American Association for Clinical Chemistry
Better health through laboratory medicine
2008 New Product Review

 


Chemtrue® rapid diagnosis intelligent test reader

The Chemtrue Rapid Diagnosis Intelligent Test Reader is a new immunodiagnostic instrument composed of a specialty optical fiber probe, monolithic processor, and IC card. It incorporates the principle of reflected light intensity to carry out semi-quantitative analysis for gold standard test bar (card). The instrument features include: small volume; light weight; high sensitivity; rapid measurement; and simple operation. The reader can perform DOA, MAU, and cTn-I rapid tests. Worldwide distributors are wanted. *Pending FDA clearance.
 


 Gold Dot™ Test Kit

The Gold Dot test kit is an in vitro diagnostic test that measures NR2 peptide fragments of NMDA receptors in 30 minutes in plasma by magnetic particles-ELISA. Increased NR2 peptide concentrations correlate with the presence of acute cerebral ischemia (stroke) and transient ischemic attack. NR2 peptide levels should be interpreted in conjunction with clinical findings and neuroimaging. The reagents in one kit are sufficient for 41 tests. *For research use only.
 


Complete Additive Cholesterol Line

The clarified Human Cholesterol Concentrate LDL additive (cLDL) provides in vitro diagnostic manufacturers with an LDL cholesterol supplement with greater clarity, stability, and lot-to-lot consistency. Bovine Cholesterol Concentrate LDL provides an animal source LDL cholesterol concentrate for use in adjusting LDL values in control serum.


Instrument Manager Rules Library

Data Innovations, Inc. is pleased to announce the launch of its latest service, the Instrument Manager (IM) Rules Library. This easy-to-use, online reference provides examples using the industry’s most popular middleware product for a variety of lab efficiency-enhancing uses, ranging from autoverification and calculations, such as eGFR, to connecting instruments to multiple LIS systems. To preview the Rules Library, go to www.dirules.com and follow the instructions for guest access. Customers with Specimen Management options covered under our current support plan can enjoy full access by contacting our Customer Services department (support@datainnovations.com) for your full-access login.
 


EP Evaluator™

EP Evaluator™, Release 8 is the industry-leading product line of software programs to evaluate clinical lab methods. Flexible design provides the features needed by small, medium, and large labs to meet all CLIA ‘88 and CAP requirements for validating and evaluating methods. The program also includes three lab management modules: Inventory Management, Cost per Test, and Incident Tracking to monitor patient safety events.


Cystatin C Assay

Introducing a latex-enhanced turbidimetric immunoassay for the fast and easy determination of cystatin C. The test uses polystyrene particles coated with anti-human cystatin C that form a complex with cystatin C present in blood samples (serum or plasma) and can be measured with routine clinical chemistry analyzers. Its accurate measurement range is from 0.1–10 mg/L, so normal and abnormal values can be measured without additional dilutions. *Pending FDA clearance.


  
STA Satellite®

The STA Satellite, the newest addition to the STA® family of analyzers, is a fully-automated benchtop coagulation analyzer capable of simultaneously performing clotting, chromo-genic, 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.

 


 
Calibrated Automated Thrombogram® CAT

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 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.

 


  
STA® Liatest® FM (for Research Use Only)

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.

 


  
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.


  
STA® -Staclot® dRVV Screen and Confirm

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.


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.

 


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 LIAISON 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.

 


LIAISON® 25 OH Vitamin TOTAL-DTM  Assa

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 FDA-cleared, 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.


InnovaStar

The InnovaStar is a small clinical chemistry analyzer for POC testing in diabetes management. An advanced diabetes profile with glucose, HbA1c, and hemoglobin is determined by photometric measurement. This fully-automated 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.


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.


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 pre-formatted in convenient instrument-specific reagent cartridges for optimal operator ease of use and efficiency.

 


DSX® —Reagent Barcode Scanning

Save time, effort, and reduce reagent identification error rates with Dynex Technologies’ new Reagent Barcode Scanning capability for the DSX microplate processing system (including software upgrade). We’ve worked closely with our OEM solutions partners to develop custom reagent racks for the kits they’ve integrated with the DSX. No need to decant reagents into other bottles; the hardware/software package scans the kit-bottle barcode information and automatically incorporates it into the kit assay protocol and report. Easy. Accurate. Automatic. And more cost-effective!

 


Design & Engineering Services

Introducing Dynex Technologies’ latest business offering—design and engineering services for collaborative product development. We’re experts in microplate automation for clinical diagnostics and biotechnology— from robotic handling and fluid pipetting and dispensing, to incubation, detection, and washing. And we know how to take a product from initial concept to market-leading position. Is your unique and proprietary assay ready for market, except a dedicated system to run it on? Work with the designers and engineers behind the technology of the celebrated Dynex DSX® and DS2® automated microplate processing systems—we’ll help you develop custom components, or a complete system, that’s ideal for your application.

 


DSX® for Bead-Based Assays

Has your lab expanded beyond ELISA to the latest bead-based multiplexed assays? Improve results over manual microplate methods with the fully automated Dynex DSX microplate processing system. You’ve seen the benefits of DSX automation on ELISA. Now, Dynex Technologies’ economical dual-mode washer module expands the capabilities of the market-leading DSX. Run up to four microplates, each with traditional ELISA assays using solid-bottom plates—or bead-based assays using filter plates—simultaneously and in any combination! For bead-based assays, an adjustable vacuum manifold provides optimal bottom aspiration of a variety of plate designs and filter pore sizes to assure critical levels of accuracy, reproducibility, and throughput.


Deep-Well No-Waste DSX® Strips

LThe DSX automated ELISA processing system from Dynex Technologies uses deep wells for sample dilution, previously available only in deep-well blocks of 96 (12 x 8) wells—until now. Introducing Dynex’s Deep-Well No-Waste Strips (with holder). These economical deep-well strips, comprising eight wells each, eliminate waste from discarding and increase security from rotating partially used deep-well blocks. If your ELISA assay doesn’t use all 96 wells of our deep-well block, choose deep-well strips instead. You’ll save significantly on your consumable costs by loading only what you need for your assay run!