New Products Review

 

 

 


Abbott Diagnostics Immunodiagnostic Systems, Inc.
Abbott Point of Care Iris Diagnostics, A Division of IRIS Intl., Inc.
Aim Lab Automation Technologies Pty Ltd Iris Sample Processing
Alfa Scientific Designs Inc. KNF Neuberger, Inc.
Alifax SPA KRONUS, Inc.
Applied Biocode Lampire Biological Labs & BioMagnetic Solutions
ARK Diagnostics, Inc. LGP Consulting, Inc.
AutoGenomics, Inc. LipoScience
AVE Science & Technology Industrial Co. MediaLab, Inc.
Awareness Technology, Inc. Medica Corporation
Axxin Ltd Minigrip- An ITW Company
Beckman Coulter, Inc. Monobind Inc.
BioHelix Corporation Nova Biomedical
Bio-Rad Laboratories NuAire, Inc.
BioTek Instruments OPERON SA
Biotron Diagnostics USA Ortho Clinical Diagnostics
Burkert Fluid Control Systems Pointe Scientific, Inc.
Carolina Liquid Chemistries Polymedco CDP, LLC
Clarity Diagnostics Quantimetrix
Clinical Innovations, LLC Roche Diagnostics
CompuGroup Medical Sarstedt, Inc.
CTK Biotech, Inc. SCC Soft Computer
Diagnostica Stago, Inc. Sebia Electrophoresis
Diazyme Laboratories SENTINEL CH. SpA
Dynex Technologies, Inc. SeraCare LifeSciences
EMD Millipore Corporation SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Eppendorf Siemens Medical Solutions USA, Inc.
Eurotrol Siloam Biosciences, Inc.
Focus Diagnostics Streck, Inc.
Genemed Biotechnologies Inc. SurModics IVD
General Biologicals Corp Sysmex America, Inc.
Gen-Probe Inc. Thermo Fisher Scientific
Gold Standard Diagnostics Tosoh Bioscience
Hamilton Company U.S. ARKRAY, Inc.
IDEX Health and Science LLC Waters Corporation
iLine Microsystems S.L. WEIDMANN Plastics Technology AG

 

   

Abbott Diagnostics

OneLab*

Abbott's Informatics Portfolio with Instrument Manager provides the capability for enhanced specimen management, auto-verification, advanced reflex ordering, easier QC management, moving averages, and more. Expanding our IT offering for clinical diagnostics, Abbott has launched the OneLab Platform in select countries outside the U.S. Commercial availability in the U.S. is planned in 2013. OneLab is a single platform with three applications: 1.) Inventory Manager to improve utilization and accuracy, while reducing manual efforts to track, stock and manage inventory through radiofrequency identification technology; 2.) Decision Center to deliver business intelligence for the health network, clinical lab, and beyond; and 3.) Smart Center to standardize and automate the process of turning instrument results into medical information. *In development.

www.abbottdiagnostics.com Booth No. 1223, 1323

ACCELERATOR*

Abbott's ACCELERATOR Automation portfolio spans both task-targeted and total lab automation systems, including the Pathfinder 350S to the ACCELERATOR Automated Processing System. In early 2013, the portfolio is anticipated to expand with the ACCELERATOR p540, designed to automate key elements of sample processing without the need for a track system, and the ACCELERATOR a3600 (pending 510(k) clearance), designed to provide laboratories enhanced performance and configurability options. Combined, these systems will enable laboratories to choose the appropriate level of automation for environment and workflow. *In development.

www.abbottdiagnostics.com Booth No. 1223, 1323

ARCHITECT B12 Assay

The ARCHITECT B12 assay is a chemiluminescent, microparticle, intrinsic factor assay for quantitative determination of vitamin B12 in human serum on the ARCHITECTiSystem. Results should be used in conjunction with other data such as symptoms, results of other tests, and clinical impressions. If the B12 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. It is recommended that each laboratory establish its own reference range. For in vitro diagnostic use. ARCHITECT is a trademark of Abbott Laboratories in various jurisdictions.

www.abbottdiagnostics.com Booth No. 1223, 1323

ARCHITECT Active-B12 Assay

Total serum vitamin B12 may not reliably indicate vitamin B12 status. To get more sensitivity and specificity in diagnosing vitamin B12 deficiency, the concept of measuring active-B12 (holotranscobalamin) or holo-TC has been supported in some data. The ARCHITECT Active-B12 assay is a chemiluminescent, microparticle, immunoassay for quantitative determination of holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 is used as an aid in diagnosis and treatment of vitamin B12 deficiency. Each laboratory should establish control ranges to monitor the acceptable performance of the assay. For diagnostic purposes, results should be used in conjunction with other data, such as symptoms, results of other tests, and clinical impressions.

www.abbottdiagnostics.com Booth No. 1223, 1323

ARCHITECT 25-OH Vitamin D Assay

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent, microparticle, immunoassay for quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is used as an aid in assessment of vitamin D sufficiency. The assay has shown excellent precision (<10% CV), as well as good correlation versus the predicate device, the DiaSorin LIAISON 25-OH Vitamin D, and versus the reference method, LC-MS/MS. It is recommended that each laboratory establish its own reference range. Results should be used in conjunction with other data, such as symptoms, results of other tests, and clinical impressions. For in vitro diagnostic use. ARCHITECT is a trademark of Abbott Laboratories in various jurisdictions.

www.abbottdiagnostics.com Booth No. 1223, 1323

AbbottLink 4.0

AbbottLink 4.0 provides the ability to further enhance your instrument service experience by providing key areas of support and insight. By pro-actively identifying areas on your analyzer that require attention, you are able to potentially reduce downtime. Through the AbbottLink Customer Portal, you have the ability to generate reports that assist in improving your testing efficiencies. New features include: instrument screen sharing; ability to update assay files, calibration files, and package inserts through Abbott-mail easy downloads; and remote software updates. ARCHITECT version 8.0 software required.

www.abbottdiagnostics.com Booth No. 1223, 1323

 

Abbott Point of Care

i-STAT Advanced Quality Features

The new i-STAT Advanced Quality Features (AQF) are software enhancements that help the lab optimally manage their POCT program by improving compliance, oversight, and control to drive operational excellence. i-STAT AQF includes: liquid QC pass/fail determination; liquid QC scheduling and lockout; customizable reportable ranges; operator competency notification; and positive patient ID. Abbott Point of Care understands the challenges of managing a POCT program and is committed to providing innovative solutions to help drive your success.

www.abbottpointofcare.com Booth Number 1323

 

Aim Lab Automation Technologies Pty Ltd.

PathFinder 350A Archiver*

Do you have a problem in your laboratory with RSI injuries from capping tubes? Is your staff tied up in the mundane task of manually archiving samples? Aim Lab Automation Technologies' new bench-top PathFinder 350A Archiver is an easy-to-use, fully automated capper and sorter for the post-analytical management of specimen tubes. Samples are unloaded automaticallyfrom analyzer racks, capped, and stored in low-cost storage racks. Any samples with outstanding tests, including send-outs, can be sorted into different destination racks for further processing. At last, an affordable solution to the capping, sorting, and archiving of samples. *Available outside the U.S.

www.aimlab.com Booth No. 316

   

Alfa Scientific Designs Inc.

SplitScreen Integrated Multi-Drugs of Abuse Cup

This patented SplitScreen Integrated Multi-Drugs of Abuse Cup allows for seven test strips/result window. The cup can test up to 14 analytes plus adulteration. Select configurations available for over-the-counter sale or for use in the facilities requiring CLIA-waived status. The cup is manufactured in the U.S. and features push-button activation, enabling the operator to initiate the test at their convenience. The split-specimen feature provides a retained urine sample for confirmatory purposes, and the flat-test result windows provide the operator with the ability to photocopy test results.

www.alfascientific.com Booth No. 438

 

Alifax SPA

ALFRED AST Blood Culture Susceptibility Test/MRSA*

Alifax clinical susceptibility testing of positive blood culture samples reports results in only 6 hours with the new Alfred 60/AST. The Alfred 60/AST is the first fully automated system that performs bacterial culture, RAA, and susceptibility testing on positive urine, human biological liquids, isolated colonies, and blood culture. The system produces high sensitivity and specificity by automating the whole process of sample inoculation, reading, and LIS connection. The new rapid screening of MRSA also produces results in only 2–6 hours, reducing the risk of contamination and allowing positive patients to be quickly isolated. *Available outside the U.S.

www.alifax.com Booth No. 4506

 

Applied BioCode, Inc.

BioCode-HP Analyzer for 4,096-plex Molecular Assays*

Applied BioCode's Barcoded Magnetic Beads (BMBs) are a breakthrough "digital multiplexing" technology, and its new BioCode-HP Analyzer enables simultaneous detection of up to 4,096 targets from a single sample, providing 393,216 data points from a 96-well microplate. BMBs offer excellent barcode classification and faster reaction time than with existing microarray-based technologies. BMBs are an ideal technology to move assays from bio-discovery, to biomarker validation, and to IVD clinical applications. The BioCode-HP is suited for various high-plex applications including HLA, blood group genotyping, micro RNA, and biomarker discovery/validation studies. *For research use only.

www.ApBioCode.com Booth No. 1051

   

ARK Diagnostics, Inc.

ARKNext Generation AED Assays

ARK Diagnostics, Inc., a leader in next-generation TDM assays, is pleased to release a menu of assays for newer generation antiepileptic drugs. ARK is the sole provider of FDA-cleared, homogeneous enzyme immunoassays to measure levetiracetam (Keppra®) or gabapentin (Neurontin®) in serum or plasma. Assays for lamotrigine (Lamictal®), topiramate (Topamax®), and zonisamide (Zonegran®) also are available. ARK produces high-quality, liquid-stable, ready-to-use assays of choice for precise results on a variety of automated clinical chemistry analyzers. With excellent specificity and reportable ranges, these assays offer rapid turn-around times to meet the needs of patients and physicians.

www.ark-tdm.com Booth No. 2353

ARKMethotrexate Assay

ARK Diagnostics, Inc. introduces the new ARK™ Methotrexate Assay, a homogeneous enzyme immunoassay (serum or plasma) for automated clinical chemistry analyzers. ARK 's liquid-stable, specific, ready-to-use formulation delivers a limit of detection <0.05 µmol/L. Calibrators range from 0–1.20 µmol/L, and six-level controls and dilution buffer are available. ARK is the leader in the next generation of TDM assays for therapeutic drug management. The assay is FDA-cleared and also is available in Australia, Canada, and Europe.

www.ark-tdm.com Booth No. 2353

  

AutoGenomics, Inc.

INFINITI® ACE System*

The INFINITI® ACE System is an automated, multiplexing platform that provides load-and-go automation for a broad spectrum of >50 applications. Using a novel BioFilmChip microarray, these tests can be run on the INFINITI and INFINITI Plus platforms. The INFINITI ® ACE is a stand-alone, automated reader that can scan and analyze 96 microarrays in just 15 minutes. *For research use only. Not for use in diagnostic procedures.

www.autogenomics.com Booth No. 2813

 

AVE Science & Technology Industrial Co.

AVE-76 Series Urine Formed Element Analyzer*

AVE Science & Technology has taken the lead in integrating machine-vision technology into microscopic morphology examination, successfully developing the AVE-76 Series Urine Formed Element Analyzer. The AVE-76 Series Analyzer is fully automated and fulfills the standardized quantitation and morphological analysis of all urine formed elements. With advanced target locating and tracking technology, threshold concentration (3–5 cells/µL) samples can be detected without centrifuging or staining. With fast screening and recognition technology, the throughput is up to 200 tests/hour. Only positive samples need verification; re-examination is not needed. The system's identification accuracy is >95%. *Available outside the U.S.

www.c-ave.com Booth No. 2822

 

Awareness Technology, Inc.

IONyteISE Analyzer*

IONyte™ is the smart, new bottle-free ISE electrolyte analyzer designed for reliable and economical Na+, K+ and Cl- results from whole-blood or serum samples. A large, color touch screen guides the user step-by-step with simple prompts, error messages, and graphics. Reagent packs simply plug in with no user contact to waste material. Reagent packs, long-life electrodes, and the instrument all contain unique electronics to simplify operation and minimize down time. IONyte™ stands ready and calibrated 24/7 unless the reagent-saving sleep mode is selected. Co-designed, co-manufactured, and co-distributed internationally by an alliance of Awareness Technology (U.S.) and BioMed Brokers (Argentina). *Available outside the U.S.

www.awaretech.com Booth No. 700

Dexall Allergy Kits*

Awareness Technology now offers an elegant line of ELISA and rapid tests: total IgE; Ig E-specific allergens, panels, and mixes; Type III IgG-specific antibody tests for hypersensitivity and pneumonitis antigens; and autoimmune and infectious diseases. The Dexall ActiTip® system makes it easy to randomly select tests and create custom panels. The unique and patented H. pylori rapid multi-test indicates subclasses IgG, IgM, and IgA. All ELISA products have FDA clearance, while lateral-flow products are available only outside the U.S. All products are manufactured in U.S. and have the CE mark. Instrumentation also available. *Available outside the U.S.

www.awaretech.com Booth No. 700

  

Axxin Ltd.

T16-ISO Isothermal Instrument*

Axxin's T16-ISO Isothermal diagnostic instrument bridges the gap from assay chemistry to market with world leading innovation, capability, and cost effectiveness. The T16-ISO Instrument enables the next generation of diagnostic DNA/RNA isothermal amplification in a compact, sensitive instrument suitable for field-based and POC diagnostic applications. The instrument uses a touch-screen LCD, graphical user interface for advanced workflow management and includes a modular-optical head, currently configured for simultaneous FAM, HEX, and ROM ™ fluorescence channel detection. Supporting two banks of 8-well standard 0.2-mL tubes, the instrument operates at 37–65?C. The instrument can be configured for both stand-alone and PC-connectivity modes for research and field applications. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.axxin.com Booth No. 1657

 

Beckman Coulter, Inc.

UniCel DxH Slidemaker Stainer

With the new DxH SMS, slide making has never been easier. Using innovative, proprietary technology, the DxH SMS is redefining acceptability in automated slides. This highly integrated and automated Slidemaker Stainer uses wedge-smearing technology to create a perfect slide every time. The DxH SMS is designed for reliability from the ground up. With "no-pinch" valves and fewer parts, the SMS is dependable slide after slide. Using thermal transfer technology, the system is designed to allow printing directly on the slide. Direct slide loading provides load-and-go capability with no process intervention to help increase daily productivity.

www.beckmancoulter.com Booth No. 1301

Beckman Coulter's AU5800 Series

Beckman Coulter's newest chemistry analyzers, the AU5800 chemistry series, are the fastest AU analyzers designed—uniquely meeting the demands of high- to ultra-high volume hospital and commercial laboratories. Available in one to four module configurations with optional single/dual ISE flow cells, AU5800 series'throughput ranges from 2,000 photometric chemistry tests/hour for the single module AU5810, up to 8,000 photometric tests/hour (9,800 tests/hour with dual ISE) with the four module AU5840. The series can be used as a stand alone and is designed for connectivity with Beckman Coulter automation solutions to provide integration with the company's clinical IS and immunoassay platforms.

www.beckmancoulter.com Booth No. 1301

  

BioHelix Corporation

IsoAmp HSV

IsoAmp HSV is the first "instrument-free," nucleic acid test system. This FDA-cleared test combines all the critical requirements for molecular diagnostic testing: high performance, ease-of-use, and budget effectiveness. The high performance begins with sensitivity and specificity at 97% and 92%, respectively, expands with each device having its own internal quality control, and finishes with results available in <90 minutes. IsoAmp's simple workflow of sample dilution, amplification at 64° for 60 minutes, followed by visual detection make this nucleic acid test the easiest molecular diagnostic test on the market today. With no capital equipment expenditures and simplified labor requirements, your laboratory will be able to introduce nucleic acid testing or expand your current testing to your outreach centers.

www.biohelix.com Booth No. 2638

   

Bio-Rad Laboratories

LiquichekCardiac Markers Plus Control LT*

Bio-Rad, the leader in third-party QC, introduces multiple Level 1 controls for troponin I assays. In addition to our current L1, L2 and L3, Liquichek™ Cardiac Markers, Plus Control LT now includes Levels 1A, 1B and 1C. These new, multiple Level 1 controls allow laboratories to select a low troponin I value better suited to their platform. *Available outside the U.S.

www.bio-rad.com Booth No. 1101

My eInserts™*

My eInserts™ is an innovative Internet-based tool that will allow Bio-Rad quality control (QC) customers to customize their QC product inserts at any time by selecting only the analytes, units, instruments, and/or methods of interest. Customized inserts can be saved and selections can be viewed, printed, or edited as needed. Automatic email notifications provide the most current updates to control products. My eInserts will significantly reduce the time spent searching for data. And as a part of ongoing green efforts from Bio-Rad, laboratory professionals will appreciate wasting less paper in the process. Learn more at www.myeinserts.com *Available outside the U.S.

www.bio-rad.com  

VIROTROL® HIV-1 Ag Controls*

Bio-Rad's VIROTROL® HIV-1 Ag control can now be used across a broader range of instruments for detecting human immunodeficiency virus (HIV) type 1 antigens. This control allows increased assay options including new 4th generation HIV Ag/Ab testing methods. This unassayed, third-party control is a liquid, human serum-based product with an 18-month shelf life and 60-day, open-vial stability offered in a convenient dropper bottle. *Available outside the U.S.

www.bio-rad.com Booth No. 1101

EQAS Online*

Bio-Rad now extends its EQAS reporting options beyond paper and software with the introduction of new Internet-based reporting solutions: EQAS Online/Mobile. Eliminate the need for locally installing software and gain the freedom to manage your laboratory's EQA information. Updates to contact profile, program, and test configurations, as well as data entry can be achieved in real time with these simple solutions. Integration with Unity™ (Interlaboratory Program) allows an EQAS participant to use a common laboratory number and coding structure between systems. EQAS Online is available through www.QCNet.com/eqasonline and may be accessed from any Internet-connected PC, tablet, or smartphone (EQAS Mobile). *Available outside the U.S.

www.bio-rad.com Booth No. 1101

BioPlex® 2200 Rubella and CMV IgM Kit

Bio-Rad Laboratories' BioPlex® 2200 Rubella and CMV IgM kit is the first and only fully automated, random-access multiplex kit for detection of IgM antibodies to rubella and cytomegalovirus. This qualitative, multiplex, flow-immunoassay kit consolidates two traditional single-analyte tests into one reagent-saving serological panel and requires only 5 µL of patient sample. Enhance your laboratory work-flow efficiency with throughputs of up to 200 tests/hour and time-to-first result of 45 minutes, an improvement over traditional methods. The BioPlex® 2200 Rubella and CMV IgM kit joins an expanding menu of autoimmune and infectious disease tests on Bio-Rad Laboratories' BioPlex® 2200 system.

www.bio-rad.com Booth No. 1101

PhDlx System

The PhD™ lx system is built on the robust platform of the original PhD™ system. Both systems have the flexibility to process 20 IFA slides or two EIA microplates. The unique modular design allows for efficient sample processing. Individual workstations can be networked to the same computer for higher throughput and backup capacity. The unified IFA/EIA software application runs independently of the workstations so work lists can be programmed at any time with bi-directional LIS capabilities. Streamlined, versatile, and secure, the PhD™ lx system can handle your laboratory's routine assay processing tasks, freeing you up to focus on other important tasks.

www.bio-rad.com Booth No. 1101

   

BioTek Instruments

405Touch Microplate Washer

The new 405™ Touch Microplate Washer incorporates a high-resolution LED, backlit touch screen with an ultra-wide viewing angle for intuitive and flexible onboard control of microplate washing. A 5.7-in. graphical, color display seamlessly guides users through protocol development and execution. USB flash-drive ports enable convenient file transfer and storage. Easy operation is guaranteed with a quick menu and predefined sample methods. Diverse work-flow requirements are accommodated with a range of configurations, maintaining all the features of BioTek's industry-leading washers. The new key features of the 405 Touch Microplate Washer include automated, internal four-buffer switching and quick-release manifold designs.

www.biotek.com Booth No. 855

 

Biotron Diagnostics Inc.

Advanced Temperature Stable Microbiology Culture Media*

Biotron Diagnostics U.S. is launching our newest, joint-venture, export manufacturing company (ISO 9001:2008, GMP, and CE certified) of state-of-the-art microbiology products, BIOTRON-VIBLES U.S. Our microbiology product line includes: kits for collection and transport of specimens; blood-culture bottles; dehydrated culture media; ready-to-use culture media; mycobacteria culture media; sensi-disc for mycobacteria susceptibility testing; media slants (plain and antitubercular drugs); antimicrobial susceptibility discs, rings and chemotherapeutic agents; and water/food/diary/hygiene/environmental microbiological analysis kits.Biotron Diagnostics Inc.'s main mission is to develop, design, produce, market, and distribute U.S.-made, FDA-approved, high-quality IVD kits and reagents for the U.S. and worldwide. *Available outside the U.S.

www.biotrondiagnostics.com Booth No. 1758

 

Burkert Fluid Control Systems

Twin Power Dual Solenoid Valves

Twin Power Valves incorporate a dual-solenoid design that allows use of a smaller valve without sacrificing performance. Available in 10-mm, 16-mm, and 22-mm sizes, the higher power density of Twin Power Valves provides the same flow and pressure resistance in 50% less space. Integrated power-saving, hit-and-hold electronics decrease energy use by 75%, reducing the risk of heat transfer from the coil to the media. Based on the proven Rocker principle, the Twin Power design features a more robust separating diaphragm and a low, dead-volume fluid cavity, resulting in less carryover, as well as better flushability and cleanability. By offering high-performance, wetted materials, Twin Power Valves can handle the most aggressive fluids.

www.burkert-usa.com Booth No. 639

  

Carolina Liquid Chemistries

CLC720® Free Standing Chemistry Analyzer

The CLC 720® Free Standing Chemistry Analyzer is the newest stand-alone chemistry analyzer on the market for large clinics, small hospitals, and reference laboratories. Capable of performing >80 tests, ranging from CMPs, BMPs, liver, kidney, and lipid panels to others such as semi-quantitative drugs-of-abuse, specific proteins, and more. Capable of 560 tests/hour with ISE, the CLC 720 analyzer is smaller, quieter, uses less water, space, heat, electricity, reagents, and consumables than similar analyzers. The instrument was a top-five finalist in the Cook Innovation Award.

www.carolinachemistries.com Booth No. 2111

 

Clarity Diagnostics

NextPAP

Clarity NextPAP™ is a xylene-free, liquid-based cytology testing kit that replaces the conventional method of Pap smear pre-paration used in screening for the presence of atypical cells, cervical cancer, and its precursor lesions (LSIL, HSIL), as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytological Diagnoses. NextPAP brings all the advantages of automated, liquid cytology PAP testing to a manual platform and uses mono-layer technology along with a liquid cover slip that speeds up read time and eliminates the need for rescreening.

www.claritydiagnostics.com Booth No. 507

 

Clinical Innovations, LLC

ROM Plus® Fetal Membranes Rupture Test

ROM Plus® Fetal Membranes Rupture test is a rapid, qualitative test for in vitro detection of amniotic fluid in vaginal secretions of pregnant women. It uses a combination of monoclonal and polyclonal antibodies to detect alpha-fetoprotein (AFP) and placental protein 12 (PP12 or insulin growth factor binding protein-1) found in amniotic fluid. Housed in a convenient test cassette, ROM Plus® quickly and accurately provides test results essential to optimizing perinatal outcomes.

www.romplustest.com Booth No. 754

  

CompuGroup Medical

LabNexus Laboratory Outreach Solution*

LabNexus Laboratory Outreach Solution offers a variety of methods to share laboratory data. Interface services and a web portal provide the latest technology, allowing you to be more competitive and grow your business. LabNexus Interface Services provide a direct link from the reference laboratory to a practice's electronic health record practice management, and/or hospital information systems. LabNexus Web Portal provides safe and reliable access to laboratory data in real-time. It is a secure, easy-to-navigate, and readily accessible portal, allowing providers to deliver the highest quality care to their patients.*Available outside the U.S.

www.CGMus.com Booth No. 5344

  

CTK Biotech, Inc.

Positivia Malaria Rapid Test Controls*

Positive controls for HRP-II, Pf-LDH, Pv-LDH, and aldolase in individual or combination formulations for use with malaria Ag rapid tests are now available from CTK Biotech, Inc. Rapid tests have built-in controls to ensure adequate sample migration but do not ensure the intended reactivity. This new external control may be used to guarantee that the most important aspect of the test, the result, is reliable. Positivia controls are non-biohazardous and are stored at room temperature so they can be used in the event that a test falls out of recommended temperature range during shipment or storage or when false results are suspected. *Available outside the U.S.

www.ctkbiotech.com Booth No. 5210

  

Diagnostica Stago, Inc.

STA Coag ConneXion®

STA Coag ConneXion® consolidates all coagulation data generated by Stago instruments prior to release and reporting. Capabilities include: result review and auto-validation; multiple reporting/validation ranges; and manual or automatic reruns triggered by expert rules or rerun ranges. The system also offers QC monitoring with remote QC option. In addition, it features a metering manager to monitor test and QC results. One to four instrument connections are available on a single system. User rights management and authentication is available. Patient data is easily accessible with sample tracking, multi-criteria database queries, and patient management files with patient and QC archiving.

www.stago-us.com Booth No. 801, 1001

STA Compact® PLUS*

STA Compact® PLUS combines the reliability and proven performance of the STA Compact® with the innovative software features of the STA Coag ConneXion®. You have the added benefit of a command-center monitor configuration to provide optimal ergonomic performance. The STA Compact® performs simultaneous clotting, chromogenic, and immunological assays in true random-access mode. Software capabilities include: result review and auto-validation; automatic or manual sample reruns; and built-in expert routine and special coagulation rules. The system also offers comprehensive QC monitoring with the addition of a remote QC option. Patient data is easily accessible with sample tracking and multi-criteria database queries. *In development.

www.stago-us.com Booth No. 801, 1001

STA® Liquid Anti-Xa

Now available from Diagnostica Stago, STA® Liquid Anti-Xa is a new, ready-to-use reagent for quantitative determination of plasma levels of unfractionated (UFH) and low-molecular weight (LMWH) heparins. Linearity is now extended up to 1.10 IU/mL for UFH and 2.00 anti-Xa IU/mL for LMWH. This new reagent has a 7–8 day, on-board stability and is available in either 4-mL or 8-mL vial sizes, meeting the needs of your laboratory.

www.stago-us.com Booth No. 801, 1001

 

Diazyme Laboratories

Glycated Albumin Assay Kit

Diazyme's Glycated Albumin Assay Kit is a two-part, liquid-stable reagent that can be used with most automated clinical chem-istry analyzers. It also is more specific and accurate than conventional non-enzymatic, NBT-based fructosamine tests. Serum GSP concentrations in conjunction with HbA1c can be used to determine the glycation gap, offering improved diagnostic value by more reliably predicting complications of diabetes such as coronary artery and kidney disease. In addition, the glycated albumin test serves as an intermediate term indicator of average blood glucose for the past 2–3 weeks, closing the existing information gap between daily blood glucose testing and the 2–3 month snapshot provided by HbA1c testing.

www.diazyme.com Booth No. 4424

SMART® Cystatin C

Diazyme introduces the first cystatin C point-of-care system as an aid in diagnosis and treatment of renal disease. Cystatin C has emerged as a superior biomarker to serum creatinine for estimating GFR and predicting risk of cardiovascular events. The SMART system's small size and footprint make it ideal for assessing renal function in diabetes clinics and prior to administration of nephortoxic drugs in oncology and interventional radiology departments, thereby minimizing the risk of acute kidney injury and contrast-induced nephropathy. The SMART system features a growing menu of special chemistry assays for near-patient testing.

www.diazyme.com Booth No. 4424

 

Dynex Technologies, Inc.

AgilityELISA Microplate Automation System

DYNEX Technologies has redefined ELISA processing with the new Agility™ ELISA microplate automation system­—an ingenious, state-of-the-art processor featuring the most advanced walk-away automation in the category. Agility allows up to 12 prepared microplates to be loaded on-board, processing all 12 within a single work list. Agility also minimizes hands-on time thanks to revolutionary reagent loading technology, eliminating nearly all liquid-transfer steps with Agility SmartKit™ reagent packs. The SmartKit packs contain all reagents for each assay in a durable kit that is loaded directly onto the instrument in one step—no manual reagent pipetting is required! Achieve optimal turnaround and productivity with Agility.

www.dynextechnologies.com Booth No. 1136

 

EMD Millipore Corporation

AFS® Essential Water Purification Systems

EMD Millipore's AFS® Essential range of water purification systems includes seven new models that provide pure-water flow rates from 8–24 L/hour. All systems are designed to produce clinical laboratory reagent water that complies with the CLSI® guideline. The AFS® 10E and AFS® 15E system integrate patented Elix® EDI technology to produce CLRW consistently and reliably and at a predictable, low running cost. The AFS® E systems' full monitoring and data archiving capabilities, easily accessed with Millitrack® software, provide the traceability to fulfill accreditation needs. The AFS® Essential range of systems is robust, and offers economical and reliable pure-water solutions for clinical analyzers.

www.millipore.com/labwater Booth No. 5024

  

Eppendorf

Xplorer plus® Electronic Pipette

Eppendorf presents its new electronic pipette, the Eppendorf Xplorer plus®. The intuitive operating concept and ergonomic display of our Xplorer set new standards in simplicity, precision, and reproducibility. With the Xplorer plus® there are additional intelligent applications and adjustable fixed-volumes, allowing much faster and easier programming. It also has a history function that automatically saves the last parameters for faster use. A password can be used to guarantee the highest degree of protection for your programming and settings, and much more. Together, these features mean no more delays due to complicated programming or inflexible processes. Eppendorf Xplorer plus® is pipetting "reloaded." Now available in every laboratory.

www.eppendorfna.com Booth No. 1104

 

Eurotrol, Inc.

CueSee® Blood Gas, Electrolyte, Metabolite Linearity Verification Material*

CueSee® Blood Gas, Electrolyte, Metabolite Linearity Verification Material (BGEM LVM) is an aqueous, assayed, quality-control material for calibration verification of most blood gas instruments. CueSee BGEM LVM is available as a five-level kit covering the clinically significant ranges, measuring pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glu, lac, urea, creatinine, and Mg++. The pO2 and pCO2 levels have been optimized to extend the AMR for these analytes, with levels much higher than traditional blood gas controls. The CueSee product line includes a free on-line data submission program with statistical and graphical analysis, along with peer-review data. *In development.

www.eurotrol.com Booth No. 716

CueSee® Online

CueSee® Online is an interactive web-site tool to assess performance of in vitro diagnostic products. Ideal for hospital laboratories, point-of-care sites, proficiency testing schemes, and manufacturers of instruments or controls, CueSee Online is a new, free service to Eurotrol customers. QC data is submitted via the website and is collected from participants all over the world. The results are presented as statistical reports and graphical presentations and include peer comparisons for all tests.

www.eurotrol.com Booth No. 716

ACU-Drop®*

ACU-Drop® is Eurotrol's unique, new dropper bottle featuring a dropper tip and hinged cap, all in one piece. This new design concept allows users to open, dose, and close the bottle with one hand. With its hinged cap, ACU-Drop® eliminates the possibility of losing or transposing traditional screw-caps. With the dropper tip and cap integrated into one piece, one step may be eliminated from the filling process. ACU-Drop® is available in various colors and bottle sizes to suit many needs, including filled bottles or bottles ready for your own product. *In development.

www.eurotrol.com Booth No. 716

 

Express Diagnostics

AnemiaCheck POC Quantitative Hematocrit Test*

More than 1.5 billion people worldwide are diagnosed with low hematocrit or anemia. To enable timely, cost-effective diagnosis, IntraMed Diagnostics, a subsidiary of Express Diagnostics Intl., introduces AnemiaCheck™. This rapid, point-of-care device delivers quantitative hematocrit results in 15 minutes without instrumentation. Simple and easy-to-use, AnemiaCheck is a single-use, disposable device ideal for both physician use and pharmacy distribution for at-home testing. A linear regression compared AnemiaCheck migration distances and spun hematocrit values, generating a correlation coefficient of 0.975. When calculated hematocrits were examined, 67 of 68 AnemiaCheck samples produced results within +/-3% of the expected hematocrit value. *For research only. Not for use in diagnostic procedures. Available outside of the U.S.

www.anemiacheck.com Booth No. 2359

SalivaScan Oral Fluid Drug Test*

The DrugCheck® SalivaScan™ oral-fluid drug test includes the first sponge saturation indicator on the market. No more throwing away devices due to inadequate specimen. The indicator strip in the collection swab changes color once the sponge contains enough saliva. The advanced oral-fluid collection media (sponge) contains no ascorbic acid or additives and reduces viscosity for faster-running tests and more uniform results. The swab locks into the device for a tamper-evident, airtight seal. SalivaScan offers market-leading cutoffs of 16 drugs-of- abuse, with 10 available test channels/device. Extraction ports allow for simplified lab confirmation. *Available outside of the U.S.

www.salivascan.com Booth No. 2359

  

Focus Diagnostics

Simplexa® Flu A/B and RSV Direct

The Simplexa® Flu A/B and RSV Direct assay from Focus Diagnostics is a real-time, RT-PCR assay for in vitro, qualitative direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA. With Simplexa direct chemistry, extraction and amplification are performed in one protocol with no separate nucleic acid extraction step. Each kit includes three direct amplification discs that run up to 8 samples/run, and results are available in about 1 hour. The Simplexa Flu A/B and RSV Direct assay is designed for use on the 3M™ Integrated Cycler, a highly versatile, real-time PCR instrument with a small footprint of <1 sq ft.

www.simplexadx.com Booth No. 2407

Simplexa® C. difficile Universal Direct

The Simplexa® C. difficile Universal Direct assay from Focus Diagnostics is a real-time PCR assay for in vitro, qualitative direct detection of the toxin B gene (tcdB) of C. difficile. With Simplexa direct chemistry, extraction and amplification are performed in one protocol, eliminating the separate nucleic acid extraction step. The universal disc can run up to 96 samples/run, and results are available in about 1 hour. Simplexa C. difficile Universal Direct is designed for use on the 3M™ Integrated Cycler, a highly versatile, real-time PCR instrument with a small footprint of <1 sq. ft.

www.simplexadx.com Booth No. 2407

  

Genemed Biotechnologies Inc.

Accelerated IVD Product Commercialization

Genemed has 20 years of PCR IVD development and contract manufacturing experience. We offer complete product design services from concept through productrealization. We are FDA-registered and ISO 13485:2003-certified. We offer process validation services and have flexible formulation and filling capabilities, from hundreds to millions of vials. We have a 20,000-sq. ft. facility with Class 100 manufacturing suites. We are ranked as a top-tier supplier for one of the top-ten IVD companies. If you are looking for help developing your IVD product, please come to see us during the Clinical Laboratory Expo.

www.genemed.com Booth No. 5228

 

General Biologicals Corp.

BioFibroScore Non-Invasive Liver Fibrosis Diagnostic Platform

BioFibroScore is a non-invasive liver fibrosis diagnosis platform that provides an alternative way for clinicians to diagnose liver behaviors, from liver fibrosis to cirrhosis. BioFibroScore has been developed and validated in >500 samples in HBV, HCV, alcoholic liver disease, and metabolic/non-alcoholic liver disease. It combines three biomarker scores and diagnostic algorithms to show various fibrosis stages (four stages). Data show that BioFibroScore has a proven record on early fibrosis stage detection.

www.gbc.com.tw Booth No. 2628

 

Gen-Probe Incorporated

APTIMA® Trichomonas vaginalis Assay

The GEN-PROBE APTIMA® Trichomonas vaginalis Assay is the first NAAT to be FDA-cleared for detection of Trichomonas vaginalis, a sexually transmitted parasite that is more prevalent than Neisseria gonorrhoeae and Chlamydia trachomatis. Untreated infections can negatively impact reproductive health and increase risk for HIV acquisition and transmission. Published data demonstrate NAATs offer improved sensitivity for detection of Trichomonas compared with current testing methods, including wet mount and culture. The APTIMA Trichomonas vaginalis Assay is cleared for use with the TIGRIS® DTS® System to test clinician-collected endocervical or vaginal swabs, urine, and PreservCyt™ solution specimens from symptomatic or asymptomatic women.

www.gen-probe.com Booth No. 2615

APTIMA® HPV Assay

The APTIMA® HPV Assay is a target-amplification, nucleic acid probe test for in vitro qualitative detection of E6/E7 viral mRNA from 14 high-risk HPV types. Studies show that this test is highly sensitive, yet significantly more specific, for cervical disease compared to HPV DNA assays.

www.gen-probe.com Booth No. 2615

PANTHER® System*

Created to be a "sample-in-result-out" instrument, the PANTHER system automates all aspects of nucleic acid testing (NAT) on a single, integrated platform that includes a bi-directional host interface, the ability to test multiple analytes from a single tube, and random-access and full automation for true walk-away freedom. These features are brought together with an intuitive design for ease-of-use, helping small-to-medium sized laboratories maximize operator efficiency and productivity. The PANTHER System automates all phases of molecular diagnostics testing from sample preparation, amplification, and detection to reporting results. Integrating the PANTHER System with APTIMA® assay kits for NAT offers true freedom from hands-on processing. *Available outside the U.S.

www.gen-probe.com Booth No. 2615

  

Gold Standard Diagnostics

ThunderBoltCLIA+EIA Automated Platform

The ThunderBolt™ CLIA+EIA platform is fully integrated into Gold Standard Diagnostics' comprehensive lab automation solution. Specific benefits include: 1.) the ability to adapt to throughput and technology needs by simultaneously processing chemiluminescence alongside ELISA. thereby efficiently and economically handling large- or small-batch sizes, and 2.) space-saving design that reclaims 60% of the bench space of competing platforms with the same capabilities. Powerful, flexible, and easy-to-use additional features include open architecture, patented intelligent-rack technology, positive-sample identification, built-in bar-code scanner, orbital shaker, convection incubator, <3% CV at 1 µL, on-board optics for remote trouble-shooting access, bi-directional LIS interface, and customizable reports.

www.gsdx.us Booth No. 2222

 

Hamilton Company

Microlab XRP*

Hamilton's most innovative liquid handler, the Microlab XRP, organizes labs through vertical integration. Advanced logistics management includes below-deck integration of third-party devices and innovative plate and tip shuttling, increasing deck space availability and throughput. System modularity and expandability provide users with an adaptable platform, while superior technology, including accurate and precise, contact-free, low-volume pipetting, automatic transportation of labware, and easy-to-use, scientist-friendly software, make XRP a leader in laboratory automation. *Available outside the U.S.

www.hamiltoncompany.com Booth No. 5116

MICROLAB NIMBUS Enclosed*

The NIMBUS delivers a high-density deck in a compact footprint, for easy bench-top positioning. It provides a clean pipetting environment that minimizes risk of inadvertent contamination and is valuable in a range of applications, such as sample preparation, extraction, and amplification. The affordable system uses the same proprietary air-displacement technology that is built into all Hamilton STAR workstations, delivering the highest levels of pipetting performance and accuracy. Nimbus enclosed features a locking-cover set that minimizes environmental contamination. *Available outside the U.S.

www.hamiltoncompany.com Booth No. 5116

  

IDEX Health and Science

Spiral Transition Manifold Technology

IDEX Health and Science presents Eastern Plastics® Spiral Transition™, a new manifold technology. For >50 years, manifolds have been used to distribute fluids in diagnostic and life science instrumentation, but until now, directional changes in fluid flow within a manifold's internal pathways have been limited to sharp turns with sharp internal corners.  Sharp corners restrict fluid flow, create dead volume, and are notorious for clogging. With Spiral Transition™, sharp corners are eliminated to create a fully swept fluid path for improved flow rates, carryover reduction, and zero dead volume. Only with this patent pending technology, which can be designed into new and existing manifolds, can you achieve a truly optimized fluid path.

www.idex-hs.com Booth No. 1022

 

iLine Microsystems

microINR System*

microINR is the next-generation, point-of-care and self-testing system for oral anticoagulation therapy (OAT) monitoring. This device has been developed to fulfill the needs of the existing models in decentralized OAT monitoring. The microINR system tackles these demands through its compact, easy-to-use design, low-volume sample requirement, and multi-level quality control. microINR employs patented technology and provides accurate and reproducible results as proven in extensive performance evaluations. The system was CE mark certified in February 2011 for patient self-testing and for use by healthcare providers. *Pending FDA approval. Available outside the U.S.

www.ilinemicrosystems.com Booth No. 409

  

Immunodiagnostic Systems Inc.

IDS-iSYS 1,25-Dihydroxy Vitamin D Test*

The 1,25-Dihydroxy Vitamin D test on the IDS-iSYS system is the first automated assay to use the award winning immunocapsule for 1,25-dihydroxy vitamin  D extraction  prior to assay. This innovative automated assay is set to transform 1,25-dihydroxy vitamin D testing workflow  with fast, accurate, and reliable results. The IDS-iSYS 1,25-Dihydroxy Vitamin D kit is a complete test system with the proven immunocapsule extraction used in conjunction with an automated, magnetic-particles, chemiluminescence immunoassay. This enables the quantitative determination of 1,25-dihydroxy vitamin D in human serum or plasma in a single, working day. This assay compliments the IDS-iSYS 25-Hydroxyvitamin D test. *Not available in the U.S.

www.idsplc.com Booth No. 1229

IDS-iSYS Intact PTH Assay

The Intact Parathyroid Hormone (PTH) on the fully automated IDS-iSYS system provides a quantitative measurement of intact PTH in serum or plasma. Intact PTH levels aid in differential diagnosis of hyperparathyroidism, hypoparathyroidism, hyperpercalcemia or hypocalcemia resulting from disorders of calcium metabolism. Intact PTH can be assayed at the same time as 25-OH vitamin D, allowing laboratorians to consolidate their workload onto a single system to improve productivity and efficiency.

www.idsplc.com Booth No. 1229

IDS-iSYS Growth Disorder Assay: IGFBP-3

IDS has received FDA clearance for its fully automated IGFBP-3 assay. Together with the previously cleared IDS-ISYS hGH and IGF-I assays, the IGFBP-3 assay broadens the available growth panel offering on the fully automated IDS-iSYS in the U.S. Measuring IGFBP-3, when used along with IDS-iSYS hGH and IGF-I assay results, is useful in diagnosis of growth hormone-related disorders and monitoring of treatment. The IDS growth assays fully conform to the standards of the 2011 consensus statement on the standardisation of GH and IGF-I assays, including excellent lot-to-lot consistency and re-establishment of the IGF-I reference range with the latest WHO standard (WHO IS 02/254).

www.idsplc.com Booth No. 1229

IDS-iSYS Hypertension Panel*

The fully automated IDS-iSYS Aldosterone assay is used for quantitative determination of aldosterone on the IDS-iSYS platform. This is the first, fully automated aldosterone assay available in the diagnostic market. The hypertension menu brings together the IDS-iSYS Aldosterone and Direct Renin assays, making the IDS-iSYS platform the first system to offer a unique, fully automated hypertension panel. The unique panel transforms testing for laboratory professionals by delivering accurate and reliable results in <90 minutes for assessment of the aldosterone-renin ratio. *Not available in U.S.

www.idsplc.com Booth No. 1229

 

Iris Diagnostics, A Division of IRIS Intl., Inc.

Iris Alifax® Automated Hematology ESR Systems

The Iris family of Alifax® Automated Hematology ESR Systems consists of Alifax Test 1 for high-volume laboratories and Alifax Roller 20 PN for low-to-medium volume laboratories and pediatric specimens. Capillary photometry technology (test 1) is independent of hematocrit value, generates 1,000 readings/specimen, and reports an ESR in <35 seconds. Test 1 technology overcomes variables and limitations of the standard Westergren sedimentation method detailed in CLSI requirements.

www.irisdiagnostics.com Booth No. 1115

 

Iris Sample Processing

ThermoBrite Elite Automated Laboratory Assistant*

The ThermoBrite® Elite automates the time- consuming, pre- and post-hybridization steps in fluorescence in situ hybridization testing for FFPE, cytology, or hematology slides along with the added benefit of onboard denaturation/hybridization. In addition to freeing up valuable skilled technologists, automation enables better standardization and reproducibility. Just load the slides and walk away. Return for probe introduction/cover slipping, and then let the system perform the overnight hybridization and post-hybridization wash. With this compact, flexible, bench-top instrument, users can determine batch size from 1–12 slides/run and number of batches/day with offline hybridization on our standard ThermoBrite instrument. *Available outside the U.S.

www.proiris.com Booth No. 1115

 

KNF Neuberger, Inc.

FEM Metering Pumps

New KNF diaphragm-dosing pumps for liquids (types FEM 1.02 and FEM 1.09) introduce ideal solutions and deliver superior accuracy and repeatability over a long service life. These compact pumps integrate simple, two-phase stepper motors engineered for optimized levels of controllability and cost efficiency. An optional and adaptable control module easily integrated into any system can expand control potential to suit particular application requirements. Applications include medical diagnostics, industrial dosing systems, fuel cells, semiconductor processing, and wafer analysis, among others. The FEM 1.02 pump achieves flow rates from 0.2–20 mL/min and the FEM 1.09 pump has rates from 0.9–90 mL/min.

www.knf.com/usa Booth No. 348

 

KRONUS, Inc.

Zinc Transporter 8 (ZnT8) Autoantibody ELISA*

KRONUS®, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new ELISA test kit for measuring autoantibodies to the insulin secretory granule zinc transporter (ZnT8), the product of the SLC30A8 gene in humans. *For research use only. Not for use in diagnostic procedures.

www.kronus.com Booth No. 1623

Aquaporin-4 (AQP-4) Autoantibody ELISA*

KRONUS®, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new ELISA test kit for measuring autoantibodies to Aquaporin-4 (AQP-4). AQP-4 is the most abundant water-channel protein in the central nervous system and is expressed extensively within the brain and spinal cord regions. This new ELISA kit allows for accurate and specific determination of autoantibodies to AQP-4. *For research use only. Not for use in diagnostic procedures.

www.kronus.com Booth No. 1623

 

Lampire Biological Labs and BioMagnetic Solutions

Cell Isolations: Pyrafluids and Magnetic Separator

We offer high-gradient magnetic separators for 3-, 15- and 50-mL sample volumes along with a dipole separator for handling microtiter-well strips. Two common capture magnetic pyrafluids are offered: goat anti-mouse and strepavidin. These materials are highly magnetic, 110-nm nanoparticles that are readily separated with the open-field magnetic separators offered by Lampire and BioMagnetic Solutions. The materials are biodegradable and compatible with mammalian cells.

www.lampire.com Booth No. 1134

 

LGP Consulting, Inc.

KapSafe Automated Recapper

The KapSafe™ Automated Recapping System is an automated, pneumatics-free, high-speed, bench-top recapper designed to safely and automatically recap tubes for storage or archiving. The small footprint KapSafe System (24-in. w x 24-in. d x 33-in. h) automatically recaps all standard vacuum collection tubes (13–16 mm diameter, 75–115 mm height) at speeds up to 1,400 tubes/hour. The KapSafe protects lab workers from repetitive motion injuries associated with manual recapping. The system provides walk-away operations with a hopper capacity of 4,200 caps and an input capacity of up to 20 multiple types of racks with various-sized tubes.

www.lgpconsulting.com Booth No. 959

 

LipoScience

Vantera® Clinical Analyzer*

Your lab's advantage in a new era of lipid testing. Introducing the first analyzer to use nuclear magnetic resonance (NMR) technology designed specifically for the clinical laboratory. The analyzer requires no special knowledge of NMR to operate and is designed for low maintenance, work-flow efficiency, and seamless lab integration. It allows simultaneous analysis of multiple lipid analytes, without any assay-specific reagents to modify the chemical composition of the specimen. It features clinically proven NMR technology with more than 7 million NMR LipoProfile® tests processed. Future assays are in development for diabetes and other metabolic disorders. *Pending FDA clearance.

www.liposcience.com Booth No. 4524

  

MediaLab, Inc.

Document Control for Clinical Labs

MediaLab's new web-based document control system helps clinical laboratories meet CAP, CLIA, Joint Commission, and ISO requirements. Provide your employees with online policy and procedure manuals. Guide your supervisors and lab directors through the process of editing, approving, and revising documents. Never let an important deadline slip by: automatic e-mail reminders keep users informed of periodic (annual or biannual) review deadlines and other required tasks. It's hosted by MediaLab, so there's no software to install and no local IT support needed. Employees can access policies and procedures 24/7 from any Internet-connected computer.

www.medialabinc.net Booth No. 5216

  

Medica Corporation

EasyRA Clinical Chemistry Analyzer

The EasyRA is a fully automated clinical chemistry analyzer for use in low-to-moderate volume hospital and physician office laboratories. New software capabilities allow for both standard chemistry testing, and now, urine drugs-of-abuse testing, as well as turbidimetric and enzymatic immunoassay tests. The highlight of this versatile analyzer is the incredibly easy and intuitive icon-driven user interface and touch-screen monitor. Additionally, our onboard RFID technology simplifies reagent inventory management, keeping the operator well informed. The EasyRA sets a new standard in its class with a combination of unprecedented ease-of-use, intuitive user interface, and limited maintenance.

www.medicacorp.com Booth No. 5044

EasyCell® Assistant Remote Review Software

EasyCell® Assistant Remote Review Software adds workstations for greater efficiency and collaboration. Now, hematology technologists can review cell images from anywhere and share images with colleagues located at distant centers of excellence. Images from difficult cases can be conveniently sent for second opinions. Access to EasyCell® Assistant image files permits historical comparison of results. EasyCell® Assistant uses image-processing and pattern-recognition technology to automatically locate white cells on a blood smear, pre-classify the cells, and then present them to a technician for review on an LCD display. Images of these cells are then displayed and grouped by cell type for confirmatory review.

www.medicacorp.com Booth No. 5044

 

Minigrip—An ITW Company

Lab Guard® Specimen Bag with Destroyable Biohazard Symbol

Lab Guard® Specimen Bag with new destroyable biohazard symbol incorporates the following features: a patented destroyable biohazard symbol that saves money and a patented TearZone® non-perforated, easy-open top that won 't leak. It is also FDA registered. For more than 25 years, hospital and laboratory experts across the country have known and trusted Minigrip's Lab Guard® brand for specimen transportation. Now, Lab Guard® Specimen Bags offer new features that make them even better and easier to use.

www.minigrip.com Booth No. 505

 

Monobind Inc.

Vitamin B12 AccuBind® ELISA and AccuLite® CLIA Assays*

Researchers and small labs can now meet their vitamin B12 testing needs using Monobind's open-system AccuBind® ELISA and AccuLite® CLIA assays. Suitable for manual and automated methods, with Monobind's or the lab's equipment, Monobind's vitamin B12 uses a proprietary polyclonal antibodydeveloped by Monobind in an enzyme immunoassay that offers superior specificity to competitive protein binding assays. Monobind's proven platform for ELISA and chemiluminescence, based on streptavidin-biotin technology in a 96-well microplate, enables robust, accurate, and reproducible results. Comparison studies of Monobind's quantitative vitamin B12 in human serum and plasma find strong correlation with leading automated systems. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.monobind.com Booth No. 4614

sTfR AccuBind® ELISA and AccuLite® CLIA Assays*

Soluble transferrin receptor (sTfR) is the most reliable test to measure iron-deficiency anemia (IDA) and anemia of chronic disease (ACD) marked by chronic inflammation with or without iron deficiency. Other iron tests are affected by inflammation and do not measure sTfR accurately (ferritin declines, sTfR increases). sTfR also is important in monitoring bone marrow or stem-cell transplants for chronic renal disease. Monobind's open-system AccuBind® ELISA and AccuLite® CLIA sTfR is suitable for manual and automated testing, has a short assay time of 1.5 hours, and is based on streptavidin-biotin technology in a 96-well microplate, providing robust, accurate, and reproducible results that strongly correlate with leading automated systems. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.monobind.com Booth No. 4614

 

Nova Biomedical

StatStrip® Lactate Point-of-Care Analyzer

StatStrip Lactate is a hand-held, true point-of-care system that brings lactate testing directly to the patient's bedside. StatStrip Lactate 's single-use biosensor provides lab-like results in 13 seconds on 0.6 µL of venous or arterial blood at a fraction of the cost of lactate testing on a blood gas analyzer. StatStrip Lactate's small sample size, fast results, and easy operation make routine screening and serial testing of lactate practical in any department that treats critically ill patients, and it is especially well-suited for rapid detection of serious illness, such as sepsis or septic shock.

www.novabiomedical.com Booth No. 2431

Stat Profile® pHOx Ultra Blood Gas Critical Care Analyzer

Stat Profile pHOx Ultra Blood Gas Critical Care Analyzers provide a comprehensive, 20-test menu, including gases, electrolytes, chemistry, hematology, and co-oximetry. pHOx Ultra analyzer provides a full 20-test profile on just 200 µL of whole blood in 2 minutes or less. It features: simple, one-button operation; snap-in reagent cartridges; long-life biosensors; fully automated quality control; multiple analyzer networking; remote analyzer setup/remote control; and comprehensive data management. No other blood gas critical care analyzer can match the clinical value of the pHOx Ultra test menu to effectively manage high-acuity, critically ill patients. Individual tests include pH, PCO2, PO2, SO2%, hematocrit, hemoglobin, sodium, potassium, chloride, ionized calcium, ionized magnesium, glucose, BUN, creatinine, lactate, and bilirubin.

www.novabiomedical.com Booth No. 2431

 

NuAire, Inc.

Awel Benchtop Centrifuges

NuAire, manufacturer of ergonomic laboratory equipment, has partnered with Awel to bring a full line of laboratory centrifuges to North and Latin America. Exclusive, patented features are designed to increase productivity and safety. AWELook's ergonomic and compact design saves bench space, increases sight lines, and decreases the technician's reach to retrieve samples, thereby reducing fatigue. AWELight's visual, end-of-cycle indicator illuminates lights on the centrifuge handle to notify technicians that samples are ready to be removed, increasing workflow. AWELock's rapid rotor exchange allows technicians to change from one application to the next within seconds. Visit the NuAire booth for a live demonstration.

www.nuaire.com Booth No. 2147

 

OPERON, S.A.

Norovirus Lateral-Flow Test: Strip and Cassette*

Norovirus Lateral Flow-Test is a rapid immunochromatographic test for qualitative detection of Genogroup I (GI) and Genogroup II (GII) in independent bands. Compared to other tests on the market, its main innovation is detection of GI and GII in independent bands. The assay is extremely quick and easy to perform, requiring only10 minutes for sample preparation and 15 minutes for reading results. It does not require special equipment; the technologist merely dissolves the stool sample in a buffer and adds a quantity of the supernatant to the strip. The colored bands makes it very easy to interprete.*In development.

www.operon.es Booth No. 4731

LisaKIT Chagas ELISA Microplate Test

LisaKIT Chagas is a qualitative ELISA microplate test for detecting circulating antibodies in sera to Trypanosoma cruzi (T. cruzi), the causative agent of Chagas disease. LisaKIT Chagas may be used as a confirmatory and/or supplemental serodiagnostic. Compared to other tests in the market, its main innovation is the inclusion of five different recombinant antigens of T. cruzi, which diminishes possible cross-reactions with malaria and leishmania. It is clean-room manufactured, has ready-to-use reagents, and the results are easily identified by color. It uses deionized water as the wash solution and requires less steps and developing time than other tests.

www.operon.es Booth No. 4731

 

Ortho Clinical Diagnostics

VITROS Total PSA II Assay*

Ortho Clinical Diagnostics announces the availability outside of the U.S. of the VITROS® Total PSA II Assay. The VITROS Total PSA II Assay is intended for in vitro quantitative measurement of total (free and complexed) prostate-specific antigen (tPSA) in human serum and plasma (heparin and EDTA) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System. Product availability is subject to regulatory requirements. *Available outside the U.S.

www.orthoclinical.com Booth No. 811

VITROS® Free PSA Assay*

VITROS® Free PSA is for in vitro quantitative measurement of free prostate-specific antigen (fPSA) in human serum and plasma (heparin and EDTA) and is used in con-junction with the VITROS Total PSA II assay to derive a ratio of free PSA to total PSA (% fPSA). The assay is available on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System. Product availability is subject to regulatory requirements. *Available outside the U.S.

www.orthoclinical.com Booth No. 811

VITROS® 25-OH Vitamin D*

VITROS® 25-OH Vitamin D Total Assay is intended for in vitro quantitative direct measurement of total 25-OH Vitamin D (equimolar D2 and D3) in human serum and plasma, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System. The results are used in the assessment of vitamin D sufficiency. Product availability subject to regulatory requirements. *Pending FDA clearance. Available outside the U.S.

www.orthoclinical.com Booth No. 811

 

Pointe Scientific, Inc.

AU Chemistry Reagent Line, Bar-Coded Bottles

Pointe Scientific introduces a new, generic, chemistry-reagent line packaged into bar-coded bottles that allows easy application to the Beckman Coulter AU 400/640/800 chemistry analyzers. The Pointe Scientific reagents are liquid-stable, and they have been shown to be accurate and precise. They also may offer significant cost savings over the instrument manufacturer's branded reagents. The new Pointe Scientific reagent line includes reagents necessary for a basic metabolic panel, a lipid panel, and liver function panels. Calibrators and controls also are available.

www.pointescientific.com Booth No. 2513

TORCH Immunoassay Kits, ELISA Methodology

Pointe Scientific introduces a line of TORCH immunoassay kits. These kits are made in the U.S. and employ ELISA methodology. The ELISA methodology provides excellent sensitivity, specificity, accuracy, and precision. The assay kits determine: IgG and IgM antibodies to Toxoplasma gonddi; IgG and IgM antibodies to Rubella; IgG and IgM antibodies to CMV; and IgG antibody to HSV. These assays have been shown to yield results comparable to other TORCH methods on the market.

www.pointescientific.com Booth No. 2513

 

Polymedco CDP, LLC

OC-Sensor IO Automated FIT Analyzer*

OC-Sensor IO is the latest in automated FIT analyzers used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps, and colitis. Featuresinclude: full automation; capability to run 88 tests/hour; 5,000-sample memory; sample bar-code reader; 5.7-in. touch panel LCD display; closed-sampling bottle; and LIS capability. Increase your lab's productivity, remove subjectivity of reading results, and automatically update patient records with the OC-Sensor IO. The compact design (14.2 in. w x 22.1 in. d x 16.7 in. h) is ideal and features easy implementation. Samples are completely closed and the laboratorian will never come in contact with the patient sample.*Pending FDA clearance.

www.polymedco.com Booth No. 1015

 

Quantimetrix

Complete D 25-OH Vitamin D Control*

Complete D 25-OH Vitamin D Control from Quantimetrix is an FDA-cleared, ready-to-use, refrigerated, liquid control designed to make your laboratory quality control simple. The product is formulated with real human serum containing 25-OH vitamin D2 and D3, with a 2-year refrigerated shelf life from date of manufacture and 1-year, open-vial stability when stored at 2–8°C or 30 days at room temperature. Values are traceable to the NIST SRM 972. Data are provided for LC-MS-MS, Diasorin Liaison, IDS-Direct EIA, IDS-RIA, and LC-MS-MS isotope-dilution methods. The control is packaged in two levels, 3x3 mL/box. *Available outside the U.S.

www. quantimetrix.com Booth No. 2423

 

Roche Diagnostics

CC/IA Rules Package

This Clinical Chemistry/ Immunoassay (CC/IA) Rules Package for Roche middleware provides a complete autoverification framework with almost 100 starter rules. The rules are designed to work specifically with Roche analyzers. Pre-written rules may reduce the amount of time needed to implement. Rules also aid in producing actionable, healthcare information in a more consistent and timely manner and allows personnel to focus on exceptions rather than normal results. Initial studies have shown that accounts without rules have been able to implement this package within 90 days and increase autoverification from zero up to as high as 82%.

www.mylabonline.com Booth No. 1831

cobas p 312 Pre-analytical System*

This system from Roche Diagnostics is a compact, stand-alone system for decapping, sorting, and archiving of sample tubes for SWA, hematology, coagulation, and urinalysis. Professional laboratory management is no longer a question of size—the cobas p 312 pre-analytical system is the beginning of a new dimension of efficiency in laboratory automation. Designed to meet the needs of the small-to-mid volume customer, the cobas p 312 pre-analytical system combines superior sample management and increased workflow efficiency with a high density of functionality all on a very small footprint. *Available outside the U.S.

www.mylabonline.com Booth No. 1831

MagNa Pure 96 Instrument IVD

This industry-first solution for automated, high-throughput nucleic acid purification processes up to 96 standard-volume samples simultaneously—in <1 hour, including setup time—to help labs significantly increase productivity. The MagNA Pure 96 Instrument purifies DNA, RNA, and viral nucleic acids from a broad range of sample types using proven magnetic glass-particle technology and barcoded, prefilled trays with ready-to-use reagents to reduce hands-on time. Labs can tailor the preprogrammed software protocols to their sample requirements to yield high-purity nucleic acids for downstream clinical and research applications.

www.mylabonline.com Booth No. 1831

Elecsys HBsAg II Quant Immunoassay*

The Elecsys HBsAg II quant immunoassay is designed for in vitro quantitative determination of the hepatitis B surface antigen (HBsAg) in confirmed HBsAg-positive human serum and plasma. *For research use only. Not for use in diagnostic procedures.

www.mylabonline.com Booth No. 1831

Elecsys Anti-HBc Immunoassay

The Elecsys Anti-HBc immunoassay is for in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium heparin, sodium citrate, K2-EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. Detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for monitoring HBV disease or therapy. The electrochemiluminescence immunoassay is intended for use on the MODULAR ANALYTICS E170 immunoassay analyzer.

www.mylabonline.com Booth No. 1831

cobas p 630 Instrument

The cobas p 630 instrument unites primary tube handling with fully automated sample preparation, amplification, and detection for molecular diagnostics on the COBAS® AmpliPrep / COBAS® TaqMan® system. The complete system provides molecular laboratories with a flexible and integrated solution for automated pre-analytics and real-time PCR diagnostic testing. The cobas p 630 instrument helps labs enhance throughput for molecular virology tests, while protecting the integrity of the primary patient sample through sample full traceability and a dedicated pre-analytical instrument. A single cobas p 630 instrument can provide primary tube handling for up to three COBAS® AmpliPrep and COBAS® TaqMan® systems.

www.mylabonline.com Booth No. 1831

cobas® 4800 BRAF V600 Mutation Test

The cobas 4800 BRAF V600 Mutation Test identifies patients whose tumors carry the BRAF V600E mutation and are eligible for treatment with ZELBORAF® (vemurafenib), an orally administered targeted therapy for BRAF V600E mutation-positive melanoma. The first FDA-approved in vitro diagnostic for BRAF mutation detection in melanoma, this real-time PCR test was clinically validated in the BRIM2 and BRIM3 studies. It is performed on DNA extracted from formalin-fixed, paraffin-embedded tissue using the cobas 4800 system. Combining speed, accuracy, and reliability, the cobas 4800 BRAF V600 Mutation Test provides consistent, objective, and reproducible results, allowing healthcare professionals to make therapy decisions quickly and confidently.

www.mylabonline.com Booth No. 1831

HSV-1 lgG Immunoassay*

An electrochemiluminescence immunoassay for in vitro qualitative determination of IgG class antibodies to HSV-1 in human serum and plasma, the Roche HSV-1 lgG test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV infection. The predictive value of positive and negative results depends on the population's prevalence and the pre-test likelihood of HSV-1. The HSV-1 test is intended for use on the cobas e 601, cobas e 602, cobas e 411, and Elecsys® 2010 instruments. *Pending FDA clearance. Available outside the U.S.

www.mylabonline.com Booth No. 1831

HSV-2 lgG Immunoassay*

An electrochemiluminescence immunoassay for in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and plasma, the Roche HSV-2 lgG test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV infection. The predictive value of positive or negative results depends on the population's prevalence and the pre-test likelihood of HSV-2. The HSV-2 test is intended for use on the cobas e 601, cobas e 602, cobas e 411, and Elecsys® 2010 instruments. *Pending FDA clearance. Available outside the U.S.

www.mylabonline.com Booth No. 1831

Elecsys Anti-HBc IgM Immunoassay

The Elecsys Anti-HBc IgM immunoassay is intended for in vitro qualitative determination of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. This electrochemiluminescence immunoassay's performance has not been established for monitoring HBV disease or therapy. The Elecsys Anti-HBc IgM immunoassay is intended for use on the MODULAR ANALYTICS E 170 module and the cobas e 601, cobas e 602, and cobas e 411 systems.

www.mylabonline.com Booth No. 1831

cobas® CT/NG Test

Performed on the fully automated cobas® 4800 system, the CT/NG test detects Chlamydia trachomatis and Neisseria gonorrhoeae in a multiplex, dual-probe, real-time PCR assay. It may be used with vaginal swab specimens self-collected in a clinical setting or with male urine from symptomatic or asymptomatic individuals. The cobas 4800 system offers true walk-away automation of nucleic acid purification, PCR set-up, and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. It also runs the clinically proven cobas HPV Test and cobas BRAF V600 Mutation Test, needs minimal daily maintenance, and requires less hands-on time than most similar systems.

www.mylabonline.com Booth No. 1831

sFlt-1 Immunoassay*

Available for research use only on the Roche Elecsys® 2010, MODULAR ANALYTICS E 170, cobas e 411, cobas e 601, and cobas e 602 analyzers, this soluble fms-like tyrosine kinase-1 assay employs the sandwich principle and detection using electrochemiluminscence technology. With a 12-week open stability, 6-week onboard stability, and calibration stability of up to 1 month, this assay provides an efficient method for sFlt-1 testing for research facilities. *For research use only. Not for use in diagnostic procedures.

www.mylabonline.com Booth No. 1831

PlGF Immunoassay*

Available for research use only on the Roche Elecsys® 2010, MODULAR ANALYTICS E 170, cobas e 411, cobas e 601, and cobas e 602 analyzers, this soluble fms-like tyrosine kinase-1 assay employs the sandwich principle and detection using electrochemiluminscence technology. With a 12-week open stability, 6-week onboard stability and calibration stability of up to 1 month, this assay provides an efficient method for sFlt-1 testing for research facilities. *For research use only. Not for use in diagnostic procedures.

www.mylabonline.com Booth No. 1831

Elecsys® Vitamin D Total Immunoassay*

An electrochemiluminescence assay designed to detect vitamin D sufficiency from both serum and plasma samples, this fully automated, total vitamin D assay (25-hydroxy-vitamin) can be combined with routine testing on existing Roche immunoassay analyzers and integrated chemistry/immunoassay systems, enabling labs to address the growing demand for vitamin D testing while maximizing their productivity. The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602, and MODULAR ANALYTICS E170 analyzers. *Pending FDA clearance. Available outside the U.S.

www.mylabonline.com Booth No. 1831

Cardiac Troponin T- hs (TnT-hs) Assay*

The assay is an electrochemiluminescence immunoassay for in vitro quantitative determination of cardiac troponin T (TnT-hs) in human serum and plasma. Available for sale outside of the U.S., this assay can be used as an aid in differential diagnosis of acute coronary syndrome to identify necrosis (acute myocardial infarction). The Roche TnT-hs assay is intended for use on the MODULAR ANALYTICS E170 module and the cobas e 601, cobas e 602, cobas e 411, and Elecsys 2010 instruments. *In development.

www.mylabonline.com Booth No. 1831

cobas p 512 Pre-analytical System

Designed to run up to 1,000 primary tubes/hour, this stand-alone, fully-automated system provides centrifugation, registration, sorting, decapping, recapping, and archiving of sample tubes for SWA, hematology, coagulation, and urinalysis. Task-targeted automation from Roche offers both a high level of pre-analytical automation for greater efficiency and flexibility to customize based on the needs of the laboratory. The cobas p 512 pre-analytical system is designed to accommodate the needs of the mid-to-high volume customer using state-of-the-art technology to create custom sample handling solutions that help improve workflow on a smaller footprint.

www.mylabonline.com Booth No. 1831

cobas p 612 Pre-analytical System

Designed to run up to 655 primary tubes/hour, this stand-alone, fully automated system provides centrifugation, registration, sorting, decapping, aliquoting, recapping, and archiving of sample tubes for SWA, hematology, coagulation, and urinalysis. Task-targeted automation from Roche offers both a high level of pre-analytical automation for greater efficiency and flexibility to customize based on the needs of the laboratory. The cobas p 612 pre-analytical system is designed to accommodate the needs of the mid-to- high volume customer using state-of-the-art technology to create custom sample handling solutions that help improve workflow.

www.mylabonline.com Booth No. 1831

 

Sarstedt, Inc.

Minivette® POCT 100 µL*

Already available in 20-µL and 50-µL volumes, Sarstedt has expanded its line of Minivette® POCT to include a 100-µL option. Minivette® POCT devices enable precise and hygienic collection, transfer, and subsequent dispensing of small capillary-blood samples for POC tests. Blood is easily collected via capillary action into the capillary end of the Minivette® POCT. The sample is held securely in the capillary during transfer without spills and then dispensed with a slight push of the opposing integral piston. Minivette® POCT devices are offered plain or prepared with EDTA or heparin. *Available outside the U.S.

www.sarstedt.com Booth No. 1155

Bulk Loader 2000*

The new Bulk Loader 2000 from Sarstedt is a stand-alone instrument that accessions and sorts capped specimen tubes into target bins. Tubes are dumped into a loading hopper for walk-away processing; no pre-sorting or racking is required. The Bulk Loader 2000 identifies the tube type and ID number and places each tube into one of eight bins per customized sorting rules. Each bin accommodates up to 200 tubes and can be unloaded at any time without stopping the system. The Bulk Loader 2000 can process up to 2,000 capped tubes/hour. *Available outside the U.S.

www.sarstedt.com Booth No. 1155

 

SCC Soft Computer

Holomic SmartRDT Reader on Cellphone*

Holomic SmartRDT Reader on Cellphone improves your rapid tests with lateral flow immunoassay devices. This low-cost reader is an attachment for Android smartphones or iPhones. It reads strips under controlled conditions and stores images and results in the smartphone as well as in the cloud. Featuring one reader for many RDTs and diseases, the Holomic Smart RDT provides reliable readings and avoids operator errors, quantifies diagnostic conditions, and automatically captures data for health-care information systems. The applications work anywhere RDTs are used, including physicians' offices, hospitals, telemedicine, and large scale monitoring of epidemics in public health. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.softcomputer.com Booth No. 5500

 

Sebia Electrophoresis

Hb A1c: Next Generation by Capillary Electrophoresis*

The Next Generation of HbA1c assay, based on the principle of capillary electrophoresis (CE), provides high-resolution, clear-cut, and precise separation of HbA1c and HbA0 fractions. CE allows elimination of direct interferences on the A1c fraction (carbamylated, acetylated, labile, common Hb variants such as HbS, HbD, HbE), as well as analytical exclusion of HbA2 and HbF from the measurement. It also allows for high accuracy of results and extremely low CVs. CAPILLARYS 2™ Flex Piercing HbA1c, with whole-blood, closed-tube capacity, will offer the best equilibrium in precision, robustness, and throughput along with the ability to run traditional electrophoresis testing. *Pending FDA clearance. Available outside the U.S.

www.sebia-usa.com Booth No. 4743

MINICAP FLEX Piercing: Whole Blood Hb Testing*

Whole-blood hemoglobinopathy testing by capillary electrophoresis with cap-piercing capabilities is now available with the MINICAP FLEX Piercing instrument. The MINICAP FLEX Piercing system with its small footprint is designed to optimize and completely automate electrophoresis testing in low-to-medium volume laboratories. Simply place a bar-coded primary tube on the system and walk away; the whole-blood plasma samples are automatically inverted prior to analysis and a continuous-access sample wheel allows for addition of samples at any time. True positive sample ID is achieved with full traceability. A complete test menu is available to include protein electrophoresis, immunotyping, and chronic alcohol abuse marker. *Available outside the U.S.

www.sebia-usa.com Booth No. 4743

CAPILLARYS 2 FLEX Piercing:Whole Blood Hb*

Whole-blood hemoglobinopathy testing by capillary electrophoresis (CE) with fully automated CE technology now has cap piercing capabilities with the CAPILLARYS 2 FLEX Piercing system. Whole-blood plasma samples are automatically inverted before sampling to ensure thorough homogenization of the sample and accurate Hb results. A high-resolution hemoglobin separation takes place concurrently in eight capillaries with a fast sample throughput of 37 results/ hour. CAPILLARYS 2 FLEX Piercing is a continuous-feed system that provides full traceability from bar-coded primary sample tube to final result. A complete test menu is available, including serum and urine protein electrophoresis, immunotyping, and chronic alcohol abuse marker. *Pending FDA clearance.

www.sebia-usa.com Booth No. 4743

 

SENTINEL CH. SpA

STAT-NAT DNA-MIX*

STAT-NAT is a Sentinel proprietary technology developed with a new protective compound capable of stabilizing the activity of DNA- or RNA-dependent polymerases for a very long time without temperature-controlled storage requirements. The mixes can be stored for at least 1 year at room temperature. The product features include: CE-marked; applicable for most of molecular diagnostic and research applications, such as real-time, melting curve analysis, high-resolution melting, and sequencing; self-containing mixes, such as hot-start polymerase and one vial/one test; room-temperature storage; reproducibility, standardization, uniformity for test development; no temperature control during shipment; sample volume flexibility primers; and practically non-existent working time. *Available outside the U.S.

www.sentineldiagnostics.com Booth No. 4650

 

SeraCare Life Sciences

SeraCon Vitamin D Depleted Diluent*

Improve your assay consistency and sensitivity with ultra-low vitamin D-depleted human plasma. This diluent's composition closely resembles normal human plasma, not horse or synthetic, to ensure test accuracy and effectiveness. It meets the needs of the most sensitive test methods and is certified to be <1 ng/mL vitamin D 25-hydroxy, D2/D3 as tested by LC/MS/MS and immunoassay. It's chemistry profile mimics normal human serum, and the total protein and sodium levels are closer to normal human serum. Suitable for LC/MS applications, it is visually clear and free of precipitate. This diluent meets large-scale manufacturing needs with low bio-burden and lot-to-lot consistency, and it is available in large lot sizes of up to 200 L. *For research use only. Available outside the U.S.

www.seracare.com Booth No. 804

 

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

BC-6800 Auto Hematology Analyzer*

The BC-6800 Auto Hematology Analyzer applies our unique SF Cube technology along with laser scatter and fluorescence to obtain 3D-cell analysis for WBC five-part, RET, and NRBC. The throughput is up to 125 samples/hour, and the autoloader can hold 100 sample tubes at one time. The Focusing Flow-DC method optimizes the RBC histogram, and it enables optical PLT counting, ensuring more accurate PLT results especially for microcytic RBC and large PLT samples. The 3D-cell analysis also makes it possible to distinguish immature cells such as blasts, atypical lymphocytes, and immature granulocytes. The unique "InR#, InR‰" parameters provide information about the presence and severity of malaria. There are four dedicated WBC counting channels to ensure a more accurate result. *Available outside the U.S.

www.mindray.com Booth No. 2235

BS-2000 Modular System*

The BS-2000 Modular System is the fastest, fully integrated clinical chemistry system designed by Mindray. This modular system, with a throughput range of 2,000 photometric tests/hour for the single module and up to 4,400 tests/hour for dual modules with electrolyte tests, is most suitable for high-volume hospitals and clinical laboratories. With its complete line of original reagents, calibrators with methodological traceability, and controls, the BS-2000 Modular System provides versatile options that offer customers a high level of efficiency, automation, and scalability. It also will lay the foundation for integration with future Mindray products. *Available outside the U.S.

www.mindray.com Booth No. 2235

 

Siemens Healthcare Diagnostics, Inc.

INNOVANCE® VWF Ac Assay*

The INNOVANCE® VWF Ac Assay is a reliable and convenient tool for diagnosis and management of bleeding disorders. Employing innovative technology, the test uses polystyrene particles (latex-based beads) rather than platelets for quantitative determination of von Willebrand factor (VWF) activity and provides excellent stability and accurate results. The assay is available on all automated Siemens Hemostasis Systems, enabling highly effective VWF activity determinations in laboratories of all sizes. *Pending FDA clearance.

www.siemens.com/diagnostics Booth No. 1701, 1708

EMIT II Plus 6-Acetylmorphine Assay

The EMIT® II Plus 6-Acetylmorphine Assay accurately detects heroin use without cross-reactivity to morphine, morphine metabolites, and many common analgesics. With >99% agreement with the reference method (GC/MS) and a low analytical sensitivity of 1.1 ng/mL on the Viva® series analyzers, your laboratory can confidently screen for both qualitative (10ng/mL cut-off) and semi-quantitative results. The assay offers a convenient and effective way to selectively test for heroin use. In addition, it enables your laboratory to adjust to changing testing requirements and produces results in as few as 11 minutes.

www.siemens.com/diagnostics Booth No. 1701, 1708

Sysmex CA-600 Series Systems

The new Sysmex® CA-600 Systems provide enhanced reliability for low-volume hemostasis laboratories. The CA-660 System is designed for routine clotting assays and features automated clotting, chromogenic, and immunologic detection capabilities. The systems maintain the high standards for up time and reliability established by the CA-500 Systems and will become the new workhorses in the low-volume hemostasis laboratories. The Sysmex CA-600 Series is economical and easy-to-operate, with features such as secure data transfer through a 2-dimensional bar-code reader, low maintenance, onboard quality control, and a color touch screen.

www.siemens.com/diagnostics Booth No. 1701, 1708

Personalized Education Plan Administrator*

Personalized Education Plan (PEP) Administrator integrates with PEP (patent pending) and provides an intuitive interface to simplify the process of managing education and training. PEP Administrator allows you to guide, plan, and monitor the progress of individual learners according to their specific competency needs. It consolidates continuing education from any source and automatically summarizes the progress of every individual. PEP Administrator also automates the time-consuming administrative tasks required to establish compliance. PEP Administrator makes planning, recordkeeping, certification, and compliance verification as simple as a keystroke. *Available in the U.S., Canada, and Puerto Rico.

www.siemens.com/diagnostics Booth No. 1701, 1708

Dimension® Vista 500 LOCI TPSA and FPSA Assays

LOCI® TPSA and FPSA for the Dimension Vista® 500 Intelligent Lab System consolidate PSA testing on a single platform. They are the only PSA assays on the market to employ LOCI technology, a homogeneous, sandwich chemiluminescent immunoassay for quantitative measurement of total prostate-specific antigen (TPSA) and free prostate-specific antigen (FPSA). Measurements of TPSA and/or FPSA aid in detecting and managing prostate cancer. Calculations of percent FPSA aid in distinguishing cancer from benign prostate conditions.

www.siemens.com/diagnostics Booth No. 1701, 1708

ADVIA Centaur Syphilis Assay

The ADVIA Centaur® Syphilis Assay is an in vitro diagnostic immunoassay for qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium, or sodium heparinized, citrate) using ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP Immunoassay Systems. It is intended as an aid in diagnosing syphilis. This assay offers sensitive, specific detection of treponemal antibodies with all the productivity and consolidation benefits of the ADVIA Centaur Systems. Automated syphilis testing provides efficiency and decreases the risk of error compared to manual testing procedures. This assay is not intended for blood- and tissue-donor screening.

www.siemens.com/diagnostics Booth No. 1701, 1708

Dimension® Mycophenolic Acid Assay (MPAT)

With the addition of the Mycophenolic Acid (MPAT) Assay to the immunosuppressant drugs (ISD) test menu, laboratories can perform any combination of cyclosporine, tacrolimus, sirolimus, and mycophenolic acid testing on a single, integrated system. As with our other ISD assays, the MPAT assay requires no specialized equipment or personnel, and no manual sample manipulation is needed. With efficient load-and-go processing and results available in as few as 7 minutes, the MPAT Assay on Dimension® Systems is easy to fit into your daily routine.

www.siemens.com/diagnostics Booth No. 1701, 1708

ADVIA Centaur® Vitamin D Total Assay

Laboratories can now meet the increased demand for vitamin D total testing with precise, consistent results in as few as 18 minutes. The Vitamin D Total Assay on the ADVIA Centaur® XP system is an equimolar, fully automated vitamin D total assay that is traceable to liquid chromatography-mass spectrometry. The assay measures the total 25-hydroxyvitamin D [25(OH)D] level (~100% D2 and D3) in serum and plasma to aid in assessing vitamin D sufficiency. This measurement ensures patients are evaluated for deficiency, sufficiency, and toxicity.

www.siemens.com/diagnostics Booth No. 1701, 1708

AptioAutomation

Aptio™ Automation combines peak performance, adaptability, and intelligent tech-nologies with Siemens' workflow expertise to deliver a unified solution that transforms lab operations. For mid-to-high volume labs, Aptio Automation offers an adaptable total lab solution with next generation pre-, intra-, and post-analytical modules and the flexibility to connect to multi-discipline analyzers. With the integration of the CentraLink ® Data Management System and the automation-ready Siemens analyzers, Aptio Automation delivers a centralized, intelligent system for optimized workflow backed by Siemens' unmatched customer care. Let an Aptio Automation specialist help transform your lab with a customized solution.

www.siemens.com/diagnostics Booth No. 1701, 1708

Stratus® CS Acute CareDiagnostic System

The Stratus® CS Acute Care™ Diagnostic System provides lab-quality results for patients presenting with chest pain in the ED. The first results are available in 14 minutes, so clinicians can meet the new OP-16 guidelines for troponin when used at the POC. The Siemens D-Dimer assay is able to exclude pulmonary embolism (PE) (exclusion of PE in conjunction with non-high PTP model), enabling physicians to provide more timely assessments. Our broad test menu allows for better risk stratification of patients from a single sample.

www.siemens.com/diagnostics Booth No. 1701, 1708

RAPIDPoint® 500 Lactate Assay

Siemens Healthcare Diagnostics introduces lactate on its RAPIDPoint® 500 Blood Gas System, providing point-of-care coordinators with an important new tool for assessing lactic acidosis, or abnormally high acidity of the blood. Lactic acidosis is seen frequently in critically ill patients and has a number of potential causes, including conditions such as shock, diabetes, liver disease, and sepsis.

www.siemens.com/diagnostics Booth No. 1701, 1708

Tissue Preparation System

The Siemens Tissue Preparation System, used with the VERSANT® Tissue Preparation Reagents kit, is a fully automated solution for extraction of RNA and DNA from formalin-fixed paraffin-embedded (FFPE) tissue samples. Full automation of all steps, including deparaffinization and lysis, improves productivity while offering standardization and delivering quality nucleic acids. A single set of reagents that can extract both RNA and DNA from the same sample providing increased flexibility. Eliminating hazardous chemicals enhances lab safety and reduces costs associated with disposal. This technology supports a more efficient, reproducible process to meet the extraction challenges from this difficult sample type.

www.siemens.com/diagnostics Booth No. 1701, 1708

CLINITEK Novus Automated Urine Chemistry Analyzer*

Offering a full spectrum of tests and a throughput of up to 240 samples/hour, the CLINITEK Novus™ analyzer stream-lines workflow, simplifies routine analysis and STAT testing, and delivers consistent, high-quality results, even during peak periods. A digital imaging measurement system improves accuracy of results, andnew ergonomic features such as the tiltable, color touch screen and intuitive user interface, customized menu options, simplified, cassette-based test handling, and automatic entry of cassette lot number and expiration date enhance ease-of-use. *Available outside the U.S.

www.siemens.com/diagnostics Booth No. 1701, 1708

 

Siloam Biosciences, Inc.

OptiMaxELISA Strip Plates*

Siloam Biosciences, Inc. introduces OptiMax™ ELISA Strip Plates, powered by Optimiser™ microfluidic technology. The plates provide clinical laboratory professionals currently using standard 96-well plates with rapid results. Measuring up to six different analytes/sample in as little as 15 minutes, OptiMax strip plates conform to ANSI standards, are compatible with open-automation systems, and reduce time-to-results for clinical immunoassays using traditional immunoassay protocols and reagents. OptiMax strip plates are compatible with fluorescence and luminescence assays. *For research use only. Not for use in diagnostic procedures. Pending FDA clearance.

www.siloambio.com Booth No. 2832

OptiMaxHigh Throughput 96-well IVD Plates*

OptiMax™ High Throughput 96-well IVD Plates allow clinical laboratory professionals currently using standard 96-well plates to attain results for >30 clinical samples in <30 minutes. OptiMax plates, powered by Siloam Biosciences ' Optimiser™ microfluidic technology, conform to ANSI standards and are compatible with open-automation systems. IVD microplate automation systems using OptiMax™ microplates allow random-access capability with individual sample analysis completed in as fast as 15 minutes, providing 2–3 fold higher throughput and faster time-to-results. Discover how the OptiMax™ plates can enhance your current automation system. *For research use only. Not for use in diagnostic procedures. Pending FDA clearance.

www.siloambio.com Booth No. 2832

 

Streck, Inc.

Streck's Product Selection Guide*

The Product Selection Guide at www.streck.com is a quick reference to help clinical and research laboratory staff determine which Streck products work best with their instruments. Customers may search by instrument or instrument manufacturer to find the right controls and calibrators. The Streck website provides access to technical support from an experienced team of medical technologists, as well as access to STATS, Streck's interlaboratory quality control program that gives participating labs monthly computerized reports comparing their values with a peer group using the same instrument type and control lot. *Available outside the U.S.

www.streck.com Booth No. 1647

A1c-Cellular® Linearity*

A1c-Cellular® Linearity is the only commercially available hemoglobin A1c (HbA1c) linearity/calibration verification material with intact red blood cells. It is a five-level, assayed linearity material for assessing instrument accuracy and verifying the patient reportable range of the HbA1c parameter. It tests the entire reportable range of the instrument system, including the lyse step. Instrument-specific target values and expected ranges are provided for immediate instrument accuracy verification. Other features are: no required reconstitution; 7-day, open-vial stability and 105-day, closed-vial stability; cap-pierceable vials for autosampling on analyzers with those capabilities; and barcodes for instruments with barcode scanning. *Available outside the U.S.

www.streck.com Booth No. 1647

Cell-Chex™*

Cell-Chex™ is a spinal and body fluid control with distinct white blood cell (WBC) and red blood cell (RBC) populations for manual counts. When stained in the same manner as a patient sample, the WBCs can be differentiated. The two-level control is assayed for total RBC and WBC counts, a five-part WBC differential, as well as a two-part polymorphonuclear and mononuclear differential. Level 1-UC contains urate crystals and Level 1-CC contains CPPD crystals to aid in identification of crystals in synovial fluid. *Available outside the U.S.

www.streck.com Booth No. 1647

UA-Cellular® for IQ*

UA-Cellular® for IQ is Streck's micro urinalysis control designed specifically for Iris Diagnostics iQ® automated urine analyzers. UA-Cellular for IQ contains components at two clinically significant levels, providingthorough evaluation of the iQ instrument 's ability to both identify and quantify white blood cells, red blood cells, non-squamous epithelial cells, and crystals. The product is contained in convenient 120-mL squeeze bottles with a flip-top cap dispenser that accurately allots the amount of control needed into sample tubes without waste. UA-Cellular for IQ offers an open-vial stability of 30 days and a closed-vial stability of 105 days. *Available outside the U.S.

www.streck.com Booth No. 1647

UA-Cellular® for UF*

UA-Cellular® for UF is Streck's micro urinalysis control designed specifically for Sysmex® UF urine analyzers. UA-Cellular for UF contains cellular components at two clinically significant levels, providing thorough evaluation of the Sysmex UF analyzer's ability to qualify and quantifywhite blood cells, red blood cells, epithelial cells, crystals, casts, and bacteria. The product is contained in convenient 60-mL squeeze bottles with a flip-top dispenser that accurately allots control material into sample tubes without waste. UA-Cellular for UF has an open-vial stability of 30 days and a closed-vial stability of 105 days. *Available outside the U.S.

www.streck.com Booth No. 1647

Philisa® Thermal Cycler*

The Philisa® Thermal Cycler by Streck is an innovative, high-speed polymerase chain reaction (PCR) instrument with the potential to improve laboratory efficiency and flexibility. Industry-leading ramp rates, excellent thermal control, and thin-walled plastic Philisa PCR tubes enable users to perform reliable PCR in <15 minutes. The small footprint, intuitive Windows-based software, and access to Streck 's team of technical experts make the Philisa Thermal Cycler an excellent choice for any lab.*Available outside the U.S.

www.streck.com Booth No. 1647

Cell-Free DNABCT*

Cell-Free DNA™ BCT is Streck's 10-mL blood collection tube for preserving and stabilizing cell-free plasma DNA. The patented preservative in Cell-Free DNA BCT stabilizes white blood cells, preventing the release of genomic DNA during sample processing and storage and reducing post-sampling DNA background. Samples collected in Cell-Free DNA BCT are stable for up to 14 days at room temperature, allowing convenient sample collection, transport, and storage. Processing patient samples for detection and analysis of circulating cell-free DNA requires minimal sample manipulation. Sample handling is less labor-intensive and time-consuming than traditional methods of plasma sample preparation. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.streck.com Booth No. 1647

Cell-Free RNABCT*

Cell-Free RNA™ BCT is Streck's 10-mL blood collection tube for preserving and stabilizing cell-free RNA in plasma for up to 3 days at ambient room temperature. The patented preservative in Cell-Free RNA BCT preserves cell-free RNA in plasma and prevents the release of non-targeted background RNA from blood cells during sampleprocessing and storage. With Cell-Free RNA BCT, processing patient samples for detecting and analyzing circulating cell-free RNA requires minimal sample manipulation. Sample handling is less labor-intensive and time-consuming than traditional methods of plasma sample preparation. *For research use only. Not for use in diagnostic procedures. Available outside the U.S.

www.streck.com Booth No. 1647

CD-Chex® Plus*

CD-Chex® Plus is a positive procedure assayed control for monitoring immunophenotyping by flow cytometry. CD-Chex Plus determines the accuracy and reproducibility of all steps involved in immunophenotyping, including red blood cell lysis. It provides the most assayed CD markers in the industry, including T lymphocytes, B lymphocytes, granulocytes, monocytes, and NK cells. It is assayed for normal levels of CD34+ cells found in peripheral blood. CD-Chex Plus CD4 Low offers a depressed CD4 absolute number often indicated in patients with immunodeficiency diseases. The controls are available in 2.5-mL glass vials and 3-mL cap-pierceable plastic vials with an open-vial stability of 30 days and a closed-vial stability of up to 90 days. *Available outside the U.S.

www.streck.com Booth No. 1647

CD-Chex® Plus BC*

CD-Chex® Plus BC is a positive procedure assayed control for immunophenotyping on Beckman Coulter® flow cytometry systems. CD-Chex Plus BC determines the accuracy and reproducibility of all steps involved in immunophenotyping, including red blood cell lysis. It provides the most assayed CD markers in the industry, including T lymphocytes, B lymphocytes, granulocytes, monocytes, and NK cells. CD-Chex Plus BC is assayed for normal levels of CD34+ cells found in peripheral blood. CD-Chex Plus BC CD4 Low offers a depressed CD4 absolute number often indicated in patients with immunodeficiency diseases. The controls have 30-day, open-vial stability and up to 90-day, closed-vial stability and are available in plastic, cap-pierceable vials with 3-mL of control.*Available outside the U.S.

www.streck.com Booth No. 1647

 

SurModics IVD

BioFX® TMB Extended Range HRP Microwell Substrate

BioFX® TMB Extended Range HRP Microwell Substrate (TMBX) is a recent addition to SurModics' family of TMB HRP substrates. Substrate choice is a critical consideration during assay development and can impact factors such as sensitivity, dynamic range, and reproducibility. Using TMBX in a quantitative assay can increase the assay 's upper limit of quantitation and maintain the detection limits and analytical sensitivity achieved with other substrates in our TMB family. Using TMBX also improves the reproducibility of the assay through lower backgrounds and control of assay timing.

www.surmodics.com Booth No. 2246

 

Sysmex America, Inc.

Sysmex WAM SelectHematology Middleware

Sysmex WAM Select™ is a middleware solution that enables enhanced efficiency and control over hematology workflow and results management for small-to-medium sized clinical laboratories performing <350 hematology orders/day. This easy-to-use hematology software solution for laboratories with Sysmex® X-Series instruments and the Sysmex SP-1000i™ slidemaker/stainer interfaces to both instruments. It also interfaces through a single ASTM interface to the LIS. Data can be stored online for up to 90 days for easy access and delta checking. This comprehensive system includes a hematology-specific rules library with true auto-validation capability. It is packaged to enable fast installation with minimal disruption to laboratory operations.

www.sysmex.com/us Booth No. 1347

Sysmex® XN-Series Hematology Analyzers*

The Sysmex® XN-Series Hematology Analyzers enable laboratories of any size to implement advanced clinical and operational capabilities. All configurations provide advanced clinical parameters including: NRBCs with every CBC; immature granulocytes with every diff; RET-He within the reticulocyte profile; and an all-new, fluorescent platelet channel for IPF to aid in differential diagnosis of thrombocytopenia. The series-wide compact design delivers a smaller footprint for increased physical productivity. Smaller reagent sizes and concentrated reagents simplify consumable inventory management. Scalable options exist for auto-validation approaches, from onboard decision rules to Sysmex WAM ™ middleware. The XN-Series also is supported by the Sysmex Peak Performance Program, a rich and comprehensive set of systems and resources that work together to ensure the laboratory's long-term success. *Pending FDA clearance. Available outside the U.S.

www.sysmex.com/us Booth No. 1347

Sysmex UX-2000Integrated Urinalysis Instrument*

The Sysmex UX-2000 is the first, truly integrated urinalysis solution that combines chemistry strips technology with Sysmex's proven automated microscopy into one automated system. Its use of advanced technology streamlines workflow, providing faster turn-around times and reducing labor costs. The UX-2000 provides mid-to-high volume labs with increased clinical utility, productivity, and space-saving benefits in one compact design. *Pending FDA clearance. Available outside the U.S.

www.sysmex.com/us Booth No. 1347

 

Thermo Fisher Scientific

CEDIA® Oral Fluids Immunoassays

These new Thermo Scientific CEDIA Oral Fluid assays use the same well-respected CEDIA® technology as the urine drug monitoring products. Sample collection is easier to administer during field visits or check-ins. Observation of oral-fluid collection is noninvasive, reducing the risk of sample adulteration. Kits of different sizes are available for a range of lab testing needs. Calibrators and controls are liquid, ready-to-use. The CEDIA Oral Fluid Control Set is packaged at ±50% of cut-off and can be used with any lot of reagent. Oral fluid screening is now faster and more cost-effective with applications for a variety of clinical chemistry analyzers.

www.thermoscientific.com Booth No. 2215

QMS® Tacrolimus Immunoassay* 

The Thermo Scientific QMS® Tacrolimus Immunoassay is intended for quantitative determination of tacrolimus in whole-blood samples as an aid in management of patientsreceiving tacrolimus therapy post kidney, liver, or heart transplantation. The assay uses the quantitative microparticle systems technology, based on a competitive-inhibition principle. System bar-coded reagents that are liquid and ready-to-use provide added convenience when using the Indiko benchtop analyzer. The assay offers superior performance with excellent low-end sensitivity and interference with common metabolites and endogenous substances. *Available outside the U.S.

www.thermoscientific.com Booth No. 2215

MAS® Omni•CORE Control  

Thermo Scientific MAS Omni·CORE provides consolidation of general chemistry and immunology QC products. The inclusion of CRP, rheumatoid factor, and multiple serum protein analytes with a general chemistry panel into a single, tri-level QC material streamlines lab QC testing, decreases costs, and improves overall lab efficiency. MAS Omni·CORE is liquid and ready-to-use, and it has a 3-year shelf life and 30-day, open-vial stability. The MAS Omni products offer a true third-party control solution with instrument-specific value assignment that is aligned with the new generation of integrated instrument systems.

www.thermoscientific.com Booth No. 2215

MAS® Omni•Immune Control

Thermo Scientific MAS® Omni•IMMUNE™ consolidates immunochemistry QC testing. Inclusion of routine immunoassays, cancer markers, and newer specialty tests into a single, three-level QC material streamlines lab QC testing and rolls three historically distinct products into a single vial. Value assignment is provided for the newer generation of consolidated instrument systems that use multiple technologies. The new MAS Omni products help align lab QC requirements with these new instrument options.

www.thermoscientific.com Booth No. 2215

Indiko Plus Benchtop Analyzer*

Thermo Scientific Indiko Plus is a new bench-top system for clinical and special chemistry testing. This analyzer, with system reagents and consumables, provides a complete solution, offering confidence and ease-of-use. Various automated features perform analysis in an efficient way and provide quick results, enhancing the quality of patient care. The Indiko Plus' throughput is up to 350 tests/hour. The analyzer has on-board capacity for 54 samples and 42 reagents, with the flexibility to load samples and reagents without interrupting the analysis. Measurement reliability can be monitored with a real-time QC program. System applications include enzymes, substrates, electrolytes, specific proteins, drugs of abuse, and therapeutic drug monitoring tests.*In development.

www.thermoscientific.com Booth No. 2215

LabLink xL® Cloud Communicator*

Thermo Scientific LabLink xL is a fully web-based quality assurance program used in conjunction with the class-leading MAS Quality Control portfolio. LabLink xL provides real-time peer comparison and internal QC review and Westgard-rule validation. The LabLink xL Cloud Communicator provides a revolutionary way to directly transfer QC data from the Data Innovations middleware to LabLink xL via the cloud in a fully-automated and real-time process. Developed in partnership with Data Innovations, the Cloud Communicator requires no additional software installation, allowing for rapid implementation and short start-up times for data submission. *In development.

www.maslablink.com Booth No. 2215


ImmunoCAP® Tryptase Assay

ImmunoCAP Tryptase is the first and only commercial assay in the U.S. that is available on CLIA moderate-complexity, fully automated laboratory instruments. ImmunoCAP Tryptase is now cleared for use on the Phadia® Laboratory Systems: Phadia 100, Phadia 250; and Phadia 1000. ImmunoCAP Tryptase measures the level of tryptase in serum/plasma. Human tryptase is present in mast cells, and serum/plasma basal levels of tryptase give an indication of the number of mast cells. Elevated basal levels of tryptase are an indicator of systemic mastocytosis.

www.thermoscientific.com/phadia Booth No. 2215

EliA® Rheumatoid Factor Assay

EliA Rheumatoid Factor IgA and EliA Rheumatoid Factor IgM are fully automated, standardized RF tests that quantitatively measure IgM and IgA class rheumatoid factor (RF). RF alone or combined with the well-known EliA CCP (cyclic citrullinated peptide) provide clinicians with a reliable and simple tool to aid in early diagnosis. Both tests are available on the Phadia® 100 and Phadia 250 Laboratory Systems and feature: quick turnaround time; master curves with monthly calibration; on-board instrument dilution capability; and a discrete, single-well, random-access, non-microtiter plate format.

www.thermoscientific.com/phadia Booth No. 2215

EliA® Cardiolipin and EliA ß2-Glycoprotein I IgA Assays*

EliA® Cardiolipin IgA and ß2-Glycoprotein I IgA Assays are fully automated, standardized tests that measure IgA isotype. EliA Cardiolipin IgG, IgM, IgA, and EliA ß2-Glycoprotein I IgG, IgM, IgA are important clinical markers for antiphospholipid syndrome. All three important isotypes will soon be available on the Phadia® 100 and Phadia 250 Laboratory Systems and feature: quick turnaround time; master curves with monthly calibration; on-board instrument dilution capability; and a discrete, single-well, random-access, non-microtiter plate format. *Pending FDA clearance.

www.thermoscientific.com/phadia Booth No. 2215


AssayAssure Sample Stabilization System
*

A common concern for multicenter research trials and sample testing is the consistency of test results at different centers largely because of sample instability. There is concern from reviewers about varying levels of sample degradation because various centers may have the sample stored under differing ambient temperatures and they may test the sample immediately after it arrives or after some delay. This can affect the qualitative and quantitative characteristics of the target molecule and comparing between multicenter research trial results becomes difficult. Thermo Scientific AssayAssure stabilizes sample chemistry at the time of collection, ensuring specimen integrity throughout sample testing.*For research use only. Not for use in diagnostic procedures.

www.thermoscientific.com/assayassure Booth No. 2215

 

Tosoh Bioscience, Inc.

ST AIA-PACK HCY*

Tosoh Bioscience is expanding its AIA test menu by adding one more assay: the ST AIA-PACK HCY. The new ST AIA-PACK HCY is designed for in vitro diagnostic use for quantitative measurement of homocysteine in human serum, EDTA plasma, and heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK HCY uses Tosoh's unit-dose, test cup technology, and the assay time is approximately 18–20 minutes. The unit-dose test cup uses a dry reagent format that requires no pre-mixing, no pre-measuring, no on-board refrigeration, and it does not create waste. *Pending FDA clearance.

www.tosohbioscience.us Booth No. 2601

 

U.S. ARKRAY, Inc.

AUTION ELEVEN AE-4020 Urine Chemistry Analyzer

The ARKRAY AUTION ELEVEN™ AE-4020 is a semi-automated urine chemistry analyzer. The AUTION ELEVEN has a throughput of 514 tests/hour and provides first results within 60 seconds. The AUTION ELEVEN can be used as a stand-alone analyzer or as a backup to the AUTION MAX™ AX-4030. The AUTION ELEVEN uses the proven AUTION Sticks 10EA that provide 10 qualitative or semi-quantitative results, including specific gravity. The AUTION Sticks 10EA can also be used on the high-volume automated AUTION AX-4030 analyzer, as well as read visually with a color chart.

www.arkraylab.com Booth No. 5508

AUTION Hybrid AU-4050 Urine and Sediment Analyzer*

The ARKRAY AUTION Hybrid™ AU-4050 is a high-throughput, fully automated urine analyzer, testing both urine chemistry and urine sediment on one platform. The compact footprint of 32 x 29 x 29 in. allows the AUTION Hybrid to be placed easily on the laboratory bench. The AUTION Hybrid allows for minimal operator interaction with continuous sample loading, throughput of 100–200 tests/hour, reflex testing, and a bi-directional interface. The AUTION Hybrid is a complete urinalysis system solution. The AUTION Hybrid AU-4050 joins the AUTION MAX AX-4030, AUTION MAX AX-4280 and the AUTION ELEVEN in ARKRAY's family of urinalysis analyzers. *Pending FDA clearance.

www.arkraylab.com Booth No. 5508

AUTION Sticks 10EA

The ARKRAY AUTION™ Sticks 10EA are multi-parameter test strips intended for use with the AUTION ELEVEN and the AUTION MAX AX-4030 urine chemistry analyzers. They may also be read visually using the color chart. The AUTION Sticks 10EA are a "one-strip-solution" for urine chemistry testing. The AUTION Sticks 10EA consist of 10 chemically treated pads to detect the presence of glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, and specific gravity. A correction pad is included to compensate for urine color and its effect on the color reaction of the reactive pads.

www.arkraylab.com Booth No. 5508

 

Waters Corporation

MassTrak Online SPE Analyzer

The MassTrak™ Online SPE Analyzer uses advanced fluidics and solid-phase extraction (SPE) cartridge technology to seamlessly integrate SPE sample preparation with LC/ MS analysis in a single platform. Composed of an ACQUITY® Online SPE Manager, ACQUITY UPLC and an ACQUITY TQD™ Mass Spectrometer, the MassTrak Online SPE Analyzer enhances overall laboratory productivity and sample throughput, improves LC/MS assay results, and facilitates the quick development of optimized methods for LC/MS assays. Intended for in vitro diagnostic use, especially in high-volume laboratories, this new platform represents a significant step forward in automation and integration of sample preparation with LC/MS analysis to help better realize the power and value for routine use of LC/MS in clinical laboratories.

www.waters.com Booth No. 5108

MassTrak Automated Offline Sample Preparation

The MassTrak™ Automated Offline Sample Preparation platform provides a pathway to easily automate solid-phase extraction (SPE) sample preparation for LC/MS assays in the clinical laboratory. The platform combines the productivity of a robotic, liquid-handling system configured especially for SPE sample preparation, with an ACQUITY® UPLC and ACQUITY TQD™ for LC/MS sample analysis. Faster, more productive and consistent than manual SPE sample preparation, the MassTrak Automated Offline Sample Preparation platform can provide a potent, yet flexible, sample preparation system for low-to-moderate volume clinical laboratories looking to enhance their analytical capabilities and capacity for LC/MS assays.

www.waters.com Booth No. 5108

 

WEIDMANN Plastics Technology AG

Embedded RFID Tags for Diagnostic Disposables

Product identification and ambient condition tracking are becoming more and more important. Flash drives permit information stored during the life cycle of a product to be easily added to or written over. Radio frequency identification (RFID)-inlays can be positioned anywhere on the product, as well as partially or completely embedded in plastic, a process that can now occur as part of the injection-molding process. The sensitive electronics are protected by a special technology designed precisely for this application, which is a WEIDMANN Plastics Technology exclusive.

www.weidmann-plastics.com Booth No. 2741
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