title: Evaluation of a rapid and simple fourth-generation HIV screening assay for qualitative detection of HIV p24 antigen and/or antibodies to HIV-1 and HIV-2.
abstract: The performance was assessed of a new, rapid, visual and qualitative immunoassay for the detection of HIV p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2. Characterised serum or plasma specimens from patients diagnosed with HIV infection were tested: 179 samples of known Ab-positive patients harbouring different subtypes of HIV-1 (n=154) and HIV-2 (n=25) and 200 samples from individuals not infected with HIV. The assay's Ag sensitivity was assessed by testing HIV seroconversion panels (n=10) and primary HIV infection specimens (n=57). In addition, the influence of the genetic variability of HIV-1 on Ag detection was evaluated using dilutions of culture supernatants infected with different subtypes (n=50). The performance of the rapid test was compared to a "gold standard" testing algorithm with the use of a single Ag ELISA and with the Vironostika((R)) HIV Uni-Form II Ag/Ab test, a fourth-generation ELISA. The new assay, the Determine HIV-1/2 Combo demonstrated 100% (98.2-100.0) Ab specificity (200/200) and 100% (98.0-100.0) Ab sensitivity (179/179). In these samples, the observed Ag sensitivity was 86.6% (58/67) with the Determine HIV-1/2 Combo test and 92.5% (62/67) with the Vironostika compared to the reference single Ag ELISA. The assay could not detect Ag in one group O, one subtype F and two subtype H cell supernatant isolates. None of the HIV-2 Ag could be detected.
authors.affiliation: Department of Microbiology, Institute of Tropical Medicine, Nationalestraat, Antwerpen, Belgium. gbeelaert@itg.be
authors.forename: G
authors.initials: G
authors.lastname: Beelaert
authors.forename: K
authors.initials: K
authors.lastname: Fransen
mesh_terms: D014644:Genetic Variation; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification*; D015498:HIV-2 / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008403:Mass Screening / Q000379:methods*; D012680:Sensitivity and Specificity; D013997:Time Factors; D014773:Virology / Q000379:methods*
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24