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Due to the high sensitivity of a PCR reaction, care should be taken to keep reagents and amplification mixtures free of contamination.

  • All samples should be handled as if infectious, using good laboratory procedures as outlined in Biosafety in Microbiological and Biomedical Laboratories and in the CLSI Document M29-A4.4,5
     
  • Only personnel proficient in handling infectious materials and the use of the cobas omni Utility Channel Reagent Kit and the cobas® 5800/6800/8800 Systems should perform this procedure.
     
  • All human-sourced materials should be considered potentially infectious and should be handled with universal precautions. If spillage occurs, immediately disinfect with a freshly prepared solution of 0.5% sodium hypochlorite in distilled or deionized water (dilute household bleach 1:10) or follow appropriate site procedures.
     
  • Use only supplied or specified required consumables to ensure optimal test performance.
     
  • Safety Data Sheets (SDS) are available on request from your local Roche representative.
     
  • Closely follow procedures and guidelines provided to ensure that the test is performed correctly. Any deviation from the procedures and guidelines may affect optimal test performance.
     
  • False positive results may occur if carryover of samples is not adequately controlled during sample handling and processing.
     
  • Inform your local competent authority about any serious incidents which may occur when using this assay.

4.    Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institutes of Health HHS Publication No. (CDC) 21-1112, revised December 2009.
5.    Clinical and Laboratory Standards Institute (CLSI). Protection of laboratory workers from occupationally acquired infections. Approved Guideline-Fourth Edition. CLSI Document M29-A4: Wayne, PA ;CLSI, 2014.
 ", "Country": "XR", "Code": "Sensitivity", "Name": "Sensitivity" }, { "Language": "en", "Value": "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.", "Country": "XR", "Code": "Intended Use", "Name": "Intended Use" }, { "Language": "en", "Value": "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.", "Country": "XR", "Code": "Principle", "Name": "Principle" }, { "Language": "en", "Value": " 
Amount of sample requiredAmount of sample processed + minimally 150 μL in cobas omni secondary tubes
Amount of sample processedIndicated as Processing volume (μL) in the Utility Channel Tool
", "Country": "XG", "Code": "Features", "Name": "Features" }, { "Language": "en", "Value": "cobas omni Utility Channel Reagent Kit
(UC)

(P/N 09052011190)
Kit componentsReagent ingredientsQuantity per kit
192 tests
192 test cassette

Proteinase Solution (PASE)
Tris buffer, < 0.05% EDTA, calcium chloride, calcium acetate, 8% (w/v) proteinase
EUH210: Safety data sheet available on request.
EUH208: Contains Subtilisin. May produce an allergic reaction.
22.3 mL
RNA Internal Control
(RNA-QS)
Tris buffer, < 0.05% EDTA, armored RNA construct containing primer and probe-specific sequence regions (non-infectious RNA in MS2 bacteriophage), < 0.1% sodium azide21.2 mL
Elution Buffer (EB)Tris buffer, 0.2% methyl-4 hydroxybenzoate21.2 mL
Master Mix
Reagent 1
(MMX-R1)
Manganese acetate, potassium hydroxide, < 0.1% sodium azide7.5 mL
Master Mix Reagent 2
bottle
cobas omni Utility Channel Master Mix Reagent 2
(UC MMX-R2)
Tricine buffer, potassium acetate, < 18% dimethyl sulfoxide, glycerol, < 0.1% Tween 20, EDTA, < 0.12% dATP, dCTP, dGTP, dUTPs, < 0.01% internal control forward and reverse primers, < 0.01% fluorescent-labeled oligonucleotide probes specific for RNA-IC, < 0.01% oligonucleotide aptamer, < 0.01% Z05D DNA polymerase, < 0.1% AmpErase (uracil-N- glycosylase) enzyme (microbial), < 0.1% sodium azide19.6 mL
(2 x 9.8 mL)
", "Country": "XR", "Code": "Content", "Name": "Content" } ] } } ] }

cobas omni Canal utilitaire

cobas omni Canal utilitaire

Élargissez vos possibilités

 

L’outil cobas omni Utility Channel fonctionne sur les systèmes cobas 6800 et 8800. Il permet d'élargir le menu des tests en regroupant sur une seule plateforme les analyses via le canal ouvert et les tests de diagnostic in vitro (IVD) de Roche. Le canal ouvert intègre les tests IVD, ainsi que des tests développés en laboratoire (LDT).

La possibilité de regrouper et d'automatiser un plus grand nombre de tests sur une seule plateforme permet d'accroître l'efficacité opérationnelle, de tirer le maximum de l’espace disponible et de minimiser les investissements.

cobas omni utility channel workflow image
Tests valid&eacute;s pris en charge par l&rsquo;outil Omni Utility Channel

Adénovirus

HSV/VZV

Omni Utility Channel Primer Probe Sets

C.Difficle

HSV 1/2  / VZV

Influenza A/B & RSV

PivNG

Les ensembles amorce/sonde pré-testés pour l’outil cobas omni Utility Channel peuvent être consultés sur le site Internet www.idtdna.com

Quelques tests LTD con&ccedil;us par nos clients &agrave; l&rsquo;aide du syst&egrave;me Omni Utility Channel

Usutu

Norovirus

 

Réalisez des gains d'efficience supplémentaires sans compromettre la qualité des tests grâce à l’outil automatisé cobas omni Utility Channel conçu pour une utilisation sur le système cobas® 6800 et le système cobas® 8800. La consolidation et l'automatisation complète des DIV et des LDT sur une seule plateforme permettent d'optimiser l'espace du laboratoire, de minimiser les investissements et de réduire les coûts opérationnels.

Conception flexible

Réalisez les tests souhaités quand vous le voulez avec le cobas omni Utility Channel.

  • Effectuez jusqu'à 3 tests
  • Réalisez jusqu'à 3 tests différents à partir d'un seul échantillon
  • Un flux de tests simplifié grâce à des processus, des consommables et des réactifs universels

Réalisez des gains d'efficience supplémentaires sans compromettre la qualité des tests grâce à l’outil automatisé cobas omni Utility Channel conçu pour utilisation sur le système cobas® 6800 et le système cobas® 8800. La consolidation et l'automatisation complète des DIV et des LDT sur une seule plateforme permettent d'optimiser le flux de travail du laboratoire, de minimiser les investissements et de réduire les coûts opérationnels.

Les ensembles amorce/sonde pré-testés pour l’outil cobas omni Utility Channel peuvent être consultés sur le site Internet www.idtdna.com

Systèmes apparentés

Image produit du syst&egrave;me cobas® 6800

Système cobas® 6800

Transformez vos processus de diagnostic in vitro : deux interventions simples par cycle suffisent et permettent d'obtenir jusqu'à 8 heures de temps libre1.

En savoir plus
Image produit du syst&egrave;me cobas® 8800

Système cobas® 8800

Une intervention minimale de l'opérateur révolutionnent l'avenir des applications à haut débit.

En savoir plus

Référence :

  1. Manuel opérateur cobas 6800 V.4.0 12/2017

Le cobas omni Utility Channel Reagent Kit fournit les réactifs, ainsi que les sondes et amorces de contrôle interne nécessaires à l'utilisation de la fonctionnalité de canal ouvert des cobas® 5800/6800/8800 Systems pour les tests sur acides nucléiques s'appuyant sur la réaction en chaîne par polymérase automatisée afin de développer des tests pour une utilisation en diagnostic in vitro. Le kit de réactifs est destiné à être utilisé par des professionnels qualifiés dans l'environnement du laboratoire. Le type d'échantillon pour les tests doit être déterminé et validé par le client, en fonction des besoins spécifiques au test.
Dispositif médical de diagnostic in vitro. Classe A
Mandataire : Roche Diagnostics GmbH (Allemagne) – Distributeur : Roche Diagnostics France
Lire attentivement les instructions figurant dans la fiche technique

Etabli : 11/2022

Aperçu

Detailed Specifications

Commander

Compatible Instruments

...
    ...

    Performances du cobas omni Utility Channel

    • Manipulation des échantillons

      Aucun tri préalable n'est requis pour les échantillons IVD et LDT

    • Flexibilité

      Détecte jusqu'à 12 cibles par run

    • Types d’échantillons

      Plasma/sérum, échantillons contenant de l'alcool, écouvillons

    • Rendu des résultats

      Résultats déclarés comme réactifs/non réactifs en fonction de la valeur Ct

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