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

Xét nghiệm định lượng acid nucleic sử dụng trên hệ thống cobas^® 5800/6800/8800

IVD

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Vi rút viêm gan C (HCV) được xem là yếu tố gây bệnh chính cho 90% đến 95% trường hợp viêm gan sau truyền máu.^1-4 HCV là một vi rút RNA, chuỗi đơn (+), với bộ gen gồm khoảng 9500 nucleotide mã hoá cho 3000 amino acid. Là một vi rút lây truyền qua đường máu, HCV có thể lây truyền qua đường máu và các sản phẩm từ máu. Việc ứng dụng rộng rãi các biện pháp sàng lọc máu nhiễm HCV đã làm giảm đáng kể nguy cơ lây nhiễm bệnh viêm gan qua đường truyền máu. Tỷ lệ nhiễm HCV là cao nhất liên quan đến tiêm chích ma túy và mức độ thấp hơn ở các hình thức phơi nhiễm qua da khác.⁴

Việc định lượng RNA HCV để đo tải lượng vi rút ban đầu và để theo dõi trong khi điều trị đã được thiết lập đầy đủ để chứng minh hiệu quả đáp ứng kháng vi rút của phối hợp điều trị pegylated interferon và ribavirin (pegIFN/RBV).^5-9 Hướng dẫn hiện hành để theo dõi và điều trị HCV10,11 khuyến cáo thực hiện xét nghiệm định lượng RNA HCV trước khi bắt đầu điều trị kháng vi rút, ở những khoảng thời gian xác định trong quá trình điều trị (điều trị dựa theo đáp ứng, RGT), và ở thời điểm 12 tuần hoặc muộn hơn sau khi chấm dứt điều trị.

Việc không phát hiện RNA HCV bằng một xét nghiệm có độ nhạy cao, 12 tuần sau khi chấm dứt điều trị, là mục tiêu của điều trị và cho thấy rằng đáp ứng vi rút bền vững (SVR) đã đạt được.¹⁰

Xác định động học vi rút trong quá trình điều trị đã được sử dụng để cá nhân hóa thời gian điều trị với các thuốc kháng vi rút tác động trực tiếp (DAA) được cấp phép trong thời gian gần đây, các chất ức chế protease telaprevir và boceprevir.^12-15

Mục đích sử dụng

cobas^® HCV:

Xét nghiệm cobas^® HCV là một xét nghiệm khuếch đại acid nucleic in vitro để phát hiện và định lượng RNA của vi rút viêm gan C (HCV), kiểu gen từ 1 đến 6, trong huyết tương chống đông bằng EDTA hoặc huyết thanh hoặc từ mẫu huyết tương khô trên cobas^® Plasma Separation Card (PSC) của người bị nhiễm HCV.

Xét nghiệm cobas^® HCV được sử dụng để hỗ trợ chẩn đoán nhiễm HCV ở đối tượng sau: người có bằng chứng có kháng thể kháng HCV và có bằng chứng mắc bệnh gan, người nghi ngờ nhiễm vi rút hoạt động và có bằng chứng có kháng thể kháng HCV, và người có nguy cơ nhiễm HCV và có kháng thể kháng HCV. Việc phát hiện RNA HCV cho thấy rằng vi rút đang nhân lên và đó là bằng chứng nhiễm vi rút hoạt động.

Xét nghiệm được sử dụng để quản lý bệnh nhân nhiễm HCV mạn tính kết hợp với các dấu hiệu lâm sàng và cận lâm sàng khác. Xét nghiệm có thể được sử dụng để tiên lượng khả năng đáp ứng vi rút bền vững (SVR) giai đoạn sớm trong quá trình điều trị kháng vi rút, và để đánh giá đáp ứng của vi rút đối với phác đồ điều trị kháng vi rút (điều trị dựa theo đáp ứng) thể hiện qua thay đổi nồng độ RNA HCV trong huyết thanh hoặc huyết tương chống đông bằng EDTA. Kết quả phải được biện luận trong bối cảnh của tất cả các kết quả lâm sàng và xét nghiệm có liên quan. Mẫu huyết tương khô trên cobas^® PSC có thể được sử dụng theo các hướng dẫn thực hành lâm sàng và đặc tính hiệu năng của xét nghiệm.

cobas^® HBV/HCV/HIV-1 Control Kit:

cobas^® HBV/HCV/HIV-1 Control Kit được sử dụng là mẫu chứng dương cho mẻ chạy trên các hệ thống cobas^® 5800/6800/8800 cho các xét nghiệm cobas^® HBV, cobas^® HCV, và cobas^® HIV-1.

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Tài liệu tham khảo:

Farci P. Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome [Science 1989;244:359-362]. J Hepatol. 2002;36:582-5. PMID: 11983439.
Armstrong GL, Wasley A, Simard EP, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144:705-14. PMID: 16702586.
Rustgi VK. The epidemiology of hepatitis C infection in the United States. J Gastroenterol. 2007;42:513- 21. PMID: 17653645.
Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001;345:41-52. PMID: 11439948.
McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998;339:1485-92. PMID: 9819446.
Davis GL, Esteban-Mur R, Rustgi V, et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med. 1998;339:1493-9. PMID: 9819447.
Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial. Lancet. 2001;358:958-65. PMID: 11583749.
Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-82. PMID: 12324553.
Hadziyannis SJ, Sette H, Jr., Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: A randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004;140:346-55. PMID: 14996676.
Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: An update. Hepatology. 2009;49:1335-74. PMID: 19330875.
Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54:1433-44. PMID: 21898493.
Poordad F, McCone J, Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195-206. PMID: 21449783.
Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-16. PMID: 21696307.
Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1207-17. PMID: 21449784.
Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-28. PMID: 21696308.

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Thuốc thử xét nghiệm định tính và định lượng RNA HCV

cobas^® HCV

Vật liệu kiểm soát dương tính xét nghiệm định tính và định lượng RNA HIV-1, định lượng DNA HBV, định tính và định lượng RNA HCV

cobas^® HBV/HCV/HIV-1 Control Kit

Chủ sở hữu số lưu hành:

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Tầng 27, Tòa nhà Pearl Plaza, 561A Điện Biên Phủ, Phường Thạnh Mỹ Tây, Tp. Hồ Chí Minh, Việt Nam

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cobas^® HCV