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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

VERSANT HCV RNA 1.0 Assay (kPCR)Performance Characteristics

Description Value

Dynamic Range • 15 to 100,000,000 IU/mL

• LoD = 15 IU/mL (Upper 95% CI 14.2 IU/mL)

Genotype and Subtype Detection and Recovery

• Quantifies all genotypes 1–6 within ± 0.5 log IU/mL†

• Follow up HCV genotype and subtype detection of 15 HCV subtypes, including 1a, 1b, and 6 (c-l) available with VERSANT HCV Genotype 2.0 Assay (LiPA)

Product Specifications

Description Value

Reagent Storage Conditions

HCV Assay (Box 1): –30 to –10˚C

HCV Assay (Box 2): –30 to –10˚C

Sample Preparation Reagents (Box 1): 15–30°C

Sample Preparation Reagents (Box 2): 2–8°C

Sample Input Volume 500 µL§

Product Features

Description Value

Contamination Control

UNG and physical barriers

Calibrators and Controls

Two calibrators Three controls (high positive, low positive, negative)

Validated Specimen Types

Plasma or serum

Turnaround Time Up to 178 patient results per shift‡

Ordering Information

Catalog Description Quantity

10469013 VERSANT HCV RNA 1.0 Assay (kPCR), Box 1 96 tests

10469014 VERSANT HCV RNA 1.0 Assay (kPCR), 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

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

2

1 2 3 4 5 6 7 8

Abbott Quant (log IU/mL)

VERSANT kPCR vs. Abbott

VERS

ANT

kPCR

Qua

nt (l

og IU

/mL)

1

3

4

5

6

7

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.

5’ 3’Core E1 p7 NS2 NS3 NS4A NS4B NS5A NS5BE2

VERSANT HCV RNA 1.0 (kPCR) Target – HCV 5’ untranslated region (5’ UTR)

3’ UTR

Open Reading Frame

5’ UTR Structural Proteins Non-Structural Proteins

VERSANT HCV RNA 1.0 Assay (kPCR) vs. Abbott RealTime HCV Assay

Order No. 99-17-10263-01-76 | 09-2017 | © Siemens Healthcare Diagnostics Inc., 2017

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

Siemens Healthineers HeadquartersSiemens Healthcare GmbHHenkestr. 12791052 Erlangen, GermanyPhone: +49 9131 84-0siemens.com/healthineers