Accumetrics

Assays to Measure Platelet Function

Accumetrics, San Diego, has developed a family of assays to measure platelet function in response to antiplatelet therapy. The VerifyNow® system simplifies platelet-function testing in the lab using a small tabletop analyzer that requires no routine maintenance. The single-use assay cartridge incorporates a tube of whole blood that requires no sample preparation or pipetting steps, thereby minimizing preanalytical error. The VerifyNow Aspirin assay is waived by the Clinical Laboratories Improvement Act and incorporates arachidonic acid to measure platelet response to aspirin therapy. Patient results are available within 5 minutes, allowing for a rapid assessment of whether the desired platelet-function state has been achieved. The P2Y12 assay, recently cleared by the US Food and Drug Administration, uses a dual-channel cartridge that incorporates ADP and iso-TRAP to report the inhibition of platelet function by clopidogrel. Assay results are available in less than 3 minutes. The rapid result reporting allows informed therapy decisions to be made immediately. The VerifyNow IIb/IIIa assay incorporates the agonist iso-TRAP to measure the effect of the GP IIb/IIIa inhibitors abciximab and eptifibatide on platelet function. Results are reported within 2 minutes. This assay’s ease of use allows it to be incorporated at either the patient’s point of care or the core laboratory. The VerifyNow System is a whole-blood, optical aggregometer that mixes the sample with fibrinogen-coated beads and the appropriate platelet-activating agonist to induce aggregation of functional platelets. Sensors detect the amount of light transmitted through the sample and report platelet activity by a proprietary algorithm. Also, both the aspirin and P2Y12 assays incorporate a whole-blood quality-control channel in every cartridge. The applications for these assays range from measuring platelet inhibition prior to and after surgery or PCI, to measuring platelet function of patients on chronic antiplatelet therapy.
(800) 643-1640; www.accumetrics.com

Antek HealthWare

Laboratory Information System

Antek HealthWare, Reisterstown, Md, is the developer of the LabDAQ laboratory information system. With more than 1,700 installations, this product remains a popular Windows®-based LIS. LabDAQ is found in virtually every clinical laboratory environment and easily meets the needs of labs in hospitals, clinics, and physicians’ offices as well as reference laboratories. It is a flexible system, with the ability to grow and change with the laboratory. It effectively manages laboratory data and resources. Key features include a comprehensive quality-control module, tools for medical-necessity compliance, a library of management and patient reports, security tools for HIPAA compliance, and connectivity to other systems (for example, electronic medical records, HIS, and practice-management systems) or reference laboratories. The system offers consolidated and cumulative patient reports, extensive quality-assurance functions, and management tools to monitor workload, review cost accounting, and allocate resources appropriately. LabDAQ enhances productivity and provides information needed to operate efficiently and profitably. LabDAQ is “Expanding the Connected Laboratory” by introducing a new option called DAQaccess. DAQaccess allows users to access it anytime, anywhere. From remote sites, it is possible to order tests and review patient test results via the Internet. It is easy to use, secure, and HIPAA compliant. Remote drawing stations can check for medical necessity, and print ABNs and specimen labels. This product is ideal for physicians who practice at multiple locations—they can access all of their patients’ results, not just the most recent result, at any time. Other options include bar-code labeling, AutoFAX, insurance filtering, e-mail distribution of results, and a microbiology module.
(800) 359-0911; www.antekhealthware.com

Bio-Rad Laboratories

Handheld drug screener

TOX/See™ from Bio-Rad Laboratories, Hercules, Calif, is a one step, hand-held, point-of-care device for the qualitative detection of 14 of the most commonly abused drugs or their metabolites in human urine. The new tests for oxycodone, buprenorphine, and propoxyphene have been added to a test menu of 11 other drugs (amphetamines, methamphetamine, MDMA (ecstasy), opiates, cocaine, PCP, THC, benzodiazepines, barbiturates, methadone and TCA). With the ability to simultaneously detect 12 drugs in 5 minutes, TOX/See™ is well suited for the needs of emergency departments. Test results are stable for reading for at least 1 hour to accommodate busy laboratory schedules. Additionally, TOX/See™ features integrated test controls, easy-to-read results, and an 18-month shelf life at room temperature. The completed test card can be photocopied and archived for health and legal records. Each TOX/See cassette is individually packaged to maximize convenience and ease of use.
(800) 224-6723; www.bio-rad.com

Bio-Rad Laboratories

Trilevel control

Liquichek D-dimer Control from Bio-Rad Laboratories, Hercules, Calif, is a trilevel control for monitoring the performance of D-dimer tests on most automated coagulation and chemistry/immunochemistry analyzers. This control includes values for the bioMérieux Vidas®, Roche Cobas Integra and Hitachi® systems, Diagnostica Stago STA® Series, Instrumentation Laboratory ACL® Series, Mitsubishi PATHFAST, Dade Behring Stratus® CS®, BCT/BCS®, and Sysmex® CA series. The control is liquid, ready to use; and each level is individually packaged in 6- x 1.0-mL configurations. This product has a 15-day open-vial stability at 2°C to 8°C and a 3-year shelf life when stored at -20°C to -70°C. Controls from a third party manufacturer provide an unbiased assessment of any testing system. They can help detect assay problems early and improve the quality of results. The Unity™ Interlaboratory Program is available through the life of the lot. You may also subscribe to one of our Unity QC data-management solutions designed to improve the effectiveness of your statistical process control.
(800) 224-6723; www.bio-rad.com/diagnostics

Bio-Rad Laboratories

Hematology controls

Effectively manage a hematology lab with quality-control solutions from Bio-Rad Laboratories, Hercules, Calif. With its hematology controls, crossovers could be reduced from every 1 to 2 months to only 4 times per year. The controls cover a wide range of instruments, including Abbott Cell-Dyn®, Beckman Coulter®, ABx and SYSMEX analyzers. Liquichek™ Hematology Control (A) for Abbott analyzers with 3- and 5-part differential technology has a 21-day open-vial stability and a 120-day shelf life at 2°C to 8°C. Bio-Rad also offers Liquichek Reticulocyte Control (A) with a 21-day open-vial stability and a 110-day shelf life at 2°C to 8°C. For Beckman Coulter analyzers, the company offers Liquichek Hematology Control (C) with complete CBC and VCS five-part differential technology, plus a 16-day open-vial stability and a 105-day shelf life at 2°C to 8°C. Liquichek Reticulocyte Control for Coulter instruments is also available, and it has a 31-day open-vial stability with a 105-day shelf life at 2°C to 8°C. The Unity™ Interlaboratory Program is available through the life of the lot. Customers can also subscribe to one of its Unit QC Data Management Solutions designed to improve the effectiveness of statistical process control.
(800) 224-6723; www.bio-rad.com/diagnostics

Bio-Rad Laboratories

Immunoassay control

The Liquichek™ specialty immunoassay control from Bio-Rad Laboratories, Hercules, Calif, is the first liquid, third party, multi-analyte control that includes Intact PTH with 30-day open-vial stability. It is a unique control designed to complement the popular Lyphochek® and Liquichek immunoassay plus controls. This product is specially formulated to include Intact PTH, Anti-TPO, Anti-Tg, C-Peptide, IGF-I, 25-Hydroxy vitamin D, and osteocalcin. This human-based product has a 2-year shelf life when stored frozen. It provides 30-day open-vial stability at 2°C to 8°C for Intact PTH and most analytes. Assayed values are provided for manual and automated test methods. Three critical levels are available. The Unity™ Interlaboratory Program is available through the life of the lot. Customers can also subscribe to one of its Unity QC Data Management Solutions designed to improve the effectiveness of statistical process control. A sample of Liquichek specialty immunoassay control is available upon request.
(800) 224-6723; www.bio-rad.com/diagnostics

Biosite

Laboratory testing

Designed for point-of-care or laboratory testing, Triage® Meters from Biosite, San Diego, are reliable and interface-ready, providing test results in as few as 15 minutes. The Triage Meters run triage tests and panels, such as BNP, Tn I, Myoglobin, CK-MB, D-Dimer, and abused drugs, including a qualitative urine acetaminophen test. The San Diego-based company’s unique multi-marker approach delivers more diagnostic information rapidly. The Triage Meters provide quality, speed, and control you can count on. Biosite’s Encompass™ Services team assists customers with implementing triage solutions and provides consulting services, focused education, and training. Biosite products are used in more than 50% of US hospitals and in more than 40 countries, and they are being used in more than 200 emergency departments nationwide as part of an overall process-improvement initiative to reduce turnaround times and improve patient management.
(888) 246-7483; www.biosite.com

Cargille Laboratories

High-Density Storage Systems

Sample storage sets from Cargille Laboratories, Cedar Grove, NJ, are available in a variety of box sizes, containers, and closures to serve high-density storage applications that require cataloged storage in minimal space. Each complete set includes a partitioned box, vials, closures, dry gummed labels, a reference chart, and an exterior card holder and card. Empty Standard Set boxes and additional special models boxes are available. There are 18 different sets; and all boxes, vials, and closures are available separately. The boxes are versatile enough to store liquids, powders, small specimens, and parts in labeled vials or bottles. The compact sets include alpha-numerically indexed compartments for accurate and rapid retrieval of samples. The boxes are constructed with a moisture- and abrasive-resistant exterior covering that is suitable for incubator, refrigerator, deep-freeze, and controlled-atmosphere applications.
(973) 239-6633; www.cargille.com

Computer Service and Support Inc (CSS)

Remote Results

CSS, Linwood, NJ, has announced its newest Web-based innovation, WebResultView. With this new product, users can have instant and secure access to their patient results anytime and anywhere. With WebResultView’s friendly graphical interface, anyone can search and view his or her results quickly and easily. WebResultsView can act as a stand-alone remote access with interfaces to other laboratory information system vendors.
(800) 336-4CSS; www.csslis.com

Giles Scientific Inc

Automated testing and reporting

Giles Scientific Inc, Santa Barbara, Calif, produces Biomic V3, which has a color image analysis that instantly reads, interprets, and records quality-control and routine testing for antibiotic disk (Kirby Bauer) testing. This improves consistency, accuracy, and reading speed, eliminating personal interpretation and transcription errors. An extensive list of QC and epidemiology reports is included, based on the CLSI M39 guidelines. All test results are monitored by an advanced expert system, based on 2006 CLSI guidelines, to flag unlikely results. The Biomic V3 Microbiology System also reads commercial bacteria and yeast-identification panels including RapID™ (Remel), API® (bioMérieux), Crystal™ (BD), and CHROMagar™ (BD). High-resolution color test images (both AST and ID) can be saved for further evaluation. Biomic V3 serves as a primary or complementary AST-ID system for microbiology laboratories of all sizes and setups. A bidirectional laboratory information system interface can be added to further speed up the workflow. Users can create and modify drug panels to match changing formulary and physician needs. The Biomic V3 connects to a standard Windows®-based PC and requires no routine maintenance or service.
(800) 603-9290; www.biomic.com

Hardy Diagnostics

Strep test

Hardy Diagnostics, Santa Maria, Calif, produces a StrepB Carrot Broth™ Kit used for the selective enrichment and identification of beta-hemolytic group B streptococci (Streptococcus agalactiae) (GBS) from clinical specimens. Approximately 10% to 35% of women are asymptomatic carriers of GBS in the genital and gastrointestinal tracts. The Centers for Disease Control and Prevention recommends the screening of all pregnant women for vaginal and rectal GBS colonization between 35 and 37 weeks of gestation. Carrot Broth is inoculated directly from ano-vaginal specimens. For positive specimens, a color change in the broth to orange or red can be noted in as little as 6 hours after incubation. No further confirmation tests or subculturing is required after the color change is seen. Carrot Broth was found to be 99% sensitive and 100% specific for specimens with 108 CFUs/ml of GBS organisms. The Hardy Diagnostics Carrot Broth increases sensitivity and decreases turnaround time. Also, it lowers overall costs, since positive results do not need further testing or subculturing.
(800) 266-2222; www.hardydiagnostics.com

Hemco

Workstation Enclosures

Hemco, Independence, Mo, manufactures EnviroMax clean workstation enclosures to provide a clean and sterile environment for lab work processes and instrumentation. The enclosure is equipped with HEPA filtration and optional UV lighting to maintain a class 100 clean and sterilized work area. The structural framework is made from powder-coated steel and can be unitized (welded in one piece) or modular (assembled together) to meet space requirements. Standard catalog sizes are available, or enclosures can be custom built to exact size and design specifications. Access can be from one or all sides through either hinge up or horizontal slide door panels. Glass or acrylic doors and wall panels enclose the work area with optional cord ports, electrical multi-plug outlets, or utility connects; or plumbing service fixtures can be factory installed. Special glazing, films, or materials are available to address special lighting needs, photoresist, or reduced foot candle filtered/tinted requirements. Fluorescent lighting is provided and maintains a bright and nonglare environment. The HEPA filters are 99.99% effective at .3 micron and are powered by 115v low-decibel fans that operate with a speed control to provide a desired flow rate. Work surfaces from chemical resistant, to electrostatic dissipative, to stainless steel are offered. These surfaces can then be mounted on laboratory cabinets, heavy-duty open leg benches, or mobile table options to meet specific user needs.
(816) 796-2900; www.hemcocorp.com

Kronus Inc

Diabetes autoantibody test kits

Kronus, Boise, Idaho, makes diabetes autoantibody test kits that allow for the accurate detection of autoantibodies to the three key autoantigens—glutamic acid decarboxylase (GAD), IA-2, and insulin—for the assessment of the immune process associated with immune-mediated (Type 1) diabetes. Generally present and measurable several years prior to the clinical onset of disease, the measurement of GAD, IA-2, and insulin autoantibodies can help identify individuals at risk and provide vital information with regard to the autoimmune progression of diabetes.
(800) 457-6687; www.kronus.com

L.E.S.S. Inc

Cuvette and rotor reprocessing service

Laboratory Environment Support Systems Inc (L.E.S.S.), Scottsdale, Ariz, makes laboratory plastics reusable. Since 1982, LESS Inc has used its patented process to clean and recycle more than 2 billion cuvettes/rotors for clinical laboratories throughout North America and Europe. The company’s reprocessing service has saved laboratories in excess of $50 million while making significant contributions to the environment. Feel free to inquire about other disposable plastic products that you may have an interest in reprocessing.
(800) 621-6404; www.lessinc.com

MAINE STANDARDS

Maine Standards Introduces Validate CM1 Kit

Maine Standards Co, Windham, Me, offers the Validate® Cardiac Markers 1 (CM1) kit for easy calibration verification/linearity testing of CK-MB and myoglobin. Validate CM1 works on virtually all automated immunoassay systems and is the only linearity product line with multiple configurations. It is designed for the industry’s most widely used instruments, and it is geared to validate and maximize reportable ranges while minimizing manual dilutions. CM1 test kits contain human serum-based samples with human CK-MB and myoglobin. All Validate test kits are a liquid format and contain enough product volume for two testing cycles on an instrument system. Maine Standards Co offers data-reduction service free of charge with the purchase of all Validate kits. The service includes both a linearity analysis and a peer-group analysis, with a turnaround time of just 5 business days. Another option is for laboratories to use MSDRx™, Maine Standards’ exclusive do-it-yourself software, to deliver instant linearity analysis and send data via e-mail for peer-group analysis. Maine Standards Co manufactures kits to test 69 analytes in the following categories: general chemistries; electrolytes; enzymes; therapeutic drug monitoring; lipids; urine chemistries; osmolality; and, now, cardiac markers. The quality system for Maine Standards Co is registered to ISO 13485:2003.
(800) 377-9684; www.mainestandards.com

Nanogen

Molecular reagents

Nanogen’s CFTR Analyte Specific Reagents are the newest addition to the NGEN brand of molecular reagents from the San Diego-based company. These ASRs are primers and probes that target mutations associated with the cystic fibrosis gene and may be used by laboratories to develop and optimize in-house test methods such as population-carrier screening. The NGEN CFTR reporter reagent contains oligonucleotides targeting the 23 ACOG/ACMG recommended wild type and mutant sequences. Additionally, probes for the benign mutations I506V, I507V, and F508C, as well as the poly T variants, are included. The flourescently labeled allele-specific probes, when used with an appropriate flourescence-detection technology, provide an objective measure for genotyping each polymorphism individually and unambiguously. A primer mix for the amplification of sequences for more than 600 CFTR mutations is available separately and provides the laboratory with the flexibility to target the mutations they need for CFTR testing should they opt to report more than the recommended 23 mutations. NGEN CFTR ASRs allow the laboratory to simply, economically, and confidently perform CFTR population-carrier screening in-house, while meeting the standard of care. Like all NGEN-brand reagents, these new CFTR reagents are specifically designed for PCR amplification, SNP genotyping, insertion/deletion detection, or pathogen-sequence detection by the use of a two-color fluorescence-detection system. The product line includes reagents for mutations associated with Factor V/prothrombin, hereditary hemochromatosis, and sequences associated with respiratory syncytial virus; influenza A and B; and parainfluenza 1, 2, and 3.
(877) 626-6436; www.nanogen.com

Psyche Systems

LIS extension applications

Psyche Systems, Milford, Mass, has expanded its e.lixa® suite of laboratory information system (LIS) extension applications. e.lixa represents a new class of laboratory software designed to add new functionality to a laboratory’s existing LIS easily and affordably. A laboratory can select one or all of e.lixa’s modules based on its particular need: to handle new types of molecular or genetic testing, to enhance the marketability of its services to gain or retain new clients, or to more easily address compliance requirements. e.lixa gives the laboratory the tools it needs to meet new business demands without the cost and complexity of an upgrade or a new LIS. At its core, e.lixa operates a powerful Microsoft SQL relational database designed to hold all current and historic patient and specimen information. It enables laboratory staff to leverage tools like e.inquiry and e.charts to quickly and easily generate detailed statistical and patient-result reports with colorful graphs for more meaningful analysis of any parameter recorded by the laboratory. With e.reports and e.orders, physicians can place test orders and receive results online through a secure Web page from any PC. Hospitals and independent laboratories realize a high return on investment by enhancing their services and improving reimbursement rates, while maximizing their existing IT resources through Psyche’s eXerva® application hosting services. As a hosted service, e.lixa’s powerful database is replicated in real time with the laboratory’s current LIS database to allow detailed analysis on the most current patient information captured, and it serves as an off-site data back-up.
(800) 345-1514; www.psychesystems.com

Quantimetrix Corp

Cardiac markers

Cardiasure Cardiac Markers controls from Quantimetrix Corp, Redondo Beach, Calif, are intended as a means of monitoring serum cardiac analyte testing methods. A new feature is the addition of NT-proBNP, CRP, Digoxin, and L-homocysteine. It is compatible with most major chemistry analyzers including AIA®, AxSYM®, ACS:180®, Access®, Dimension®, Elecsys®, Stratus®, Synchron®, and TOSOH A/A. This product has a liquid, human serum matrix; it comes with full 3-year frozen stability; and it can be refrozen twice. It is available at four levels (Level 4 with decreased levels of Troponin I and T) with a 90-day unopened and a 60-day open-vial stability when stored at 2°C to 8°C, and it is packaged in a dropper-tip plastic bottle for ease of use. A comparative quality control program—Quantrol™, available for Quantimetrix Corp products—provides labs with free monthly reports to monitor test performance and trend analysis.
(800) 624-8380; www.4qc.com

SCC Soft Computer

Laboratory information system

Clearwater, Fla, company SCC Soft Computer’s laboratory information system (LIS) solution, SoftLab, provides quantifiable improvements in clinical outcomes, workflow efficiencies, and return on investment. SoftLab is a premier LIS that helps clients reach top productivity in the laboratory environment. It provides health care facilities with full multisite consolidation, flexible patient and management reporting, specimen tracking, and more. Organizations using SoftLab will appreciate significant productivity enhancements thanks to the system’s critical result warning function, extensive call-management feature, and superior rules-based auto-verification. In addition, SoftLab provides improved fiscal management by greatly improving charge captures, reducing processing days in accounts receivable and eliminating overuse, duplicate test orders, and combined test orders. SoftLab is built on the latest third-generation client/server architecture. This includes common object request broker architecture, which promotes enterprisewide connectivity and allows for the incorporation of new technologies. Through PUSH technology, information displayed on-screen is updated automatically and in real time, making new, critical patient data instantly available.
(727) 789-0100; www.softcomputer.com

Specialty Laboratories

Test for liver health

Specialty Laboratories, Valencia, Calif, is a leading researched-based, full-service clinical reference laboratory focused on developing and performing esoteric clinical tests in allergy and immunology, endocrinology, gastroenterology, genetics, infectious disease, molecular diagnostics, nephrology, neurology, oncology, and rheumatology for clients nationwide. Specialty’s HCV Liver Fibrosis GenotypR™ helps direct early therapy to patients at risk for liver fibrosis when the opportunity for sustained viral response is greatest. The test identifies eight genomic markers associated with risk of progression to liver fibrosis and calculates a cirrhosis risk score.
(800) 421-4449; www.specialtylabs.com

Streck

Automated body-fluid control

Streck, Omaha, Neb, a developer and manufacturer of hematology controls for the clinical laboratory, has introduced Cell-Chex Auto, a body-fluid control for automated body-fluid analysis on the Abbott Cell-Dyn 3200, Cell-Dyn 4000, Abbott Sapphire, Coulter LH750, and Sysmex XE-2100. Cell-Chex Auto verifies the accuracy of the lower RBC and WBC linearity limits of the instruments’ reportable ranges. All three levels of Cell-Chex Auto are lower than the low abnormal level of daily hematology controls and calibration material. Cell-Chex Auto is available in 3.0-mL plastic cap-pierceable vials. Each level is packaged separately. This product offers a closed-vial stability of 75 days and an open-vial stability of 30 days. Today’s hematology instruments are equipped with advanced technologies that improve efficiency and maintain testing accuracy. Automating body fluids will decrease turnaround times for most body fluid samples by eliminating the need for manual hemacytometer testing by one or more technologists.
(800) 228-6090; www.streck.com

Thermo Fisher Scientific

Sample-verification system

Thermo Fisher Scientific, Pittsburgh, has introduced the Shandon CheckMate™ verification system specifically designed to eliminate sample-mismatch errors in the anatomical pathology (AP) laboratory. Quality, safety, and result integrity in the pathology laboratory are major concerns; and with the Shandon CheckMate, Thermo Fisher offers this automated system to verify—with certainty—that sample containers, cassettes, and slides are accurately matched. This system completely eliminates sample-mismatching errors by accurately scanning and matching bar codes from slides, cassettes, and specimen containers at various workstations in the laboratory. Visual and audio indicators ensure that IDs are properly matched. This innovation dramatically improves result integrity in the AP laboratory by replacing error-prone, time-consuming manual checks, eliminating paperwork and identifying errors when and where they occur. Verification data can be accessed by lab managers for reporting and quality-improvement purposes. The verification system can be quickly installed at any selected workstation in the AP laboratory. The system, composed of bar-code scanners, a mini PC, and the proprietary CheckMate software, can be installed independent from the laboratory information system (LIS), enabling slides and cassettes to be matched at workstations not connected to an LIS such as microtomes.
(800) 678-5599; www.thermofisher.com

Thermo Scientific

Tissue processor

Thermo Scientific, Pittsburgh, has introduced the first xylene-free tissue-processing protocol that works without the use of microwaves or excessive heat. This application is now available on the Shandon Excelsior ES Tissue Processor. This breakthrough not only eliminates all xylene-disposal costs, recycling expense, and significant health hazards, but it also speeds processing and in many instances improves the quality of stained slides compared to traditional processing. Processing temperatures never exceed 45°C for dehydrants and 65°C for wax, guaranteeing the integrity of the processed tissue by the use of only moderate temperatures to assist the transfer from dehydrant to infiltrating media. These benefits can be realized with no mechanical or software changes to the current Shandon Excelsior ES. With this innovation, the Shandon Excelsior ES offers customers a low cost of ownership, the least hands-on time, and one of the highest levels of safety of any tissue processor on the market.
(800) 547-7429; www.thermo.com/shandon

Whitney Products Inc

Disposable Test Tube Rack

The Test n’ Toss disposable test tube rack is built for use in clinical labs, hospitals, research labs, reference labs, EMS, even physician offices and alternate care sites. The rack, designed with the lab professional in mind, holds up to 80 16-x-100 mm tubes in a leak-resistant plastic shell to contain spills; and it is inexpensive enough to dispose of when contaminated. Clear walls allowing users to see rack contents. A second shell can be used as a cover, completely enclosing contents for transport or storage and allows racks to be stacked to save on storage, incubator, or refrigerator space. Uniquely designed divider shelves can be used singly or in pairs for extra stability. The rack can be refrigerated to 0°F (-18°C) and can be incubated to 140°F (60°C).
(800) 338-4237; www.whitneyproducts.com