between Geenius HIV1/2 and WB was excellent (weighted Kappa = 0.89). The Geenius HIV1/2 is simple and time-saving compared with WB. It has an excellent performance and can be a reliable alternative to WB. HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.
authors.affiliation: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
authors.forename: Hee-Won
authors.initials: HW
authors.lastname: Moon
authors.affiliation: Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Huh
authors.affiliation: Eone Laboratories, Incheon, Korea.
authors.forename: Gwi Young
authors.initials: GY
authors.lastname: Oh
authors.affiliation: Green Cross Laboratories, Yongin, Korea.
authors.forename: Sang Gon
authors.initials: SG
authors.lastname: Lee
authors.affiliation: Seoul Clinical Laboratories, Yongin, Korea.
authors.forename: Anna
authors.initials: A
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
authors.forename: Yeo-Min
authors.initials: YM
authors.lastname: Yun
authors.affiliation: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
authors.forename: Mina
authors.initials: M
authors.lastname: Hur
mesh_terms: D015153:Blotting, Western; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification*; D015498:HIV-2 / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D056910:Republic of Korea