The Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 2.0, Real-Time PCR Assay Accurately Quantifies Hepatitis C Virus Genotype 4 RNA

Chevaliez, Stéphane; Bouvier‐Alias, Magali; Rodriguez, Christophe; Soulier, Alexandre; Poveda, Jean-Dominique; Pawlotsky, Jean‐Michel

doi:10.1128/jcm.02004-12

Cited by 36 publications

(27 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The test accurately quantified HCV RNA concentrations in plasma and serum samples taken from a total of 126 patients infected with HCV genotype 4, regardless of its subtype or the presence of nucleotide polymorphisms within the 5 0 untranslated region of the viral genome known to result in underestimation of HCV RNA concentrations with version 1.0 of the test (namely an A-to-T substitution at position 165, either alone or in conjunction with a G-to-A substitution at position 145) [18].…”

Section: Accuracy and Precisionmentioning

confidence: 99%

COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, Version 2.0: An In Vitro Test for Hepatitis C Virus RNA Quantification

Deeks

2014

Mol Diagn Ther

View full text Add to dashboard Cite

The COBAS(®) AmpliPrep/COBAS(®) Taqman(®) HCV Quantitative Test, version 2.0, is an in vitro, fully automated, real-time, nucleic acid amplification test indicated for quantifying hepatitis C virus (HCV) RNA levels in the plasma/serum of patients infected with HCV of genotypes 1-6 who are receiving anti-viral therapy. By quantifying levels of HCV RNA in these patients, the test can be used early in the course of treatment to predict the likelihood of a sustained virologic response being achieved and can also be used to assess virologic response during treatment as part of response-guided therapy. The test has excellent sensitivity, high specificity and a broad linear range of quantitation. It correlates well with version 1.0 of the same test, but has the benefit of better sensitivity and genotype inclusivity and a smaller sample input volume. It also correlates well with other available HCV tests, including other quantitative real-time PCR tests (specifically the COBAS(®) Taqman(®) HCV Test, version 2.0, used with the high pure system, and the Abbott Realtime and Artus HCV QS-RGQ tests), the Versant(®) branched DNA quantitative test, the COBAS(®) Amplicor HCV Qualitative PCR Test and the Versant(®) HCV qualitative transcription-mediated amplification assay. The test is not indicated for HCV infection diagnosis or to screen for the presence of HCV in blood/blood products.

show abstract

Section: Accuracy and Precisionmentioning

confidence: 99%

COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, Version 2.0: An In Vitro Test for Hepatitis C Virus RNA Quantification

Deeks

2014

Mol Diagn Ther

View full text Add to dashboard Cite

show abstract

“…htm). However, it is necessary to remember that not all HCV genotypes are detected equally by NAT assays, most likely because of nucleotide mismatches which has occurred before [58,59] . HCV RNA in the serum is probably the earliest detectable marker of acute HCV infection, preceding the appearance of anti-HCV antibody by several weeks [35] .…”

Section: Detection Of Viral Rnamentioning

confidence: 99%

Hepatitis C virus: Virology, diagnosis and treatment

2015

WJH

162

114

View full text Add to dashboard Cite

More than twenty years of study has provided a better understanding of hepatitis C virus (HCV) life cycle, including the general properties of viral RNA and proteins. This effort facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. Quantization and genotyping of HCV RNAs are important to determine the optimal duration of anti-viral therapy and predict the likelihood of response. In the early 2000s, pegylated interferon plus ribavirin became the standard anti-HCV treatment. However, this therapy is not ideal. To 2014, boceprevir, telaprevir, simeprevir, sofosbuvir and Harvoni are approved by Food and Drug Administration for the treat of HCV infections. It is likely that the new all-oral, interferon-free, pan-genotyping anti-HCV therapy will be available within the next few years. Majority of HCV infections will be cured by these antiviral treatments. However, not all patients are expected to be cured due to viral resistance and the high cost of antiviral treatments. Thus, an efficient prophylactic vaccine will be the next challenge in the fight against HCV infection. Core tip: Understanding the general properties of hepatitis C virus (HCV) viral RNA and proteins facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. To 2014, in addition to pegylated interferon and ribavirin, boceprevir, telaprevir, simeprevir, sofosbuvir and Harvoni are approved by Food and Drug Administration to treat HCV infections. The majority of HCV infections can be cured by these anti-viral treatments. An efficient prophylactic vaccine will be the next challenge in the fight against HCV infection. REVIEWSubmit a

show abstract

“…tional probe, has been released in Western Europe and the United States to resolve the problem of underestimation of HCV genotype 4 viral RNA (4). CAP/CTM HCV v2.0 detected and quantified the HCV genotype 2a RNA in the two specimens that were not detected by v1.0 at 4.17 log 10 IU/ml and 5.05 log 10 IU/ml.…”

mentioning

confidence: 99%

Hepatitis C Virus Genotype 2 May Not Be Detected by the Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 1.0

Watanabe¹,

Tanoue

Maekawa

et al. 2013

J Clin Microbiol

View full text Add to dashboard Cite

A ccurate hepatitis C virus (HCV) RNA quantification is essential for the management and efficacy of treatment of chronic hepatitis C. The HCV RNA level is assessed using real-time PCRbased assays. Two highly sensitive commercial assays for HCV RNA quantification are available in many countries: the Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM HCV) (Roche Molecular Systems, Inc., Pleasanton, CA) and the Abbott RealTime HCV assay (ART HCV) (Abbott Molecular, Inc., Des Plaines, IL). Despite its good performance with most HCV strains, the CAP/CTM HCV test version 1.0 (v1.0) fails to detect genotype 4 strains with single nucleotide polymorphisms at positions 145 and 165 in the 5= untranslated region (5= UTR) (1). HCV genotype 4 is restricted to particular geographical areas, and many countries, including Japan, continue to use CAP/CTM HCV v1.0 to monitor HCV RNA quantification.We report two Japanese patients with HCV genotype 2a in whom HCV RNA was undetectable by CAP/CTM HCV v1.0, although hepatitis C viremia was confirmed by the ART HCV test (4.0 and 5.0 log 10 IU of HCV RNA/ml) and the Architect HCV core antigen assay (Abbott Diagnostics, Lake Forest, IL) (95 and 107 fmol/liter). This failure could be related to two or three substitutions in the putative binding site for the TaqMan probe (Fig. 1). The substitutions are at position 145, as described for HCV genotype 4 (1), and positions 158 and 169, which have not been reported previously.Underestimation of HCV genotype 2 RNA by CAP/CTM HCV v1.0 has been reported previously (2), but failure to detect HCV genotype 2a RNA is critical as this genotype is the second most common HCV genotype. Recently, a second version of the assay, CAP/CTM HCV v2.0 (3), with redesigned primers and an addi-

show abstract

The Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 2.0, Real-Time PCR Assay Accurately Quantifies Hepatitis C Virus Genotype 4 RNA

Cited by 36 publications

References 20 publications

COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, Version 2.0: An In Vitro Test for Hepatitis C Virus RNA Quantification

COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, Version 2.0: An In Vitro Test for Hepatitis C Virus RNA Quantification

Hepatitis C virus: Virology, diagnosis and treatment

Hepatitis C Virus Genotype 2 May Not Be Detected by the Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 1.0

Contact Info

Product

Resources

About