Search Search
User Profile
Change
Select your user profile

cobas omni Utility Channel

For use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
cobas omni Utility Channel

cobas omni Utility Channel

Open channel testing, allowing you to do more with less.

cobas omni Utility Channel
Do you have any questions?
Contact us

Open channel testing, enabling you to do more with less

In today's cost-driven healthcare environment, many laboratories are searching for ways to increase operational gains. Open channel assays, including IVD and Laboratory Developed Tests (LDTs), can play an important role not only in achieving financial objectives but in redefining a laboratory's value within the wider healthcare environment. 

Related information

MWA Illustration

Expand your testing possibilities

The cobas omni Utility Channel, a dedicated open channel for use on the cobas® 5800/6800/8800 Systems, enables a broader testing menu by consolidating open channel assays with Roche IVD assays on a single platform. This is a key component of the Molecular Work Area, giving labs the ability to consolidate and automate a wider array of testing on a single platform. 

Validated Assays

Consolidate and automate a wider array of CE-IVD testing on the cobas® 5800/6800/8800 Systems with validated assays on the cobas omni Utility Channel.

Validated assays minimize variability and complexity in testing, reducing workload and alleviating risk of error for laboratories.

Female lab technician operating cobas omni Utility Channel touchscreen

Custom designed LDTs

Truly customize your menu by developing LDTs on the cobas omni Utility Channel for further lab consolidation. The LDT testing workflow uses the same processes, consumables and reagents as IVD testing.

Configure your assays to detect up to 12 individual targets from three different PCRs in a single run with no pre-sorting required.

Woman using the cobas omni Utility Channel on a cobas ® 6800 System

Greater flexibility and scalability

The consolidation and full automation of IVD and LDTs help to maximize laboratory space, minimize capital investment, and decrease operational costs, giving your laboratory the flexibility to explore opportunities with confidence.

to be determined when image selected
Simplifying workflows through seamless integration - cobas omni Utility Channel

cobas omni Utility Channel performance summary

  • Sample handling

    No pre-sorting required for LDT or IVD samples

  • Flexible testing

    Detect up to 12 targets per run

  • Sample types

    Common sample types supported between IVD and LDT testing

  • Result reporting

     Results reported as Reactive/Non-Reactive based on your Ct range

Registration status 

IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

You might be interested in

...
    ...
    Contact us

    Overview

    Detailed Specifications

    Ordering Information

    Compatible Instruments

    ...
      ...

      Technical Documents

      Access important product documentation including relevant certificates and other resources.

      After clicking below, you will be redirected to eLabDoc, where you can select your local country-specific documents.
      Document repository artboard
      IVD For in vitro diagnostic use.
      UC-TIB-HSV/VZV
      UC-TIB-HSV/VZV Real time PCR kit for qualitative detection of human Herpes Simplex Virus 1/2 and Varicella Zoster Virus.
      For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.       Real time PCR kit for qualitative detection of human Herpes Simplex Virus 1/2 and Varicella Zoster Virus. For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.
      IVD For in vitro diagnostic use.
      cobas p 480 instrument
      cobas p 480 Instrument Improve workflow, reduce the risk of contamination, and make the most of your technician’s time. For support of cobas® 4800/6800/8800 Systems.
      IVD For in vitro diagnostic use.
      cobas® 5800 System
      cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
      IVD For in vitro diagnostic use.
      cobas® 6800 System
      cobas® 6800 System Embrace the future of molecular testing with proven PCR performance. Learn about the cobas® 6800 System’s broad menu of high-quality assays, including HIV, HPV, CT/NG, Hepatitis, CMV, WNV, respiratory infections, and more!
      IVD For in vitro diagnostic use.
      cobas® 8800 System
      cobas® 8800 System Run up to 1,056 tests in an 8-hour shift and experience unparalleled automation - only 3 user interactions per run for up to 4 hours of walk-away time.
      IVD For in vitro diagnostic use.
      cobas s 201 system
      cobas® s 201 system Experience the combination of real-time PCR technology and modular automation in the first multi-dye, nucleic acid amplification technology (NAT) screening system for blood and plasma.
      IVD For in vitro diagnostic use.
      LightCycler® PRO System
      LightCycler® PRO System LightCycler® PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> WNV Test
      cobas® WNV Test Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      cobas® connection modules (CCM)
      cobas® connection modules (CCM) cobas® connection modules allow the connection of the standalone automation systems, cobas p 512 and cobas p 612, to analytics and post-analytics through a fast track.
      IVD For in vitro diagnostic use.
      <b>cobas<sup>®</sup> eplex</b> system
      cobas® eplex system The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
      Country Specific Labeling See country-specific product labeling for regulatory status.
      cobas® eplex RP 2 panel
      cobas® eplex respiratory pathogen panel 2
      IVD For in vitro diagnostic use.
      cobas® eplex blood culture identification Fungal Pathogen panel
      cobas® eplex blood culture identification gram-positive (BCID-GP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
      IVD For in vitro diagnostic use.
      cobas® eplex blood culture identification Fungal Pathogen (BCID-FP) panel
      cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
      IVD For in vitro diagnostic use.
      cobas® eplex blood culture identification Gram-Negative panel
      cobas® eplex blood culture identification gram-negative (BCID-GN) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
      IVD For in vitro diagnostic use.
      UC-TIB-AdV
      UC-TIB-AdV Real time PCR kit for quantification of human Adenovirus.
      For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.       Real time PCR kit for quantification of human Adenovirus. For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.
      IVD For in vitro diagnostic use.
      cobas® liat system
      cobas® liat system Bring accurate and reliable PCR results to the POC, enabling answers patients and clinicians need in 20 minutes or less to support triage and patient management.
      IVD For in vitro diagnostic use.
      Product Image for cobas® 4800 system
      cobas® 4800 system Discover real-time PCR amplification and detection featuring fully automated sample preparation, high quality nucleic acid extraction and robust engineering.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B v2
      cobas® SARS-CoV-2 & Influenza A/B v2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B v2) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C.RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> PIK3CA Mutation Test
      cobas® PIK3CA Mutation Test
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> ADV/hMPV/EV-RV UC
      cobas® ADV/hMPV/EV-RV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (PCR) assay for the timely in vitro qualitative detection and discrimination of human Adenovirus (ADV), Metapneumovirus (hMPV) and Enterovirus/Rhinovirus (EV-RV).This test is intended for the use as an aid in the diagnosis and differentiation of ADV, hMPV and EV-RV in nasopharyngeal swab specimens from patients with signs and symptoms of a respiratory infection.The results from cobas® ADV/hMPV/EV-RV UC must be interpreted within the context of all relevant clinical, epidemiological, and laboratory data. Negative results do not preclude viral infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is intended for professional use in a clinical laboratory setting.
      <b>cobas</b><sup>®</sup> Paraflu 1-4 UC
      cobas® Paraflu 1-4 UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
      Country Specific Labeling See country-specific product labeling for regulatory status.
      cobas z 480 analyzer
      cobas z 480 analyzer The cobas z 480 analyzer is a component of the modular cobas® 4800 System, and can also exist as a standalone instrument for automated amplification and detection of clinical and research assays. The cobas z 480 analyzer offers advanced real-time PCR technology for high-quality results.
      IVD For in vitro diagnostic use.
      cobas prime pre-analytical system
      cobas® prime Pre-analytical System The industry’s leading instruments converge to form a single solution that transforms your operation into a laboratory of the future. This fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline lab operations.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Babesia
      cobas® Babesia Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Babesia
      cobas® Babesia Nucleic acid test for use on the cobas® 6800/8800 Systems INTENDED USE #1 CE-IVDThe cobas® Babesia test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples or in pools comprised of aliquots of individual samples.This test is not intended for use as an aid in diagnosis of Babesia infection.This test is not intended for use on samples of cord blood.This test is not intended for use on cadaveric blood specimens.INTENDED USE #2 US-IVDThe cobas® Babesia test for use on the ccobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples or in pools comprised of aliquots of not more than six individual samples.This test is not intended for use as an aid in diagnosis of Babesia infection.This test is not intended for use on samples of cord blood.This test is not intended for use on cadaveric blood specimens.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B
      cobas® SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID‑19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C.RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.cobas® SARS-CoV-2 & Influenza A/B is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B
      cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® liat system Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® liat system.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV
      cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® liat system Diagnose and differentiate influenza A/B & RSV for effective clinical management and infection control with the POC multiplex PCR test for use on the cobas® liat system.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> EGFR Mutation Test v2
      cobas® EGFR Mutation Test v2
      <b>cobas</b><sup>®</sup> EZH2 Mutation Test
      cobas® EZH2 Mutation Test The cobas® EZH2 Mutation Test is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), in accordance with the approved therapeutic product labeling.Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> KRAS Mutation Test
      cobas® KRAS Mutation Test
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Strep A
      cobas® Strep A Nucleic acid test for use on the cobas® liat system With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® liat system aids clinicians to make immediate, informed treatment decisions.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Cdiff
      cobas® Cdiff Nucleic acid test for use on the cobas® liat system Provide accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff with the POC PCR test for use on the cobas® liat system.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      <b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
      cobas® SARS-CoV-2 Duo Qualitative and quantitivate test for use on the cobas® 5800/6800/8800 Systems Proposed UseThe cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 Duo) is an automated real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.cobas® SARS-CoV-2 Duo is intended for research use only and is not for use in diagnostic procedures.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> WNV Test
      cobas® WNV Test Nucleic acid test for use on the cobas® 6800/8800 Systems
      LSR For life science research only. Not for use in diagnostic procedures.
      <b>cobas<sup>®</sup> omni</b> Optimization Kit
      cobas omni Optimization Kit cobas omni Optimization Kit - Rapid optimization of LDTs for consolidation on the cobas omni Utility Channel - For Research Use Only. Not for use in diagnostic procedures.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      LightMix<sup>®</sup> Digital PIK3CA E545K
      LightMix® Digital PIK3CA E545K Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
      TIB MOLBIOL order number: 20-3004-32       Using PCR methodology, an 83 bp fragment covering the PIK3CA E545K mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      LightMix<sup>®</sup> Digital BRAF V600E
      LightMix® Digital BRAF V600E Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
      TIB MOLBIOL order number: 20-3002-32       Using PCR methodology, a 117 bp fragment covering the BRAF V600E mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      LightMix<sup>®</sup> Digital KRAS G12D
      LightMix® Digital KRAS G12D Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
      TIB MOLBIOL order number: 20-3003-32       Using PCR methodology, a 72 bp fragment covering the KRAS G12D mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      LightMix<sup>®</sup> Digital EGFR_Ex19del
      LightMix® Digital EGFR_Ex19del Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
      TIB MOLBIOL order number: 20-3001-32       Using PCR methodology, an 87 bp fragment (wild-type sequence) covering the EGFR exon 19 deletions is amplified with specific primers. The mutation site is analyzed using two labeled probes: a reference probe (HEX-labeled) and an indel probe (FAM-labeled). The reference probe is designed to bind to the amplicon irrespective of mutation presence, and the indel probe is designed to bind to the wild-type sequence but not to any of the mutated sequences. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No- Template-Control (NTC) (e.g. PCR grade water) in each run.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      LightMix<sup>®</sup> Digital EGFR T790M
      LightMix® Digital EGFR T790M Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
      TIB MOLBIOL order number: 20-3000-32       Using PCR methodology, a 113 bp fragment covering the EGFR T790M mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
      <b>navify<sup>®</sup></b> Sample Tracking
      navify® Sample Tracking navify® Sample Tracking is an application/integration layer that allows transporting operational data from partner (3rd party services or devices) solutions to the laboratory and vice versa, no direct interaction with the users using laboratory or sample transport / control apps.The transport to the partner is only transferring the needed information to perform the action needed on the partner side.Collecting order information from IT system from the laboratory (standardization of data during the collection)Providing information to the partnersAggregating data from the partners into the order information (operational data)Interfaces with other devicesThe navify® Sample Tracking is meant to be used only in combination with the following devices:IT system in the lab that holds order information and Rest API to expose dataData exchange with Middleware, LIS, HIS and EMRData exchange within third party apps out of the lab (Partners that are doing collection and transport of the samples)
      IVD For in vitro diagnostic use.
      <b>cobas<sup>®</sup></b> Malaria
      cobas® Malaria for use on the cobas® 5800/6800/8800 Systems
      GLU For general laboratory use.
      cobas® mobile solution
      cobas® mobile solution cobas® mobile solution is a state of the art tablet solution that enables you to interact with your instruments by using mobile applications
      IVD For in vitro diagnostic use.
      <i><b>Resistance</b>Plus</i><sup>®</sup> MG
      ResistancePlus® MG Multiplex real-time PCR assay for the identification of Mycoplasma genitalium and detection of mutations associated with resistance to azithromycin The ResistancePlus® MG kit simultaneously detects M. genitalium and 5 mutations at positions 2058 and 2059 in the 23S rRNA gene (E. coli numbering) that are associated with resistance to azithromycin (macrolide-based antibiotic).The ResistancePlus® MG kit is a 1-wellreal-timePCR multiplex consisting of 3 readouts. Readout 1 indicates the presence or absence of M. genitalium through detection of the MgPa gene; Readout 2 indicates the presence of a A2058G, A2059G, A2058T, A2058C or A2059C mutation in the 23S rRNA gene; and Readout 3 is an internal control to monitor extraction efficiency and qPCR inhibition. The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is validated onsamples extracted using the MagNA Pure 96 System (Roche), MICROLAB STARlet IVD (Hamilton), NUCLISENS® easyMAG® (Biomérieux) and real-time detection on the Roche LightCycler® 480 Instrument II (LC480 II) andcobas z 480 analyser (z480).
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HIV-1/HIV-2 Qualitative
      cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> EBV
      cobas® EBV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      <b>cobas</b><sup>®</sup> SARS-CoV-2
      cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® liat system Inform decisions at the POC with targeted RT-PCR SARS-CoV-2 test results in 20 minutes for both asymptomatic and symptomatic individuals using the cobas® liat system.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      <b>cobas</b><sup>®</sup> HBV RNA
      cobas® HBV RNA Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® HBV RNA for use on the cobas® 5800/6800/8800 Systems (cobas® HBV RNA) is an automated real-time RT-PCR assay for the in vitro quantitative detection of circulating HBV RNA in EDTA plasma and serum. cobas® HBV RNA is intended for research use only and is not for use in diagnostic procedures. cobas® HBV RNA can be used to support scientific research to understand the potential use of this new biomarker.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> CT/NG
      cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HSV 1 and 2 Test
      cobas® HSV 1 and 2 Test for use on the cobas® 4800 System
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> DNA Sample Preparation Kit
      cobas® DNA Sample Preparation Kit The cobas® DNA Sample Preparation Kit is used for manual sample preparation to isolate genomic DNA from formalin-fixed paraffin-embedded tumor tissue (FFPET) samples.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HCV
      cobas® HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HCV
      cobas® HCV Quantitative nucleic acid test for use on the cobas® 4800 System
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> TV/MG
      cobas® TV/MG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <i><b>Resistance</b>Plus</i><sup>®</sup> GC
      ResistancePlus® GC Multiplex real-time PCR assay for the detection of Neisseria gonorrhoeae and markers associated with susceptibility and resistance to ciprofloxacin The ResistancePlus® GC kit simultaneously detects the bacterium Neisseria gonorrhoeae (GC) and the gyrA S91 (wild type) or gyrA S91F (mutant) markers that are associated with susceptibility or resistance to the fluoroquinolone antibiotic, ciprofloxacin.The ResistancePlus® GC kitis a 1-wellreal-timePCR multiplex consisting of 5 readouts: Readout 1) GC opa gene, Readout 2) GC porA gene, Readout 3) gyrA S91 (wild type), Readout 4) gyrA S91F (mutant), and Readout 5) Internal control (to monitor extraction efficiency and PCR inhibition). The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is compatible with samples extracted using the MagNA Pure 96 System (Roche), EZ1 Advanced XL (Qiagen), QIAsymphony® SP (QIAGEN) and real-time detection on the LightCycler® 480 Instrument II (LC480 II, Roche), cobas z 480 analyser (z 480).
      IVD For in vitro diagnostic use.
      <b>cobas<sup>®</sup></b> MPXV
      cobas® MPXV Qualitative assay for use on the cobas® 6800/8800 Systems cobas® MPXV for use on the cobas® 6800/8800 Systems (cobas® MPXV) is a real-time PCR assay for the qualitative detection of DNA from Monkeypox virus (MPXV, clade I/II) in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of monkeypox infection by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42.U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.Results are for the identification of monkeypox virus (clade I/II) DNA, which is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection. Positive results are indicative of the presence of monkeypox virus (clade I/II) DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results obtained with this device do not preclude monkeypox virus (clade I/II) infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.Laboratories within the United States and its territories are required to report test results to the appropriate public health authorities. cobas® MPXV is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 6800/8800 Systems.cobas® MPXV is only for use under the Food and Drug Administration’s Emergency Use Authorization.
      RUO For Research Use Only. Not for use in diagnostic procedures.
      <b>cobas</b><sup>®</sup> SARS-CoV-2 Variant Set 1
      cobas® SARS-CoV-2 Variant Set 1 Qualitative assay for use on the cobas® 6800/8800 Systems The cobas® SARS-CoV-2 Variant Set 1 for use on the cobas® 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations E484K, N501Y and deletion HV-69/70 in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management.The cobas® SARS-CoV-2 Variant Set 1 assay is intended for research use only and is not for use in diagnostic procedures.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> cfDNA Sample Preparation Kit
      cobas® cfDNA Sample Preparation Kit The cobas® cfDNA Sample Preparation Kit is used for manual sample preparation to isolate circulating cell-free DNA (cfDNA) from plasma samples.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> 4800 BRAF V600 Mutation Test
      cobas® 4800 BRAF V600 Mutation Test
      <b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
      cobas® SARS-CoV-2 Duo Qualitative and quantitative assay for use on the cobas® 6800/8800 Systems
      RUO For Research Use Only. Not for use in diagnostic procedures.
      <b>cobas<sup>®</sup></b> HDV
      cobas® HDV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems cobas® HDV for use on the cobas® 5800/6800/8800 Systems (cobas® HDV) is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis D virus (HDV) RNA in human EDTA plasma or serum. cobas® HDV is intended for research use only and is not for use in diagnostic procedures. cobas® HDV can be used to support scientific research to understand the potential use of this biomarker.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HCV GT
      cobas® HCV GT HCV genotyping test for use on the cobas® 4800 System cobas® HCV GT is an in vitro nucleic acid amplification test for the qualitative identification of Hepatitis C Virus (HCV) genotypes 1 to 6 and genotype 1 subtypes a and b in human EDTA plasma or serum from individuals with chronic HCV infection, using the cobas® 4800 system: the cobas® x 480 instrument for automated sample processing and the cobas® z 480 analyzer for automated amplification and detection. cobas® HCV GT is intended for use in selecting individuals with chronic HCV infection for antiviral therapy and in determining the duration of therapy regimens according to the antiviral therapy prescribing information.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> 4800 CT/NG v2.0
      cobas® 4800 CT/NG v2.0 The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting) clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Factor II and Factor V Test
      cobas® Factor II and Factor V Test
      <b>navify<sup>®</sup></b> Analytics for Molecular Lab
      navify® Analytics for Molecular Lab navify® Analytics for Molecular Lab makes use of data that has been aggregated and prepared by the navify® Analytics platform to provide operational insights for customers with th cobas® 6800, cobas® 5800, cobas® 8800, and the dashboards are intended for review of: Test volumes Errors Instrument efficiency Positivity rate Quality Control Dashboards provide users the ability to set basic and advanced filters, filtering on specific data elements and viewing details. Snapshots of dashboards can be created for trending and comparison, as well as initiating a discussion thread with other users with common interests. The dashboards available to an individual user are based on the user's defined role.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> MAI
      cobas® MAI for use on the cobas® 5800/6800/8800 Systems cobas® MAI for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in human respiratory specimens including raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples. This test is intended for use in conjunction with mycobacterial culture as an aid in the diagnosis of pulmonary M. avium and M. intracellulare complex (MAC) infections.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> MTB
      cobas® MTB for use on the cobas® 5800/6800/8800 Systems cobas® MTB for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycobacterium tuberculosis complex (MTBC) DNA, in human respiratory specimens; including raw sputum, and digested and decontaminated (N-acetyl-L- cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples. This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended as an aid in the diagnosis of pulmonary tuberculosis, and in conjunction with other laboratory findings, as well as clinical signs and symptoms.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> MTB-RIF/INH
      cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of rifampicin-resistance associated mutations of the rpoB gene, and isoniazid-resistance associated mutations in the katG and inhA genes, of Mycobacterium tuberculosis, from human respiratory specimens. The test is intended for use on raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/ NaOH treated) sputum and bronchial alveolar lavage (BAL) samples, that tested positive for Mycobacterium tuberculosis complex (MTBC) by cobas® MTB. This test is intended for use in conjunction with culture and drug susceptibility testing, and as a reflex test together with cobas® MTB, as an aid in the diagnosis of infection with a multidrug resistant M. tuberculosis (MDR-TB).
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Plasma Separation Card
      cobas® Plasma Separation Card The cobas® Plasma Separation Card is intended for the collection and stabilization of dried plasma from whole blood specimens, for subsequent in vitro diagnostic examination.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> MPX
      cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> MPX
      cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas<sup>®</sup></b> TaqScreen MPX Test, version 2.0
      cobas® TaqScreen MPX Test, version 2.0
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> DPX
      cobas® DPX Duplex HAV & parvovirus B19 nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma.This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV UC
      cobas® Influenza A/B & RSV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
      IVD For in vitro diagnostic use.
      Roche Cell Collection Medium
      Roche Cell Collection Medium Roche Cell Collection Medium is designed for the preservation and transport of cells to be used in molecular testing and/or for the preparation of cytology slides.
      IVD For in vitro diagnostic use.
      <b>cobas<sup>®</sup></b> Respiratory flex
      cobas® Respiratory flex Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> HEV
      cobas® HEV Nucleic acid test for use on the cobas® 5800/6800/8800 Systems The cobas® HEV test for use on cobas® 5800/6800/8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (HEV) RNA (genotypes 1-4) in human plasma.This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (red cells, platelets, and plasma), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for HEV.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> BKV
      cobas® BKV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>navify<sup>®</sup></b> Algorithm Suite
      navify® Algorithm Suite A software solution that combines and analyzes data to help make clinical decisions and guide clinical workflows. It integrates, enables and consolidates a group of clinical high medical value algorithms, all in one unique access point.
      <b>navify<sup>®</sup></b> Quality Performance
      navify® Quality Performance navify® Quality Performance is a web-based comparison tool that enables clinical laboratories to quickly and accurately evaluate the performance of their assays through statistical analysis of the daily quality control (QC) data generated by Roche Serum Work Area systems. This innovative eService generates real-time reports using QC data collected from laboratories around the world that use the same control lots, instruments, and assays. These reports allow users to compare their lab’s performance against their peer group. navify® Quality Performance’s user-friendly interface lets you easily access information relevant for ISO 15189 guidelines and review trends, without manually entering data.
      <b>navify<sup>®</sup></b> Inventory
      navify® Inventory navify® Inventory is an application to manage and control laboratory inventories. It allows monitoring and controlling storage, use, and ordering of products needed in laboratories for testing. It prevents excessively high or low inventory levels and monitors expiry dates.navify® Inventory supports all tasks for managing and controlling the inventory in a laboratory, including automatic reordering. Reagents, consumables, calibrators, spare parts and any disposable product is supported by the system. This product is not intended for the diagnosis, user interfacing, monitoring, or treatment of patients.
      <b>navify<sup>®</sup></b> Control
      navify® Control navify® Control provides a single workstation that allows you to control your lab instruments and lab software from a central location.
      IVD For in vitro diagnostic use.
      symbol for cobas synergy software
      cobas® Synergy Software For use with cobas® 6800/8800 Systems, cobas® 5800 system, Microlab® STAR IVD, and Microlab® STARlet IVD High capacity pooling and archiving of blood donations
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> CMV
      cobas® CMV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      <b>cobas<sup>®</sup> infinity</b> central lab
      cobas® infinity central lab
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> CMV Test
      cobas® CMV Test Quantitative nucleic acid test for use on the cobas® 4800 System cobas® CMV is an in-vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Zika Test
      cobas® Zika Test Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> CHIKV/DENV
      cobas® CHIKV/DENV Nucleic acid test for use on the cobas® 6800/8800 Systems cobas® CHIKV/DENV for use on the cobas® 6800/8800 Systems is a qualitative in vitro test for the direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV) serotypes 1-4 RNA in human plasma.The test is intended for use to screen donor samples for CHIKV RNA or DENV RNA alone or to simultaneously screen for both CHIKV and DENV RNA in plasma from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use of samples of cord blood.This test is not intended for use as an aid in diagnosis for CHIKV or DENV.
      IVD For in vitro diagnostic use.
      <b>cobas</b><sup>®</sup> Zika Test
      cobas® Zika Test Nucleic acid test for use on the cobas® 6800/8800 Systems
      Product image for cobas® MRSA/SA Test
      cobas® MRSA/SA Test
      cobas<sup>®</sup> Cdiff Test
      cobas® Cdiff Test
      cobas® HPV Test image
      cobas® HPV
      Product image for cobas® HIV-1 Test
      cobas® HIV-1 Test
      cobas® HBV Test
      cobas® HBV Test
      cobas® SARS-CoV-2 Qualitative Test
      cobas® SARS-CoV-2 Qualitative Test
      cobas® SARS-CoV-2 test kit
      cobas® SARS-CoV-2 Test
      cobas CV DV
      cobas® CHIKV/DENV
      ctDNA collection tubes
      Cell-Free DNA Collection Tube
      Zika
      cobas® Zika
      error errorMessage
      Sorry, we couldn't find the content you are looking for
      Please try again later