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

G Beelaert, K Fransen

    Research output: Contribution to journalA1: Web of Science-article

    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
    Original languageEnglish
    JournalJournal of Virological Methods
    Volume168
    Issue number1-2
    Pages (from-to)218-222
    Number of pages5
    ISSN0166-0934
    DOIs
    Publication statusPublished - 2010

    Keywords

    • B780-tropical-medicine
    • Viral diseases
    • HIV
    • AIDS
    • Evaluation
    • Performance
    • Rapid diagnostic tests
    • Screening
    • Immunoassay
    • Detection
    • P24 antigen
    • Antibody detection
    • Assessment
    • Sensitivity
    • Specificity
    • Laboratory techniques and procedures

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