Regulatory compliance, 9115 hague road, indianapolis, indiana 46250, made application by renewal to the drug enforcement administration. One of its premium products is the roche elecsys 2010 an ultraefficient chemistry analyzer that offers many advantages easy and trouble free operation, workflow flexibility, broad measuring ranges, faster turnaround times, and more. Performance characteristics of seven automated ca 125 assays. Hsctnt concentrations were measured 6 years apart, using the same novel highly sensitive assay elecsys troponin t, roche diagnostics, indianapolis, indiana. The elecsys 2010 has scheduled daily, weekly, every 2 weeks, monthly, and every 2 months maintenance. Ppus020880418 roche diagnostics 9115 hague road indianapolis, in 46256 usdiagnostics. Roche diagnostics corporation 9115 hague rd indianapolis, in. Refer to the appropriate operators manual for analyzerspecific assay instructions. The elecsys vitamin b12 assay employs a competitive test principle using intrinsic factor specific for vitamin b12.
Roche antibody testing continues expansion inside indiana. Protocol type cobas roche diagnostics 10 of 61 host interface manual for use in the us document version 2. Roche diagnostics makes no representations or warranties with respect to damages. She stated 78 patient samples were tested on b6 2010 and she provided discrepant pth results for one patient sample. Roche diagnostics elecsys 1010 immunoassay system 1 6 v 3. Roche elecsys 2010 user guide pdf document documents mx. Roche diagnostics gmbh elecsys analyzer host interface manual elecsys. On the c501 module the cobas 6000 utilizes spectrophotometric and ionspecific electrode measuring systems. By notice dated march 16, 2010, and published in the federal register on march 24, 2010 75 fr 14186, roche diagnostics operations inc. Accessories for elecsys 1010 2010 and cobas e 411 analyzers.
Technical document resource more than 800,000 documents available on demand for centralized diagnostics, tissue diagnostics, molecular diagnostics, life science, sequencing and custom biotech product information. Screening of blood for human tcell lymphotropic virus type 1 and type 2 htlv1 and 2, respectively is important to diagnose and prevent infection and ensure the safety of blood supplies. Paperless and always uptodate with 247 access, use your customer login to gain access to bulletins, operator manuals, and o. Open bottle caps manually before use and close manually. Roche diagnostics mannheim at sandhoferstrasse 116 d68305 mannheim.
Aminoterminal propeptide of type i procollagen p1np was determined by electrochemiluminescent immunoassay on an elecsys 2010 automated analyzer roche diagnostics, mannheim, germany. The maintenance is outlined on the checkoff chart at the instrument. Roche elecsys 2010, which is available in the form of sample disk or a rack handling system, can be operated in both continuous and random access modes. Today, roche creates innovative medicines and diagnostic tests that help millions of patients globally. Nov 01, 2007 although some components of the assay validation such as imprecision were somewhat less robust than the roche elecsys package insert claims total imprecision on elecsys 2010 of 2. Roche diagnostics host interface manual for use in the us document version 2. Roche diagnostics name, address, 9115 hague rd contact. Cardiologists tnt gen 5 stat is trusted by the number one and number two best hospitals for cardiology. Satisfactory results were achieved for withinrun and betweenrun imprecision during 10 days.
The roche elecsys 2010 disk version is a well respected swiss designed and manufactured benchtop immunoassay system. Roche diagnostics roche diagnostics pursued a conservative course and submitted a 510k for the analyzer under k062279. If sample spills on the instrument, use correct personal protective equipment ppegloves, lab coat, etc. For adoptive transfer experiments, singlecell suspensions of. Because of the differing results, the patient went to several different hospitals for testing. Evaluation of sensitivity and specificity performance of.
Guidelines concerning the optimal turnaround time for bnp and ntprobnp have not been firmly established. Roche diagnostics showcases new technology at 2012 clinical. You appear to be using incognitoprivate browsing mode or an ad blocker, which may adversely affect your experience on the site. Manual elecsys 2010 roche diagnostics le blog des jeunes. Roche diagnostics develops innovative products and services that address the prevention, diagnosis, monitoring, screening and treatment of diseases. Roche diagnostics elecsys1010 immunoassay system 1 2 v 3. Store the elecsys t3 reagent kit upright in order to ensure.
Us the roche diagnostics cobas e 411 analyzer is a fully automated, randomaccess, 331244052 elecsys e411operators manual. The robust and attractive analyzer boasts 48 assays and a throughput 86 tests per hour. Pdf roche diagnostics gmbh elecsys analyzer host interface. Roche elecsys 2010 for rapid and dynamic diagnosis block. Roche diagnostics in indianapolis says its antibody test for the novel coronavirus is now operational at 20 commercial and hospital labs across the u.
Analytical evaluation of p1np assay, a biochemical marker of. Supporting early and confident diagnosis with elecsys troponin thigh sensitve 16 as supported by the use of the 01 hour rulein and ruleout algorithm recommended by international guidelines 8 elecsys troponin thigh sensitive can help support your clinical decisions. Refer to the appropriate operator s manual for analyzerspecific assay instructions. The assay is designed for use on all roche immunoassay systems for low, mid and highvolume testing environments, including the elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and modular.
Find their customers, contact information, and details on 427 shipments. The elecsys vitamin b12 assay employs a competitive test principle. The white bottle with a transparent lid contains suspended magnetic microparticles that act as the carrier material of the rutheniumlabeled. Roche is actively assisting 110 sites in the transition to tnt gen 5 stat, while an additional 60 sites are currently being coached on the golive process. To power on the instrument, switch the operators switch to the on position. The cobas e 411 analyzer is an updated version of the elecsys 2010 analyzer. Elecsys 2010 roche diagnostics elecsys 2010 immunoassay. Serum cyfra 211 in advanced stage nonsmall cell lung cancer. Box 50457 indianapolis, in 462500457 317 5212000 fax.
Roche diagnostics 8004285074 3175212000 0 operator on campus 2018 roche 671607470818 7 5 6 8 10 9 12 11 4 3 1 2 ashington st. As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in basel, switzerland. The customer stated the results from the elecsys 2010 analyzer were reported outside the laboratory. Plasma or serum hbv dna was quantified using cobas ampliprepcobas taqman roche diagnostics with a lower. Hsctnt was measured in serum specimens from visit 2 collected in 19901992 and stored at. Precision comparison between elecsys and a manual method on. We collected two serum samples, one before the first cycle of chemotherapy and the second before the second cycle, and analyzed these for serum cyfra 211 using an electrochemiluminescence immunoassay and the elecsys 2010 system roche diagnostics corp. Roche cobas e 411 interface manual pdf download manualslib.
Roche diagnostics, indianapolis, indiana, usa on the 1010 elecsys immunoanalyzer roche diagnostics. Vitamin b12 or folate are both of diagnostic importance for the. The setting is changeable when host communication is off. Jul 18, 2012 the assay is designed for use on all roche immunoassay systems for low, mid and highvolume testing environments, including the elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and modular analyticse 170 analyzers. Manual elecsys 2010 roche diagnostics download through medicines and leading diagnostics. Elecsys 2010, modular analytics e170 or cobas e analyzer. Roche diagnostics corporation showcases new technology at.
Roche diagnostics 9115 hague road indianapolis, in 462500457. The patient provided data for eight samples, of which two had discrepant results on the elecsys 2010 analyzer. Accessories for elecsys 10102010 and cobas e 411 analyzers. Serum levels of cardiac troponint ctnt were measured by a clinical quantitative sandwich enzyme immunoassay technique, which crossreacts with mouse troponin troponin t stat. Oct 05, 2015 laboratory procedure manual roche diagnostics corporation, indianapolis, in 46250. Roche elecsys 2010 roche diagnostics elecsys 2010 has the power and efficiency to meet the needs of medium and large volume testing facilities. The dade system stratus cs is also suitable for use at the pointofcare. The sample was repeated on the same elecsys 2010 rack analyzer and generated 11. Mar 23, 2012 as the world leader in invitro diagnostics, roche diagnostics supplies a wide variety of reliable instruments and tests facilitating rapid disease screening and diagnosis in laboratories. Elecsys hepatitis assays brochure roche diagnostics usa. The elecsys htlviii assay is a newly developed, electrochemiluminescence screening assay for the detection of htlv12 infection. Roche diagnostics elecsys1010 immunoassay system 1 12 v 3.
Details for the maintenance can be found in section 4 of the users guide and section 2 of the tutorial guide. Immunoassay for the in vitro quantitative determination of follicle. Roche elecsys 2010 user guide barcode assay scribd. Roche diagnostics mannheim, sandhoferstrasse 116 d68305. This operators manual is intended to be used as an instructional aid in the. Do not test samples from patients who have indicated or whose clinical status or hi story would indicate they. Modular analytics e170, elecsys 2010 and cobas e analyzers. Roche elecsys 2010 and modular analytics e170 elecsys module. Complete operators manual for the roche cobas hitachi elecsys e411. The sensitivity and specificity of the elecsys htlviii assay were. Elecsys troponin thigh sensitive roche diagnostics usa. Change made possible cardiac roche diagnostics usa. As of july 16, this product is not yet available in the u.
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