Single-tube solution for HIV-1 and HCV enhances blood safety.

The PROCLEIX^® HIV-1/HCV Assay detects both viruses in a single tube, thanks to transcription-mediated amplification (TMA) technology. It was the first nucleic acid testing (NAT) solution to be approved for blood screening in the US. And to receive the CE Mark in Europe.

Most other screening technologies rely on the detection of serological markers. However, these markers may not appear in blood until up to three months after an infection, leaving a “window period” of potential transfusion-transmitted infection.

By detecting viral nucleic acids directly, the PROCLEIX^® HIV-1/HCV Assay greatly shortens this time period and increases the level of safety for donated blood, tissue and organs.¹

Studies and modeling data indicate a 50 percent reduction in the window period between infection and detection for HIV-1 and a 70 percent reduction for HCV.²

In addition, the PROCLEIX^® HIV-1/HCV Assay can be used for low- and high-volume testing on pooled or individual donor samples. It can be used to test plasma samples from blood, organ and tissue donors. See Intended Use for details.

 

PROCLEIX is a trademark of Novartis Vaccines and Diagnostics, Inc.

Learn more on the TMA technology

References

1. PROCLEIX^® HIV-1/HCV Assay package insert, IN076.
2. Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The Risk of Transfusion-Transmitted Viral Infections. N Engl J Med. June 27, 1996;445:1685-90.

Download the Intended Use document
(1.32 MB)