VERSANT HCV RNA 1.0 Assay (kPCR)Highly Sensitive Viral Load Assay for the VERSANT kPCR Molecular System

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.}

• 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
   

• 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

• 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.}

The VERSANT® HCV RNA 1.0 Assay (kPCR)* is a real-time kinetic polymerase chain reaction (kPCR) assay for quantitative detection of human hepatitis C virus (HCV) RNA in plasma or serum of HCV-infected individuals. The assay is intended to be used in conjunction with clinical presentation and other laboratory markers of disease status to aid in the management of HCV-infected individuals undergoing antiviral therapy.

• Referenced to the WHO 3rd Hepatitis C Virus (HCV) RNA International Standard (60/100) for IU/mL
• Conversion factor: 1 IU/mL = 4.3 copies/mL
• Lot-to-lot reproducibility ensured with Gold Standard Master Calibrators (secondary standards to WHO standard)

• 15-100,000,000 IU/mL (64.5 – 430,000,000 copies/mL)
• LOD = 15 IU/mL (64.5 copies/mL)

• 2 log IU/mL – 23.8 to 30.4% (0.11 - 0.13 log SD)
• 3-4 log IU/mL – 22.8 to 23.6% (0.10 log SD)
• 5-8 log IU/mL – 26.5 to 35.6% (0.11 - 0.15 log SD)

Catalog No.      Description
10469013          VERSANT HCV-1 RNA 1.0 (kPCR) Kit, IVDD Box 1 (96 tests) *
10469014          VERSANT HCV-1 RNA 1.0 (kPCR) Kit, IVDD Box 2 (96 tests) *
10286026          VERSANT Sample Preparation 1.0 Reagents Box 1 (96 tests) *
10286027          VERSANT Sample Preparation 1.0 Reagents Box 2 (96 tests) *

^{*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.}