Procleix® Ultrio Elite® Assay

The Procleix Ultrio Elite Assay bears CE marking. The assay is in development and not available for use and sale in other countries.

The Procleix Ultrio Elite Assay is our latest NAT assay designed to offer increased blood safety through HIV-1, HIV-2, HCV and HBV detection. The test has been CE marked and is in development for use in other countries.

Comprehensive Assay Design

  • The Procleix Ultrio Elite Assay is designed to offer increased blood safety through the detection of HIV-1, HIV-2, HBV and HCV:
    • Detects multiple groups, subtypes, and genotypes of HIV-1, HIV-2, HBV, and HCV
    • Targets two highly conserved regions of HIV-1 (pol, LTR)
    • HIV-1 groups M (A-H), N, and O
    • HBV genotypes A-H; target enhancement reagent for optimized HBV detection
    • HCV genotypes 1-6
    • Includes HIV-2 to meet regional needs
    • May be used with cadaver, source plasma, or heparinized samples
    • Suitable for IDT or minipools of 4, 8, or 16
  • The Procleix Ultrio Elite Assay protects against mutant and breakthrough transmissions through its redundant detection of highly conserved HCV and HIV-1 regions.

Assay Performance

  • Has comparable sensitivity and specificity to the Procleix® Ultrio Plus® on the Procleix® Tigris System for HIV-1, HCV and HBV.
  • Reduces the risk of Transfusion Transmitted Infections (TTIs) and shortens window periods of HIV-1, HIV-2, HCV and HBV.


The Procleix Ultrio Elite Assay can reduce the infectious window period by 61 to 96% for HIV-1, HCV and HBV with individual donation testing (IDT) 1,2,3
Procleix® Ultrio Elite Assay Performance

Window period comparisons are based on Weusten calculation model using 50% detection limits by probit analysis of test results from specific WHO panels and reported in the Procleix Ultrio Elite Assay package insert. 1,2,3 Window period comparison may vary based on serology testing methods, variability of WHO panels, testing strategies, and genotypes of the virus in the geographic country of use.

 

Results with confidence

Transcription Mediated Amplification (TMA) is easy to use with simultaneous detection of HIV-1/HIV-2/HCV/ HBV in a single tube, without the need for sample/ tube transfers or thermocycling.

 

References

  1. Procleix Ultrio Elite Assay Package Insert, 502186EN Rev A (ex-US).
  2. Weusten, J. et al. Transfusion 2002;42:537-548.
  3. Weusten, J. et al. Transfusion 2011;51:203-215.

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Grifols and Novartis have announced an agreement for Grifols to acquire the transfusion diagnostics unit of Novartis.

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