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special section Advertisement has a large touch-screen user interface and reads a standard 96-well microplate in less than 15 seconds. The versatile open system features cutoff modes, point-to-point, and regression calculations. It prints results on the internal thermal printer or outputs results to a PC to create custom-formatted reports. Awareness Technology, Inc. Circle No. 359 in the Reader Service Card MINICAP Automated SPE With a small footprint, the MINICAP instrument is designed to optimize and completely automate electrophoresis testing in low- to medium-volume laboratories. Simply place a bar-coded primary tube on the system and walk away. A continuous-access sample wheel allows for the addition of samples at any time, and true-positive sample ID is achieved with full traceability. The MINICAP Protein 6 assay is FDA cleared for separation and quantitation of the six major serum protein fractions by capillary electrophoresis.. The MINICAP reagent compartment accommodates multiple assay buffers in anticipation of future menu expansion. Sebia Electrophoresis Circle No. 360 in the Reader Service Card STA Satellite® Analyzer The STA Satellite, the newest addition to the STA® family of analyzers, is a fully-automated benchtop coagulation analyzer capable of simultaneously performing clotting, chromogenic, and immunological assays. The STA Satellite analyzer offers complete automation for low-to- medium-activity coagulation labs and is suitable as a backup analyzer for organizations with central and satellite labs. It offers technological advances to ensure a high level of system reliability, ease of operation, and flexibility—all within a small footprint. Diagnostica Stago, Inc. Circle No. 361 in the Reader Service Card Calibrated Automated Thrombogram® Assay* The Calibrated Automated Thrombogram, or CAT, is an exciting new technology using a fluorogenic substrate in an easy-to-use automated platform to measure the initiation, burst, and subsequent inactivation of thrombin in clotting platelet-poor or platelet-rich plasma. It is a global hemostasis assay for the investigation of hypo- and hyper-coagulability and the effects of anti-thrombotics and 28 CliniCal laboratory news JuLy 2008 2008 NEw Pr o d u c t rE v i E w other pharmaceuticals on thrombin generation. A unique thrombin calibrator eliminates potential sample-specific interferences, such as the inner filter effect, substrate depletion, and variability in sample color and light intensity. Diagnostica Stago, Inc. represents Thrombinoscope as the exclusive distributor in the U. S. *For research use only. Diagnostica Stago, Inc. Circle No. 362 in the Reader Service Card STA® Liatest® FM Assay* The STA Liatest FM is an immunoturbidimetric assay for the quantitative determination of soluble fibrin monomer complexes (SFMC) on the STA line of analyzers. The test uses microparticles coated with monoclonal antibodies specific for SFMC that are mixed with the test plasma. The presence of SFMC causes agglutination of the microparticles, resulting in a change in absorbance that is measured at 540nm. High plasma levels of SFMC are usually observed in patients with disseminated intravascular coagulation (DIC). STA Liatest FM Calibrator and STA Liatest FM Control complete the Liatest FM product line. *For research use only. Diagnostica Stago, Inc. Circle No. 363 in the Reader Service Card STA® Control LA 1+2 STA Control LA 1+2 are a lupus anticoagulant (LA) positive and negative control material. The two levels of assayed controls are for use with the STA Staclot dRVV Screen and Confirm using the STA line of instruments. The controls are available in 1-mL vials with an onboard stability of 8 hours when used on the STA line of instrumentation. Diagnostica Stago, Inc. Circle No. 364 in the Reader Service Card STA® -Staclot® dRVV Screen and Confirm Assays The STA-Staclot dRVV Screen and Confirm are fully-automated assays for the detection of lupus anticoagulants (LA) in patient plasma by the diluted Russell viper venom method. Each reagent is bar coded for ease of use on the STA line of analyzers. The STA Staclot dRVV Screen assay uses a reagent with a low phospholipid concentration that enhances its sensitivity, resulting in a prolongation of the clotting time. The STA Staclot dRVV Confirm assay uses a reagent with a high phospholipid concentration that neutralizes the LA present in the plasma, resulting in a shortening of the clotting time. Diagnostica Stago, Inc. Circle No. 365 in the Reader Service Card ABL80 FLEX CO-OX Instrument* The ABL80 FLEX CO-OX incorporates the patented oximetry technology found in Radiometer’s benchtop analyzers, making it available in a portable, cartridge-based instrument. Radiometer’s ultra-sonic hemolyzation is well-established as superior to chemical hemolyzation, demonstrating superior measurement performance and zero risk of contamination from chemical agents. The ABL80 FLEX CO-OX offers the portability and ease-of-use advantages already benefiting users of the ABL80 FLEX platform. Its small footprint, rapid start-up, and fast measurement time make it ideal for use in clinical areas, while full connectivity and auto QC ensure the lab maintains control of the testing process. *Pending FDA clearance. Radiometer America, Inc. Circle No. 366 in the Reader Service Card Little Dipper Processor for FISH From day one, this robotic system automates processing of FISH samples using Vysis or other probes, including post-hybridization steps. The Little Dipper processor provides precise temperature control and washing action that enhances test results and day-to-day reproducibility. It also can be used for processing microarrays used in new aCGH tests from Agilent, Roche/NimbleGen, Illumina, and others. SciGene Circle No. 367 in the Reader Service Card LIAISON® Treponema Assay Introducing the LIAISON Treponema Assay, the first fully-automated, FDA-cleared chemiluminescent immunoassay to aid in the diagnosis of syphilis infection. With high sensitivity, as well as excellent specificity, the LIAISON Treponema Assay is used as a clinical lab screening or confirmatory test. Its ability to detect both IgM and IgG antibodies to Treponema pallidum ensures improved sensitivity in the diagnosis of early syphilis infections, compared with RPR and EIA methods. The use of recombinant antigens limits cross reactivity and provides superior specificity. Labs benefit from the excellent throughput of 180 results per hour and the total walk-away system. DiaSorin Circle No. 368 in the Reader Service Card LIAISON® Borrelia burgdorferi Assay The LIAISON Borrelia burgdorferi assay is the only fully-automated, FDA-cleared, chemiluminescent immunoassay available for Lyme disease serology. The use of the VlsE recombinant antigen provides the LIAI- SON Borrelia burgdorferi assay with superior specificity, reducing the diagnostic time and cost. The truly reactive samples are identified in the first step of the recommended testing algorithm, reducing the amount of subsequent Western blot testing. Thanks to the high immunogenicity of the VlsE antigen, Lyme infections can be identified from the early stages and treatment can be started promptly. The LIAISON Borrelia burgdorferi assay has excellent throughput and random access capability. DiaSorin Circle No. 369 in the Reader Service Card LIAISON® 25 OH Vitamin TOTAL-DTM Assay The LIAISON 25 OH Vitamin TOTAL-DTM Assay uses chemiluminescent immunoassay technology for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma, or lithium-heparin plasma for assessment of Vitamin D sufficiency. The new TOTAL-D is the only FDAcleared, fully-automated assay measuring 100% of Vitamin D2 and D3. The improved precision offers intra and inter CV of ≤ 10% and functional sensitivity of < 4 ng/mL. The automated LIAISON Analyzer offers the lab a throughput of 100 tests per hour and time to first result of 35 minutes. DiaSorin Circle No. 370 in the Reader Service Card
2008 NEw Pr o d u c t rEv i Ew special section Advertisement Total P1NP Assay The total P1NP assay from Roche Diagnostics is useful for monitoring therapy of patients with osteoporosis. It detects increased bone turnover in postmenopausal women and is sensitive to significant changes induced by anabolic or anti-resorptive therapies. The advantages of the automated serum total P1NP include: little diurnal variability allowing for draws at any time, unlike previous markers; rapid, 18-minute assay time; and intra- and inter-assay variations lower than 2% and 5%, respectively. Total P1NP documents changes that exceed the LSC in a majority of individuals. Roche Diagnostics Circle No. 371 in the Reader Service Card ONLINE TDM Tobramycin Test The ONLINE TDM tobramycin assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with tobramycin rapidly aggregate in the presence of a tobramycin antibody. The presence of tobramycin in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest tobramycin concentration. The 12-week onboard stability of the cobas c pack, along with calibration stability, allow for a convenient and economical method for TDM of tobramycin in serum, K2 or K3 EDTA, or sodium or lithium-heparin plasma on the Roche cobas c 501 analyzers. Roche Diagnostics Circle No. 372 in the Reader Service Card proBNP II Assay The Roche Diagnostics ProBNP II assay, launched in April, is a 2nd-generation assay using monoclonal antibodies for the detection of NT-proBNP. Monoclonal antibodies provide consistent high quality through improved lot-to-lot consistency and excellent precision, ranging from 1.6%–4.6% CV over the full measuring range. The unique NT-proBNP claim, “aid in the assessment of increased risk of cardiovascular events in patients who have stable coronary artery disease (CAD),” promotes quality management of cardiovascular risk with patients diagnosed with CAD and creates an outreach growth opportunity for labs. Roche Diagnostics Circle No. 373 in the Reader Service Card ONLINE TDM Phenobarbital Test The ONLINE TDM Phenobarbital assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with phenobarbital rapidly aggregate in the presence of a phenobarbital antibody. The presence of phenobarbital in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest phenobarbital concentration. The 90-day onboard stability of the cobas c pack, along with calibration stability and 200 test cobas c pack configuration, allows for a convenient and economical see us at the 2008 clin lab expo, booth no. 2421 method for TDM of phenobarbital in serum, K2 or K3 EDTA, or sodium or lithiumheparin plasma on the Roche cobas c 501 analyzers. Roche Diagnostics Circle No. 374 in the Reader Service Card ONLINE TDM Quinidine The ONLINE TDM Quinidine assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with quinidine rapidly aggregate in the presence of a quinidine antibody. The presence of quinidine in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation CliniCal laboratory news JuLy 2008 29
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
Page 9 and 10: abnormal lipoproteins. Using the NH
Page 11 and 12: among healthcare workers is whether
Page 13: Quality Gaps in Communicating Labor
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Page 18 and 19: special section Advertisement Onboa
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