Manufacturer specifications cobas taqman 48 analyzer. Roche cobas analyzers the cobas 4000 analyzer series include the cobas c 311 module for clinical chemistry and the cobas e 411 module for immunoassays. At pathqld, specimens were tested for c trachomatis dna using the cobas taqman. The required number of cycles is preprogrammed into the cobas taqman 48 analyzer. Lightcycler 480 instrument operators manual is correct at the time of printing. Instrument manual for use with the cobas taqman analyzer or cobas taqman 48 analyzer and the amplilink software, version 3. The hbv dna for cobas taqman was isolated by a manual and generic preparation sample kit high pure system viral nucleic acid kit, based on the bonding of nucleic acid to glass fibers, in accordance with the manufacturers instructions. In the realtime pcr era, cobas ampliprep cobas taqman. Daily operation 1 switch on the cobas mira analyzer. Taqman snp genotyping assays thermo fisher scientific. The cobas taqman 48 analyzer automatically repeats this process for. How to use this manual to help you find information quickly, there is a table of contents at the beginning of the manual and each chapter. Ii contact addresses manufacturer roche diagnostics ltd. This instrument operates with robotic precision to dramatically reduce handson time and enhance user productivity.
The purpose of this study is to evaluate the usefulness of the new realtime pcr cobas taqman 48 analyzer, comparing it to the existing cobas amplicor hbv monitor based on. Performance of the new roche cobas ampliprepcobas taqman. The cobas taqman human immunodeficiency virus type 1 hiv1 assay roche molecular systems, branchburg, nj technology combines the extraction of total nucleic acids on the. Rapid highthroughput, platebased realtime pcr amplification and detection instrument. Mar 07, 2018 summary of safety and effectiveness cobas ampliprepcobas taqman hiv1 test, 48 tests. Cobas taqman 48 analyzer specifications instrument specifications.
The quantitation of hbv dna was carried out in parallel by amplicor and taqman analyzers. Cobas taqman 48 analyzer and roche diagnostics are the top leaders of the pcr and evolution. Doubleclick any message to display the message detail dialog box. Roche diagnostics cobas taqman 48 analyzer pcr for sale. Ability to connect the cobas ampliprep and avoidance of manual sample. Ability to connect the cobas ampliprep and avoidance of manual sample preparation, which automates the entire process from preparation to. This lightcyler 480 instrument quick guide was created by the roche diagnostics corporation commercial education department. The combination of the two analyzers with cobas it 3000 solution provides true operational integration for small laboratories. Cobas taqman 48 analyzer and roche diagnostics are the top leaders of the.
User defined workflow software for free programmable. However, roche diagnostics gmbh reserves the right to make any changes necessary without notice as part of. This manual covers the complete cobas 4800 system comprised of the cobas 4800 software, the cobas x 480 instrument used for sample preparation, and the cobas z 480 analyzer used for amplification and detection using realtime pcr. Direct questions or concerns regarding the contents of this document to. The cobas ampliprep cobas taqman hcv test is a nucleic acid amplification test for the quantitation of hcv rna in human serum or plasma. The hbv dna for cobas taqman was isolated by a manual and generic. Amplilink software provides a simple, efficient user interface between the cobas taqman 48 analyzer and the custombuilt, windows based pc supplied with the system.
Blood screening virology genomicsoncology companion. Tips o the system stores only the most recent confirmed messages in the message log. Jul 01, 2010 higurashi et al 16 evaluated cobas taqman 48 with an assay sensitivity of 58. View and download roche cobas 4800 system system manual online.
Used roche taqman 48 pcr dna related for sale dotmed. The cobas taqman analyzer or cobas taqman 48 analyzer automatically repeats this process for a designated number of cycles, with each cycle intended to double the amount of amplicon dna. The lightcycler 480 system is a highperformance, medium to highthroughput pcr platform 96 or 384well. Evaluation of the cobas 4800 ctng test for detecting. Results from the analyzer printout are manually entered into excel spreadsheet and doublechecked. How to use this manual to help you find information quickly, there is a table of contents at the beginning of. Software amplilink software is a windowsbased, liscompatible user interface that manages up to 3 cobas taqman 48 analyzers. One amplilink data station will connect one cobas p 630 instrument to up to three cobas ampliprep instruments and three analyzers combination of cobas taqman and cobas taqman 48 analyzers, helping to maximize throughput capabilities and optimize laboratory efficiencies. Manual or cobas ampliprep instrument cobas taqman 48 analyzer. Tga approved for four viral load monitoring assays hiv1, hcv, hbv and cmv. Manufacturer specifications cobas taqman 48 analyzer, roche diagnostics please note.
To order these products, please contact your roche order management team. Page 94 magna pure compact operators manual version 1. Calibration and control cobas mira system users guide 9 changing control values 1 press racks. Cobas ampliprepcobas taqman hiv1 qualitative test instructions. Specimen preparation is automated using the cobas ampliprep instrument with amplification and detection automated using the cobas taqman analyzer or the cobas taqman 48 analyzer. Evaluation of the cobas taqman 48 realtime pcr system for. Two of its drawbacks are the laborintensive manual extraction of hcv rna and the frequent requirement of serum dilution for accurate quantification 5. System software is perfected and standardized with all cobas platforms. User instructions, 4 ml of whole blood collected in k3 edta should be. The letter identified the affected product, problem and. Cobas ampliprepcobas taqman hiv1 qualitative test, version. The cobas ampliprepcobas taqman 48 hiv1 test is based on three major. Rhhby announced today the fda approval of a new preanalytical instrument that provides an integrated primary tube. Broccolo et al 17 reported the use of taqman chemistry for the quantitative identification is 6110 gene segment and on senx3regx3 intergenic region with 98, 97 and 94, 100 per cent of sensitivity and specificity respectively 17.
Enter any desired search criteria in the specimen search section and click find specimens. Fully automated real time pcr analyzer that uses a closed system tubes, making it practical and easy to integrate into your laboratory daily routine. The cobas taqman 48 analyzer can be combined with manual sample preparation using high pure system and for viral load monitoring also with automated sample preparation unsing cobas ampliprep. However, roche diagnostics gmbh reserves the right to make any changes necessary without notice as part of ongoing product development.
The test is analyzed on a rochehitachi cobas 6000 chemistry analyzer. Cobas taqman 48 analyzer specifications instrument. In future applications with the lightcycler system and cobas taqman 48 analyzer these data files can be transferred to the respective instruments. Cobas taqman 48 analyzer molekulare diagnostik roche. The two separate thermal units thermal cyclers with operating time from 90 to. No differences were found in the sensitivity of the tests. The specimens found grid loads with specimens that match the search criteria and have the cobas taqman hiv1 qual test. Amplification occurs only in the region of the hcv genome. Cobas 4800 system analytical instruments pdf manual download. Laboratory procedure manual centers for disease control. Broad differences between the cobas ampliprep total nucleic acid isolation cobas taqman 48 hepatitis c virus hcv and cobas hcv monitor v2. Higurashi et al 16 evaluated cobas taqman 48 with an assay sensitivity of 58. Roche sent an urgent medical device correction umdc letter dated may 20, 2014 via ups grount receipt required to affected customers.
Automates sample preparation in preparation for amplification and detection automates the sample preparation steps of realtime polymerase chain reaction pcr testing for analysis on the cobas taqman analyzers. Used roche diagnostics, cobas taqman 48 analyzer, pcr for. Mar 29, 2011 service technicians forum cobas integra 400 plus service manual roger cantonjos allied hospital supply i need service manual of cobas integra 400 plus. Service technicians forum cobas integra 400 plus service manual roger cantonjos allied hospital supply i need service manual of cobas integra 400 plus. When the cobas taqman hiv1 test is run, the information on the general. Performance of the pc is significantly improved compared to the elecsys 2010. Cobas integra 400 plus service manual service technicians forum. The purpose of this study is to evaluate the usefulness of the new realtime pcr cobas taqman 48 analyzer, comparing it to the existing cobas amplicor hbv monitor based on conventional pcr technology. Broad differences between the cobas ampliprep total nucleic acid isolationcobas taqman 48 hepatitis c virus hcv and cobas hcv monitor v2. Broad differences between the cobas ampliprep total nucleic. Summary of safety and effectiveness cobas ampliprepcobas taqman hiv1 test, 48 tests. Roche magna pure compact instrument operators manual pdf. None of the equipment posted for sale on is owned by medwow, should you have any questions regarding a specific item, please direct them to the appropriate seller by making use of the available communication channels on the items page.
A the user who accepted the cal will be submitted o. Broccolo et al 17 reported the use of taqman chemistry for the quantitative identification is 6110. 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. In the realtime pcr era, cobas ampliprep cobas taqman systems have been.
Together, these features help labs improve efficiency by effectively eliminating manual steps. Fda approved for four viral load monitoring assays hiv1, hcv, hbv and cmv. Cobas ampliprep instrument from roche molecular systems. It can be used for diagnostic applications and for.
Broad differences between the cobas ampliprep total. Engineered for peace of mind fully automated sample preparation with realtime polymerase chain reaction pcr technology for amplification and detection best combination of. Number of days stated is based on rdc installation guidelines as outlined in implementation binder for each platform. The specimens found grid loads with specimens that match the search criteria and have the cobas. Taqman snp genotyping assays taqman predesigned snp genotyping assays, taqman custom snp genotyping assays, and taqman drug metabolism enzyme genotyping assays catalog number 43579, 43584, 43576, 43582, 43574, 43580, 4362691, 43349, 4332077. The cobas ampliprep tnai cobas taqman 48 roche assay cappctm combines automated hcv rna extraction with realtime pcr on the cobas taqman 48 instrument ctm48. Refer to the following for detailed operating instructions. Instrument manual for use with the cobas taqman analyzer or. Works in combination with the cobas ampliprep instrument to automate sample preparation, amplification, and quantitation of rna or dna.
This manual describes the cobas c111 features and general operational concepts, and it provides operating, maintenance, and emergency procedures. The document revision information section is located at the end of this document. Cobas ampliprepcobas taqman hcv test package insert. Roche cobas 4800 system system manual pdf download. Roche receives fda approval for cobas p 630 preanalytical. Manufacturer specifications cobas taqman 48 analyzer, roche. In addition, a complete index can be found at the end. 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. There was an excellent correlation between the sample with a viral load within the. Direct questions or concerns regarding the contents of this.
None of the equipment posted for sale on is owned by medwow, should you have any questions. The cobas ampliprepcobas taqman hiv1 test, version 2. Page 54 cobas c 111 host interface manual field name reference format m. The cobas p 630 instrument has a number of additional automation features that ensure full. Material safety data sheets for the roche cobas ampliprep tnaitaqman 48 ruo.