Molecular Hepatitis C: (HCV)

Hepatitis C: (HCV)

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Overview
Virology Hepatitis C HCV

Redefining HCV Viral Load Monitoring

The first FDA-approved HCV RNA viral load test for use as an aid in the diagnosis of active HCV infections.

CONSOLIDATE 2 TESTS INTO 11

Aid in the diagnosis of HCV infection1

Detection of HCV RNA in HCV antibody (+) to confirm active infection

Management for patients with chronic HCV1

Predict the probability of SVR during a course of antiviral therapy and assess viral response to therapy

HCV — An ever-changing virus

Accurately detect and quantitate all HCV genotypes 1 through 6

The combination of error-prone RNA replication with a high rate of virus production results in extreme genetic variability of hepatitis C virus (HCV). A quantitative HCV RNA test must thus be able to tolerate sequence mismatches for accurate and reliable results.

  • Two non-overlapping detection probes, when combined with two staggered primers, ensure assay performance with HCV isolates containing sequence heterogeneity.
  • Mismatch tolerance enables the test to accurately quantify the target despite nucleotide changes in the viral genome while maintaining high specificity for HCV RNA.

Accurate detection and quantitation of all HCV genotypes 1 through 6. cobas® HCV detects 7 genotypes/subtypes at a concentration of 9 to 15 IU/mL by PROBIT at 95% hit rate analysis (500 μL sample processing volume). 1

We are committed to continuous global surveillance with mutating viruses and the latest innovation in assay design.

The HCV RNA Quantitative Test Is Based upon Real-Time PCR Gold Standard Technology

The #1 choice that patients depend on

Receive the unmatched reliance of Roche PCR tests with 82% of U.S. virology market share2 and 34 million HCV tests performed3.


Only proven HCV test used in all clinical trials of DAAs7,8,9,10,11,12,13

Drugs Trade Name Approval Status Genotypes Assay Used in Clinical Trial
Combination of two drugs - Ribavirin and Intron Rebetron 1998 not specified Roche High pure
Peginterferon alfa-2b Pegintron 2001 not specified Roche High pure
Peginterferon alfa-2a Pegasys 2002 not specified Roche High pure
Ribavirin, USP Copegus 2002 not specified Roche High pure
Boceprevir Victrelis 2011 1 Roche High pure
Teleprevir Incivek 2011 1 Roche High pure
Simeprevir Olysio 2013 1 Roche High pure
Sofosbuvir Sovaldi 2013 1,2,3,4,5,6* Roche High pure
Sofosbuvir + Ledipasvir Harvoni 2014 1,4,5,6* Roche High pure
Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir Viekira Pak 2014 1 Roche High pure
Ombitasvir, Paritaprevir, Ritonavir Technivie 2015 4 Roche High pure
Daclatasvir Daklinza 2015 3 Roche High pure
Grazoprevir/Elbasvir Zepatier 2016 1,4 Roche CAP/CTM HCV v2
Sofosbuvir+Velpatasvir Epclusa 2016 1,2,3,4,5,6 Roche CAP/CTM HCV v2

Accurate as of March 2016.

Consistent performance, regardless of platform3

The same linear range and specificity that you expect

 
Intended use 1. Diagnosis of chronic HCV infection
2. Monitoring patients on HCV therapy
3. Assessment of SVR
Sample types Serum, EDTA & PPT Plasma
Linear range 15- 1.E+08 IU/mL
  Analytical sensitivity (LOD by probit analysis)
EDTA plasma (IU/mL) 11* 12*
Serum (IU/mL) 12* 13.7*
Specificity 100%
Primer and probe design Dual probe
Genotypes covered Genotypes 1-6
Contamination control with AmpErase Yes

* No statistically significant difference.- worst performance LoD across genotypes.


Get additional Performance data and learn more about the innovation with cobas® 6800/8800 Systems

Evolutionary virology assay development program

Continuous innovation and menu expansion

cobas® HBV Test

Quantitate HBV viral loads with Confidence

The cobas® HBV test is a real-time PCR test that provides quantitative HBV DNA results that have an impact on the workflow in your laboratory without compromising the results you rely on.

cobas® HIV-1 Test

The Gold Standard in HIV-1 Molecular Testing

The cobas® HIV-1 test for viral load monitoring has a unique dual target design, amplifying two separate regions of the HIV-1 genome. The test provides confidence in results for patients living with the HIV-1 virus.

cobas® CMV Test

Standardization for patients. Simplification for laboratories.

The cobas® CMV test is a fully automated FDA-approved CMV test that delivers the benefits of standardization for clinical decision making, while providing improved efficiencies the laboratory truly needs.

COBAS, AMPLIPREP, and TAQMAN are trademarks of Roche.

References:
1. cobas® HCV Package Insert 07175418001-01EN ver 1.0.
2. Independent market research validated through secondary sources.
3. Data on File with Roche Diagnostics, September 2015.
4. cobas® Am pliPrep/ cobas® TaqMan HCV test, v2 .0 Package Insert 06450393001-0 lEN v.1.0.
5. VICTRELIS® (full prescribing information). Merck & Co., Inc., Whitehouse Station, NJ; 2011.
6. INCIVEK® (full prescribing information). Vertex Pharmaceuticals Incorporated; 2013.
7. OLYSIO® (full prescribing information). Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP; 2014.
8. SOVALDI (full prescribing information). Foster City, CA: Gilead Sciences, Inc.; 2013.
9. HARVONI (full prescribing information). Foster City, CA: Gilead Sciences, Inc.; 2014.
10. VIEKIRA PAK (full prescribing information). North Chicago, IL. Abb\lle, Inc.; 2014.
11. TECHNIVIE (full prescribing information) North Chicago, IL, AbbVie, Inc : 2016.
12. DAKLINZA (full prescribing information) Princeton, NJ, Bristol-Myers Squibb Company: 2015.
13. ZEPATIER (full prescribing information) Whitehouse Station, NJ 2016.

Explore

cobas® HCV Test Intended Use1

COBAS® AmpliPrep/COBAS® TaqMan System & cobas® 6800/8800 Systems

The cobas® HCV assay detects and quantitates HCV RNA and is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

The cobas® HCV assay is intended for use in the management of patients with chronic HCV undergoing anti-viral therapy:

  • To measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response.
  • Results must be interpreted within the context of all relevant clinical and laboratory findings.

Method correlation2

Excellent correlation to COBAS® AmpliPrep/COBAS® TaqMan HCV Test, v2.0



cobas® HCV Test Innovation Review

Key improvements in simplicity and functionality

 

Benefits

CLIA complexity categorization High Moderate Increases flexibility with personnel
Tests per package 72 96  
Control packaging Included in kit Packaged separately Reduces waste
Onboard open reagent stability 64 hours 30 days  

References:

  1. cobas® HCV Package Insert 07175418001-01EN ver 1.0.
  2. Data on File with Roche Diagnostics, September 2015.
  3. cobas® Am pliPrep/ cobas® TaqMan HCV test, v2.0 Package Insert 06450393001-01EN v.1.0.
Performance

cobas® HCV Test Performance Summary

Gold Standard Performance with additional benefits

 
HCV CAP/CTM cobas® 6800/8800 systems
Intended use 1. Diagnosis of chronic HCV infection
2. Monitoring patients on HCV therapy
3. Assessment of SVR
CLIA complexity categorization High Moderate
Linear range 15- 1.E+08 IU/mL
Analytical sensitivity (LOD by probit analysis)  
EDTA plasma (IU/mL) 11* 12*
Serum (IU/mL) 12* 13.7*
Packaging All reagent components (72 test kits) HCV test-specific reagent (96 tests/kit)
Control packaging Included in kit Packaged separately
Genotypes covered Genotypes 1-6
Primer and probe design Dual probe
Sample types Serum, EDTA & PPT Plasma
Sample size 650 uL
Contamination control with AmpErase Yes
Specificity 100%

Need additional performance data?

References:
1. cobas® Am pliPrep/ cobas® TaqMan HCV test, v2.0 Package Insert 06450393001-01EN v.1.0.
2. cobas® HCV Package Insert 07175418001-01EN ver 1.0.

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Updated August 25, 2016