PROCLEIX^® ULTRIO^® Assay

Overview

The first 3-in-1 Nucleic Acid Test for HIV-1, HCV and HBV.

The PROCLEIX^® ULTRIO^® Assay is intended to deliver all the benefits of the PROCLEIX^® HIV-1/HCV Assay while targeting a third grave threat to the blood supply: HBV. Nucleic Acid Testing (NAT) detects viral RNA and DNA during the very early stages of infection, reducing the window period between infection and detection. Using Transcription-Mediated Amplification technology developed by Gen-Probe Incorporated, the PROCLEIX^® HIV-1/HCV Assay revolutionized blood screening as the first multiplex, single-tube solution for early detection of HIV-1 and HCV. Developed by Gen-Probe in collaboration with Novartis Diagnostics. Manufactured by Gen-Probe Incorporated. Distributed by Novartis Vaccines and Diagnostics, Inc.

 

 

Benefits

First 3-in-1 Nucleic Acid Test

• Designed with TMA technology to simultaneously test HIV-1, HCV, and HBV in a single tube*
• Produces one result for three markers in the same time as the PROCLEIX^® HIV-1/HCV Assay, without adding staff or instrumentation Optimized Efficiency
• Up to 696 results in pools of 8, or 87 individual donor test results per operator
• Fast turnaround: results in 5-6 hours

 

Maximized Utility

The PROCLEIX^® ULTRIO^® Assay tests:

• Plasma and serum specimens from donors of whole blood and blood components, and from other living donors
• Plasma and serum specimens from organ donors
• Blood specimens from cadaveric donors

Ease of Use:

• Single-tube process minimizes material transfer steps; potential for contamination
• Color change confirms addition of each reagent
• Bar-coded sample tracking provides positive sample identity

Minimal impact on current operation:

• Uses familiar PROCLEIX^® instrumentation
• Modular PROCLEIX^® System for low- to mid-volume testing
• Typically requires no changes in lab configuration, staffing or equipment
• Similar to established protocols

Developed by Gen-Probe in collaboration with Novartis Diagnostics. Manufactured by Gen-Probe Incorporated. Distributed by Novartis Vaccines and Diagnostics, Inc.

Download the Intended Use document
(1.32 MB)

 

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