PROCLEIX^® ULTRIO Plus^® Assay

Not available for use and sale in all countries.

The PROCLEIX ULTRIO Plus Assay is CE Mark certified and approved for use in other markets. The assay is not currently available for commercial sale in the United States or China.

The PROCLEIX ULTRIO Plus Assay is our latest NAT assay designed to detect HIV-1, HCV, and HBV in individual donors of blood, organs, cells, and tissues. The test currently has CE mark certification and is being developed for use in other countries.

Overview

Raise the bar on blood safety

The PROCLEIX ULTRIO Plus Assay is a NAT innovation from Novartis Diagnostics that raises the bar on blood safety and offers a wide range of customized solutions. ULTRIO Plus provides increased blood safety through exceptional HIV- 1, HCV, and HBV sensitivity as well as optimal efficiency and flexibility within a complete nucleic acid testing solution.

 

 

Benefits



Reduce the risk of transfusion-transmitted infections through exceptional sensitivity and reduced window periods.

 

Strength in HIV-1 and HCV detection

The PROCLEIX ULTRIO Plus protects against mutant and breakthrough transmissions through its redundant detection of highly conserved HCV and HIV-1 regions.¹

• Two separate regions of the HIV-1 genome (pol, LTR) targeted¹
• Detects genetic variants of HIV-1 and HCV²
  • HCV Genotypes 1-6

 

Reducing the HBV window period by 61%

The HBV sensitivity of the PROCLEIX ULTRIO Plus Assay reduces the HBV window period by 61%, or 23 days relative to the standard antigen test.^3,4,5

• New Target Enhancer Reagent (TER) provides optimal viral disruption, amplification, and detection of viral DNA.
• Offers protection against occult HBV (OBI), which may not be detected by even the most sensitive HBsAg assays.⁵
• Excellent sensitivity to HBV Genotypes A-G.

 

Flexibility in throughput capacity and testing formats

ULTRIO Plus is compatible with either the fully automated PROCLEIX^® TIGRIS^® System for NAT or the semi-automated PROCLEIX^® System, and screening can be performed in either individual or pooled samples

• PROCLEIX TIGRIS System processes approximately 500 tubes in nine hours or 1000 tubes in 17 hours.
• PROCLEIX System (eSAS) processes 200 tubes in six hours (single system) or 400 tubes in six hours (double system).
• Run individual donations or in pools of up to 16 on either PROCLEIX platform.

 

Single-platform discrimination



Both the PROCLEIX TIGRIS System and the PROCLEIX System enable screening and discrimination on the same platform.

• All NAT testing can be completed using a single platform – no separate discriminatory system required.
• Discriminatory reagents contain full complement of probes for HIV-1, HCV or HBV
• Feel confident in the sample resolution by using discriminatory reagents that have sensitivities equivalent or better than the screening assay.

 

Full NAT automation and process control

The PROCLEIX TIGRIS System offers increased efficiency through process controls and minimal hands-on time.

• Optimize workflow with the only integrated, fully automated NAT system available.
• Help ensure result integrity with 250 in-process controls that monitor key aspects of the chemistry reactions and system operations.
• Minimize operator intervention and variability with fully enclosed system.

 

Results with confidence

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

 

TMA Advantage

Workflow efficiency

• No sample / tube transfers required;
  original sample collection tubes may be used,
  no special processing tubes required

Minimized operator-induced variability

• Single tube reaction

Simplified process – requires no extra instrumentation for extraction or use of a thermocylcer

• Efficient amplification using isothermic conditions

Sample flexibility – no restrictions on accepted sample anticoagulants

• Compatibility with Heparin

 

Your Partner in Protection

The PROCLEIX ULTRIO Plus Assay is another demonstration of Novartis Diagnostics’ ongoing commitment to safeguarding the global blood supply. We are proud of our legacy of pioneering research in the field of infectious diseases and we will continue to focus on preventing transfusiontransmitted diseases worldwide.

 

References

1. Giachetti, C. et al. Highly Sensitive Multiplex Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA. J Clinical Microbiology (2002) 40(7):2408-2419
2. Assal A et al. Comparison of the analytical and operational performance of two viral nucleic acid test blood screening systems: Procleix Tigris and cobas s 201. Transfusion. (2009) 49:289-300
3. Busch, MP, Evolving Approaches to Estimate Risks of Transfusion-Transmitted Viral Infections: Incidence-Window Period Model after Ten Years. Dax EM, Farrugia A, Vyas GN (editors): Advance in Transfusion Safety – Volume IV, Developments in Biologicals (Basel), Basel, Karger, 2007, vol 127, pp 87-112.
4. Kleinman SH, Busch MP, Assessing the impact of HBV NAT on window period reduction and residual risk, J Clinical Virology Suppl. 1 (2006) S23-S29.
5. Lin, CK, et al., Evaluation of the Procleix Ultrio Plus Assay, a Second Generation Multiplexed Assay for HIV-1, HCV and HBV. Transfusion 48(Suppl), 100A, 2008.