Multicenter evaluation of hemoglobin a1c assay on capillary electrophoresis. Furthermore, a method comparison between the sebia minicap flex piercing and two hplc methods, that is, the bio. Capillarys 2 flex piercing is an instrument utilizing capillary electrophoresis developed to be versatile while providing a clearcut and precise protein separation with high throughput. Sebia capillarys 2 flex piercing full automation with cap piercing technology versatile instrument serum, urine protocol currently under validation, whole blood capped tubes true innovation whole blood analysis for hemoglobin electrophoresis with no preanalytical preparation cap piercing for improved workflow and biohazard precautions a true innovation for hemoglobinopathy testing. A comparative evaluation of the analytical performances of capillarys 2 flex piercing, tosoh hlc723 g8, premier hb9210, and roche cobas c501 tinaquant gen 2 analyzers for hba1c determination. Evaluation of the sebia minicap flex piercing capillary. Capillarys 2 and capillarys 2 flexpiercing minicap system capillary electrophoresis cleared in k073002 hydrasys 1 and hydrasys 2 if cleared in k960029. Principle of the test 119 cdt quantification of transferrin isoforms by electrophoresis is a technique used in clinical laboratories for screening samples from patients for chronic.
Minicap the sebia capillary electrophoresis automated solution for small to medium size laboratories minicap instrument offers flexibility for small to medium size laboratories. The minicap flex piercing sebia is a 2silicacapillary automated. Sebia will perform one 1 annual electrical and mechanical calibration procedure on each covered system during the term of this contract. Capillarys 2 flex piercing the reference in routine capillary electrophoresis for medical laboratories. Do not freeze and thaw the reconstituted controls more than 30 times. Sebia electrophoresis minicap electrophoresis system. Here we report the results of the evaluation of the hba1c kit on minicap flex piercing. Capillarys 2 flex piercing sebia capillarys 2 neonat fast sebia capillarys 3 tera sebia capillarys 3 octa sebia minicap flex piercing sebia gel electrophoresis assist sebia gelscan sebia hydrasys 2 sebia hydrasys 2 scan sebia hydrasys 2 focusing sebia hydrasys 2 scan focusing sebia elisa test kits elisa hepatitis dia. The precision study was performed following the clinical laboratory standards institute clsi ep15a2 guideline. Minicap the sebia capillary electrophoresis automated solution for small to medium size laboratories. A comparative evaluation of the analytical performances of.
Sebias semiautomated agarose gel electrophoresis systems are designed to automate the many tedious steps involved in traditional electrophoresis and immunofixation testing. Minicap system, sebia, pn 1230, minicap flexpiercing system, sebia, pn 1232. It can do other tests like cdt, hemoglobin, immunotyping. The minicap flex piercing instrument offers flexibility for small to medium size laboratories. This device has been validated for use with the following sebia instruments. Sebia minicap flex piercing 2016 sebia minicap classic 2010 sebia capilarys 2 classic 2006 biomerieux. The sebia capillary electrophoresis automated solution for small to medium size laboratories the minicap flex piercing instrument offers flexibility for small to medium size laboratories. Capillarys, capillarys 2 and capillarys 2 flexpiercing for itif control. Evaluation of the sebia capillarys 2 flex piercing for the. Capillarys hb a1c provadeny na automatickem pristroji capillarys 2 flexpiercing, capi 3 hb a1c provadeny na automatickem pristroji capillarys 3 a, minicap hb a1c provadeny na automatickem pristroji minicap flexpiercing. Sample mixing cap piercing minicap flex piercing multiparameter instrument, large test menu. It features whole blood analysis, with no preanalytical preparation. Minicap flex piercing analyzer the minicap flex piercing sebia is a 2silicacapillary automated analyzer that uses whole blood specimens from primary capped tubes for hba1c testing.
Pdf evaluation of the sebia capillarys 2 flex piercing. After giving it some thought, and given the large volume of hba1c tests we carry out, we reached an agreement with them to dedicate the capillarys 2 flex piercing to. Comparison of enzymatic assay for hba1c measurement abbott. Sebia is the worlds largest supplier of specialty diagnostic tests based on electrophoresis technology and automation, with more than 75% of the world market and 16,000 laboratories served worldwide. Sebias capillary electrophoresis, until recently only used for monitoring patients, can now be used in laboratories equipped with sebias devices capillarys 3 tera, capillarys 2 flex piercing, minicap flex piercing, in all countries where the ce marking is required, for the diagnosis of diabetes. The sebia minicap flex piercing system utilises the proven, high performance technology of capillary electrophoresis for clear separation of. Sebia minicap sebia hydrasys sebia hyrys 2 bactalert 3d 120 bactalert 3d 240 vitek 2 vitek 2 compact bactec 9050 iris iq200 uf500iufi. The fully automated instrument meets the needs of the laboratory while providing clearcut and precise separations utilizing the capillary electrophoresis technology. Sebia continues to innovate with our fourth generation of capillarys instruments, the capillarys 3 tera. We studied 120 patients referred to a clinical laboratory for hba1c assay.
In this instruction sheet, the name minicap is used for automated minicap and minicap flex piercing instruments. The sebia capillarys2 flex piercing system utilises the proven, high performance technology of capillary electrophoresis for clear separation of analytes. The costs and reliability of the results are very good so if the time is not a big issue the minicap fully automated is a good choice. Manufacturer specifications minicap, sebia electrophoresis please note. Pdf a comparative evaluation of the analytical performances.
This multiparameter instrument offers a comprehensive menu on serum and whole blood f. Assessing agreement between the three common clinical. The aim of the present study was to compare the performance parameters of the three common methods of hba1c assay, including the roche, sebia and tosoh g8 systems. Professionsbachelorprojekt ved bioanalytikeruddanelsen. For rinsing capillaries in automated instrument capillarys 2 flexpiercing, sebia, for capillary electrophoresis. Sebia enters into agreement with sanofi to develop.
On specimens hg01 through hg04, perform fractionation. Using ce, hemoglobin variants are separated by high voltage 9400 v in an alkaline buffer solution ph, 9. Pdf evaluation of the sebia capillarys 2 flex piercing for. The minicap flex piercing sebia is a 2silicacapillary automated analyzer that uses whole blood specimens from primary capped tubes for hba 1c testing. Reliable measurement of hemoglobin a1c hba1c has great importance in the diagnosis and monitoring of diabetes mellitus. The main use for us was protein and hba1c capillary electrophoresis. The analytical performance of the sebia minicap flex piercing system was evaluated. Minicap tm flex piercing sebias newest instrument, the minicap flex piercing, offers flexibility, scalability and full automation for low to midvolume laboratories. Manufacturer specifications hydrasys 2, sebia electrophoresis please note.
For rinsing capillaries in automated instrument capillarys 2 flex piercing, sebia, for capillary electrophoresis. Sebias automated portfolio, the capillarys 3 tera, capillarys 2 flex piercing, and minicap flex piercing systems, provide full walkaway capability. If interfering hemoglobin is present, do not quantitate. Sebia is the worlds largest supplier of specialty diagnostic tests, based on. Evaluation of the sebia minicap flex piercing capillary electrophoresis for hemoglobinopathy testing. Figure 1 from a comparative evaluation of the analytical. The minicap flex piercing hba1c was compared to the capillarys 2 flex piercing hba1c and a strong correlation between both methods was achieved on. Evaluation of the sebia capillarys 2 flex piercing for the measurement of hba1c on venous and capillary blood samples article pdf available in american journal of clinical pathology 1416. Recent studies have been published regarding the performance of the recently commercially released sebia capillarys 2 flex piercing analyzer sebia cap 2fp. Aug 08, 2010 sebia autosampler for gel electrophoresis. Complete automation with high resolution for small to medium size labs. 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. Evaluation of the s ebia m inicap f lex p iercing capillary.
The capillary electrophoresis based on a solid experience. Request pdf evaluation of the sebia minicap flex piercing capillary electrophoresis for hemoglobinopathy testing introductioncapillary zone electrophoresis. Lt capillarys 2 flexpiercing kvantificering af hba1c ved kapill. Sebia enters into agreement with sanofi to develop multiple. This innovative hba1c assay provides clearcut and precise results with no interference from common analytical interfering substances or hemoglobin variants. Sebia electrophoresis products hydrasys hydrasys 2. In this instruction sheet, the name minicap is used for automated minicap and minicap flexpiercing instruments. Sebia signs agreement with janssen biotech to develop a. Sebia continues to innovate with our latest generation of instruments, the capillarys 3 tera family including octa. Capiclean pro minicap nebo minicap flexpiercing capiclean pro minicap flexpiercing slozeni lahvicka koncentrovaneho roztoku capiclean capiclean, sebia, kat. Minicap flex piercing from sebia uk limited selectscience. Jaisson s, leroy n, meurice j, guillard e, gillery p. Minicap flex piercing the sebia capillary electrophoresis automated solution for small to medium size laboratories enen.
Oct 17, 20 jaisson s, leroy n, meurice j, guillard e, gillery p. Capillarys, capillarys 2 and capillarys 2 flex piercing for itif control. In the blandaltman plots the solid lines show the mean difference, while the dotted lines show the mean difference 1. First evaluation of capillarys 2 flex piercing sebia as a new analyzer for hba1c assay by capillary electrophoresis. First evaluation of capillarys 2 flex piercing r sebia as a new analyzer for hba1c assay by capillary electrophoresis. Sebia is seeking clearance to import the capillarys 2 and capillarys 2 flex piercing device described above, and by this submission is notifying fda of its intent to market these products in the united states. Mar 08, 2018 the precision study was performed following the clinical laboratory standards institute clsi ep15a2 guideline. Furthermore, a method comparison between the sebia minicap flex piercing and two hplc methods, that is, the biorad variant classic and the biorad d10 systems was performed by measuring. Capillarys 2 and capillarys 2 flex piercing minicap system capillary electrophoresis cleared in k073002 hydrasys 1 and hydrasys 2 if cleared in k960029. The minicap flex piercing offers whole blood and cap piecing technology for the next generation of hba1c testing.
When reporting quantitation results, report values as you do for actual patient specimens. Apply in a microtube 500 l of capillarys minicap cdt wash solution. Sebia hba1c assay now has ce mark for diagnosis of. First evaluation of capillarys 2 flex piercingr sebia as a new analyzer for hba1c assay by capillary electrophoresis. Sebia is the worlds largest supplier of specialty diagnostic tests, based on electrophoresis technology and automation, with more than 70% of the world market. Promyvaci nadobka na destilovanou ci deionizovanou vodu a nadobka na odpad. Networking of all sebia instruments within a laboratory between offsite locations. The fully automated instrument meets the needs of the laboratory while providing clearcut and precise separations utilizing the capillary electrophoresis. To prevent microbial proliferation, change the water every day. The hydrasys and hydrasys 2 are compact systems that carry out all phases of electrophoresis from sample application to migration to incubation to staining. The minicap instrument offers flexibility for small to medium size laboratories.
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