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Roche nucleic acid testing solutions: Efficiency and quality for labs of all sizes
Over 60 million blood and plasma donations are tested on Roche nucleic acid testing systems each day.1 From launching the first nucleic acid testing assays for blood screening, Roche has consistently remained at the forefront of keeping the blood supply safe through active surveillance of emerging infections and rapid development of screening solutions.
Roche nucleic acid testing instruments, assays, and reagents have been developed using the gold standard real-time Polymerase Chain Reaction (PCR) technology, a very sensitive technology that detects DNA and RNA molecules of infectious agents such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) at an early stage of an infection. Easily integrated into pre- and post-analytic solutions, our instruments enable donor screening facilities to automate operations, boost throughput, and achieve quicker turnaround times, leading to greater overall workflow efficiency.
Roche's state-of-the-art nucleic acid testing assays provide comprehensive genotype coverage and excellent sensitivity, working together with analyzers that provide efficient workflows and deliver fast results. Roche’s leading molecular diagnostic solutions provide predictable operational outcomes for laboratories and help reduce the risk of disease transmission and adverse health effects in patients.
Featured products
IVD
For in vitro diagnostic use.
cobas® MPX-E
The cobas® MPX-E test for use on the cobas® 5800/6800/8800 systems is a qualitative in vitro test for the direct detection of human immunodeficiency virus type 1 (HIV-1) group M RNA, HIV-1 group O RNA, human immunodeficiency virus type 2 (HIV-2) RNA, hepatitis C virus (HCV) RNA, hepatitis B virus (HBV) DNA, and hepatitis E virus (HEV) RNA in human plasma and serum. This test is intended for use to screen donor samples for HIV-1 group M RNA, HIV-1 group O RNA, HIV-2 RNA, HCV RNA, HBV DNA, and HEV RNA in plasma and serum samples from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating and in testing of cadaveric (non-heart beating) donors. Plasma and serum from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma and serum samples may be tested individually, or plasma may be tested in pools comprised of aliquots of individual samples. For donations from cadaveric (non-heart beating) organ and tissue donors, samples may only be screened as an individual sample. For an individual sample, results are simultaneously detected and discriminated for HIV, HCV, HBV, and HEV.The cobas® MPX-E test can be considered a supplemental test that confirms HIV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HIV and reactive for HIV on the cobas® MPX-E test. The cobas® MPX-E test can be considered a supplemental test that confirms HCV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HCV and reactive for HCV on the cobas® MPX-E test. The cobas® MPX-E test can be considered a supplemental test that confirms HBV infection for samples that are repeatedly reactive on a CE-IVD test for Hepatitis B surface antigen and reactive for HBV on the cobas® MPX-E test.
Benefits of NAT solutions from Roche
Safety
Improve blood and/or plasma supply safety
Ensure the highest level of blood safety screening and testing with:
- Comprehensive genotype coverage, for ensuring reliable detection and safe blood supply
- Increased protection with NAT screening from transfusion-transmitted infection(s) for recipients of donated blood or blood products
- Real-time PCR NAT blood tests for the direct detection or quantitation of bloodborne infectious agents or infectious agent(s)
- Highly sensitive and specific NAT testing for blood donors for less retesting and minimized loss of donors and donations
Results
Generate trusted, reproducible results with enhanced performance
High-quality assay management and analysis, including:
- Proven real-time PCR technology for ensuring reliable results
- Automated sample handling solutions and user-friendly interface for reduction in manual handling errors
- Full-process internal control helps ensure result integrity
- Real-time detection and discrimination of viral targets
- True external positive controls that have no direct effect on calibration with assay control kits
Efficiency
Absolute automation to drive increased efficiency with minimal human interactions
Consistent, accurate and reliable testing solutions leveraging the benefits of:
- Automated analyzers and workflow for reducing cross contamination and providing up to 8 hours walk-away time leading to overall workflow efficiency
- Data management options for simplified order and result handling
- Stabilized real-time PCR reagents do not require calibration
- Ready-to-use reagents do not require thawing, mixing, or pouring
- Flexibility to run simultaneously with other assays on the cobas® 5800*/6800/8800 Systems
- Radio-frequency identification (RFID) and barcodes ensure full traceability from sample-in to results-out
- Flexibility to choose the pool size that best meets your needs: individual donor testing (IDT), pools of 6, pools of 24, or pools of 96
Broad portfolio
Explore Roche NAT blood tests* and analyzers for donor screening
- Comprehensive target menu: Access a wide-ranging portfolio that detects critical viral targets, emerging zoonotic pathogens, parasites, and tropical diseases in human blood and plasma.
- Streamlined single-assay testing: Boost operational efficiency and eliminate the need for additional discriminatory testing with multi-target assays that detect and differentiate multiple viruses simultaneously.
- Advanced genotype and lineage coverage: Ensure robust screening accuracy with assays designed to identify diverse global genotypes, lineages, and strains.
Explore more
*Products of the Roche Blood Safety Solutions portfolio are not commercially available in all regions. Please contact your local Roche representative regarding availability. In the US, pre and post analytics are standalone solutions.
**cobas® DPX is an in-process test for plasma intended for further manufacture.
References:
- F. Hoffmann-La Roche Ltd. Data on file.