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 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 or from a cobas® Plasma Separation Card (PSC) dried plasma spot 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 infe 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 findings. cobas® PSC dried plasma spots may be used in accordance with clinical practice guidelines and the assay’s performance characteristics. cobas® HBV/HCV/HIV-1 Control Kit cobas® HBV/HCV/HIV-1 Control Kit is intended for use as a positive run/batch control on the cobas® 5800/6800/8800 systems with the cobas® HBV, cobas® HCV, and cobas® HIV-1 tests. 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 the highly conserved 5’-untranslated region (5’-UTR) 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).22-24 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.25,26 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. 22. 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. 23. 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. 24. 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. 25. 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. 26. 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

Quantitative nucleic acid test for use on the cobas^® 5800/6800/8800 systems

IVD

Test dual probe per la determinazione della carica virale dell’HCV, per i sistemi cobas^® 5800/6800/8800

Accurata quantificazione e rilevamento di un virus in continua evoluzione

Ogni giorno, circa 4.000 persone muoiono a causa delle conseguenze dell’epatite virale e ogni anno circa 1,4 milioni di persone¹. Roche si impegna a combattere l’epatite virale con diagnosi e monitoraggio efficaci. Per l’epatite C, cobas® HCV per l’uso sui sistemi cobas ® 5800/6800/8800, offre test dual probe della carica virale dell’HCV per identificare accuratamente la malattia e determinare la risposta del paziente al trattamento.

Scopri cosa conta davvero quando si esegue il test per l’HCV

Un test quantitativo dell'RNA del virus dell'epatite C (HCV) deve essere in grado di tollerare i mismatch di sequenza per ottenere risultati accurati e affidabili. La combinazione di una replicazione dell'RNA soggetta a errori e di un elevato tasso di produzione del virus determina un'estrema variabilità genetica dell'HCV. I medici si affidano alla valutazione regolare della carica virale dell'HCV per gestire la terapia in modo ottimale.

Il test quantitativo degli acidi nucleici cobas^® HCV offre prestazioni del test affidabili e clinicamente rilevanti basate sul design del test dual-probe di proprietà di Roche. cobas^® HCV è progettato per fornire un’elevata sensibilità per soddisfare i requisiti delle terapie attuali e future per l’epatite C cronica combinate con un flusso di lavoro efficiente per i laboratori.

L’innovativo e all’avanguardia test dual-probe per la carica virale dell’HCV distingue con precisione i segnali reali dal rumore di fondo, portando a una quantificazione più accurata delle cariche virali.

Caratteristiche

Rilevamento e quantificazione accurati dei genotipi HCV da 1 a 6
Clinicamente convalidato per l’uso con nuove terapie per l’HCV
Eccellente correlazione con COBAS^®
^{AmpliPrep/COBAS®} TaqMan^® Test quantitativo HCV, v2.0

Decisioni cliniche ottimizzate grazie a una precisa valutazione della carica virale dell’HCV

Risultati accurati della carica virale dell’RNA dell’HCV sono importanti per il monitoraggio dei pazienti trattati con DAA per decidere se proseguire la terapia e valutare il successo del trattamento
Il test a doppia sonda per l’HCV di Roche aiuta i medici a gestire meglio i pazienti con HCV facilitando una decisione clinica ottimizzata

Uso previsto

cobas^® HCV per i sistemi 4800/5800/6800/8800 (CE-IVD)

CE-IVD

cobas^® HCV è un test di amplificazione degli acidi nucleici in vitro sia per il rilevamento che per la quantificazione dell’RNA del virus dell’epatite C, nel plasma umano in EDTA o nel siero di soggetti con infezione da HCV. I campioni contenenti HCV di genotipo da 1 a 6 sono convalidati per il rilevamento e la quantificazione nel test.

Il test è destinato all’uso come supporto nella diagnosi di infezione da HCV nelle seguenti popolazioni: individui con evidenza anticorpale di HCV con evidenza di malattia epatica, individui con sospetta infezione attiva con evidenza anticorpale da HCV e individui a rischio di infezione da HCV con anticorpi anti-HCV. Il rilevamento dell’RNA di HCV indica che il virus si sta replicando e pertanto è evidenza di infezione attiva.

Il test è destinato all’uso come supporto nella gestione di pazienti con infezione da HCV sottoposti a terapia antivirale. Il test misura i livelli di HCV RNA pre-trattamento e durante il trattamento e può essere utilizzato per predire la risposta virologica sostenuta e non sostenuta alla terapia per l’HCV. I risultati devono essere interpretati in relazione a tutti i risultati clinici e di laboratorio rilevanti.

cobas^® HCV per i sistemi 5800/6800/8800 (US-IVD)

US-IVD

cobas^® HCV è un test di amplificazione degli acidi nucleici in vitro per il rilevamento e la quantificazione dell’RNA del virus dell’epatite C, nel plasma umano in EDTA o nel siero, di soggetti positivi agli anticorpi anti-HCV o con infezione da HCV. I campioni contenenti genotipi HCV da 1 a 6 sono convalidati per il rilevamento e la quantificazione nel test.

cobas^® HCV è destinato all’uso come supporto nella diagnosi dell’infezione da HCV nelle seguenti popolazioni: individui con evidenza anticorpale di HCV con evidenza di malattia epatica, individui con sospetta infezione attiva con evidenza anticorpale anti-HCV e individui a rischio di infezione da HCV con anticorpi anti-HCV. Il rilevamento dell’RNA di HCV indica che il virus si sta replicando e pertanto è evidenza di infezione attiva.

cobas^® HCV è destinato all’uso come supporto nella gestione di pazienti con infezione da HCV sottoposti a terapia antivirale. Il test può essere utilizzato per misurare i livelli di RNA di HCV pre-trattamento, durante il trattamento, alla fine del trattamento e alla fine del follow-up del trattamento per determinare la risposta virologica sostenuta o non sostenuta. I risultati devono essere interpretati in relazione a tutti i risultati clinici e di laboratorio rilevanti.

cobas^® HCV non è stato approvato per l’uso come test di screening per la presenza di HCV nel sangue o nei prodotti ematici.

Le caratteristiche prestazionali del test sono state stabilite per i soggetti trattati con determinati regimi di agenti antivirali ad azione diretta (DAA). Non sono disponibili informazioni sul valore predittivo del test quando vengono utilizzate altre terapie di combinazione DAA.

Stato di registrazione

cobas® HCV per i sistemi cobas® 4800/5800/6800/8800: CE-IVD

cobas® HCV per i sistemi cobas® 5800/6800/8800: US-IVD

Contattaci

Prestazioni del test sui sistemi cobas^® 5800/6800/8800

Tipo di campione

Plasma EDTA, siero
Quantità minima di campione richiesta

650 µL
Volume di campione processato

500 µL
Sensibilità analitica

Plasma EDTA: 12,0 lU/ml

Siero: 13,7 lU/ml
Range lineare

15 lU/ml - 1,0 x 10⁸IU/ml
Prestazioni con campioni HBV DNA-negativi

100,0% (limite di confidenza bilaterale al 95%: 99,4% - 100%)
Specificità

Genotipi HCV 1-6

Informazioni aggiuntive sul test

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Riferimenti bibliografici:

World Health Organization (WHO). World Hepatitis Day.
http://www.who.int/campaigns/hepatitis-day/2016/event/en. Consultato a luglio 2016.

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cobas^® HCV

Test dual probe per la determinazione della carica virale dell’HCV, per i sistemi cobas^® 5800/6800/8800

Accurata quantificazione e rilevamento di un virus in continua evoluzione