VERSANT HCV RNA 1.0 Assay (kPCR)
Highly Sensitive Viral Load Assay for the Atellica MDX 160 Molecular System
Perform HCV Viral Load Testing with Greater Efficiency
HCV infection is one of the main causes of chronic liver disease worldwide.1 Fortunately, with detection and appropriate therapy, the majority of HCV-infected individuals can be cured. The European Association for the Study of the Liver (EASL) recommends response-guided therapy for HCV, which includes the monitoring of treatment efficacy using a real-time PCR-based assay, with a lower limit of detection of 10-20 IU/mL.2 The VERSANT® HCV RNA 1.0 Assay (kPCR)*, which has a limit of detection of 15 IU/mL, provides excellent precision across the dynamic range and 100 percent specificity. Additionally, the assay features technology that is compatible with all HCV genotypes, providing clinicians the information that they need to manage patient therapy.
1. Lavanchy D. The global burden of hepatitis C. Liver Int 2009; 29:74-81.
2. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection Journal of hepatology, 2011.
Outstanding Assay Performance
- Quality extraction of nucleic acids ensures accuracy
- Highly sensitive and specific assay performance provides confidence
- Excellent precision across a wide dynamic quantitation range produces reliable results
- Quantitation of all genotypes (1-6) within +- 0.5 log IU/mL provides clinicians with the information they need to manage therapy
Automated and Flexible Technology
- Primary-tube sampling supports a variety of tube types and sizes
- Positive patient sample identification with barcode ID
- Flexible run sizes with 4 runs per kit over 4 weeks
- Samples can be co-extracted for simultaneous PCR plate preparation
Robust Assay Design
- Ultrasensitive kinetic PCR technology
- Maximum stability and reproducibility with calibrators and controls made from HCV ARMORED RNA (Asuragen)
- Amplicon contamination control with UNG (Uracil N-glycosylase)
- Enhanced sensitivity and specificity with BLACK HOLE QUENCHER reagent (Biosearch Technologies)
- Non-competitive internal control to monitor extraction and PCR efficiency
- Targets the highly conserved HCV 5’ untranslated region (5’ UTR), detects all genotypes 1–6
* IVDD, CE marked. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirements.
VERSANT is a registered trademark of Siemens. All other marks are the property of their respective owners.