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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 Utility Channel

Das Open-Channel-Testprinzip, damit Sie mit weniger mehr erreichen

cobas omni Utility Channel
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Das Open-Channel-Testprinzip, damit Sie mit weniger mehr erreichen

Im kostenorientierten Gesundheitswesen von heute suchen viele Labore nach einer Möglichkeit, die operativen Gewinne zu steigern. Open-Channel Assays, die die Konsolidierung von IVD-Tests mit Eigenentwicklungen (sogenannten laboratory developed tests, LDTs) ermöglichen, können zum Erreichen finanzieller Ziele beitragen und den Wert des Labors im Umfeld des Gesundheitswesen neu definieren. 

MWA Abbildung

Erweitern Sie Ihre Testkapazität

Beim cobas omni Utility Channel handelt es sich um einen offenen Kanal für die Systeme cobas® 5800, 6800 und 8800. Er ermöglicht Open-Channel-Tests mit Roche IVD-Tests auf einer gemeinsamen Plattform zu nutzen. Er nimmt in der Molecular Work Area eine Schlüsselrolle ein und ermöglicht Laboren die Konsolidierung und Automatisierung einer größeren Auswahl an Testverfahren auf einer einzigen Plattform. 

Validierte Tests

Konsolidieren und automatisieren Sie eine größere Auswahl an CE-IVD-Tests auf den Systemen cobas® 5800, 6800 und 8800-Systemen mit den validierten Tests des cobas omni Utility Channel.

Die validierten Tests minimieren Testvariabilität und -komplexität, reduzieren das Fehlerrisiko und senken die Arbeitsbelastung.

Laborantin bedient den Touchscreen des cobas omni Utility Channel
Primer- und Sondensätze

Sparen Sie mit Hilfe von Primer- und Sondensätzen, die für den cobas omni Utility Channel optimiert wurden, Zeit beim Testdesign.

Erfahren Sie mehr über die verfügbaren Primer- und Sondensätze*:

C. difficile
Influenza A/B und RSV
HSV-1/VZV beziehungsweise HVS-2/VZV
PivNG

* Nur zu Forschungszwecken. Nicht zur Verwendung bei diagnostischen Verfahren.

Nahaufnahme des cobas 8800
Kundenspezifische Eigenentwicklungen (laboratory developed tests, LDTs)

Bauen Sie ein Leistungsangebot auf, das wirklich individuell ist, indem Sie am cobas omni Utility Channel eigene Tests für die weitere Laborkonsolidierung entwickeln. Der Workflow für LDTs verwendet dieselben Prozesse, Verbrauchsmaterialien und Reagenzien wie IVD-Tests.

Konfigurieren Sie Ihre Tests so, dass bis zu 12 individuelle Targets aus drei verschiedenen PCRs in einem einzigen Test ohne Vorsortierung nachgewiesen werden können.

Benutzerin des cobas omni Utility Channel an einem cobas® 6800 System
Grössere Flexibilität und Skalierbarkeit

Die Konsolidierung und vollständige Automatisierung von IVD und LDT Tests tragen dazu bei, den Platz im Labor optimal zu nutzen, Investitionen zu minimieren und Betriebskosten zu senken. Dadurch kann Ihr Labor mit gutem Gefühl neue Möglichkeiten erkunden.

bei Bildauswahl zu bestimmen

cobas omni Utility Channel – Übersicht über die Leistungsmerkmale

  • Probenhandhabung

    Keine Vorsortierung für LDT- und IVD-Proben erforderlich

  • Flexible Tests

    Erkennung von bis zu 12 Targets pro Lauf

  • Probentypen

    Unterstützung häufig verwendeter Probentypen bei IVD- und LDT-Tests

  • Ergebnismeldung

     Ergebnismeldung als reaktiv/nicht reaktiv gemäss Ihrem jeweiligen Ct-Bereich

Zulassungsstatus 

IVD

Packungsbeilagen

Greifen Sie auf Packungsbeilagen über die Roche Diagnostics Website Ihres Landes zu.

Überblick

Detailed Specifications

Bestellung

Compatible Instruments

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