title: [Performance Assessment of a Newly Developed Rapid Diagnostic Reagent for Human Immunodeficiency Virus].
abstract: Extremely early diagnosis of human immunodeficiency virus (HIV) infection has been considered highly important for its treatment. We conducted a performance assessment of a newly developed rapid diagnostic reagent for HIV by using a fourth-generation immunochromatographic assay (Alere HIV Combo). We used whole-blood, plasma, and serum samples obtained from 250 Japanese adults who visited the Kawasaki Medical School Hospital and underwent HIV screening tests. We also used 12 types of commercial HIV-1 sero- conversion panels and World Health Organization standard antigens. This method, which has a detection sensitivity of 100% and a specificity of 99.3%, was as accurate as the chemiluminescent immunoassay (CLIA) method. In a sensitivity test using seroconversion panels in the early phase of infection, the mean duration until positive conversion was 19.3 days. With this method having a high detection sensitivity for HIV-1p24 antigen, the results from whole-blood samples were the same as those from plasma and serum samples. Therefore, it can be considered as a useful rapid measurement method for general practice.
authors.forename: Itsuhiro
authors.initials: I
authors.lastname: Nakagiri
authors.forename: Hideho
authors.initials: H
authors.lastname: Wada
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Tokunaga
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fukuda
authors.forename: Taizo
authors.initials: T
authors.lastname: Tasaka
authors.forename: Takashi
authors.initials: T
authors.lastname: Sugihara
mesh_terms: D000328:Adult; D002846:Chromatography, Affinity / Q000379:methods; D015483:HIV Antibodies / Q000276:immunology; D015488:HIV Antigens / Q000032:analysis; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens