A look at some of the exhibitors participating in the AACC 2006 Clinical Lab Exposition, July 25–27, in Chicago. | Sponsored section
Accumetrics (Booth #2173) Accumetrics develops, manufactures, and markets the VerifyNow® System, a comprehensive system for the assessment of platelet function. Modulation of platelet function plays a critical role in effectively treating cardiovascular, cerebrovascular, and peripheral vascular disease. VerifyNow is the only rapid platelet-function test shown to correlate with clinical outcomes. The tests provide physicians with an easy-to-use, automated, rapid, and accurate way to monitor platelet function to potentially optimize the effectiveness of antiplatelet therapies and to aid in guiding treatment decisions in patients who may be at risk of bleeding complications. Accumetrics markets VerifyNow tests for aspirin, Plavix®, and GP IIb/IIIa inhibitors. The applications for these assays include measuring platelet inhibition prior to and after surgery to aid in managing bleeding and reducing blood-product use, pre and post an interventional procedure, and measuring platelet function of patients on chronic antiplatelet therapy.
Ahlstrom Windsor Locks LLC (Booth #2744) As a global leader in the design, development, and manufacture of innovative filtration media, Ahlstrom provides the life sciences industry with analytical filter papers, glass microfibers, filters, prefilters, fluid barriers, extraction thimbles, germination testing papers, specialty testing papers, and more. Ahlstrom produces high-purity substrates with consistent quality for lateral flow, dipstick, and flow-through-type components for high-performance diagnostic media. They support a range of industries with innovative media designed for maximum absorbency and blotting characteristics for almost any liquid.
Ahlstrom supplies the global diagnostic industry with CytoSep®, a single layer of high-purity natural and synthetic fibers with no chemical interfering substances, no significant binding of plasma components, and no visible hemolysis. Stronger than binder-free glass with a high-loading capacity, CytopSep is used for automated assembly processes and the rapid separation of plasma for small-volume whole-blood samples. CytopSep retains red blood cells while allowing serum to flow, making it ideal for IVD and rapid test applications. New rapid diagnostic tests can be as accurate as the corresponding laboratory tests costing up to 20 times more to execute. The goal of Ahlstrom’s CytoSep is to enable further development of testing for detection of a greater range of diseases and human conditions.
The American Academy of Family Physicians (Booth #240) The American Academy of Family Physicians presents The POL Microscopy Atlas, a benchtop reference manual for provider-performed microscopic examinations. The atlas includes more than 145 photographs of cellular elements, including urine sediments, vaginal wet preps, skin preps, nasal smears, stools for fecal leukocytes, stools for pinworms, and peripheral blood smears. Each photo has a matching description and clinical associations. The atlas also contains procedures for urine sediment and vaginal wet prep examinations and for peripheral blood smears, as well as the applicable CLIA regulations. Useful for training and continuing education, the atlas is approved for 8 prescribed hours of CME for physicians and 8 contact hours for lab personnel.
Antek HealthWare LLC (Booth #209) Antek HealthWare introduces the LabDAQplus Laboratory Information System, the newest addition to the spectrum of LabDAQ solutions. Antek has installed more than 1,800 LabDAQ systems over the past 15 years in hospitals, clinics, physicians’ office laboratories, and other facilities. Antek evaluates the needs of the clinical laboratory market to develop appropriate new product features, new options, and new products. LabDAQplus is designed to meet the needs of hospitals, clinics, and larger testing facilities. Innovation, continued product improvement, ease of use, and workflow management are all hallmarks of LabDAQplus. The system is easy to navigate, flexible in design, and dynamic in use. Some of the features of LabDAQplus are insurance filtering, medical-necessity software and database, a microbiology module, a dynamic management-review module, standing orders, distribution of results via e-mail, and Web-based ordering and results. LabDAQplus also provides exclusive new management tools, including network monitoring, scheduling, and real-time workflow analysis. HL7 interfaces with other software systems within the health care environment, such as electronic medical records, practice-management systems, and hospital information systems. Bidirectional interfaces to regional and national reference labs are also available for LabDAQplus. Antek continually interfaces to new systems and reference labs. As with all LabDAQ products, Antek’s Technical Support Department is staffed with laboratory professionals, computer specialists, and network engineers to provide a superior level of service to all LabDAQ clients.
ARUP Labs (Booth #1272) ARUP Labs’ ATOP project is a laboratory-utilization review service ARUP provides to clients who have sufficient data available to analyze. The ATOP project analyzes 12 months of an institution’s ordering data, which is pulled from ARUP’s database. These data are then compared with a set of “known issues,” which have been encountered with other clients in the past. Its Utilization Review Committee then reviews tests comprising 80% of expenses to identify other potential opportunities for improvement. By sharing both its medical knowledge and technical capabilities, its ATOP project provides ARUP’s clients with a powerful tool to strengthen their abilities to provide improved local and regional laboratory services by assisting clinicians in appropriately using reference laboratory testing; using measured, proven statistics to improve test ordering and management of esoteric laboratory resources; and promoting medically appropriate, cost-efficient use of laboratory testing, resulting in cost savings for clients and ultimately improving patient care. To learn more about ARUP Laboratories’ ATOP project, please visit CLP’s Expert Insight Web page, located at www.clpmag.com, and click on Brian Jackson’s Expert Insight advice.
ARTEL (Booth #745) Quick and accurate pipette identification is essential for efficient and accurate calibration of pipettes. Artel’s new PCS® Pipette Calibration System and Pipette Tracker software include bar code scanning, automated calibration label printing, and enhanced calibration reporting to make pipette calibration more robust and compliant. The new package includes a bar code scanner, a label printer, and enhanced software. Customers can scan a bar code label on a pipette to quickly and accurately identify the pipette. Technicians can also have a bar code that will identify them and track their individual proficiency checks or calibrations. This enhances productivity and proficiency, and gives managers a simple method to track technician skills. Using the printer, users can create bar code labels for identifying pipettes, as well as calibration labels completed with all calibration data preprinted. This will ensure fast and easy calibration cycles. The new reporting feature enables users to identify the best pipette for a given volume, to trend pipette-calibration data over time, and to compare As Found and As Left pipette-calibration data on one report. The new functionality comes as an add-on module that can be added to both Pipette Tracker Standard and Pipette Tracker Pro. Join us for a demonstration at AACC and to play in our Pipetting Olympics. Individual and team medals and prizes will be provided.
AUDIT MicroControls Inc (Booth #2445) AUDIT MicroControls specializes in Calibration Verification/Linearity material and unique, as well as general chemistry, quality-control products. AUDIT now offers the laboratory MicroCV™, the most complete line of Calibration Verification material designed to meet CLIA requirements. Accessible via the Internet, the AUDITOR™ QC Program assists the laboratory with the reduction of calibration-verification data. One simply enters the raw data, and AUDITOR instantly provides an online graph that can be easily printed and stored. Recent changes allow the user to compare his or her results with those users with the same instrument, using the same lot of calibration-verification material.
bioMérieux Inc (Booth #1867) The NucliSens® easyMAG™ system from bioMérieux offers automated nucleic acid isolation from clinical samples. The fully automated easyMAG system is ideal for any size molecular biology laboratory, delivering lab technicians recovery of pure, high-quality DNA and RNA. A hallmark of this next-generation system is that it requires very few disposables. Compared to other systems, this means far less setup time and a seamless workflow. In addition, lysis, wash, and elution buffers are continuously monitored and stay on board the system for multiple runs. Manual steps are limited to loading samples, reagents, and disposables, thereby improving workflow and saving valuable time. A user-friendly touch-screen interface simplifies sample, reagent, and disposable management, and guides the operator through each run. The software provides complete traceability, from the patient sample to the final result, plus data-storage capabilities. In addition, the high-throughput system can handle up to 24 samples per run, and results are available in less than 1 hour. bioMérieux was recently awarded the 2006 Technology Innovation of the Year award by Frost & Sullivan in the field of in vitro diagnostics for development of the easyMAG system.
Bio-Rad Laboratories Inc (Booth #939) Unity Real Time™ is an expert quality-control data-management solution that facilitates regulatory compliance under CLIA and ISO 15189. The system provides high-quality run validation with comprehensive audit trails, facilitates bench technologist and supervisory QC data review, offers advanced data analysis charts and reports, and monitors ongoing performance of QC rules with Analytical Goal options. Users may participate in the Unity™ Interlaboratory Program to compare their results against the industry’s largest, most reliable peer groups. Unity Real Time can also be used with Westgard Advisor™ to automatically recommend and implement optimal QC rules for each test.
Centerchem Inc (Booth #2229) Pefakit® APC-R Factor V Leiden is a functional coagulation assay for activated protein C resistance that provides complete and distinct discrimination between the heterozygous, homozygous, and normal phenotypes caused by the Factor V Leiden mutation (FV:Q506). In contrast to other available methods, Pefakit APC-R Factor V Leiden shows no interference from factors upstream in the coagulation cascade, no interference from protein C or S, Lupus anticoagulants, elevated FVIII levels, heparins, or prothrombin G20210A. Pefakit APC-R FVL will create significant cost and time savings in the lab due to its accurate and reproducible determinations, all in an easy-to-use kit that is adaptable to semiautomated or automated coagulation analyzers. Validated methods for most coagulation analyzers are available upon request.
Chembio Diagnostic Systems Inc (Booth #343) Chembio Diagnostic Systems Inc has developed Dual Path Platform (DPP*) technology that offers significant advantages over commercially available, conventional lateral flow (LF) tests. DPP has at least a 10X increase in both analytical and clinical sensitivity over current LF assays. A digital reader has been developed for quantitative reading of DPP results. Dual-migration paths enable DPP to decrease the required time to complete the test relative to conventional LF assays. DPP offers the ability to test a wide variety of solid and liquid samples, including but not limited to blood, serum, urine, oral fluid, feces, and sputum. An added advantage of DPP is the ability to simultaneously test multiple analytes with the same degree of sensitivity without compromising specificity. DPP provides all the advantages of POC LF testing: RT storage, ready-to-use reagents, minimal sample volumes, prolonged shelf life, and an internal control. Chembio is developing new assays using DPP and is actively pursuing licensing agreements with several interested companies. Chembio currently develops and manufactures rapid serological tests for infectious diseases, including HIV/AIDS, tuberculosis (human and veterinary), Chagas, and other neglected diseases. The company’s current LF tests require no special equipment or cold chain storage. A minimum sample volume (finger-stick whole blood, serum, or plasma) is required, and test results are provided in less than 15 minutes. Chembio recently received approval from the FDA for its SURE CHECK® HIV 1/2 STAT-PAK™ and HIV 1/2 STAT-PAK™ rapid tests.
Diagnostic Chemicals Limited (Booth #1848) Diagnostic Chemicals Limited (DCL) has added a new, fully liquid-stable, wide range C-reactive protein (CRP) assay to its already broad offering of clinical diagnostic products and services. The availability of DCL’s Wide Range CRP assay will benefit physicians, medical laboratory professionals, and clinical researchers alike. Using a highly sensitive immunoturbidimetric method, this two-part reagent system quantitatively and accurately determines concentrations of CRP in serum over a wide range of clinically significant concentrations. DCL’s Wide Range CRP reagent incorporates a highly purified monoclonal murine antihuman CRP antibody bound to latex beads, which provides an extended reportable range from 0.01 to 36.0 mg/dL without compromise to low-end sensitivity, or precision. DCL’s Wide Range CRP assay demonstrates no significant interference effects from lipemia, hemolysis, and ascorbic acid; and maintains long-term, reliable performance characteristics. A variety of kit-packaging configurations is available, making it well suited for use in hospital, reference, and physician’s office laboratories, regardless of workflow demands. DCL’s Wide Range CRP is optimized for use with fully automated testing systems, and a comprehensive listing of instrument applications is readily available for a number of chemistry analyzers. Additional calibration materials are also available to fully support the assay.
The Drucker Co (Booth #101) The Horizon Model 842VES, Plasmafuge-6, is the most compact of Drucker’s Performance Series centrifuges. The 842VES offers control over almost every aspect of the unit’s operation, from variable acceleration and deceleration to easy time and speed input. High speed and force capability produce platelet-poor/free plasma and greatly reduce processing times. The exclusive Drucker horizontal rotor allows for quick and easy sample loading and complete horizontal separation. The user can save settings in one of 10 memory locations and recall them at the touch of a button.
Fujirebio Diagnostics Inc (Booth #1959) Fujirebio Inc, the parent company of Fujirebio Diagnostics Inc, is the developer of the particle agglutination T. pallidum assay, SERODIA®TP•PA, which offers a convenient, sensitive, and specific gelatin particle-agglutination test for the detection of antibodies to Treponema pallidum. The SERODIATP•PA assay requires no special instruments, conjugate procedures, or equipment for the preparation and running of tests. SERODIATP•PA can be used with serum or plasma (EDTA, heparin, or sodium citrate) with equally reliable results. It is easy to read and has clear cutoff values. SERODIATP•PA is distributed in the United States by Fujirebio Diagnostics Inc.
HORIBA ABX Diagnostics (Booth #863) HORIBA ABX Diagnostics has announced the availability of its new Pentra 400 Benchtop Clinical Chemistry System with workflow optimization in mind. This innovative design reintroduces the benchtop, small-footprint concept targeted for low- to moderate-volume laboratories and as a backup alternative for high-volume esoteric testing. The Pentra 400 delivers simplified QC and patient data management with touch-screen capability. Quality results are produced from precision analysis of up to 420 tests per hour, using a well-designed combination of 52 onboard reagent positions. The Pentra 400 incorporates optical holographic grating technology that yields the highest quality of measurement—delivering BMP panels in less than 7.5 minutes. This flexible analyzer delivers continuous loading capabilities, automatic sample dilution, and rules-based results validation—all engineered to simplify the sampling process and enhance lab productivity. Recognized in more than 140 countries across five continents, HORIBA ABX joins efforts with 38 companies of varying strengths in developing semiconductor, analytical, and measurement systems to demonstrate its perpetual strive for excellence. IVD Technology has listed HORIBA ABX as the fifth highest-growth IVD manufacturer with average revenue increases exceeding 50%.
Iris Sample Processing Inc (Booth #165) The need for faster turnaround times and greater throughput can now be met with the new StatSpin Express 3 primary tube centrifuge. The fixed-angle rotor holds as many as eight blood tubes from 1.5 mL to 10.0 mL. The Express 3 can be placed next to any laboratory analyzer for stat chemistry, cardiac, or coagulation testing. Plasma or serum is obtained in as little as 2 minutes. The system is simple to use, and the small footprint frees up bench space so it can be used at the workstation. Tube inserts are available to accommodate a wide range of tube sizes. The powerful brushless motor is maintenance-free and is backed with a 2-year warranty.
Kronus Inc (Booth #2371) Following an extensive clinical study, Kronus has received 510(k) clearance from the US Food & Drug Administration for its glutamic acid decarboxylase (GAD) autoantibody test kit. The immunoassay test kit is for the semiquantitative determination of glutamic acid decarboxylase antibody in human serum. Measurement of antibodies to GAD is useful as an aid in the diagnosis and management of immune-mediated diabetes.
Luminex Corp (Booth #2412) Luminex has introduced the Luminex® 200™ System, the latest advancement in its line of microsphere-based multiplexing detection instruments based on the company’s proprietary xMAP® technology. The Luminex 200 is designed to meet the multiplexed testing needs of the clinical and research laboratory professional. Features include tool-free probe adjustment; precision-machined alignment plate to the XY platform; and a quieter, more reliable air compressor. In addition, the Luminex 200 is designed around the same xMAP technology as the Luminex 100. This enables customers who upgrade to this system to continue to use applications validated on earlier Luminex systems. Luminex Corp develops proprietary biological-testing technologies with applications throughout the life sciences and diagnostics industries. The company’s xMAP system is an open-architecture, multianalyte technology platform that delivers fast, accurate, and cost-efficient bioassay results. The Luminex 200 System has a device master file (DMF) on file at the US Food and Drug Administration (FDA), and kits developed by Luminex strategic partners that have received 510(k) clearance from the FDA can be used on the Luminex 200 system for diagnostic purposes.
Orchard Software (Booth #2203) Nearly 600 laboratories across the country have turned to Orchard Software for their laboratory information systems—including all types and sizes of multisite and multispecialty clinics and physician’s office laboratories, hospitals, regional reference labs, student health services, and public health organizations. Orchard’s award-winning Harvest™ LIS uses process automation; robust instrument, billing, HIS, EMR, and reference lab interfaces; and rules-based technology to address regulatory and integration issues and simplify laboratory workflow. Orchard Harvest LIS improves reimbursements and simplifies the time-consuming task of medical-necessity validation by automatically screening ICD-9 codes, testing frequency, and experimental procedures during order entry. As an HL7 organization member and stand-alone lab system, Orchard specializes in seamless integration, which makes host system, EMR, billing, and reference lab interfaces routine, and linking multiple sites possible. Orchard’s Microbiology and Anatomic Pathology Modules eliminate paper and electronically integrate these departments with the rest of the laboratory. For remote order entry and results delivery via the Internet, Orchard offers Webstation™.
Ortho-Clinical Diagnostics (Booth #827) The VITROS® 5,1 FS chemistry system offers design advantages in addition to menu expansion. The system features Ortho-Clinical Diagnostics’ proven MicroSlide™ Technology for the highest reportable result efficiency, and Intellicheck® Technology for system monitoring, advanced clot and bubble-detection management, and intelligent error reduction. MicroSensor™ Technology provides rapid (0.75-second), reagentless sample quality/indices assessment and flags only the impacted tests, which saves time and minimizes the opportunity for reporting of erroneous results. VITROS MicroTip Technology features disposable tips and cuvettes, which eliminate the maintenance, the cost, and, most important, the risk of sample and reagent carryover and cross contamination associated with traditional chemistry systems.
Quantimetrix Corp (Booth #2227) Quantimetrix Corp develops and manufactures innovative clinical diagnostic products for domestic and international distribution, including Lipoprint, the only FDA-cleared test intended to measure cholesterol levels in all lipoprotein fractions and subfractions. The Lipoprint system is a high-resolution diagnostic test for cholesterol components that are not routinely tested by other methods. The predominance of small, dense, low-density lipoprotein (LDL) particles is associated with a threefold increase of cardiovascular-disease risk, even at normal concentrations of LDL cholesterol. The Lipoprint test provides detailed results within the subfractions of LDL. The Lipoprint system is easy to use and can be installed at any clinical or research laboratory.
Response Biomedical (Booth #1452) Response Biomedical has developed leading-edge proprietary technology for the rapidly growing medical-point-of-care diagnostic markets. RAMP is currently used by health care professionals in hospital emergency departments, clinical laboratories, medical clinics, and physician’s offices worldwide. The company has received regulatory clearance from Health Canada and the US Food and Drug Administration to market its RAMP cardiac marker tests for detecting myoglobin, troponin I, and CK-MB to assist in the rapid diagnosis of heart attack or acute myocardial infarction. A new assay for NTproBNP is under development (under license from Roche Diagnostics) and is expected to be approved in the fourth quarter of 2006. RAMP provides a quantitative result in approximately 15 minutes, compared to several hours’ turnaround time for traditional laboratory testing. The results from independent multicenter US clinical trials of RAMP tests for troponin I and CK-MB demonstrated improved performance over the current market-leading quantitative point-of-care system.
RNA Medical (Booth #248 and #249) RNA Medical®, a division of Bionostics Inc, has introduced Safe-Wrap Combo blood collection tubes for use with i-STAT blood gas, electrolyte, and chemistry cartridges. These tubes are Mylar-wrapped glass capillary collection devices that have been treated with calcium-balanced lithium heparin. The Mylar minimizes the risks associated with broken glass capillaries by containing both the glass and the sample in the event of accidental breakage. Some regulatory agencies suggest wrapped glass capillaries as a safer alternative to plain glass. Safe-Wrap combo blood collection tubes may be used for cartridges requiring either 95 µL or 65 µL of sample. Each tube features fill lines at 95 µL and 65 µL. A porous plug is positioned at the desired fill line prior to collection. A plunger is included for dispensing the sample into the cartridge. Safe-Wrap Combo tubes are packaged in cylinders containing 50 capillaries and 50 plungers.
Scantibodies Laboratory (Booth #2436) The most commonly reported effect of heterophilic antibody assay interference is the false positive assay result. HBR in liquid or coated tube form (HBT) is a powerful, clinically proven reagent that has inactivated heterophilic antibodies for more than 10 years in plasma or serum. Compiled test data speak for themselves. HBR does the job of protecting both the lab and its patients from heterophilic interference resulting in false positive test results.
Spiral Biotech Inc (Booth #1548) The Anoxomat OP can automatically achieve anaerobic and microareobic environments in a jar, using the evacuation-replacement method of McIntosh & Fildes. Within 1 minute, the Anoxomat creates a microareobic environment, with 70% removal of the original atmosphere. An anaerobic environment is obtained in 3 minutes. Several published research studies conducted by leading experts have independently confirmed the efficiency of Anoxomat. Benefits include a built-in quality-assurance system that indicates audibly and visibly the presence of leaks, and monitors catalyst activity and gas input. In addition, the easy-to-use Anoxomat reduces cost of ownership as disposables are totally eliminated.
Wescor Inc (Booth #1456–1457) Wescor has achieved a significant advancement in sweat testing with the Nanoduct® Neonatal Sweat Analysis System. The collection and analysis technologies of Macroduct® and Sweat-Check™ have been combined and miniaturized to accommodate the tiny limbs of newborn infants. Now simple, fast, and accurate sweat testing can be performed on infants during the first days of life. The Nanoduct System is a quantum leap in CF diagnosis. Its continuous-flow sensor requires only a miniscule specimen and monitors real-time sweat electrolyte concentration with unprecedented resolution. While Nanoduct is designed for neonates, it works equally well on patients of any age.