Elecsys^® HIV Duo

IVD

Elecsys<sup>®</sup> HIV Duo

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
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

Maartens, G., Celum, C., Lewin, S.R. (2014). HIV infection: epidemiology, pathogenesis, treatment, and prevention. Lancet 384, 258-71.
Killian, M.S., Levy, J.A. (2011). HIV/AIDS: 30 years of progress and future challenges. Eur J Immunol 41, 3401-11.
Shaw, G.M., Hunter, E. (2012). HIV transmission. Cold Spring Harb Perspect Med. 2:a006965.
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.
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.
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.
HIV Duo Package Insert- 2020-05 V1.0.

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