PROCLEIX ULTRIO Assay

One tube. One test. The power of three.

Combining three tests in a single tube, the ULTRIO Assay is a qualitative in-vitro nucleic acid amplification test for the detection of HIV-1 RNA, HCV RNA, and HBV DNA in plasma and serum specimens from human donors. Because ULTRIO tests for 3 markers simultaneously, it represents a powerful and efficient solution for your blood screening needs. PROCLEIX ULTRIO Assay offers: Reduced risk of transfusion transmitted infections In the world of blood screening, confidence in results is of critical importance. While ELISA blood screening technology relies on the detection of serological markers, these markers may not appear in blood until up to three months after an infection, leaving a window period in which a risk of transfusion-transmitted infection is increased. The PROCLEIX ULTRIO Assay reduces this window period by detecting the presence of the viral RNA or DNA directly. Scientific models estimate that NAT significantly reduces the infectious window period in both individual and mini-pool donation testing formats.
Procleix ULTRIO Window Period in Days
Detection of HIV-1 ID NAT 5.6 MP NAT 9.0 Ab or Ag 15.0 Detection of HCV ID NAT 4.9 MP NAT 7.4 Ab or Ag 58.3 days Detection of HBV ID NAT 24.6 MP NAT 31.1 Ab or Ag 38.3 days

Figure 1: Scientific models estimate that NAT reduces the infectious window period by 35-91% for HIV-1, HCV, and HBV with individual donation testing (IDT), and by 17 to 87% for with mini-pool (pools of 16) nucleic acid testing. 3,4

Optimal nucleic acid testing flexibility and efficiency Achieve maximum flexibility with the ability to run ULTRIO on either the semi-automated PROCLEIX System, ideal for low to medium volume laboratories, or the fully automated TIGRIS System for mid to high volume laboratories. PROCLEIX ULTRIO allows laboratories to: Gain workflow efficiencies when running ULTRIO and WNV Assays on the PROCLEIX TIGRIS System for full automation of NAT. Perform multiplex screening and discriminatory NAT on the same PROCLEIX platform. Screen whole blood, organ and tissue, or plasma all in same assay; intended usage also includes cadaveric blood samples, source plasma, as well as the ability to run heparinized samples.

Exceptional assay performance Developed using probes and primers designed to increase detection of different viral subtypes, the PROCLEIX ULTRIO Assay provides excellent specificity and analytical sensitivity for the combined detection of HIV-1, HCV and HBV The . PROCLEIX ULTRIO Assay offers: Ability to detect HCV genotypes 1-6.2 Redundant detection via primers targeting two highly conserved regions of the HIV-1 gene to help prevent HIV-1 mutant break-through transmissions.1
Analytical Sensitivity of the PROCLEIX ULTRIO and Discriminatory Assays on the PROCLEIX TIGRIS System for the Detection of HIV-1, HCV and HBV5
Detection Probabilities Panel Tested HIV-1 B copies/mL HIV-1 B copies/mL HIV WHO (97/656) IU/mL HCV WHO (96/790) IU/mL HCV WHO (96/790) IU/mL HBV WHO (97/746) IU/mL HBV WHO (97/746) IU/mL Assay ULTRIO Assay dHIV-1 Assay dHIV-1 Assay ULTRIO Assay dHCV Assay ULTRIO Assay dHBV Assay 95% (95% Fiducial Limits) 28.8 (25.9-32.7) copies/mL, 47.9 (43.1-54.5) IU/mL6 32.1 (28.7-36.7) copies/mL, 53.6 (47.90-61.2) IU/mL6 20.3 (18.1-23.1) 3.0 (2.7-3.4) 3.2 (2.8-3.6) 10.4 (9.2-12.2) 8.5 (7.6-9.8)

Specificity of the PROCLEIX ULTRIO and Discriminatory Assays in Normal Blood Donors
ULTRIO PROCLEIX System PROCLEIX TIGRIS System 100% 99.60% dHIV-1 99.86% 100% dHCV 99.46% 99.73% dHBV 99.73% 100%

Your Partner in Protection

The PROCLEIX ULTRIO Assay is another demonstration of Novartis Diagnostics ongoing commitment to safeguard the global blood supply. We are proud of our legacy of pioneering research in the field of infectious disease and we will continue to focus on preventing transfusion-transmitted diseases worldwide.
1. M. Schmidt, M.K. Hourfar, E. Seifried, HIV-1 Realtime Detection in Two Conserved Regions Increases Blood Safety. 30th International Congress, ISBT, P-679, June 2008. 2. F. Gonzales and S. McDonough, Applications of Transcription-Mediated Amplification to Quantification of Gene Sequences, Gene Amplification. 1998 Ed. Francois Ferre, Birkhauser, Boston. PP. 189-204. 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): Advances 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 Clin Virol 36 Suppl. 1 (2006) S23S29. 5. Data from PROCLEIX ULTRIO Assay exUS Package Insert 500690EN Rev. B run on the TIGRIS PROCLEIX System. 6. Palla et al.,Vox Sanguinis, 2006; 90:59-62

This material may only be used in countries where the product(s) and/or indications mentioned in the material are approved. For a complete list, visit www.novartisdiagnostics.com/approvals.

Represented in the U.S. by: Novartis Vaccines and Diagnostics, Inc. 4560 Horton Street Emeryville, CA 94608 USA Tel: (800) 452-6877

Asia/Pacific office: Novartis Vaccines and Diagnostics (HK) Ltd. Units 1506-07 DCH Commercial Centre 25 Westlands Road Quarry Bay, Hong Kong Tel: +852 2161 3100

European office: Novartis Vaccines and Diagnostics SAS 10 Rue Chevreul 92150 Suresnes, France Tel: +33 1 55 49 00 30

Copyright 2010 Novartis Vaccines and Diagnostics, Inc. Developed by Gen-Probe Incorporated in collaboration with Novartis Vaccines and Diagnostics, Inc., and marketed by Novartis Vaccines and Diagnostics, Inc. ULTRIO and PROCLEIX are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a trademark of Gen-Probe, Incorporated. SS-006EN-JUL10