Sneak a peek at the AACC Annual Meeting
The 2002 AACC Annual Meeting and Clinical Lab Expo will be held July 28th – August 1 at the Orange County Convention Center in Orlando, Fla. The Clinical Lab Expo is the largest dedicated exhibition of equipment, instruments and services for clinical laboratories in the world.
Attendees will learn about a wide variety of the new laboratory products. A few vendors spoke with CLP and provided a sneak peak at their AACC booths.
Olympus’ AU640 chemistry-immuno analyzer
Olympus Diagnostic Systems Group will show new e-Class chemistry-immuno analyzers at AACC. Designed to optimize workflow within low to medium volume test labs, the new AU400 and AU640 e-Class systems feature versatile performance with a 122-test menu that includes chemistry, specific proteins, DAT, TDM, thyroid and esoteric tests. The new systems provide the versatility found within the current Olympus AU400 and AU640 lineup including true random access testing, pediatric sampling and immediate STAT interrupt, 80 sample loading capacity and continuous sample rack feed plus a throughput of up to 400 tests per hour (800 with electrolytes) on the AU400; 800 tests per hour (1,200 with electrolytes), on the AU640. The e-Class systems utilize enhanced hardware and Windows NT software that enable labs to save time, reduce operating costs and customize workflow.
The Scientific Equipment Group of Olympus will showcase its recently launched IX81 motorized inverted microscope system for advanced imaging and research applications. In addition to full digital control, the system offers the optical and mechanical performance necessary for advanced imaging, analysis and live cell applications.
Booths 4610 and 1740
Roche Diagnostics is moving efficiency and productivity ahead with the release of Integrated Modular Analytics, a high throughput combined Clinical Chemistry and Immunoassay system. This system features a single point of entry, single user interface and single host connection. Enhanced Intelligent Process Management optimizes sample routing providing high sample throughput, fast availability of patient results, seamless integration of STAT samples into routine workflow and efficient integration of autorerun and auto dilution tests. Easy to perform setup and automaintenance functions further enhance result throughput. For Roche, Integrated Modular Analytics with single platform disease management is taking workstation consolidation to the next level.
J&J/Ortho Clinical Vitros 5.1 IS system
J & J/Ortho Clinical Diagnostics
AACC attendees this year can examine working prototypes in Ortho’s new Vitros Fusion Series: the 3,1 newly featured this year for mid- to low-volume hospital labs and the 5,1 unveiled last year for high-volume labs. The Fusion System integrates routine and special chemistry assays without compromising routine chemistry test throughput. Like other Vitros analyzers, the Fusion 5,1 and 3,1 feature Ortho Clinical Diagnostics demonstrated slide technology and random access operation. The Fusion Series also supports special chemistry assays, including TDMs, proteins and DAUs, through the addition of the new MicroTip chemistry technology. MicroTip enables special chemistry tests to be performed without plumbing, drains or fixed probes. With these instruments, labs can consolidate virtually all their clinical chemistry tests on one platform.
Other innovations designed into these systems include: MicroSensor technology, which uses fiber-optic wavelength scans of samples to detect interfering substances and flag results; Smart Metering technology to ensure sample integrity; Intellicheck software; and TriFlex technology to automate dilution, repeat and reflex testing.
bioMérieux will have new coagulation instruments, amino assay systems and microbiology and probe technologies on display at AACC.
Dade Behring will showcase a host of new products at AACC.
The Syva Emittox Salicylic Acid Assay is a convenient, ready-to-use, liquid assay for the quantitative analyses of salicylic acid in human serum or plasma. Sensitivity of this assay is 1.5 mg/dL with a range of 1.5-80 mg/ dL. The assay’s monoclonal antibody provides maximum specificity.
N Latex Lp(a) is an in vitro diagnostic reagent for the quantitative determination of lipoprotein(a) in human serum and heparinized plasma by means of particle enhanced immunophelometry. The N Latex Lp(a) assay can be run on Dade Behring’s BN II, BN100 and BN ProSpec systems.
Dade Behring’s new LabPro Alert system adapts to the unique organism population of each testing facility. Easy to configure, customized rules detect alert conditions based not only on organism identification and susceptibility patterns, but location, client, physician, source and biochemical profiles. Rules are specific and relevant. And unlike other expert systems, LabPro Alert can monitor individual patients for changes in therapeutic response or as carriers of resistant organisms.
Another new introduction is ESßL plus, a new panel to enable microbiology laboratories to definitively confirm the presence of Extended Spectrum Beta-lactamase (ESßL) enzymes that have been detected by screening methods.
The Sysmex CA-7000 Analyzer is the newest addition to the family of coagulation analyzers offered by Dade Behring. It is a fully automated analyzer with high performance capability for use in large-scale laboratories. The Sysmex CA-7000 Analyzer measures 550 results/ hour when testing PT and aPTT simultaneously. The cap-piercing option reduces pre-analytical processing time. The Sysmex CA-7000 Analyzer provides the latest technology in clotting, chromogenic and immunologic methodologies utilizing complete random access capabilities. (pending FDA 510 clearance/not available for sale in the U.S.)
Beckman Coulter will showcase a broad variety of products at AACC.
Premiering at this year’s AACC annual meeting, the Synchron LXi 725 Clinical System helps laboratories decrease preanalytical process steps, improve turnaround time and increase safety. The system allows laboratories to access high-performance ISE, spectrophotometry and near-infrared particle immunoassay (NIPIA) detection systems, as well as chemiluminescence for state-of-the-art immunoassay testing. The system also features automation to simplify sample handling and data management for enhanced workflow and results management.
The LXi is a consolidated system incorporating closed-tube aliquotting (CTA) and closed-tube sampling (CTS) technology. Closed-tube sampling (CTS) technology helps laboratories increase productivity and lower overall costs by reducing sample processing time. This CTS capability also helps improve workplace safety by reducing operators’ exposure to biohazards and repetitive motion injuries. The test menu for the LXi includes approximately 150 assays, including basic critical care, drugs of abuse, therapeutic drug monitoring, cancer, cardiac, fertility, thyroid tests and more. The system accommodates 65 analytes onboard at once, including 24 immunoassay and 41 chemistry.
Synchron LX20 Pro Clinical System is an advanced chemistry analyser that also uses closed-tube sampling (CTS) technology, and an NPIA detection system which operates at 940 nm. Currently, the Synchron LX20 Pro test menu includes more than 100 reagents comprised of general chemistries, critical care chemistries, proteins, serologies and esoteric chemistries as well as therapeutic drug monitoring (TDM) and drugs-of-abuse testing (DAT) reagents. The Synchron LX20 Pro boasts 1,440 tests per hour and can analyze 11 chemistries – albumin, BUN, calcium ISE, carbon dioxide, chloride, creatinine, glucose, phosphorus, potassium, sodium and total protein – in just 42 seconds. Other features include continuous auto-loading, closed-tube obstruction detection/correction, automatic critical sample rerun and default panel testing so that users can program specific test parameters.
The Power Processor Preanalytical Automation System is a robotic workstation that automates many labor-intensive tasks involving sample preparation and analysis. The Power Processor automatically performs sample log-in, bar-code reading, centrifugation, cap removal, serum level measurement and sample sorting into sample tube racks.
Diagnostics Products Corporation
DPC will showcase the Immulite family of systems at AACC. The new Immulite 1000 Automated Immunoassay System provides enhanced ease of use and more productivity. Its features include Windows 2000 software, a touch screen user interface, a consolidated instrument footprint, remote diagnostics, on-board dilutions for selected assays and positive secondary sample identification. The Immulite 1000 will launch with the same menu and reagents available on the Immulite platform. The menu of almost 100 assays includes routine tests such as those for thyroid function, reproductive endocrinology, cardiac status and tumor markers, as well as esoteric tests such as those for infectious disease, diabetes and bone metabolism.
The company will also launch Questra Smart Service Solution device relationship management software. The software will be integrated into the Immunolite family of instrument systems to reduce operator intervention and increase system availability. The new capability, called DPC Realtime Service, is a management solution for consumables, people and equipment. It reduces the need for reactive visits by field service technicians to repair and replenish instruments in hospital and reference laboratories by sending a stream of operational updates and system condition alerts from the instrument directly to the service organization for analysis and action. DPC Realtime Service can automatically notify the service organization when a critical situation occurs, sending an alert through wireless-enabled PDAs or cell phones.
Philips Medical Systems
Philips will showcase its Blood Analysis Portal, a significant, new component of the Philips multi-parameter patient monitoring system, which includes physiologic and biochemical measurements. It is designed for use with the Philips CMS and V24/V26 monitors in adult, pediatric and neonatal intensive care, operating room and post-anesthesia and emergency care settings. The Blood Analysis Portal analyzes blood by the patient’s side in approximately 90 seconds, using as little as 125uL of sample. It delivers results for blood gases, electrolytes, chemistries, hematocrit and other calculated parameters. The Blood Analysis Portal uses disposable cartridges that contain the same technology as large, laboratory benchtop equipment, only in miniature. It uses IRMA cartridges (BG, CC, H4, and H3), which are manufactured by Diametrics Medical, Inc. The Blood Analysis Portal is integrated with the LIS through the Integrated Data Management System (IDMS). This technology now fully integrates both physiologic measurements (heart rate, EKG, etc.) with biochemical measurements. Immediacy of diagnostics test information is essential for precise titration and, ultimately, for improved therapy in adult, pediatric and neonatal intensive care; operating theater and post-anesthesia; and emergency settings – environments where patient care commands immediate turnaround of blood test results for clinical decision making. With the Blood Analysis Portal, neither the sample nor the caregiver leaves the patient’s side.
LifeScan will unveil a major connectivity update for its institutional product line, SureStep Flexx and SureStep Pro POC glucose testing for hospitals. These products incorporate the DataLink Data Management System for the transmission and management of glucose data between the point of care and the laboratory/health information system (LIS or HIS). LifeScan has expanded its menu of LIS vendors through further strategic partnerships with Telcor, Inc., makers of the vendor neutral QML Quick-Multi-Linc data management system, and Medical Automation Systems, makers of the RALS Plus vendor neutral system. Both of these open systems can link diagnostic instruments from a variety of vendors, enabling customers to use LifeScan blood glucose products with chosen diagnostic devices throughout the institution.
Booths 2418 and 2419
Greiner bio-one Vacuette plans to highlight its Vacuette Safety Blood Collection Set, a single-use, sterile, winged blood collection safety needle bonded to flexible “low memory” tubing that prevents coiling and facilitates disposal. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to prevent accidental needle stick injury. The blood collection set complements Greiner’s line of virtually unbreakable plastic blood collection tubes.
Several new plastic tubes will also be shown. The Greiner Sodium Heparin Vacuette plasma tube is coated with 14 IU of heparin per 1 ml of blood to inhibit clotting. A Non-additive Serum Tube is designed to collect serum for use in antibody testing or test procedures where clot activators or anticoagulants may interfere with test results. It can also be used as a cost effective discard tube.
Two new EDTA tubes contain a readily soluble dry powder coating with a concentration of 1.8 mg EDTA per 1 ml of blood that binds calcium ions and blocks the coagulation cascade. The K3 EDTA tube matches the standardization of many lab analyzers, so there is no need to recalibrate before running tests. Greiner also provides a K3 EDTA blood bank tube with a 6ml collection size that can be used to perform crossmatch tests with whole blood. For low volume collection, Greiner provides K3 EDTA as part of the Minicollect Capillary Collection System. Another in the EDTA series, the K3 EDTA Gel Tube, is designed for use in molecular diagnostic test methods such as PCR, or other nucleic acid test procedures where an undiluted plasma specimen is required. The gel in this whole blood collection tube forms a stable barrier between the plasma and the cellular components, allowing for transportation of the tube without removal of the plasma. The closed evacuated system substantially reduces the possibility of exposure to bloodborne pathogens such as HIV and HCV at collection and sample processing sites.
Instrumentation Laboratories will be showing a new cartridge for the Gem Premier 3000 multi-use cartridge testing analyzer. The new cartridge, which is pending FDA clearance, incorporates a quality control program in the cartridge. This intelligent quality management saves labor by eliminating external quality control. The new cartridge features ongoing quality control, identifies different electronic signal patterns, incorporates automatic corrective action and automatically documents problems.
Triple G Systems Group, Inc.
Triple G plans to showcase Ultra 3.2, its new laboratory information systems product, at AACC. Designed for high volume distributed laboratory operations, Ultra 3.2 facilitates management and automation of the clinical lab including identification, tracking and routing of specimens. Ultra 3.2 also manages workflows and aggregates test results across sites and across platforms.
Nikon Instruments will be featuring its Eclipse E400, a standard laboratory microscope with an ideal combination of ergonomics and optical imagery for use as a clinical microscope. In-line focus and stage controls are ergonomically positioned to allow a natural sitting posture for comfort and convenience over long periods of use. An ergonomically designed binocular tube allows for adjustment of eyepiece angle and length to suit a wide range of individual operators. A comfortable, compact, solid and stable body design allows for less operator fatigue during long periods of observation. The low-profile stage height is approximately 20mm lower than conventional models facilitating smooth nosepiece rotation and ease of specimen handling for quicker, more efficient, and strain-free operation. Excellent optical performance allows for brilliant, sharp images in all magnifications, high resolution and contrast, chromatic aberration free correction (CF) and top transmission rates. The E400 also allows for multiple observation techniques such as brightfield, darkfield, epi-fluorescence and phase contrast. The Nikon Eclipse E400 was designed to fit the user rather than forcing the user to fit the microscope.
Wampole’s Athena Multi-Lyte
Booths 1221 and 1222
Wampole will showcase the Athena Multi-Lyte ANA test system. The new system is a multiplexed, homogeneous, fluorescent-based microparticle immunoassay designed to detect and distinguish autoantibodies present in the human serum in one brief, simple assay. The serological assay is composed of a bench-top flow analyzer and differentially dyed and distinguishable microspheres, which serve as the solid phase for the immunoassay. Each set of distinct microspheres has a unique autoantigen covalently bound to its surface. The instrument can detect, distinguish and identify discrete microspeheres, enabling a multitude of immunoassays to be done simultaneously on a serum sample in a single microwell. The Athena Multi-Lyte system offers laboratories a simple and streamlined alterative to subjective IFA and labor-intensive ELISA. A patient specimen can be analyzed for all significant ANA markers simultaneously. It saves labor and eliminates the need to split samples and purchase and inventory 10 different immunoassays.
C.C.I./ Custom Comfort, Inc.
Custom Comfort will launch a new height adjustable chair at AACC. The reclining phlebotomy chair is fully adjustable and features padded armrests. The chair can be easily adjusted to an ergonomic working height for technicians.
The company will also have two different styles of reclining phlebotomy chairs on display. The chairs are available in standard and taller seat heights and standard and wider width and offer three positions—upright, recline and full recline.
Custom Comfort will also showcase an adjustable height infant phlebotomy station (3091AH). Mounted on an ergonomic base, the fully upholstered chair has padded arm extension where an infant’s arm can be secured. An attached side tray provides a convenient space for storing supplies.
Diamedix recently acquired Sigma and will be featuring its new syphilis test at AACC.
National Laboratory Training Network
The National Laboratory Training Network (NLTN) is a training system sponsored by the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC). Dedicated to quality laboratory practice through continuing education, the NLTN works with state and federal agencies, public health laboratories, universities, professional organizations and business and industry to sponsor high quality, low cost continuing education opportunities for testing personnel in medical, public health and environmental laboratories throughout the United States and its territories. NLTN programs address emerging infectious diseases, quality assurance, safety and testing regulations. The new NLTN Lending Library Index lists over nine hundred training and educational materials available for loan, free of charge, to laboratory scientists. NLTN offers on-site wet workshops and didactic seminars as well as continuing education in a variety of delivery formats including computer-assisted instruction, facilitated distance learning modules, and an online interactive seminar, truly providing continuing education at the customers’ convenience.
Carl Zeiss MicroImaging
Carl Zeiss will showcase two new microscopes at AACC—the Axiostar plus and Axioskop 40.
The Axiostar plus is a further development of the Axiostar entry-level microscope. The upright Axiostar plus features a fluorescence module for reflected light illumination, and a filter slider permits up to three fluorescence cubes to be used simultaneously. Fluorescence excitation is provided by HBO 50 mercury. The Axiostar plus has an ergonomic base plate that permits the separate setting of four different viewing angles and four different viewing heights. Other user-friendly features are tubes with a 30º viewing angle and the extended and variably adjustable stage drive with soft-touch controls. LED illumination provides brilliant images while the color temperature remains stable.
The Axioskop 40 and Axioskop 40 FL combine the optical and mechanical stability of the research class with the requirements of routine applications. All of the major contrasting techniques are available on the Axioskop 40 and Axioskop 40 FL. The 23-mm field-of-view, optimized halogen illumination with a lamp life of more than 4,000 hours, and the fluorescence version’s 5-position reflector wheel for push and click modules, the constant viewing angle of 20º and the possibility of continuous vertical adjustment by up to 50 mm are focused on customer requirements. The flat front cap of the transmitted-light version ensures optimum specimen viewing from above.
American Bio Medica Corporation
American Bio Medica Corporation will show Rapid One Oxy, an on-site point of care assay capable of detecting oxycodone, and Rapid One Ecstasy, a one-step immunoassay capable of detecting MDMA use at concentration levels of 1000 ng/mL in urine.
American Bio Medica will also show its on-site saliva-based test for drugs of abuse Rapid Drug Screen OralStat-6. The product can simultaneously test for six drug categories: THC, opiates, cocaine, PCP, amphetamine and methamphetamine. Utilizing a simple saliva sample, it delivers easy-to-read positive or negative results within 10-15 minutes.
American bio Medica’s Ecstasy test strip
Helena Laboratories will highlight its Actalyke XL for heparin monitoring at AACC. The advantages of the new Actalyke XL Activated Clotting Time Analyzer from Helena Point of Care include greater accuracy and reproducibility, strong data handling features and wireless interface. The Actalyke XL offers many advanced features: dual test wells, dual clot detection, powerful data management features, QC functions with lockout option, demographic storage, data storage on disk, touch screen interface, battery back-up for portability, wireless radio frequency networking and NCCLS-POCT 1-A compliance. The XL is fully compatible with all ACT tubes.
Helena Laboratories will also show a new Split-Beta Serum Protein Assay. This new assay takes full advantage of the automated sample application, separation and staining of the SPIFE desktop electrophoresis system. While some laboratorians prefer classic five-banded serum protein separations, others prefer a split-beta separation. With SPIFE Split-Beta gels, the proteins migrating in the beta region are split into two fractions, b1 and b2, between transfer and C3 complement. In some instances, this may allow easier detection of beta-migrating monoclonal gammopathies. Both the classic and split-beta formulations provide crisp, clear separation of the protein fractions.
Booths 2529 and 2629
Polymedco’s booth will feature the Poly-Chem System automated chemistry immunoassay analyzer. Poly-Chem is an automated chemistry immunoassay countertop analyzer with the features of a floor model analyzer. The Poly-Chem System has an extensive test menu including Chemistries, Cardiac Risk Markers, Immunoglobulins, Rheumatoid/Acute Phase Proteins, Diabetes Control, Nutritional Analysis, Complements, Iron Transport/Storage, TDM’s and ISE’s. All reagents have a shelf life of 12-18 months from date of manufacture. Both reagents and patient samples are bar coded with auto rerun capabilities. The instrument accommodates 40 reagents on-board without sacrificing throughput: 450 tests per hour, 180 photometric in any combination, and 270 ISE (Sodium, Potassium, and Chloride). The Poly-Chem System is easy to program and easy to run. It is a random access analyzer with continuous loading and testing. Poly-Chem has wavelengths, which include 340, 415, 450, 510, 570, 600, 700, and 800 making it very flexible. Reagent and sample are pipetted, using positive displacement syringes, into the cuvette and analyzed. The first result is available in 10 minutes with test results every 27 seconds thereafter. Poly-Chem uses Pyrex glass cuvettes, which last up to 50,000 cycles. Additional features of the Poly-Chem System include: auto start-up and shut-down, auto maintenance, calibration tracking, reagent tracking and positive patient identification.
Helena’s Actalyke Mini
Wako will emphasize its homogeneous HDL and LDL cholesterol assays at AACC. The company has sold its HDL-C and LDL-C assays through other companies in the U.S., but recently launched these assays directly from Wako Diagnostics to the end user. While OEM possibilities remain, the laboratories have the benefits of purchasing from a direct manufacturer of the homogeneous HDL and LDL assays, including custom packaging for the lab needs.
Wako Diagnostics will also highlight a new lipase assay. The new Wako Lipase assay is liquid, ready-to-use reagent, which has significantly improved specificity for pancreatic lipase. Many other assays experience significant interference from lipoprotein lipase, which is not released from the pancreas making these assays not pancreatic specific.
Wako will introduce a new hybrid analyzer. The new Automated Immunological LiBASys Analyzer utilizes liquid phase binding assay methodology. (The instrument is not yet cleared for clinical use in the U.S. by the FDA). It is used in conjunction with Wako’s AFP and AFPL3% assays. These assays are currently under clinical investigation as a promising marker for early recognition, diagnosis and prognosis of hepatocellular carcinoma (HCC), which is commonly referred to as liver cancer.
Third Wave Technologies
Third Wave Technologies will spotlight its most recent introduction at AACC—Invader DNA analyte-specific reagents (ASRs) for clinical use for the following analytes: Hexosaminidase A (Tay-Sachs, 1278insTATC), Hexosaminidase A (Tay-Sachs, IVS12+1) and Hexosaminidase A (Tay-Sachs, G269S). Tay-Sachs disease is a fatal genetic disorder in children that causes progressive destruction of the central nervous system.
Invader DNA analyte-specific reagents for Connexion 26 (35delG) and Connexion 26 (167delT) will also be available. In developed countries, at least 60 percent of the deafness cases are inherited. A high proportion of cases of non-syndromic autosomal recessive deafness (DFNB) involve the GJB2 gene, which encodes the gap junction protein connexin 26. The majority of GJB2 mutations are the 35delG and 167delT mutations.
The company will also feature Invader DNA analyte-specific reagents (ASRs) for clinical use in cardiovascular risk assessment: ApoE (C112R), ApoE (R158C), GPIIIa (PLA1/A2), GPIa (C807T). These feature Third Wave’s biplex format, which allows for the simultaneous detection of all variations for each single nucleotide polymorphism (SNP). For example, the presence of the three possible genotypes for the GPla C807T polymorphism – CC, CT or TT – can be determined in a single well.
Third Wave will also show Invader reagents for the plasminogen activator inhibitor-1 (PAI-1 (-675, 4G/5G)) mutation. CLIA-approved high complexity laboratories can use these reagents to develop their own Invader PAI-1(-675, 4G/5G) assays. This ASR also uses the biplex format, which in this case allows for the simultaneous detection of all single-base insertions or deletions, as in the case of the PAI-1 4G/5G deletion. For example, the presence of the three possible genotypes for the PAI-1 4G/5G deletion—4G/4G, 4G/5G or 5G/5G—can be determined in a single well. The plasminogen activator inhibitor-1 (PAI-1) gene plays a critical role in blood clotting. The PAI-1 4G genotype has been associated with both increased risks of deep-vein thrombosis — blood-clotting in the veins lying deep in the legs — and stroke, and coronary artery disease and heart attack. ASRs for Factor V (Leiden), Factor II (Prothrombin), MTHFR (A1298C) and MTHFR (C677T) mutations, which have been associated with increased risk of deep-vein thrombosis (DVT), will also be shown.