Elecsys® HIV combi PT 4th Gen

HIV combi PT assay 01

Designed for early detection of the HIV infection

  • The human immunodeficiency virus (HIV) - the causative agent of Acquired immunodeficiency Syndrome (AIDS) - belongs to the family of retroviruses
  • HIV can be transmitted through contaminated blood and blood products, through sexual contact or from a HIV-infected mother to her child before, during and after birth
  • Reliable screening and diagnosis represents a crucial aspect of the global strategy for reducing the human and financial burden of HIV transmission
  • With the Elecsys® HIV combi PT assay the HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 can be detected simultaneously within one determination
  • This results in improved sensitivity and a shorter diagnostic window compared to anti-HIV assays
  • The assay uses recombinant antigens derived from the env- and pol-region and Reverse transcriptase of HIV-1 (including group O) and HIV-2 to determine HIV-specific antibodies
  • Specific monoclonal antibodies are used for the detection of HIV-1 p24 antigen – including an automated sample pretreatment step with incubation with a detergent agent in order to lyse HIV virions and maximize exposure of the HIV p24 antigen to increase sensitivity
Assay time 27 min.
Sample material Serum, Li-heparin, K2 EDTA and K3 EDTA plasma as well as Li-heparin plasma tubes containing separating gel
Sample volume 40 μL
Intermediate precision cobas e 411 analyzer, Elecsys® 2010 analyzer: 0.9 - 2.0 %
cobas e 601 / e 602 module, E170: 21. - 2.4 %
Clinical sensitivity 100 % (n = 1,532) tested on patients in different stages of the disease and infected with HIV-1 group M, O and HIV-2
Clinical specificity Blood donors: 99.88 % (n = 7,343)
Samples from unselected daily routine, dialysis patients and pregnant women: 99.81 % (n = 4,103)
Traceablity Human Immunodeficiency Virus Type 1 (HIV-1 p24 Antigen) - 1st Inernational Reference Reagent 1992, code 60/636
HIV combi PT assay 02

Early detection of infection with high sensitivity and specificity

Early detection of infection

  • High sensitivity for early detection of infection

Excellent analytical sensitivity

  • Analytical sensitivity below <2 IU/mL which is compliant with most recent international guidelines
  • Approved for diagnostic use and screening of blood donations

Cost efficiency

  • High clinical specificity reduces the need for repeat testing

Reliable results

  • Best in class precision
  • Best in class inclusivity to detect different HIV-1 subtypes and group HIV-2 antibodies

Performance evaluation of a new fourth generation HIV combination antigen-antibody assay:
Mühlbacher, A. et al. (2012). Med. Microbiol. Immunol. DOI: 10.1007/s00430-012-0250-5

Summary:
The Elecsys HIV combi PT assay is a fourth-generation antigen–antibody combination assay developed to allow earlier detection of seroconversion, and to have increased sensitivity and improved specificity. In addition, the Elecsys assay identified all screened HIV subtypes and displayed greater sensitivity to HIV-2 homologous antigen and antibodies to HIV-1 E and O and HIV-2 than the other assays. Overall, the specificity of the Elecsys_ assay was 99.88 % using samples from blood donors and 99.81 % when analyzing unselected samples.

Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia:
Tao CM, et al. (2013). J. Clin.Virol, http://dx.doi.org/10.1016/j.jcv.2013.05.012

Summary:
Objective: To validate the assay for screening and reliable early detection of HIV-1 infection in Asia.

Conclusions:
Overall, the Elecsys® HIV combi PT showed superior sensitivity to the comparators for detecting all subtypes. The assay detected seroconversion at a similar or shorter time interval than the comparators. The analytical sensitivity of Elecsys®HIV combi PT for HIV-1 p24 antigen was 0.90 IU/mL, which was lower than reported previously. The assay showed superior specificity (99.86%; n=4,465) to other fourth-generation assays tested.