Elecsys® HIV Duo

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> HIV Duo
elecsys hiv duo assay

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Immunoassay for the qualitative determination of HIV p24 antigen and antibodies to HIV

The human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS) and has been a major global burden for over three decades.1,2 HIV is transmitted through sexual contact, contaminated blood and blood products or from an HIV-infected mother to her child before, during and after birth.3 Diagnosis of an HIV infection can be made as early as 2 - 3 weeks after infection, based on the detection of HIV p24 antigen in the blood.4,5 Anti-HIV antibodies are detectable in serum from around 4 weeks post-infection.4,6 

With the Elecsys® HIV Duo assay, HIV-1 p24 antigen (HIV Ag), as well as antibodies to HIV-1 and HIV-2 (anti-HIV) can be detected in parallel with two separate determinations. On the basis of these determinations, the Elecsys® HIV Duo main result is calculated automatically by the analyzer. The subresults for HIV Ag and anti-HIV can be used as an aid in the selection of the confirmation algorithm for reactive samples.7

Elecsys® HIV Duo

  • Systems

    cobas® e 801 module

    cobas® e 402 analytical unit

  • Testing Time

    18 minutes

  • Test principle

    Double antibody or antigen sandwich immunoassay for the detection of HIV antigen and anti-HIV antibodies, respectively.

  • Calibration

    Individual 2-point calibration for HIV antigen and anti-HIV antibodies

  • Interpretation

    <1.0 = non-reactive 
    ≥1.0 = reactive

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, Na-heparin, K2-EDTA, K3-EDTA, ACD, CPD, CP2D, CPDA, potassium oxalate and Na-citrate plasma as well as Li-heparin has plasma tubes containing separating gel

  • Sample volume

    60 μL (2 x 30 μL)

  • Onboard stability

    16 weeks

  • Intermediate precision in positive samples

    HIV Ag- 1.5-2.2 CV%
    Anti-HIV- 1.2-1.8 CV%

  • Clinical sensitivity

    100 % (total n = 1549, HIV‑1 confirmed positive pediatric subjects, n=51, HIV‑1 confirmed positive pregnant women subjects, n=59, HIV‑1 group M subtype specimens, n=90, HIV‑1 group O specimens , n=50, and HIV‑1 p24 antigen

  • Clinical specificity

    99.90% (n = 6894 low risk population)

  • Analytical sensitivity

    0.392 IU/mL

References

  1. Maartens, G., Celum, C., Lewin, S.R. (2014). HIV infection: epidemiology, pathogenesis, treatment, and prevention. Lancet 384, 258-71.
  2. Killian, M.S., Levy, J.A. (2011). HIV/AIDS: 30 years of progress and future challenges. Eur J Immunol 41, 3401-11.
  3. Shaw, G.M., Hunter, E. (2012). HIV transmission. Cold Spring Harb Perspect Med. 2:a006965.
  4. Fiebig, E.W., Wright, D.J., Rawal, B.D. et al. (2003). Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 17, 1871-9.
  5. Busch, M.P., Lee, L.L., Satten, G.A. et al. (1995). Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors. Transfusion 35, 91-7.
  6. Guertler, L., Muehlbacher, A., Michl, U. et al. (1998). Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. Journal of Virological Methods 75, 27-38.
  7. HIV Duo Package Insert- 2022-08 V1.0.

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