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    • The combination of HIV antigen and antibody

    2022-05-11

    The combination of HIV antigen and antibody testing with the fourth generation immunoassays shortens the window cb 839 for HIV by detecting HIV antigen, which appears in the blood before seroconversion [3,5,11,12]. Analysis of the seroconversion panels indicated the Elecsys® HIV Duo assay has a good seroconversion sensitivity compared with other fourth generation assays. In 52 panels that were tested with Elecsys® HIV Duo, ABBOTT ARCHITECT® and PRISM® HIV Ag/Ab Combo in parallel, the Elecsys® HIV Duo assay detected more positive samples/total number of bleeds than the comparators. Also in an additional analysis of the same seroconversion panels, calculating the average number of days when bleedings were reactive after being NAT positive the Elecsys® HIV Duo detected positive bleedings more than half a day earlier than the comparator assays, further establishing excellent seroconversion sensitivity compared with cb 839 other fourth generation HIV assays. The assessment of the cut-off sensitivity for the Elecsys® HIV Duo assay may help to explain the high sensitivity of the assay. The cut-off sensitivity calculated in this study was 0.3 IU/mL. Cut-off sensitivities reported for other fourth generation assays range from 0.19 to 1.77 IU/mL indicating that cut-off sensitivity for the Elecsys® HIV Duo is within the lower range accepted for fourth generation assays [13]. Cases have been reported of HIV antigen/antibody assays having some cross-reactivity with Epstein-Barr Virus and metastatic cancer [14]. The Elecsys® HIV Duo assay showed no cross-reactivity with any of the 19 potentially cross-reacting factors assessed, including lymphoma and EBV infection, which is reassuring, as with routine diagnosis patients may have co-infections or medical conditions.
    Conclusion This study demonstrates that the Elecsys® HIV Duo assay shows a higher sensitivity than the tested comparator CE marked methods, and a specificity that is comparable to existing CE marked assays. In addition to the overall Elecsys® HIV Duo result, a separate HIV antigen and antibody result is reported, this could be used as an aid during the costly confirmation testing of positive and indeterminate samples. Thus, the Elecsys® HIV Duo assay is suitable for blood donor screening and routine diagnostic use.
    Funding Medical writing assistance was provided by Rose-Marie Falconer (Elements Communications Ltd, Westerham, UK) and was funded by Roche Diagnostics. Study funding was provided by Roche Diagnostics (Rotkreuz, Switzerland).
    Ethical approval
    Conflicts of interest
    Acknowledgements
    Introduction Due to impaired host immune defenses, persons infected with human immunodeficiency virus (HIV) have an increased risk and greater severity of vaccine-preventable infections, resulting in high morbidity and mortality. HIV-infected persons are more susceptible to influenza and experience prolonged duration and increased severity of illness and have higher rates of hospitalization [1], [2], [3], [4]. They also have a markedly higher risk of invasive pneumococcal disease despite immune reconstitution and suppression of HIV replication with combination antiretroviral therapy (cART) [5], [6], [7]. Individuals with co-infection of HIV and hepatitis B virus (HBV) have increased rates of HBV replication and accelerated disease progression, with increased incidence of liver fibrosis, cirrhosis, end-stage liver disease, hepatocellular carcinoma, and liver-related deaths compared with hepatitis B mono-infected patients [8]. A recent study reported an annual incidence of pertussis among unvaccinated HIV-infected adults of 10.5–17.5% [9]. As CD4+ T helper cells are critical for the clearance of pertussis [10], HIV-infected individuals could have more severe or prolonged pertussis infections than the general population [11], [12], [13]. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommends all HIV-infected adults receive inactivated vaccines against influenza, pneumonia, hepatitis B, and tetanus, diphtheria, and acellular pertussis, regardless of CD4+ T-cell count and age [14], [15], [16].