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2008 NEw Pr o d u c t rEv i Ew special section Advertisement with extended universal wash reagent and liquid waste management. Ortho-Clinical Diagnostics Circle No. 469 in the Reader Service Card VITROS® ToRC Assays Ortho-Clinical Diagnostics announces the availability of four new infectious disease assays in international markets excluding the U.S. The assays, for use on the VITROS® ECi/ ECiQ Immunodiagnostic System, are the VITROS® Rubella IgM, the VITROS® Toxoplasma IgM and the VITROS® Cytomegalovirus (CMV) IgG and IgM assays. These four new assays complement the already available VITROS Rubella IgG and VITROS Toxoplasma IgG assays. Infections with these agents are most significant during pregnancy, as they are associated with congenital defects of the newborn. These assays provide critical information to physicians caring for women prior to and during pregnancy. Ortho-Clinical Diagnostics Circle No. 470 in the Reader Service Card VITROS® 5600 Integrated System* Ortho-Clinical Diagnostics is developing the VITROS 5600 Integrated System, a high-capacity system uniquely designed to integrate more than 120 immunoassays and clinical chemistry assays on one system. The system will seamlessly integrate five proven VIT- ROS® technologies to provide high quality results, no sample carryover, and no reagent carryover. It will include MicroSlide, MicroTip, MicroWell, Intellicheck®, and MicroSensor technologies. The system will introduce a sample-centric design to optimize productivity, eliminating the need to move samples on a track or create sample aliquots. It is being designed to be easy to use with infrequent calibration and minimal maintenance. Integration by design! *In development. Ortho-Clinical Diagnostics Circle No. 471 in the Reader Service Card VITROS® 3600 Immunodiagnostic System* Ortho-Clinical Diagnostics is developing the VITROS 3600 Immunodiagnostic System, a high-capacity immunoassay system for routine and specialty immunoassay testing using three proven VITROS® technologies: MicroWell with proprietary Enhanced Chemiluminescence, Intellicheck®, and MicroSensor technologies provide high quality results without compromising workflow. The broad menu will include cardiac, thyroid, metabolic, endocrine, anemia, oncology, prenatal, and infectious disease assays. Productivity is expected to be enhanced by using intelligent sample management to optimize and prioritize assay processing. Allowing reagents and consumables to be replaced while operating also optimizes productivity. The VITROS 3600 Immunodiagnostic System: integrity and productivity by design! *In development. Ortho-Clinical Diagnostics Circle No. 472 in the Reader Service Card VITROS® Anti-HIV 1+2 assay Ortho-Clinical Diagnostics announces the availability in the U.S., Puerto Rico and U.S. territories of a new diagnostic assay for the detection of antibodies to HIV types 1 and/ or 2. The VITROS Anti-HIV 1+2 assay can be run in a fully automated, random access format on the VITROS® ECi/ECiQ Immunodiagnostic System with Intellicheck® technology. Results are readily available in less than 50 minutes. This marks the first anti-HIV 1+2 test in the U.S. capable of running in full random access at any time, with other tests, and providing immediate result reporting upon test completion. Ortho-Clinical Diagnostics Circle No. 473 in the Reader Service Card enGen Recapper and Flex Decapper Ortho-Clinical Diagnostics announces two new modules for the enGen Laboratory Automation System. The Flex Decapper removes both screw caps and traditional stoppers from tubes with randomly mixed heights and widths. This new Decapper uses sensors to determine the height and width of each tube and processes 600 tubes per hour. The Recapper applies universal caps to primary tubes ranging in size from 13mm x 75mm to 16mm x 100mm, as well as to aliquoter secondary tubes.The Recapper holds 2,000 caps on board, allows reload- ing without interrupting operation, and processes 500 tubes per hour. Ortho-Clinical Diagnostics Circle No. 474 in the Reader Service Card e-Antigram Web Site Ortho-Clinical Diagnostics introduces a new Web site, www.eantigram.com, that provides blood bank customers online access to electronic antigram profiles specific for ORTHO Reagent Red Cell products (e.g. Selectogen®, Surgiscreen®, Resolve® Panel A, Resolve® Panel B, and Resolve® Panel C). Antigrams are required for these red blood cell products to complete the tests and give the labs the information needed to transfuse the correct units of blood. Previously, antigram files have been in paper format only, requiring customers to manually enter the data into softwareassisted antibody identification systems. Electronic antigram profiles increase ease of use and eliminate non-value added work. Ortho-Clinical Diagnostics Circle No. 475 in the Reader Service Card AlbaQ-Chek® Simulated Whole Blood Controls Ortho-Clinical Diagnostics announces the availability of the AlbaQ-Check kit for QC testing in blood-bank laboratories. The AlbaQ-Chek Simulated Whole Blood Controls, manufactured by Alba Bioscience, is the only standardized QC kit in North America for use with Ortho-Clinical Diagnostics’ proprietary ID-MTS gel technology. It can be used with the ID-MTS Gel Test when performed either manually or in the automated format on ORTHO ProVue.® The addition of AlbaQ-Chek to the ID-MTS Gel Test menu offers Ortho-Clinical Diagnostics’ ORTHO ProVue and Gel customers improved efficiency, standardization, and error reduction through a cost-effective product. Ortho-Clinical Diagnostics Circle No. 476 in the Reader Service Card PATHFAST Immunochemistry Analyzer The PATHFAST immunochemistry analyzer is a compact, fully automatic instrument suitable for a hospital or POCT. The PATH- FAST comes complete with an integrated computer, LCD touch screen, and printer. Results for most assays are available in as little as 15 minutes. Convenient, ready-touse, all-in-one reagent cartridges and the ability to use whole blood saves time. Six different assays or up to six samples may be run simultaneously. The PATHFAST is ideal for use in hospitals, emergency rooms, clinics, and the physician office lab settings. Polymedco, Inc. Circle No. 477 in the Reader Service Card CliniCal laboratory news JuLy 2008 41
special section Advertisement Fluidic System Design & Manufacturing Gems® Sensors & Controls will be showcasing its expanded fluidic system engineering and manufacturing capabilities at the AACC Clin Lab Expo. Gems streamlines fluidic system design and manufacturing with contract, collaborative engineering support or turnkey responsibility from concept to production. With more than 50 years of engineering and application experience, a broad portfolio of fluid sensors and controls, and a dedication to lean manufacturing, Gems understands the critical need for a robust quality system that includes the right documentation, supplier qualification, and ISO certification. Gems offers further benefits to our customers including: reduced development costs, quicker time to market, reduced supplier base, and managed inventory. Gems® Sensors & Controls Circle No. 478 in the Reader Service Card SpeciMinder Transport System The SpeciMinder autonomous mobile robot transports specimens within clinical labs and related areas. Onboard sensors guide the SpeciMinder through its environment, eliminating the need for control markings or external beacons. With a simple elevator-like user interface, operating the SpeciMinder is intuitive and uncomplicated. The robot is designed for 24/7 continuous operation and automatically recharges itself when batteries are low. Specialized electronics manage automatic doors and elevators as part of the SpeciMinder’s normal routine. The upper carrier section can be customized for a wide variety of payloads. CCS Robotics Circle No. 479 in the Reader Service Card One Step, Rapid Cardiac Test* This rapid, qualitative immunoassay test is for professional use to aid in the diagnosis of myocardial infarctions at POC facilities, emergency department, or other hospital settings. The test operates with four drops of straight human whole blood or serum, and the results can be read within 10–15 min- 42 CliniCal laboratory news JuLy 2008 2008 NEw Pr o d u c t rE v i E w utes. Additional reagents are not required. It may be used along with a reader to provide a quantitative measurement of troponin I, CK-MB, and myoglobin. *Pending FDA clearance. Alfa Scientific Designs, Inc. Circle No. 480 in the Reader Service Card Direct Enzymatic HbA1c This fully liquid-stable, enzymatic assay was developed to provide accurate results without interference from hemoglobin variants that can decrease the reliability of other HbA1c methods. This assay is fully NGSP certified and provides highly precise and accurate HbA1c results. The product is a single-channel assay that eliminates the need for a separate hemoglobin measurement, simplifying test setup and maintenance. Parameters are available for a wide variety of clinical chemistry analyzers. In addition to universal packaging, the assay is also supplied pre-formatted in convenient instrument-specific reagent cartridges for optimal operator ease of use and efficiency. Diazyme Laboratories Circle No. 481 in the Reader Service Card Cystatin C Assay This dual-reagent, fully liquid-stable immunoturbidimetric assay has been optimized for use on general chemistry systems. Cystatin C measurements have been shown to be more reliable than serum creatinine-based measurements in detecting the early changes in GFR associated with diabetic nephropathy. This method provides accurate and reliable results across an extended testing range with highly precise CVs of less than 5%. Parameters are available for a wide variety of clinical chemistry analyzers. In addition to universal packaging, the assay is also supplied preformatted in convenient instrument-specific reagent cartridges for optimal operator ease of use and efficiency. Diazyme Laboratories Circle No. 482 in the Reader Service Card Vitamin D HPLC Test Introducing ESA Biosciences’ Vitamin D HPLC Test, the only HPLC test that is FDAcleared for the clinical assessment of vitamin D sufficiency. This assay meets the challenge of detecting the individual metabolites and reports total 25-hydroxy vitamin D. The ESA Vitamin D Test provides accurate and specific results as demonstrated through comparison with other methods: HPLC-UV and LC-MS. Composed of a reagent kit and test system, the ESA Biosciences’ Vitamin D HPLC Test provides high-quality results and is cost effective. ESA BIOSCIENCES, INC. Circle No. 483 in the Reader Service Card High Speed Sorter Sarstedt’s High Speed Sorter is a modular front- and back-end system that automates time-consuming lab processes. Options include identification, sorting, decapping, aliquotting, recapping, and the new bulk loading module that eliminates the pre-racking of incoming specimens—tubes are simply “dumped” into a hopper for walk-away processing. Two components of the system, the Decapper DC 1200 and Recapper RC 1200, are available as benchtop or stand-alone units that process up to 1,200 screw-cap, push-cap, or evacuated tubes per hour. Sarstedt, Inc. Circle No. 484 in the Reader Service Card Aware Messenger Oral Fluid Device Aware Messenger is a research device for collecting, stabilizing, and transporting oralfluid specimens used for detecting specific antibodies or analytes. Aware Messenger specimens may be adapted to conventional laboratory-based immunoassays (e.g., ELISA), enabling high-throughput batch testing, automation, quantitative results, and lower costs. The device provides a stabilized, high-quality, and immunoassay-friendly oral fluid specimen that is easily collected and requires no further processing (e.g., centrifugation). Aware Messenger specimens are rich in various analytes representative of those found in blood. Applications include detection of infectious disease antibodies and antigens, cancer markers, nucleic acids, illicit drugs, and hormones. Calypte Biomedical Corporation Circle No. 485 in the Reader Service Card Platelia Lyme IgM and Platelia Lyme IgG Tests* Bio-Rad announces a new Platelia Lyme IgM test kit and a new Platelia Lyme IgG test kit. These tests are qualitative and intended for use in the presumptive detection of human IgM and IgG antibodies respectively to Borrelia burgdorferi in human serum or plasma. They are EIA tests that can be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. *Pending FDA clearance. Bio-Rad Laboratories Circle No. 486 in the Reader Service InnovaStar POC Chemistry Analyzer The InnovaStar is a small clinical chemistry analyzer for POC testing in diabetes management. An advanced diabetes profile with glu- cose, HbA1c, and hemoglobin is determined by photometric measurement. This fullyautomated analyzer works with pre-filled, bar-coded, ready-to-use reagents (unit dose). Previous sample preparation is not necessary, and all parameters are determined from the same hemolyzate. Its excellent performance with regard to precision and specificity is comparable with other clinical chemistry analyzers. DiaSys Diagnostic Systems GmbH Circle No. 487 in the Reader Service Card The fe500pro Sample Processor The fe500pro is a fully automated platform that meets the sample processing requirements of hospitals, research institutes, and other clinical labs. It’s a reliable workhorse for the whole range of sample-handling tasks that are necessary before analytical testing in core departments. Its flexibility and modularity, along with the smallest footprint and most functionality of any pre-analytical instruments, mean it can be fitted into any existing laboratory setup to enhance the sample flow. Its unique security features increase sample security to new levels. The fe500pro—navigating you toward security and efficiency. Tecan U.S., Inc. Circle No. 488 in the Reader Service Card Parker Smart Syringe Probe The Parker Smart Syringe Probe dramatically shortens clinical lab instrument design time and improves performance by enabling simpler and more efficient processes with its compact size and integrated intelligence. It replaces bulky syringe pumps in liquid handling and diagnostic equipment,
Page 1 and 2: news brief IVD Market Growth Looks
Page 3 and 4: Clinical Laboratory News ediTorial
Page 5 and 6: GINA Opens Door for Research Partic
Page 7 and 8: CLN’s Lab 2008: improviNg heaLthC
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Page 13: Quality Gaps in Communicating Labor
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