For in vitro diagnostic use. Others cobas HCV Test 5800-6800-8800 IVD cobas® HCV RMD-58-68-88-HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 040 765 190 9 040 765 190 09040765190 9040765190 09040765190 KIT COBAS 58/68/8800 HCV 192T IVD cobas HCV 00875197006391 Reagents, kits 1 kit 192 tests true cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.cobas® HCV 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.cobas® HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used 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. The results must be interpreted within the context of all relevant clinical and laboratory findings.cobas® HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products.Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used. en cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C (HCV) RNA, genotypes 1 to 6, in human EDTA plasma or serum of HCV-infected individuals. cobas® HCV 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 test is intended for use in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (response guided therapy) as measured by changes of HCV RNA levels in serum or EDTA plasma. The results must be interpreted within the context of all relevant clinical and laboratory finding. en cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.cobas® HCV 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.cobas® HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used 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. The results must be interpreted within the context of all relevant clinical and laboratory findings.cobas® HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products.Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used. en cobas® HCV is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system is designed as one integrated instrument. The cobas® 6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 or cobas® 6800/8800 systems software(s) which assigns test results for all tests as target not detected, < LLoQ (lower limit of quantitation), > ULoQ (upper limit of quantitation) or HCV RNA detected, a value in the linear range LLoQ ≤ x ≤ ULoQ. Results can be reviewed directly on the system screen, exported, or printed as a report. Nucleic acid from patient samples, external controls and added armored RNA-QS molecules are simultaneously extracted by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors are removed with subsequent wash buffer steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. Selective amplification of target nucleic acid from the patient sample is achieved by the use of target virus-specific forward and reverse primers which are selected from highly conserved regions of HCV. Selective amplification of RNA-QS is achieved by the use of sequence-specific forward and reverse primers which are selected to have no homology with the HCV genome. A thermostable DNA polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and RNA-QS sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).14-16 Any contaminating amplicon from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR mix, during the first thermal cycling step. However, newly formed amplicon are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. The cobas® HCV master mix contains dual detection probes specific for the HCV target sequences and one for the RNA- QS. The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection of HCV target and RNA-QS in two different target channels.10,17 When not bound to the target sequence, the fluorescent signal of the intact probe is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5'-to-3' nuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and RNA-QS. 10. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. PMID: 890851814. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93:125-8. PMID: 2227421. 1 15. Savva R, McAuley-Hecht K, Brown T, Pearl L. The structural basis of specific base-excision repair by uracil- DNA glycosylase. Nature. 1995;373:487-93. PMID: 7845459. 16. Mol CD, Arvai AS, Slupphaug G, et al. Crystal structure and mutational analysis of human uracil-DNA glycosylase: structural basis for specificity and catalysis. Cell. 1995;80:869-78. PMID: 7697717. 17. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. PMID: 1368485 en cobas® HCV is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system is designed as one integrated instrument. The cobas® 6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 or cobas® 6800/8800 system softwares which assigns test results for all tests as target not detected, < LLoQ (lower limit of quantitation), > ULoQ (upper limit of quantitation) or HCV RNA detected, a value in the linear range LLoQ < x < ULoQ. Results can be reviewed directly on the system screen, exported, or printed as a PDF report. Nucleic acid from patient samples, external controls and added armored RNA-QS molecules is simultaneously extracted. In summary, viral nucleic acids are released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors are removed with subsequent wash buffer steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. Selective amplification of target nucleic acid from the patient sample is achieved by the use of target virus-specific forward and reverse primers which are selected from highly conserved regions of HCV. Selective amplification of RNA- QS is achieved by the use of sequence-specific forward and reverse primers which are selected to have no homology with the HCV genome. A thermostable DNA polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and RNA-QS sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).20-22 Any contaminating amplicon from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR mix, during the first thermal cycling step. However, newly formed amplicon are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. The cobas® HCV master mix contains dual detection probes specific for the HCV target sequences and one for the RNA-QS. The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection of HCV target and RNA-QS in two different target channels.23,24 When not bound to the target sequence, the fluorescent signal of the intact probe is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single- stranded DNA template results in cleavage of the probe by the 5'-to-3' nuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and RNA-QS. 20. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93:125-8. PMID: 22274. 21. Savva R, McAuley-Hecht K, Brown T, Pearl L. The structural basis of specific base-excision repair by uracil-DNA glycosylase. Nature. 1995;373:487-93. PMID: 7845459. 22. Mol CD, Arvai AS, Slupphaug G, et al. Crystal structure and mutational analysis of human uracil-DNA glycosylase: structural basis for specificity and catalysis. Cell. 1995;80:869-78. PMID: 7697717. 23. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. PMID: 1368485. 24. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. PMID: 8908518. en cobas® HCV is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 System is designed as one integrated instrument. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 or cobas® 6800/8800 Systems software which assigns test results for all tests as target not detected, < LLoQ (lower limit of quantitation), > ULoQ (upper limit of quantitation) or HCV RNA detected, a value in the linear range LLoQ ≤ x ≤ ULoQ. Results can be reviewed directly on the system screen, exported, or printed as a report.Nucleic acid from patient samples, external controls and added armored RNA-QS molecules are simultaneously extracted by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors are removed with subsequent wash buffer steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature.Selective amplification of target nucleic acid from the patient sample is achieved by the use of target virus-specific forward and reverse primers which are selected from highly conserved regions of HCV. Selective amplification of RNA-QS is achieved by the use of sequence-specific forward and reverse primers which are selected to have no homology with the HCV genome. A thermostable DNA polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and RNA-QS sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).15-17 Any contaminating amplicon from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR mix, during the first thermal cycling step. However, newly formed amplicon are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.The cobas® HCV master mix contains dual detection probes specific for the HCV target sequences and one for the RNA- QS. The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection of HCV target and RNA-QS in two different target channels.18,19 When not bound to the target sequence, the fluorescent signal of the intact probe is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5'-to-3' nuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and RNA-QS.15. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene 1990;93(1):125-8.16. Savva R, McAuley-Hecht K, Brown T, Pearl L. The structural basis of specific base-excision repair by uracil- DNA glycosylase. Nature 1995;373(6514):487-93.17. Mol CD, Arvai AS, Slupphaug G, Kavli B, Alseth I, Krokan HE, et al. Crystal structure and mutational analysis of human uracil-DNA glycosylase: structural basis forspecificity and catalysis. Cell 1995;80(6):869-78.18. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Bio/technology 1992;10(4):413-7.19. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome research 1996;6(10):986-94. en

cobas^® HCV

IVD

Une solution diagnostique pour la quantification de la charge virale du VHC intégrant l’approche double sonde conçue pour les systèmes cobas^® 4800/5800/6800/8800

Une quantification et une détection précises pour le dépistage d’un virus en constante évolution

Chaque jour, environ 4 000 personnes meurent des suites d'une hépatite virale et 1,4 million de personnes meurent chaque année.¹ Roche s'engage à combattre les hépatites virales grâce au dépistage et au suivi de la maladie. Pour l'hépatite C, le test de charge virale cobas^® HCV qui s'utilise sur les systèmes cobas^® 4800/5800/6800/8800 et sa technologie double sonde permettent d’identifier avec précision la maladie et déterminent la réponse du patient au traitement.

Eléments à prendre en compte lors du dépistage du VHC

Un test quantitatif de l'ARN du virus de l'hépatite C (VHC) doit être capable de tolérer des mésappariements de séquences pour fournir des résultats précis et fiables. Le VHC présente une grande variabilité génétique en raison du risque important d’erreurs de réplication et de la vitesse élevée de production du virus. Les cliniciens basent leur diagnostic sur l’évaluation régulière de la charge virale du VHC, de manière à obtenir un résultat du traitement optimal.

Le test de détection des acides nucléiques cobas^® HCV offre des performances robustes et sûres^2,3 grâce à l’approche double sonde. Le test cobas^® HCV est conçu pour assurer une sensibilité élevée, répondre aux exigences des dernières thérapies pour lutter contre les hépatites C chroniques et garantir des flux de travail efficaces.

Le test de charge virale du VHC intègre une technologie de pointe : la double sonde. Elle lui permet d’isoler précisément les signaux utiles du bruit de fond, pour une quantification précise des charges virales.

Caractéristiques^2,3

Détection et quantification précises du VHC de génotypes 1 à 6
Une excellente corrélation avec le test quantitatif COBAS^®AmpliPrep/COBAS^® TaqMan^® HCV v2.0

Des résultats précis permettant la prise de décisions thérapeutiques

L'évaluation précise de la charge virale du VHC permet de suivre les patients sous antiviraux à action directe (AAD), de décider de la poursuite du traitement et d'en évaluer le succès
Le test cobas^®HCV permet d’optimiser la décision clinique et la prise en charge des patients.

Nous contacter

Performances du système cobas^® 4800²

Types d’échantillon

Plasma EDTA, Serum
Taille minimale de l’échantillon

400 µL et 200 µL
Sensibilité analytique pour les échantillons de plasma EDTA

9.2 lU/mL (400 µL)
15.3 lU/mL (200 µL)
Plage de mesures linéaires

»
400 µL : 15 lU/mL - 1.0 x 10⁸IU/mL
200 µL : 25 lU/mL - 1.0 x 10⁸IU/mL
Performance avec des échantillons avec ADN HBC négatif

99.5% (intervalle de confiance unilatéral ≥ 98,7%)
Spécificité

VHC de génotypes 1 à 6

Performances du système cobas^® 5800/6800/ 8800³

Types d’échantillon

Plasma EDTA, Serum
Taille d’échantillon minimale

650 µL
Volume de l'échantillon

500 µL
Sensibilité analytique

Plasma EDTA : 12,0 UI/mL

Sérum : 13.7 lU/mL
Plage de mesures linéaires

15 lU/mL - 1.0 x 10⁸IU/mL
Performance avec des échantillons avec ADN HBC négatif

100,0% (intervalle de confiance unique à moins de 95% : 99.4% - 100%)
Spécificité

VHC de génotypes 1 à 6

Vous souhaitez être recontacté ?

Remplissez le formulaire ci-contre pour être recontacté par un expert de Roche Diagnostics France. Il vous fournira des informations personnalisées sur le test cobas® HCV et étudiera avec vous la façon dont il peut s'intégrer dans votre environnement de travail, et pourra vous faire bénéficier d'une démonstration pratique de son utilisation.

Nous nous engageons à vous recontacter dans les plus brefs délais pour répondre à toutes vos questions concernant le test cobas® HCV.

Les données collectées dans le cadre de ce formulaire sont traitées par Roche Diagnostics France, responsable de traitement et destinataire des données, pour :

répondre à la demande que vous nous adressez (inscription, accès au replay, renseignement, contact...). Les données sont traitées sur la base de notre intérêt légitime et sont conservées dans notre outil de gestion de la relation client pour être utilisées dans le cadre de la relation commerciale ou à des fins de prospection commerciale physique.
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Cela pourrait vous intéresser

L'hépatite C : infographie sur la prise en charge

Découvrez comment Roche travaille à l'identification et au suivi des personnes atteintes d’hépatite C, faisant ainsi du diagnostic précoce la première étape vers un traitement efficace.

...

Références :

Rapport mondial sur l'hépatite, World Health Organization (WHO). World Hepatitis Day. https://apps.who.int/iris/bitstream/handle/10665/255833/WHO-HIV-2017.06-fre.pdf;jsessionid=D7BBC6F2ADB95FDFDE926A87310856C4?sequence=1. Dernière consultation 04/02/2025.
Fiche technique cobas^® HCV sur cobas 4800 v9.0, 10/2024
Notice cobas^® HCV sur cobas 5800/6800/8800 v3.0, 09/2022

Le test cobas® HCV pour utilisation sur cobas 4800 est un test in vitro d'amplification des acides nucléiques destiné à la détection et au dosage quantitatif de l'ARN du virus de l'hépatite C (VHC), dans du sérum ou plasma EDTA humain d'individus infectés par le VHC. Ce test est validé pour la détection et le dosage quantitatif dans des échantillons contenant les génotypes 1 à 6 du VHC.
Dispositif médical de diagnostic in vitro figurant à l’annexe II liste A – CE 0123 (TÜV SÜD)
Fabricant : Roche Diagnostics GmbH (Allemagne) – Distributeur : Roche Diagnostics France
Le test cobas® HCV pour une utilisation dur cobas 5800/6800/8800 est un test in vitro d'amplification des acides nucléiques destiné à la détection et au dosage quantitatif de l'ARN du virus de l'hépatite C (VHC), dans du sérum ou plasma EDTA humain d'individus infectés par le VHC. Ce test est validé pour la détection et le dosage quantitatif dans des échantillons contenant les génotypes 1 à 6 du VHC.
Dispositif médical de diagnostic in vitro figurant à l’annexe II liste A –
CE 2797 (BSI-NL)
Mandataire : Roche Diagnostics GmbH (Allemagne) – Distributeur : Roche Diagnostics France
Lire attentivement les instructions figurant dans les manuels d’utilisation.
2205ROCHEDIAGPM001

MC-FR-00470 - Mis à jour : 02/2025

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cobas^® HCV

Une solution diagnostique pour la quantification de la charge virale du VHC intégrant l’approche double sonde conçue pour les systèmes cobas^® 4800/5800/6800/8800

Une quantification et une détection précises pour le dépistage d’un virus en constante évolution