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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.", "Language": "en", "Country": "XR", "Code": "Intended Use" }, { "Name": "Principle", "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.", "Language": "en", "Country": "XR", "Code": "Principle" }, { "Name": "Features", "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
", "Language": "en", "Country": "XG", "Code": "Features" }, { "Name": "Content", "Value": "cobas omni Utility Channel Reagent Kit

(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
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
Manganese acetate, potassium hydroxide, < 0.1% sodium azide7.5 mL
Master Mix Reagent 2
cobas omni Utility Channel Master Mix Reagent 2
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)
", "Language": "en", "Country": "XR", "Code": "Content" } ] } } ] }

cobas omni Canal utilitaire

Test des canaux ouverts, vous permettant d’en faire plus avec moins

IVD For in vitro diagnostic use.
cobas omni Canal utilitaire
Avez-vous des questions ?
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Test des canaux ouverts, vous permettant d’en faire plus avec moins

Dans le domaine de la santé actuel, axé sur les coûts, de nombreux laboratoires recherchent des moyens pour augmenter leurs gains opérationnels. Les tests à canaux ouverts, dont les tests de diagnostic in vitro et les tests développés en laboratoire (TDL), peuvent jouer un rôle important non seulement dans la réalisation des objectifs financiers, mais également dans la redéfinition de la valeur d’un laboratoire. 

Illustration de la MWA

Étendez vos possibilités de test

Le Canal utilitaire cobas omni, un canal ouvert dédié à l’utilisation sur les systèmes cobas® 5800/6800/8800, permet d’élargir la gamme de tests en consolidant les tests à canal ouvert avec les tests DIV de Roche sur une seule plateforme. Il s’agit d’une composante clé de l’espace de travail moléculaire, permettant aux laboratoires de consolider et d’automatiser un plus large éventail de tests sur une seule plateforme. 

Tests validés

Consolidez et automatisez un plus large éventail de tests CE-IVD sur les systèmes cobas® 5800/6800/8800 avec des tests validés sur le Canal utilitaire cobas omni.

Les tests validés minimisent la variabilité et la complexité des tests, réduisent le risque d'erreur et diminuent la charge de travail des laboratoires.

Female lab technician operating cobas omni Utility Channel touchscreen
Jeu d’amorces et de sondes

Gagnez du temps lors de la conception du test en utilisant des jeux d’amorces et de sondes optimisés sur le Canal utilitaire cobas omni

En savoir plus sur les jeux d’amorces et de sondes* disponibles :

C. Difficile
Grippe A/B et VRS

*À des fins de recherche uniquement. Ne pas utiliser pour les procédures diagnostiques.

Gros plan sur le cobas 8800
Développements propres spécifiques aux clients (TDL)

Personnalisez vraiment votre gamme en développant des TDL sur le Canal utilitaire cobas omni pour une consolidation plus poussée du laboratoire. Le flux de travail des tests TDL utilise les mêmes processus, consommables et réactifs que les tests DIV.

Configurez vos kits pour détecter jusqu’à 12 cibles individuelles à partir de trois PCR différentes en une seule analyse sans tri préalable.

Femme utilisant le cobas omni Utility Channel sur un système cobas ® 6800
Plus grande flexibilité et évolutivité

La consolidation et l’automatisation complète des DIV et des TDL aident à optimiser l’espace du laboratoire, à diminuer l’investissement en capital et à réduire les coûts opérationnels, donnant ainsi à votre laboratoire la flexibilité d’explorer les opportunités en toute confiance.

à déterminer lorsque l’image est sélectionnée

Résumé des performances du Canal utilitaire cobas omni

  • Manutention des échantillons

    Aucun tri préalable nécessaire pour les échantillons de TDL ou de DIV

  • Tests flexibles

    Détecter jusqu’à 12 cibles par analyse

  • Types d’échantillons

    Types d’échantillons communs pris en charge entre les tests DIV et TDL

  • Rapport des résultats

     Résultats rapportés comme réactifs/non réactifs en fonction de votre plage de Ct

Statut d’enregistrement 


Fiches techniques

Les fiches techniques sont disponibles sur le site Internet de Roche Diagnostics de votre pays.


Detailed Specifications

Référence produit

Compatible Instruments

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