American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: New Product Review

   
July 2007: Volume 33, Number 7

LOCI™ Advanced Chemiluminescence Technology

The patented LOCI technology unleashes the signaling power of chemiluminescence via oxygen channeling. This new analytical breakthrough represents an important advance in immunoassay testing by bringing a superior combination of sensitivity, simplicity, and throughput to clinical laboratories. Available on the Dimension Vista® Intelligent Lab System, LOCI advanced chemiluminescence technology offers unlimited potential to develop even the most complex immunoassays. Key LOCI assays include 10-minute Troponin-I, NT proBNP, Mass CKMB, Myoglobin, and FT4 assays, as well as 16-minute, 3rd generation TSH and FT3 assays.

 

Endogenous Thrombin Potential (ETP) Assay

The Endogenous Thrombin Potential (ETP) assay is an innovative research-use-only assay for the measurement of thrombin generation in plasma. Automated on the BCS instrument, this exciting assay may be able to assess thrombophilia and has the potential to provide more valuable information on the hemostatic status of patients

 

LabPro AlertEX System

MicroScan® microbiology systems deliver even more computerized microbiology expertise with the LabPro AlertEX system. This database of fully customizable bacterial identification and susceptibility rules ensures fool-proof reporting of intrinsic resistance while adapting to support evolving laboratory interpretative requirements. In addition to customized alerts for review or for automatic uploading to an LIS, users can view exceptions at a high level, or with a single click, expand to explicit instructions defined in laboratory SOPs. Resolution tracking documents follow-up on unusual results. LabPro AlertEX supports both specialist and generalist laboratory personnel. LabPro Information Management solutions—informatics that extend your expertise.

 

MicroScan WalkAway® plus System

Announcing the 4th generation of proven WalkAway technology and reliability—the MicroScan WalkAway plus system. By com-bining fluid-level detection with a directional LED system, the WalkAway plus system shows when and where maintenance is needed. The double-capacity reagent systems shave up to 30% off maintenance time and a direct hookup to de-ionized water provides even more savings. With the new reagent system design, caps are easy to lock and adding reagents becomes as easy as 1-2-3. The WalkAway plus system is the reliable solution for today's changing world of microbiology. MicroScan® microbiology systems—29 years of innovation.

 

Synergies plus™ Gram Positive Panels

MicroScan® microbiology systems introduces Synergies plus Gram Positive panels, offering same-day results for clinically significant antibiotic-resistant bacteria, like MRSA. Synergies plus panels combine rapid identification with read-when-ready antimicrobic results. Actionable identifications are ready in 2 hours—no other panel is faster. Read-when-ready susceptibilities overcome limitations inherent in fully rapid methods by adjusting incubation reporting times, while low dilutions of vancomycin provide a significant predictor of clinical outcomes. Customize the LabPro AlertEX System to notify staff of critical results, and benefit from productivity improvements and proactive patient care consultations. Choose Synergies plus panels for the right blend of speed and accuracy for key empiric therapy.

 

Oxycodone, Tramadol, Meperidine, and Buprenorphine Assays

Introducing immunoassays focused on testing for prescription drug abuse: oxycodone, tramadol and meperidine. All are commonly prescribed narcotic analgesics and are frequently abused, resulting in increasing numbers of emergency room visits due to overdosing. A test for buprenorphine will also be introduced, which is approved for the treatment of opiod dependence and as a replacement for methadone, treating opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.

 

EasyLink™ Informatics System

The next-generation EasyLink Informatics System middleware solution extends your laboratory's expertise, providing operators the freedom to focus on highly valued tasks.This new solution enhances the brainpower of your instruments by performing key intelligent functions. EasyLink supercharges sample and results management via autoverification, with pre-packaged rule sets and wizards, LIS backup, enhanced quality control, reporting tools, and optional specimen tracking. Streamlined, secure access to information, training, and intelligent monitoring of instruments for proactive service (Dimension Vista® only) maximizes system performance. Improve turnaround time, maximize productivity, and grow your laboratory while enhancing result quality and improving patient care with support from a trusted vendor and the EasyLink system.

 

eLuminate Reported Results System

Command control over your results reporting with eLuminate Reported Result System, a new CPRR option* for submitting usage data for results reporting purposes. eLuminate requires only a computer with Internet access and a simple set-up process. Submit test result totals extracted from your LIS online and generate reports using historical data for your hospital or lab by date, instrument, test, or panel. Improve budget planning and enhance your ability to track spending with data available for analysis in downloadable or printer-friendly formats. eLuminate is one of many innovative solutions. *Actual availability to customers may vary.

 

Liquid RF and ASL Assays

Introducing new liquid formulations of N Latex RF* and N Latex ASL* assays, part of our efforts to continue to provide solutions to our customers . The assays are available on the BNTM II and BN ProSpec® systems. With results in just 6 minutes, these highly robust, reliable, and easy-to-use reagents will help you achieve optimum efficiency in your lab. *Not available in the U.S.

 

N Latex Carbohydrate Deficient Transferrin (CDT) Assay

Introducing the N Latex CDT assay, the first fully-automated, direct CDT method to identify chronic alcohol abuse. The determination of % CDT provides a valuable aid for recognizing patients with chronically high alcohol consumption, for monitoring changes in alcohol consumption, and for monitoring abstinence. In combination with N Antiserum to human transferrin, the N Latex CDT assay offers fully automated results available in less than 20 minutes and an automatic calculation of CDT percentage on the company's BN™Systems.

 

StreamLAB® Analytical Workcell Enhancements

Introducing the StreamLAB Analytical Workcell. These new options to current automation solutions provide increased productivity potential and flexibility for your laboratory. A new Track Turn module provides a space-efficient and cost-effective alternative to laboratory renovation or other workarounds to avoid obstructions. Also available is a Tube Sealer that ensures specimen integrity and improves user safety by reducing tube handling and manual tube sealing. Open connectivity and new user-friendly middleware helps you automate with confidence.

 

Amplified Dimension® RxL Max® and Xpand Plus® Systems

Amplify your capabilities with the Dimension Integrated Chemistry Systems. The RxL Max and Xpand Plus systems, fully integrated platforms with many automated features, deliver maximum test reporting with minimum space. By bundling the features of QCC PowerPak™, the ultimate efficiency enhancer, EasyLink™ Informatics System, our middleware offering, and SpecTRACK®, our specimen tracking software, you can boost productivity and provide increased walk-away time. Choose the combination that helps you achieve your productivity goals.

 

Stratus® CS Acute Care™ CardioPhase® hsCRP Assay

The Stratus CS Analyzer now features a breakthrough in cardiovascular risk management—the first hsCRP assay cleared by the FDA for both risk stratification and risk assessment in the point-of-care setting. Measurement of hsCRP is recommended for patients at intermediate risk of coronary heart disease to determine the need for further evaluation and therapy. In addition, the use of hsCRP with cTnI can help identify high-risk patients for appropriate care. The Stratus CS Acute Care Diagnostic System provides access to a comprehensive risk-stratification menu on one platform.

Instrument Manager™ System

Introducing the most complete middleware system on the market to manage laboratory operations, including pre-analytical, analytical, and post-analytical sample processing, as well as non-clinical tasks such as equipment maintenance and specimen archiving. The Instrument Manager (IM) system is available independent of instrument or LIS vendor, laboratory department, and clinical discipline. Most recently, the FDA granted 510(k) clearance to the Instrument Manager system for use in blood banking environments. FDA clearance demonstrates the IM system's product excellence and the comprehensive systems in place to develop and support it. Directly and through business partners, more than 4,700 systems worldwide are IM-powered, supported by subsidiaries located in Brussels, Hong Kong and São Paulo.

Evaluation and Validation Software

Four new modules—one Lab Management Inventory Tracking module and three INR modules have been added to enhance this proven software program for the clinical laboratory. The new modules ensure rapid, accurate validation and evaluation of instruments to industry standards and meet all CLIA '88 and CAP method evaluation requirements. Simple to install, learn, and teach, the new modules offer quick, efficient data entry and produce easy-to-understand reports, ready to be signed and filed. The modules contain 27 validated statistical modules, including Incident Tracking, Cost Per Test, Linearity, Carryover, Precision (2), Sensitivity (2), Reference Intervals (3), Method Comparison (7), Multiple Instrument Comparison, Hematology Method Comparison, Interference, Performance Standards, and Average of Normals.



DCL Enzymatic Creatinine Reagent

Using a multi-step enzymatic approach, this new two-part, liquid-stable reagent system quantitatively measures concentrations of creatinine in serum, urine, or plasma specimens. The assay displays virtually no significant interference effects from lipemia, hemolysis, icterus, or ascorbic acid and offers a vastly reduced interference profile from many non-creatinine associated chromogens as typically observed with the traditional Jaffé method. The DCL Enzymatic Creatinine assay offers an extended product shelf life, as well as on-board and calibration stabilities in excess of 3 weeks. The reagent also features an extended reportable range—without compromise to low-end sensitivity—as well as a small sample-to-reagent ratio, reliable performance characteristics, and packaging configurations well suited for any size laboratory.

STA® Control LA 1+2 Controls

STA Control LA 1 + 2 controls 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 on-board stability of 8 hours when used on the STA line of instrumentation.

 

ROTEM® Analyzer

The ROTEM instrument is a whole blood coagulation analyzer based on the principles of rotational thromboelastometry. The ROTEM analyzer is a robust, compact system with four independent measuring channels engineered to eliminate vibration interference previously associated with other systems. Color-coded reagents allow for a custom test menu to aid in therapeutic decisions and differential diagnosis. Whether laboratory based or near the point of care, ROTEM analyzers can assist in the STAT differentiation of surgical bleeding or a hemostatic disorder. The ROTEM system is for research use only. An FDA 510(k) submission is pending.

 

STA® Liatest® FM Assay*

The STA Liatest FM test is an immuno-turbidimetric, research-use-only assay for the quantitative determination of soluble fibrin monomer complexes (SFMC) on the STA line of analyzers. Microparticles, coated with monoclonal antibodies specific for SFMC, 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 soluble fibrin monomer complex are usually observed in patients with disseminated intravascular coagulation (DIC). The STA Liatest FM Calibrator and STA Liatest FM Control complete the Liatest FM product line. *Research use only.



NEW MAGO® 4 Automated EIA and IFA Processor*

Designed to help improve your lateral flow test development, Thermo Fisher Scientific Reagent Microspheres have a new surface chemistry to offer in addition to the existing surfaces and colors already available. New amine-modified microspheres are now available in the Reagent Microsphere product line.

 

Bedside Glucose Monitor

The Nova StatStrip™ Glucose Monitoring System features a patented multi-well test strip measuring technology that creates a new class of analytical performance comparable to the quality of central laboratory testing. StatStrip eliminates common interferences that have plagued bedside glucose testing, including hematocrit, maltose, acetaminophen, uric acid, ascorbic acid, maltose, galactose, xylose, lactose, and oxygen. Its small 1-µL sample volume, fast 6-second test results, and simple, color touchscreen operation facilitate bedside glucose testing for point-of-care staff. In February 2007, StatStrip received FDA clearance for use in neonatal testing. In conjunction, its glucose measurement range has been expanded to 10-600 mg/dL.

LIAISON® Treponema Assay

Introducing the LIAISON® Treponema Assay, the first fully automated chemiluminescence immunoassay in the U.S. for the diagnosis of syphilis. With high sensitivity, as well as excellent specificity, the LIAISON® Treponema Assay can be used as a clinical laboratory screening test or a 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 to RPR and EIA methods. The use of recombinant antigens limits cross-reactivity and provides superior specificity. In addition, laboratories will benefit from the excellent throughput of 180 results per hour and the total walk-away system.



InnovaStar Analyzer

The InnovaStar instrumnet is a small clinical chemistry analyzer for point-of-care 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 precision and specificity is comparable to other clinical chemistry analyzers.


Direct Enzymatic HbA1c Assay

The Direct Enzymatic Hemoglobin A1c Assay™ uses two, ready-to-use, liquid-stable reagents and is applicable to chemistry auto-analyzers. Since it does not require a separate measurement of total hemoglobin content in the samples, the assay only needs a single channel to perform the test, in comparison with most immunoassays that require a separate measurement of total hemoglobin. The Direct Enzymatic HbA1c Assay requires no post-analytical calculations, and the results are directly reported as % HbA1c in whole-blood samples. Common hemoglobin variants do not interfere with the assay. Catalog number: DZ168A.


Enterprise Point-of-Care Blood Analysis System

EPOC™ is a complete, efficient, user-friendly and cost-effective, bedside blood analysis system that delivers lab equivalent accuracy in 30 seconds. The system includes multi-sensor, single-use analytical test cards, low-cost card readers, and PDA host systems that wirelessly capture and transmit test record information. Bar-coded test cards are stable at room temperature and provide inventory tracking and bedside card storage. Automatic quality control provides pre-analytical, analytical, and post-analytical quality assurance conformance each time a test is performed, and the first test card offers a general purpose blood gas and electrolyte combination panel.

Critical Care QC Suite

Eurotrol's suite of critical care QC products allows blood gas laboratories to validate their full reportable range and verify absolute accuracy at critical thresholds. The QC suite includes: Hypoxic pO2 Control—hemoglobin matrix, physiological oxygen saturation curve, targets at 20 and 35 mmHg (without tonometry); Hyperbaric pO2 Control—aqueous-based QC, targets at 325 and 625 mmHg; Plasma-like Linearity QC—validates linearity at five levels for pH, blood gases, electrolytes and metabolites; and CO-Ox Validation Control—hemoglobin matrix, physiologically correct hemoglobin fractions. Each control in the suite mimics fresh human specimens, is compatible with all analyzers, and provides IFCC reference method traceability where appropriate.

 

Whole-Blood Glucose Validation Program

In this unique program, whole-blood samples are used to validate the accuracy of point-of-care glucose methods, to meet method validation requirements of accreditation agencies, and to assess the competency of testing personnel. On a pre-scheduled basis, whole-blood samples are shipped to customers and then distributed to POC locations. Samples are tested within one week and results are submitted online. Performance reports are available in real time, providing reference method comparisons, inter-lab comparative statistics, network summary reports, and competency assessment documentation.

 

QC Suite for HemoCue™ Systems

Introducing a comprehensive suite of quality controls and linearity verification products for the performance validation of HemoCue systems. These quality controls mimic patient specimens, yet also provide the stability and shelf life to ensure long-term QC continuity. Analytes measured include hemoglobin, whole-blood glucose, and urine albumin. The controls are approved and distributed by HemoCue and are the number one QC used on HemoCue systems world wide. Products include: HemoTrol™, GlucoTrol-NG™, AlbuTrol™, Donor Hb Checker Control™, and Plasma/Low Hb Control™, as well as HemoLin™ and GlucoLin™ linearity verification controls.

 

ACU-CAP™ Vial Closure

The new ACU-CAP vial closure provides convenient and precise reconstitution of lyophilized materials with water or a specific reagent, or the complete mixing of two separate liquid reagents, just prior to use. The single-use device makes the reconstitution of reagents, calibrators, and quality control materials significantly more convenient for laboratories and POCT locations and eliminates the imprecision and non-analytical error associated with manual pipetting. The device is of particular interest for physiologically balanced quality control formulations that would have improved stability when certain analytes or components are stored separately.