The test is analyzed on a rochehitachi cobas 6000 chemistry analyzer. The cobas e 411 analyzer is a fully automated analyzer that uses a patented electrochemiluminescence ecl technology for immunoassay analysis. Used roche cobas 4800 pcr amplification and detection. Consequently, all hiv viruses hiv1 groups m and o and hiv2 are detected in a single channel, and thus further testing is required. Pcr technology the cobas 4800 system uses polymerase chain reaction pcr technology, which has a proven track record as the right technology for molecular screening tests and has been utilized to establish the causal link between hpv and cervical cancer. The safety alert symbol alone without a signal word promotes awareness to hazards which are generic or directs the reader to related safety information. The analyzers analytical performance, the flexible configuration of parameters and features supported by its intuitive operation and zero maintenance sensors makes cobas b 221 system a valuable and easy to use tool for all critical care applications at. Reflex testing is set up in the cobas to order a repeat of any very low result, to verify abnormal values. Blood donor screening with cobas s 201cobas taqscreen mpx. Cobas 4800 system diagnostics roche in deutshcland. Comparison of the analytical and operational performance. The cobas 68008800 systems are based on a fully integrated, fully automated modular design that can expand with the growing needs of your lab. Roche unveils the cobas 6800 and cobas 8800 systems at. The cobas b 221 blood gas system provides virtually uninterrupted performance product specifications specifications measured parameters blood gas module total specified range ph 6.
The document revision information section is located at the end of this document. The cobas taqscreen west nile virus test, for use with the cobas s 201 system, is a qualitative in vitro test for the direct detection of west nile virus wnv rna in human plasma. Package insert cobas taqscreen mpx test, version 2. Description the cobas b 221 system offers fast determination of 17 of the most important criticalcare blood parameters. The water is filtered from the reservoir through the inlet solenoid valve to the progard tl pretreatment pack. Acid phosphatase total codes ac 0120 tc preparation. The cobas s 201 system is a complete nat solution supporting the central needs of blood screening labs, combining the efficiency and reliability of realtime pcr technology with modular automation and readytouse reagents. Pi cobas taqscreen dpx test for use on the cobas s 201 system. Roche february 2014 instructions for use version 14. Cobas taqman 48 analyzer specifications instrument specifications technology the cobas taqman 48 analyzer is a fully automated amplification and detection system for nucleic acids using 5 nuclease technology. The cobas s 201 system is designed to process specimens in batches.
Blood screening virology genomicsoncology companion. Roche cobas integra 400 plus community, manuals and. Cobas taqman 48 analyzer specifications instrument specifications. Evaluation of seronegative window reduction during hiv1, hcv and hbv infection by the novel cobas taqscreen mpx test for simultaneous nucleic acid detection of hiv1 groups m and o, hiv2, hcv and hbv using the cobas s 201 system. The analyzer s analytical performance, the flexible configuration of parameters and features supported by its intuitive operation and zero maintenance sensors makes cobas b 221 system a valuable and easy to use tool for all critical care applications at the point of care i. Chemical analysis instruments coagamate xm, cobas s 201. Designed to reduce handson time and further improve laboratory efficiency, the stateoftheart cobas p 630 instrument improves your laboratory s productivity while also providing the security that only comes from robotic assurance.
Used roche cobas 4800 pcr amplification and detection system. Hiv1, hcv and hbv seronegative window reduction by the new. With the cobas integra 400 plus, innovation means 4 onboard measurement technologies, robotic handling of reaction cuvettes and improved operator ergonomics. The system used by the cobas 6000 is the millipore elix gulfstream clinical system 35c. The cobas s 201 system is a complete nat solution supporting the central needs of blood screening labs, combining the efficiency and reliability of realtime pcr technology with modular automation, readytouse reagents and a robust menu selection. This manual has detailed descriptions of cobas b 221 system features and general operational concepts, specification functions and use of controls, operating techniques, emergency procedures, product labeling and maintenance procedures. Currently, more than 250 blood banks worldwide use roches automated cobas s 201 system. Roche cobas b 221 community, manuals and specifications. Analyzer, chemistry photometric, discrete, for clinical use product code jje. Transfer of patient samples from primary or secondary transport tubes to s input tubes. Molecular diagnostics realtime pcr virology womens health.
Roche cobas integra 400 plus host interface manual pdf download. The roche cobas 4800 system is an ivd realtime pcr system for mediumthroughput applications with largely automated processes that minimize manual interaction and reduce potential handling errors. With the new cobas s 201 cobas taqscreen mpx, a fully automated extraction method and a multiplex amplification system specifically adapted to the needs of blood donation services is available. Comparison of the analytical and operational performance of. With the new cobas s 201cobas taqscreen mpx, a fully automated extraction method and a multiplex amplification system specifically adapted to the needs of. Sd and cv% for the duplicate samples run on hemocue hba1c 501 in the method comparison study were calculated to 1,54 and 3,2, respectively. With the new cobas s 201cobas taqscreen mpx, a fully automated extraction method and a multiplex amplification system specifically adapted to the needs of blood donation services is. Furthermore, the cobas z 480 analyzer is manufactured and tested according to the following international standards. The cobas s 201 system is a complete nat solution supporting the central needs of blood screening labs, combining the efficiency and reliability of realtime.
The cobas s 201 donor screening system relies on realtime pcr technology supported by technicianfriendly automated pooling, sample preparation, system monitoring and final results reporting. Roche cobas 8000 modular analyzer series, continued intended use the cobas 8000 modular analyzer series is a fully automated system for indications for clinical chemistry analysis, intended for the in vitro qualitative and use quantitative determination of analytes in body fluids. Tigris was 800fold more sensitive than cobas s 201 1. Page 1 cobas integra 400 plus analyzer cedex bio ht analyzer host interface manual version 1. Clinical laboratories need to test patient samples precisely, accurately, and efficiently. It is important that the user follow the instructions in the cobas s 201 system operators manual for proper performance of the assay.
The cobas 6000 requires a continuous supply of purified water. Rmds automated platforms and broad portfolio are focused in the areas of virology, blood screening, hpv, genomics and oncology, microbiology and sexually transmitted infections. An innovation in donor screening the cobas s 201 system was created from a unified vision an understanding of the need for improved productivity, scalability and reliability. A batch is defined as a collection of a batch is defined as a collection of specimens and controls that are pipetted, extracted, amplified and detected together. The latest member of the roche cobas modular platform family, the cobas 8000 modular analyzer series allows compact and convenient consolidation of clinical chemistry and immunochemistry assays in highworkload laboratories with a throughput of 3 to 15 million. The cobas s 201 system is a complete nat solution able to meet both current and future needs of blood screening labs this system provides the efficiency and reliability of realtime polymerase chain reaction rtpcr technology, modular automation, convenient ready touse reagents and a robust menu selection. Rochehitachi cobas e 411 analyzer special note roche diagnostics january 2008 a2 host interface manual version 2. The cobas 68008800 systems automate the preparation and analysis of samples for quantitative and qualitative nucleic acid testing using realtime pcr technology. Reduced costs long onboard reagent stability and long calibration intervals.
Hiv1, hcv and hbv seronegative window reduction by the. Enhanced lab efficiency eliminating reagent preparation and manual sample handling contribute to time savings, faster result availability and turnaround time. Results from the analyzer printout are manually entered into excel spreadsheet and doublechecked. This supports the very broad menu and easeofuse required for true workload consolidation, leading to efficiency gains only possible with only one analytical platform, one user interface. Cobas amplicor ctng cobas s 201 system lightcycler 2.
Request pdf evaluation of the roche cobas s 201 system and cobas taqscreen multiplex test for blood screening. Amplification and detection of hpv is reliable with the cobas 4800 systems expert software. Cobas taqman 48 analyzer specifications instrument. The cobas s 201 system is the only worldclass complete nucleic acid testing nat solution that provides labs with the confidence and efficiency of extensively. Evaluation of the roche cobas s 201 system and cobas taqscreen multiplex test for blood screening.
Studies show hpv mrna is indicative of infections that may lead to disease. Evaluation of the roche cobas s 201 system and cobas. Software amplilink software is a windowsbased, liscompatible user interface that manages up to 3 cobas taqman 48 analyzers. The cobas s 201 system was created from a unified vision an understanding of the need for improved productivity, scalability and reliability. This manual has detailed descriptions of cobas b 221 system features and general operational concepts, specification functions and use of controls, operating. Molecular diagnostics realtime pcr virology womens. The cobas b 101 system offers single testing hba1c or lipid panel, separately as well as dual testing hba1c and lipid panel, consecutively with fast turnaround time. Manual or cobas ampliprep instrument cobas taqman 48 analyzer.
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