For in vitro diagnostic use. Others cobas omni Utility Channel Reagent Kit 58-68-88 IVD cobas® omni Utility Channel Reagent Kit PID00000042 For use on the cobas® 5800/6800/8800 systems 09 052 011 190 9 052 011 190 09052011190 9052011190 09052011190 KIT COBAS 58/68/88 UTIL CHAN 192T IVD cobas omni Utility Channel Reagent Kit 00875197006438 Reagents, kits 1 kit 192 tests true The cobas omni Utility Channel Reagent Kit provides the reagents and internal-control primers and probes necessary to utilize the open channel functionality of the cobas® 5800/6800/8800 Systems for the automated Polymerase Chain Reaction based Nucleic Acid Testing in order to developed tests for in vitro diagnostic use. The reagent kit is intended for use by trained professionals in the laboratory setting. en The cobas omni Utility Channel Reagent Kit provides the reagents and internal-control primers and probes necessary to utilize the open channel functionality of the cobas® 5800/6800/8800 Systems for the automated Polymerase Chain Reaction based on nucleic acid testing in order to develop tests for in vitro diagnostic use. The reagent kit is intended for use by trained professionals in the laboratory setting. en Tests performed using the cobas omni Utility Channel Reagent Kit are based on fully-automated sample preparation (nucleic acid extraction and purification), PCR amplification, and target detection technologies found in the cobas® 5800/6800/8800 Systems. 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(s), and the analytic module(s). Automated data management is performed by the cobas® 5800/6800/8800 Systems softwares which assigns test results. Results can be reviewed directly on the system screen, exported, or printed as a report. Performance of tests using the cobas omni Utility Channel Reagent Kit relies on the cobas omni reagent concept, which is exclusive to the cobas® 5800/6800/8800 Systems. This concept enables use of the same sample preparation reagents (cobas omni MGP Reagent, cobas omni Lysis Reagent, cobas omni Wash Reagent, cobas omni Specimen Diluent, Proteinase, RNA internal control, Elution Buffer, and MMX-R1) for all tests run on the systems. All tests performed on the cobas® 5800/6800/8800 Systems furthermore utilize a single sample preparation process, the cobas omni sample preparation process. In summary, nucleic acid from samples, external controls, and added armored RNA (internal control) is simultaneously extracted; the nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid then 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 steps, and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at an elevated temperature. Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers provided by the customer. The cobas omni Utility Channel Master Mix Reagent 2 (UC MMX-R2), provided by Roche as part of the cobas omni Utility Channel Reagent Kit, includes an internal control. Selective amplification of the internal control is achieved by the use of sequence-specific forward and reverse primers that also are included in the UC MMX-R2 reagent. A thermostable DNA polymerase enzyme is used for both reverse transcription and PCR amplification. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), that is incorporated into the newly synthesized DNA (amplicon).1,2,3 Any contaminating amplicon from previous PCR runs is eliminated by the AmpErase enzyme included in the master mix during the first thermal cycling step. However, newly formed amplicon is not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. 1. 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. 2. 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. 3. "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. en Tests performed using the cobas omni Utility Channel Reagent Kit are based on fully-automated sample preparation (nucleic acid extraction and purification), PCR amplification, and target detection technologies found in the cobas® 5800/6800/8800 Systems. 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(s), and the analytic module(s). Automated data management is performed by thecobas® 5800 or cobas® 6800/8800 Systems software which assigns test results. Results can be reviewed directly on the system screen, exported, or printed as a report.Performance of tests using the cobas omni Utility Channel Reagent Kit relies on the cobas omni reagent concept, which is exclusive to the cobas® 5800/6800/8800 Systems. This concept enables use of the same sample preparation reagents (cobas omni MGP Reagent, cobas omni Lysis Reagent, cobas omni Wash Reagent, cobas omni Specimen Diluent, Proteinase, RNA internal control, Elution Buffer, and MMX-R1) for all tests run on the systems.All tests performed on the cobas® 5800/6800/8800 Systems furthermore utilize a single sample preparation process, the cobas omni sample preparation process. In summary, nucleic acid from samples, external controls, and added armored RNA (internal control) is simultaneously extracted; the nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid then 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 steps, and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at an elevated temperature.Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers provided by the customer. The cobas omni Utility Channel Master Mix Reagent 2 (UC MMX-R2), provided by Roche as part of the cobas omni Utility Channel Reagent Kit, includes an internal control. Selective amplification of the internal control is achieved by the use of sequence-specific forward and reverse primers that also are included in the UC MMX-R2 reagent. A thermostable DNA polymerase enzyme is used for both reverse transcription and PCR amplification. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), that is incorporated into the newly synthesized DNA (amplicon).1,2,3 Any contaminating amplicon from previous PCR runs is eliminated by the AmpErase enzyme included in the master mix during the first thermal cycling step. However, newly formed amplicon is not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.1. 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: 2227421.2. 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: 7697717.3. 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. en

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