2008 New Product Review
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EPOC™  epoc™

The EPOC System is the first truly cost-effective, wireless, and easy-to-manage POC testing solution able to deliver lab-equivalent blood gas and electrolyte results at the bedside in just 30 seconds. The system is composed of single-use EPOC Test Cards, an EPOC Reader, EPOC Host Mobile Computer, and Web-based EPOC Data Manager. System features include: room-temperature storage of single-use test cards barcoded for inventory management; internal, automated quality control; and wireless capture and transmission of patient and quality test records. The EPOC System is easily interfaced to hospital LIS/HIS systems via an HL7 interface.
 


ESA Biosciences’ Vitamin D HPLC Test  

Introducing ESA Biosciences’ Vitamin D HPLC Test, the only HPLC test that is FDA-cleared 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.


  
ACU-CAP

The new ACU-CAP vial closure provides convenient and precise reconstitution of lyophilized materials, eliminating the need for manual pipetting. The single-use device makes the reconstitution of reagents, calibrators, and QC materials significantly more convenient for labs and POCT locations and eliminates the imprecision and pre-analytical error associated with manual pipetting.


 
New Combination QC for i-STAT analyzers (with Hematocrit)

GAS-ISE-HCT QC is the first all-in-one control product of its kind with pH, blood gases, electrolytes, metabolites, and hematocrit target values. Designed for i-STAT analyzers, the product eliminates the need to use two separate cartridges with each control check and cuts QC time in half. The product is available as a three-level QC, as well as a 5-level AMR/linearity panel.


  
New PO2 AMR Validation Control

Hypoxic QC™ is the first pre-tonometered product of its kind to validate critically low (35mmHg) and extra-low (15mmHg) Po2 values. Hyperbaric QC is designed to validate the high (460mmHg) and extra-high (710mmHg) Po2 range. Together, these two products validate the full Po2 analytical measurement range (AMR) of blood gas analyzers. Hypoxic QC features active hemoglobin buffering with 10-minute open ampule stability, making it well suited to perform method comparisons as well. The Hyperbaric QC is an aqueous formulation that validates high and ultra high recovered values—ideal for cardiac catheterization labs and OR suites.

 


Transorb®

New and improved Filtrona Fibertec® Transorb® rapid diagnostics media is ideal for use as sample, absorbent, and conjugate pads for lateral flow assay applications. New equipment broadens the performance characteristics and the available material selection in fully customizing the media to test applications. Our Transorb products are engineered to select capillarity, providing dependable liquid transfer of samples and reagents. Filtrona Fibertec media will not crimp or tear like cellulose-based and fiberglass products. Its high tensile strength delivers optimum processing mechanics, and in-house fiber processing and development yield consistency and uniformity. Product is available in rolls, sheets, or pre-cut strips or pads, and in color.


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.


GenPlates®

GenPlates storage system is a proprietary format for storing and transporting biological samples at room temperature in the dry state. Samples are stored embedded in FTA® paper, a cellulose matrix chemically treated to inactivate bacteria and viruses, that preserves DNA for at least 18 years (proven in real time). As cellular material or DNA is added to the GenPlate medium, the cells lyse and the released DNA binds to the paper. When DNA is required for downstream analysis, high-quality, double-stranded DNA from both the FTA paper and S&S 903 paper can be reliably recovered using GenSolve® chemistry.
 


HandyLab "Jaguar"

Sample in, result out! HandyLab offers the first rapid, cost-effective, easy-to-use integrated molecular diagnostic platform for infectious disease testing. The Jaguar is a third-generation nucleic acid system that provides labs with full molecular diagnostic automation, including processing raw patient samples into a real-time PCR and results in as little as 45 minutes with minimal hands-on time. This innovative system enables automation of manual lab-developed tests and analyte specific reagents. HandyLab is dedicated to the development, manufacture, and sales of novel diagnostic products based on its patented and proprietary microfluidic real-time PCR and nucleic acid extraction technologies. HandyLab—Ahead of the Curve!


Hemosure® Immunological Fecal Occult Blood Test

The Hemosure Fecal Occult Blood Test (IFOBT) is the most advanced screening method for colorectal cancer available today. The technology has eliminated the need for patient dietary and medication restrictions prior to testing and it has significantly increased the chance of early detection of this very curable disease. Easily performed in clinics, doctors’ offices, hospitals, and labs. The Hemosure iFOB is FDA approved and CLIA waived.


Elisys Uno

The Elisys Uno is HUMAN’s fully automated open ELISA processor designed for the processing of a single microtiter plate, with the possibility to combine up to eight tests on one plate. The system is optimized to meet user needs for automated ELISA testing. A customized rack system permits the use of original kit components. All HUMAN and IMTEC tests are pre-programmed, and other tests can be easily added. The flexible, self-explanatory software and user-friendliness of the instrument in routine applications are among its most notable features. Additional useful software features have been implemented to ensure the accuracy and consistency of results.

 


HumaClot DuoPlus

The HumaClot DuoPlus is a new, manual, two-channel, photo-optical instrument that offers clotting, chromogenic, and immunoturbidimetric testing capabilities. The HumaClot DuoPlus can be used for a broad range of coagulation tests, and the approved clotting algorithm enables detection of low fibrinogen and fibrinogen determination from PT results. Highly reliable and nearly maintenance free, this compact instrument offers a broad range of implemented features, such as microvolume testing, an autostart function, autosensing optics to eliminate interference, and multi-language software—features that make this instrument a powerful tool for small laboratories worldwide.


Diagnostic-Grade Fittings & tubing

IDEX Health & Science introduces a new line of Upchurch Scientific® products specifically designed for the low-pressure fluidic systems in diagnostic instruments.  Based on flangeless technology proven to reduce leaks, the new Diagnostic-Grade Fittings and Tubing Assemblies eliminate the need for OEMs to ever flange instrument tubing in manufacturing or in the field. In addition to the dependable fittings for 1/8” and 1/16” OD tubing, custom tubing assemblies prove especially cost effective because they are easy for OEMs to install, and easy for owners to replace if needed. For a quote on a custom tubing assembly, visit www.upchurch.com/OEMTubing.

 


PVM eith I PV

New valve features and additional microstepping capability make the Sapphire Engineering™ Pump/Valve Module (PVM) with Integrated Piston & Valve (IPV) compatible with an even greater range of diagnostic instruments. Designed for long, service-free life—3 million cycles—the IPV requires no preventive maintenance, increasing system uptime. Ultra-hard ceramic pistons and valves eliminate the premature failure issues of competing syringe pumps, and enable the IPV to withstand even harsh, saline solutions common in diagnostic applications. OEMs can now choose the PVM with IPV for easy, plug-in replacement for the Cavro™ XP3000 and Hamilton® PSD/4 pumps.


GEM® Premier™ 4000 Critical Care Analyzer

The GEM Premier 4000 is a revolutionary analyzer with integrated CO-oximetry that quickly provides consistent, accurate, lab-quality results throughout your hospital, including BG, electrolytes, metabolites, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, BUN*, Creat*, Total Bili*, and HCO3-*. Easy-to-use, touch-screen displays make it simple to select and customize parameters, while self-contained, maintenance-free cartridges incorporate all components for patient testing. The iQM® system automates QC and continuously detects, corrects, and documents to assure quality results and compliance 24/7, regardless of operator or testing location. GEMweb® Plus software enables remote access to any networked analyzer for real-time status updates and supervision of remote locations. *In development.

 


ACL TOP® 500 CTS Hemostasis Testing System

The new ACL TOP 500 CTS Hemostasis Testing System is a bench-top, fully automated, random-access analyzer designed specifically for clinical hemostasis laboratories. Used for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis, this newest member of the ACL TOP family combines the same speed, simplicity, and intelligence as all ACL TOP coagulation analyzers, delivering testing-process automation in a more compact design. In addition to routine hemostasis analysis, the ACL TOP family, combined with IL’s extensive offering of reagents, make highly-specialized assays as easy as routine assays. All ACL TOP analyzers have the same user interface, intuitive software, reagents, and provide the same results.


STATSPIN® EXPRESS  4

Laboratories are going lean with single-piece flow. Instead of batching samples and loading them into conventional slow centrifuges, labs can now process gel tubes quickly with this new high-speed, horizontal centrifuge. It spins eight samples in 3 minutes, providing clean separation with a flat gel barrier. Samples can be put directly on the analyzer. It has a powerful, maintenance-free, brushless motor, and the entire unit is backed with a 2-year warranty. This high-speed, horizontal centrifuge is the answer to productivity and turnaround time in the chemistry lab.


ITC’s AVOXimeter® offers Co-Oximetry and Oximetry at the Point-of-Care

The AVOXimeter 1000E and 4000 are portable, easy-to-use analyzers that provide rapid, accurate assessment of a patient’s true oxygenation status at the bedside. Testing is performed in single-use,disposable cuvettes. No sample preparation is required; simply inject a whole blood sample into the cuvette and insert into the analyzer. Results are displayed and recorded in less than 10 seconds, improving efficiencies and allowing for timely diagnosis and intervention. The AVOXimeter 4000 measures oxyhemoglobin, carboxyhemoglobin, methemoglobin, total hemoglobin, and oxygen content and is used in the respiratory department, ICU, OR, NICU, and ED. The AVOXimeter 1000E is specifically designed for the cardiac cath lab and provides a measured oxygen saturation, oxygen content, and total hemoglobin concentration.

 


IRMA TRUpoint® Point of Care Lactate Testing and Creatinine MDRD-GFR Reporting

ITC announces a new assay to measure lactate concentration in blood at the patient bedside. The IRMA TRUpoint also now offers software that calculates the modification of diet in renal disease glomerular filtration rate (MDRD GFR) with every creatinine test result. The new software program takes the IRMA TRUpoint creatinine result and applies the NKDEP formula factoring the patient’s age, race, and sex to assess overall kidney function. These recent additions further enhance IRMA TRUpoint’s value for rapid, accurate POC testing in emergency and critical care situations where immediate results can make a difference in treatment decisions.


Titin Antibody (TitinAb) ELISA Test Kit

KRONUS®, a leading provider of specialized autoimmune diagnostic test kits, announces the availability of a new ELISA test kit for the measurement of antibodies to titin (TitinAb). Titin is a protein of the striated muscles with an extremely high molecular weight. The immunogenic region of titin is located on a 30-kD protein fragment. Antibodies against this fragment presumably cross-react with the epitopes of the acetylcholine receptors, making their measurement potentially useful in select indications. This new ELISA uses recombinant MGT30 peptide, providing accurate and specific determination of titin antibodies. *For research use only.


TSH Receptor Antibody (TRAb) ELISA Test Kit

KRONUS® announces the availability of an improved, non-isotopic FDA-cleared ELISA test kit for the detection and measurement of antibodies to the TSH receptor (TRAb). This improved TRAb ELISA uses the proprietary thyroid-stimulating, human monoclonal autoantibody M22—directly coupled to the peroxidase reagent—which increases assay sensitivity while simultaneously reducing assay time. Antibodies to TRAb are detectable in approximately 90% of untreated Graves’ disease patients. Their presence indicates that the patient’s thyrotoxicosis is of autoimmune etiology rather than toxic nodular goiter.