siemens.com/healthineers Clinical Relevance Viral load testing, using a real-time PCR-based method, is an established tool for the monitoring of HCV patients. Highly sensitive assays are needed in order to assess viral suppression and clearance. The latest clinical guidelines * recommend assessment of HCV viral load in conjunction with new and effective HCV treatment regimens including direct-acting antiviral agents (DAA). HCV Assay Design • Outstanding precision across dynamic range • Targets the highly conserved HCV 5’ untranslated region (5’ UTR) • Calibrators and controls made from HCV Armored RNA (Asuragen) for maximum stability • Optimized TaqMan probes with Black Hole Quenchers. VERSANT kPCR Molecular System with VERSANT MiPLX Software Solution Advancing flexibility, workflow, customization, and consolidation in the molecular laboratory. • Comprehensive and flexible solution for molecular diagnostics. • Open-channel capabilities enables customization of Siemens assays, laboratory-developed, and third- party assays. ** • Multiplexing of up to six assays from one sample in one run. • Standardized extraction method for isolation of quality nucleic acids from a wide variety of specimen types. • Consolidation of quality assays for infectious-disease testing on a single, automated platform. VERSANT HCV RNA 1.0 Assay (kPCR) VERSANT kPCR Molecular System Assay Description The VERSANT ® HCV RNA 1.0 Assay (kPCR) is an in vitro nucleic acid amplification test for quantitative measurement of hepatitis C virus (HCV) RNA in human serum and plasma samples from HCV–infected individuals. The assay is based on real-time polymerase chain reaction (PCR) technology, utilizing PCR for the amplification of specific target sequences and target- specific probes for the detection of amplified DNA. This assay is performed on the VERSANT kPCR Molecular System. Combined with Siemens Healthcare Diagnostics’ nucleic acid extraction technology, this assay provides a reliable and sensitive method for the quantitation of HCV in infected individuals. One Solution— More Choice. *EASL clinical practice guidelines: Recommendations on the treatment of hepatitis, 2017 **Customer is responsible for validating assays. Hepatitis C Testing
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VERSANT HCV RNA 1.0 Assay (kPCR)...VERSANT HCV RNA 1.0 Assay (kPCR) VERSANT kPCR Molecular System Assay Description The VERSANT® HCV RNA 1.0 Assay (kPCR) is an in vitro nucleic acid
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siemens.com/healthineers
Clinical Relevance Viral load testing, using a real-time PCR-based method, is an established tool for the monitoring of HCV patients. Highly sensitive assays are needed in order to assess viral suppression and clearance. The latest clinical guidelines* recommend assessment of HCV viral load in conjunction with new and effective HCV treatment regimens including direct-acting antiviral agents (DAA).
HCV Assay Design • Outstanding precision across
dynamic range
• Targets the highly conserved HCV 5’ untranslated region (5’ UTR)
• Calibrators and controls made from HCV Armored RNA (Asuragen) for maximum stability
• Optimized TaqMan probes with Black Hole Quenchers.
VERSANT kPCR Molecular System with VERSANT MiPLX Software Solution Advancing flexibility, workflow, customization, and consolidation in the molecular laboratory.
• Comprehensive and flexible solution for molecular diagnostics.
• Open-channel capabilities enables customization of Siemens assays, laboratory-developed, and third-party assays.**
• Multiplexing of up to six assays from one sample in one run.
• Standardized extraction method for isolation of quality nucleic acids from a wide variety of specimen types.
• Consolidation of quality assays for infectious-disease testing on a single, automated platform.
VERSANT HCV RNA 1.0 Assay (kPCR)VERSANT kPCR Molecular System
Assay Description The VERSANT® HCV RNA 1.0 Assay (kPCR) is an in vitro nucleic acid amplification test for quantitative measurement of hepatitis C virus (HCV) RNA in human serum and plasma samples from HCV–infected individuals. The assay is based on real-time polymerase chain reaction (PCR) technology, utilizing PCR for the amplification of specific target sequences and target-specific probes for the detection of amplified DNA. This assay is performed on the VERSANT kPCR Molecular System. Combined with Siemens Healthcare Diagnostics’ nucleic acid extraction technology, this assay provides a reliable and sensitive method for the quantitation of HCV in infected individuals.
One Solution— More Choice.
* EASL clinical practice guidelines: Recommendations on the treatment of hepatitis, 2017** Customer is responsible for validating assays.
Please contact your local sales representative to learn more about the full line of Siemens Healthcare Diagnostics molecular assays for infectious diseases or visit siemens.com/molecular.
VERSANT HCV RNA 1.0 (kPCR): Integrase Region Target – HCV 5’ untranslated region (5’ UTR)
Target Region
Deming Scatter Plot
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Abbott Quant (log IU/mL)
VERSANT kPCR vs. Abbott
VERS
ANT
kPCR
Qua
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og IU
/mL)
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8 N = 145Y = 0.362 + 0.98 XNote: One outlier removed
§ Total sample Input volume requirement depends on tube type and size.
† Data on file at Siemens Healthcare Diagnostics. ‡ Data on file at Siemens Healthcare DIagnostics, Nexus Global Solutions, Inc.
VERSANT and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners.
Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.
CE-marked for IVD use.
Local Contact InformationSiemens Healthcare Diagnostics Inc.Molecular Diagnostics725 Potter StreetBerkeley, CA 94710-2722USAPhone: +1 510-982-4000