New Products Review




Abbott Diagnostics LGP Consulting Inc.
ALCOR Scientific Inc. LipoScience, Inc.
ALIFAX SPA Luminex Corporation
ALPCO MediaLab, Inc.
Ansh Labs Medica
ARK Diagnostics Inc OPERON, S.A.
Arlington Scientific, Inc, (ASI) Ortho Clinical Diagnostics
Auer Precision Stamping Inc. Parker Precision Fluidics Division
AutoGenomics, Inc. Path-Tec
Beckman Coulter Inc PlexBio Co., Ltd.
BioAssay Works, LLC Pointe Scientific
Bio-Rad Laboratories Polymedco Cancer Diagnostic Products LLC
Biotron Diagnostics Polymedco, Inc.
Carolina Liquid Chemistries Corp. Quanterix
CellaVision Roche Diagnostics
CompuGroup Medical SCC Soft Computer
Corgenix Sebia
DENKA SEIKEN CO.,LTD. Serascience Limited
Diazyme Laboratories Shenzhen Mindray Bio-Medical Electronics Co.,Ltd
Dynex Technologies Inc. Siloam Biosciences, Inc.
ELGA Streck
Eurotrol SurModics IVD
GG&B COMPANY Swisslog Healthcare Solutions
Gilson, Inc. Sysmex America, Inc.
Gold Standard Diagnostics The Lee Company
IMRA America, Inc. Thermo Fisher Scientific
ITC Tosoh Bioscience
Kawasumi Laboratories America, Inc. U.S. ARKRAY, Inc.
KRONUS Inc Watson Bio Lab
 Lampire Biological Laboratories, Inc. West Medica 
Abbott Diagnostics

ARCHITECT Clinical Chemistry Hemoglobin A1c Assay*

The ARCHITECT Clinical Chemistry Hemoglobin A1c assay is in development. The availability of this assay will highlight Abbott's continued commitment to expanding its ARCHITECT metabolic assay menu and providing solutions designed to help the core lab with improving clinical outcomes. *In development. Booth No. 2837, 2953

ARCHITECT Cardiac Assays*

The ARCHITECT High Sensitive Troponin-I and ARCHITECT Galectin-3 assays are in development. Once available, these assays will further demonstrate Abbott's commitment to providing state-of-the-art cardiac assays for use in the core laboratory setting. *In development. Booth No. 2837, 2953

ACCELERATOR Automation Solutions

Abbott Diagnostics' Automation portfolio includes the standalone ACCELERATOR p540, designed to automate key elements of sample processing without the need for a track system, and the total lab solution ACCELERATOR a3600, designed to provide laboratories with enhanced performance and configurability options. Combined, these systems will enable laboratories to choose the appropriate level of automation for their environment and workflow. Booth No. 2837, 2953


ALCOR Scientific Inc.

iSED® Automated ESR Analyzer

Introducing iSED, the fully automated ESR analyzer from ALCOR that has transformed ESR testing! A first of its kind, iSED provides results in 20 seconds, requires a 100-µL sample, and brings true random-access and walk-away convenience. Simply insert the primary tubes and iSED will handle the rest with features like onboard sample mixing, built-in bar code reader, auto eject, and LIS interface capability. The 20-position sample wheel accommodates single or multiple samples in any order received. For added convenience, Seditrol® bi-level quality controls remain on-board and ready for testing 24/7. iSED truly is the perfect ESR system! Booth No. 1538



SIDECAR MRSA Plate Streaking System

Alifax presents the first fully automated MRSA screening system with PenOK Swab collection device. Its selective media produce results for a phenotype culture test in 1–6 hours and can be applied to the instruments Alfred60/AST and SIDECAR. SIDECAR is Alifax's new walk-away system that detects and streaks only positive MRSA samples on up to 240 Petri dishes loaded in a dedicated refrigerated area. Dishes are incubated onboard at 37°C for the requested analysis time. New phenotype culture tests will be available shortly for emerging multi-drug resistant bacteria, including KPC, VRE, ESBL, and GBS. Booth No. 5435



Fecal Calprotectin ELISA*

The BÜHLMANN Calprotectin ELISA, offered exclusively in North America by ALPCO, is for the extraction and quantitative measurement of fecal calprotectin in human stool. Calprotectin is a valuable biomarker of intestinal inflammation used to aid in the diagnosis of inflammatory bowel disease (Crohn's disease and ulcerative colitis) and to differentiate it from irritable bowel syndrome. The Fecal Calprotectin ELISA is Health Canada licensed. *Not for use in diagnostic procedures; for research use only. Pending FDA clearance. Booth No. 2608


Ansh Labs

PAPP-A, PAPP-A2, and picoPAPP-A Immunoassays*

Ansh Labs introduces a line of pappalysin immunoassay kits in both ELISA and CLIA formats. The PAPP-A assay is thermally stable and recognizes htPAPP-A and dPAPP-A equimolarly. picoPAPP-A accurately measures circulating PAPP-A concentrations in males and non-pregnant female subjects and in vitro systems. The picoPAPP-A, PAPP-A, and pappalysin 2 (PAPP-A2) assays were developed for investigating the physiological regulation of the IGFs and the IGF binding proteins-4 and -5, and also IGFBP-3 to a lesser extent. Data suggest that pappalysins are proatherosclerotic and have been proposed as markers of inflammation, as high serum levels are observed in subjects in studies of renal impairment, asthma, lung cancer, ovarian cancer, etc. *Not for use in diagnostic procedures; for research use only. Booth No. 4528

U.S. Anti-Müllerian Hormone and picoAMH Kits*

Ansh Labs introduces a family of AMH test kits (CLIA and ELISA) to accurately and specifically measure the wide physiological range of AMH concentrations. These kits feature a picoAMH assay with unparalleled sensitivity of 5 pg/mL and a calibration range of 10–1000 pg/mL. These assays also use well-characterized antibodies specific to the enhanced biologically active form of human AMH, and feature calibrators standardized to recombinant human AMH to ensure accuracy and reproducibility. AMH is an important emerging biomarker with numerous clinical studies investigating its potential as a measure of gonadal function in POI, gonadatoxicity, oncofertility, menopause, etc. Bovine, equine, canine, rat/mouse, primate, and other specific assays are available. *Pending FDA clearance. Booth No. 4528

TGF-Beta Superfamily Assays*

Ansh Labs introduces a comprehensive panel of assays to study the physiological roles of inhibin A, inhibin B, activin A, activin AB, and total follistatin in oncology, inflammation, metabolic disorders, and reproductive function. These assays utilize well-characterized monoclonal antibodies with unparalleled specificity to the target analyte and that exhibit negligible cross-reactivity to other TGF-Beta superfamily hormones. Each of these markers has been utilized in studies of various hormonal reproductive disorders. They play important roles in ovarian function and the regulation of folliculogenesis, including the endocrine suppression or stimulation of the pituitary to produce FSH and paracrine actions on the gonads. *Not for use in diagnostic procedures; for research use only. Booth No. 4528


ARK Diagnostics, Inc.

ARKVoriconazole Assay*

ARK™ Diagnostics, Inc., the leader in the next generation of TDM assays, is currently developing the ARK™ Voriconazole Assay—a homogeneous enzyme immunoassay to measure Voriconazole in serum or plasma. Applicable on a variety of automated clinical chemistry analyzers, ARK's liquid-stable, ready-to-use formulation delivers an assay with each system consisting of two reagents, six calibrators, and tri-level controls. The Voriconazole assay will join ARK's family of assays for therapeutic drug management. *In development. Booth No. 3835

ARKPosaconazole Assay*

ARK™ Diagnostics, Inc., the leader in the next generation of TDM assays, is currently developing the ARK™ Posaconazole Assay—a homogeneous enzyme immunoassay to measure Posaconazole in serum or plasma. Applicable on a variety of automated clinical chemistry analyzers, ARK's liquid-stable, ready-to-use formulation delivers an assay with each system consisting of two reagents, six calibrators, and tri-level controls. The Posaconazole assay will join ARK's family of assays for therapeutic drug management. *In development. Booth No. 3835

ARKFentanyl Assay*

ARK™ Diagnostics, Inc. is developing the ARK™ Fentanyl Assay, which will accurately detect fentanyl without cross-reactivity to many common opioids. Excellent agreement with reference values and an analytical sensitivity of 0.5 ng/mL on automated analyzers ensures your lab can confidently screen for both qualitative results with a 1.0 ng/mL cut-off and semi-quantitative results. The assay offers a convenient and effective way to selectively test for fentanyl use. Reagents, calibrators, and controls are liquid and ready-to-use. Urine screening is now faster and more cost-effective with applications for a variety of clinical chemistry analyzers. *In development. Booth No. 3835


Arlington Scientific, Inc.

ASiThunderbolt-AT Nontreponemal RPR Syphilis Analyzer*

Arlington Scientific, Inc. (ASI) introduces the world's first fully automated nontreponemal analyzer for digital interpretation of syphilis tests: the ASiThunderBolt-AT™. Finally, laboratories can automate nontreponemal testing and follow CDC guidelines with low-cost, automated analyzers and reagents. Drive workflow and efficiency gains with objective interpretation and standardization of RPR tests while significantly decreasing screening costs. Avoid false positives and attain the automation, data management, and accuracy desired with a CDC-recommended nontreponemal test. Detect, diagnose, and monitor patients with the most cost-effective, proven, and trusted syphilis algorithm. ASI is the worldwide leader in innovation, manufacturing, and distribution of syphilis test kits and nontreponemal syphilis analyzers. *Pending FDA clearance. Available only outside the U.S. Booth No. 2112


Auer Precision Stamping Inc.

Blood Separation Microfluidic Device*

Fractionating red and white cells from whole blood provides an optically clear plasma solution that is enriched in electrolytes, proteins, organic nutrients, inorganic compounds, and free-floating DNA. This method provides a greater opportunity for accurate and repeatable sensing of a target marker. Auer Precision, in collaboration with PortaScience, has developed the microfluidic technology to perform in-line blood separation at faster rates than commercially available today. Measurement rates <1 minute are now possible with this innovative design. The microfluidic design possibilities are extensive. Contact Auer today. *In development. Booth No. 1320


AutoGenomics, Inc.


The three forms of vaginitis—bacterial vaginosis, candidiasis, and trichomoniasis—account for more than 19 million doctors' visits each year. As it has been observed that up to 30% of patients with initial responses to therapy will experience a recurrence of symptoms within 3 months, the need for new monitoring tools is on the rise. The INFINITI® Resolve QUAD simultaneously detects Gardnerella vaginalis, Mobiluncus spp, Trichomonas vaginalis, Candida albicans, and Candida glabrata. The test is automated on the INFINITI® platform with simplified load-and-go automation, processing four patient samples on one microarray. *Not for use in diagnostic procedures; for research use only. Booth No. 2415

INFINITI® Multi Patient Arrays

With the advent of higher-throughput, highly multiplexed diagnostic technologies, the next frontier in enhancing laboratory workflow comes from the ability to combine multiple test processes into a single step. INFINITI® Multi Patient Array technology enables simultaneous processing of multiple discreet samples for highly multiplexed panels on a single microarray. These panels are automated on the INFINITI® platform with simplified load-and-go automation and can process anywhere from two to six samples on each BioFilmChip®. This technology is currently available for HPV detection and various pharmacogenomic panels. Booth No. 2415

INFINITI® High Throughput System

The INFINITI® System is an automated multiplexing platform that provides load-and-go automation for a broad spectrum of more than 50 applications. Using a novel BioFilmChip microarray, these tests can be run on various INFINITI® family analyzers. The INFINITI® High Throughput System is the newest addition to the INFINITI® family of platforms that brings high-throughput molecular automation to the bench top. The system comprises of two instruments and is capable of processing up to 500 multiplexed assays in just 8 hours with less than 30 minutes of combined hands-on time from DNA to result. Booth No. 2415


Beckman Coulter, Inc.

Prostate Health Index (phi)

phi is a new, simple blood test for better prostate cancer detection. Three times more specific in detecting prostate cancer than PSA testing alone, phi delivers more accurate information on what an elevated PSA level might mean and the probability of finding prostate cancer on biopsy. This specificity allows for a substantial decrease in the number of prostate biopsies that are negative for cancer. Booth No. 4751

REMISOL Advance v1.7

REMISOL Advance™ data management system from Beckman Coulter is a unique software product that consolidates patient test information from multiple instruments in the lab or from multiple labs in the hospital network. It streamlines laboratory workflow as well as the result-management process, offering an optional Extended Quality Control (EQC) module that enhances the laboratory quality control process even further. The latest version of REMISOL Advance™, v1.7, features a 166% increase in sample processing throughput and a 122% increase in sample data storage from the previous version. With increased device connectivity, up to 128 devices can now be connected to a single server compatible with third party instruments. REMISOL Advance is a trademark of Normand-Info SAS. Booth No. 4751

UniCel DxH 600

Building on Beckman Coulter's proven cellular analysis technology, the new UniCel DxH 600 Coulter Cellular Analysis System provides laboratories with exceptional quality results to reduce overall manual review rates and processes. By reducing the time spent on the manual reviews, the new analyzer frees busy lab technicians to focus their time on quickly and accurately reporting patient results, improving patient health, and reducing the overall cost of care. With the same technology, user interface, advanced software, and consumables as the UniCel DxH 800, the DxH 600 brings true standardization of results and process to the hematology lab, reducing the amount of required training for technicians and simplifying inventory management. Booth No. 4751

Access AccuTnI+3 for Access 2 Immunoassay System

The AccuTnI assay has a long history of proven clinical performance in the diagnosis of myocardial infarction (MI). The new Access AccuTnI+3 assay was evaluated through an extensive prospective clinical trial that enrolled over 1,900 subjects, and confirmed that our assay provides the clinical performance you need for optimal patient management. The AccuTnI+3 assay delivers the precision, and the clinical sensitivity and clinical specificity that are necessary to assist physicians with the diagnosis of MI. Booth No. 4751


BioAssay Works, LLC

QuickQuantMouse IgG Quantification Kit

BioAssay Works® has introduced a new, 5-minute test to monitor mouse-IgG production in cell-culture or ascites. For ongoing monoclonal production, the QuickQuant™ kit enables effective and easy mouse-IgG quantification and monitoring, both in cell-culture supernatant and ascites fluid. This kit reduces labor time from the traditional ELISA day-long procedure to a 5-minute assay. The Iso-Gold™ Mouse-Monoclonal Isotyping Kit determines the class, subclass, and purity of the monoclonal antibody, and the assay can be used on both tissue culture supernatant and ascites. Booth No. 3662


Bio-Rad Laboratories

BioPlex® 2200 APLS IgG, IgM*, and IgA Kits*

Bio-Rad Laboratories' BioPlex® 2200 APLS IgG, IgM, and IgA kits are the first and only fully automated, random-access multiplex kits for the semi-quantitative detection of IgG, IgM, and IgA antibodies to cardiolipin and beta-2 glycoprotein I (ß2GPI). These kits aid in the diagnosis of antiphospholipid syndrome (APS). Clinical specificity is maximized by setting the cutoff according to the Miyakis consensus guidelines of 2006 using the 99th percentile of a normal, healthy population. Enhance your laboratory workflow efficiency with throughputs up to 200 tests/hour and time-to-first result of 45 minutes. These kits join an expanding menu of autoimmune and infectious disease tests on the BioPlex® 2200 system. *Pending FDA clearance. Booth No. 3929

BioPlex® 2200 Celiac IgA and IgG Kits*

Bio-Rad Laboratories' BioPlex® 2200 Celiac IgA and IgG kits are random-access, fully automated tests that aid in the accurate and timely diagnosis of celiac disease. The key diagnostic tests, anti-tissue transglutaminase (tTG) and anti-deamidated gliadin peptide (DGP), are multiplexed in two test kits for the simultaneous measurement of IgA or IgG autoantibodies. The IgA kit includes an IgA Verification Bead (AVB) to accurately identify IgA deficiency. This condition is more prevalent in celiac disease and can complicate the interpretation of Celiac IgA serology results in traditional methods. Workflow efficiency is enhanced with a throughput of up to 200 tests/hour, time-to-first result of 45 minutes, and a small sample size of 5 µL. *Pending FDA clearance. Booth No. 3929

EQAS® Programs

Bio-Rad Laboratories expands its EQAS® Programs by offering five new, fully accredited programs. These external quality assessment programs allow for the quantitativereporting of important markers associated with respiratory disease, coagulation disorders, cardiac health, normal to abnormal/toxic levels of serum ethanol and ammonia, and a full range of lipid profile tests. As a program participant, you test one of 12 blind samples each month throughout a year-long cycle. Your lab's test performance is assessed against an international participant base, using a robust statistical analysis. Results are presented in informative, easy-to-interpret monthly and annual reports. Booth No. 3929


Optimized for smart phone devices, Bio-Rad's industry-leading software programs are now available to you from any location. QCNet Mobile provides convenient access to Bio-Rad's QCNet™, Unity™, EQAS®, and Electronic My eInserts™ services. From the palm of your hand you can submit EQAS proficiency and unity interlaboratory data, view peer report data, retrieve electronic insert means and ranges for your QC products, access QC product information, and view QC educational and support materials. Booth No. 3929

LiquichekCardiac Markers Plus Control LT

Bio-Rad, the QC market leader, 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 the platform they are using. All Levels now include values for BNP as well as NT-proBNP. Booth No. 3929

Liquid Assayed Multiqual® Premium*

Liquid Assayed Multiqual® Premium is a human serum-based, comprehensive chemistry control that includes general chemistry, immunology, and therapeutic drug monitoring analytes. This liquid control is available in a 5-mL fill size with three distinct levels and offers 96 analytes, including CRP, vancomycin, and GLDH*. Value assignment is provided for major integrated instrument platforms. Multiqual® Premium offers a 3-year shelf life when stored at -20ºC to -70ºC, and 14-day open vial stability for most analytes when stored at 2ºC to 8ºC. *Available only outside the U.S. Booth No. 3929

LiquichekWhole Blood Immunosuppressant Control

The new Liquichek™ Whole Blood Immunosuppressant Control provides four levels to monitor precision of immunoassay and chromatographic diagnostic techniques used for immunosuppressant drug testing. This convenient liquid, whole blood-based product contains everolimus and other popular drugs used in organ transplantation. The control is featured in the Unity™ Interlaboratory Program. Booth No. 3929

Bio-Rad Controls in Dimension Vista® Vials

Bio-Rad, the QC market leader, offers a comprehensive line of multi-analyte quality controls filled in Vista® vials for use on Siemens Dimension Vista® Instruments. These liquid assayed controls with validated QC stability claims for storage onboard the instrument allow for routine quality control of Vista assays. 2D vial and IFU bar codes provide automatic download of lot information and insert data for ease-of-use. Bio-Rad controls in Vista vials are supported by the Unity™ Interlaboratory Program. Booth No. 3929


Biotron Diagnostics USA

Biotron Sickle Cell Controls

Biotron Diagnostics USA now offers FDA-approved, updated state-of-the-art formulation sickle cell controls. The positive (A/S heterozygous) and negative (A/A homo-zygous) sickle cell test controls offer long stability, high accuracy and sensitivity, and excellent compatibility with most manufacturers including price advantage to other brands. Sensitivity correlates with hemoglobin electrophoresis. A positive test while using sickle cell solubility test is indicated by a cloudy turbid suspension through which the black lines are not visible, indicating the presence of sickling hemoglobin (Hb-S). The negative test for sickling hemoglobin is indicated by a transparent suspension through which the black lines are clearly visible. Booth No. 2452


Carolina Liquid Chemistries Corp.

K2/Spice Assay on the CLC720 Analyzer

The CLC720® Chemistry Analyzer now offers the K2/Spice Assay. Synthetic cannabis does not produce a positive result using current drug tests for cannabis. Now it is possible to detect synthetic cannabis's metabolite in human urine, on the CLC720 Chemistry Analyzer for large clinics, small hospitals, and reference laboratories. The CLC720 is capable of performing more than 80 tests, ranging from CMPs and BMPs to liver, kidney, and lipid panels, and more. Capable of 560 tests/hour with ISE, the CLC720 is smaller and quieter than similar analyzers, and uses less water, space, heat, electricity, reagents, and consumables. Intended for forensic use only. Booth No. 4534



CellaVision Proficiency Software

Create a lab full of morphology experts with our new product. CellaVision Proficiency Software is a new, sophisticated web-based program for proficiency testing of blood and body fluid differentials. The program works as a tool for both internal and external quality assurance and can be used by individual laboratories, universities, and external quality assurance organizations. Explore benefits such as standardized differentials, improved morphology expertise, and ensured quality throughout the organization. CellaVision Proficiency Software is quick to set up and easy to use, and can be accessed from any computer and any location. Simply open a web browser and log in to your account. Visit our website to create your free trial account. Booth No. 2545


CompuGroup Medical

CGM Endeavor—Reference Lab Information System

The developers of LabDAQ Laboratory Information System (LIS), CompuGroup Medical (CGM), introduce an LIS solution designed specifically for the reference laboratory. CGM Endeavor is built on the Oracle database, resulting in a scalable solution that allows your laboratory to grow without limits. CGM Endeavor's outreach tools provide the ability to efficiently receive orders and disseminate results in real time. The cloud-based web portal and interface services provide direct connectivity to EHRs, allowing you to focus on your business. Reference laboratories have the ability to connect with unlimited providers. CompuGroup Medical is your connectivity partner to assist in extending your laboratory services to reach a larger client base. Booth No. 2153




SkyLAB752 is a next-generation, open platform, automated ELISA analyzer. Three independent arms perform dual pipetting, washing, and reading, generating a higher throughput than any unit available today. A full plate is pipetted in 8 minutes. Liquid level and bubble detection help ensure a quality run. On board are six 2-L buffer bottles and an 8-L waste container. Twelve different assays can be performed in the same run or 384 samples with one assay. A high-quality inexpensive LED lamp reads to 3.5 OD. Internet-connected remote diagnostics also allows for remote operations by our service department, allowing for software updates and pipette head alignment. Booth No. 3009



Adiponectin Assay Kit*

Introducing a latex-enhanced turbidimetric immunoassay for the fast and easy determination of adiponectin levels in blood samples. Our new assay does not require off-line sample pre-treatment or pre-sample dilution, and it can produce results in 10 minutes, much quicker than existing ELISA kits. The test uses polystyrene particles coated with anti-human adiponectin that form a complex with adiponectin present in blood serum or plasma samples and that can be measured with routine clinical chemistry analyzers. *Pending FDA clearance. Booth No. 4053


Diazyme Laboratories

D-Dimer Assay

The Diazyme D-Dimer Assay (in vitro diagnostic use only) is for the quantitative determination of fibrinogen/fibrin degradation products (D-dimer) in human plasma. Measurement of D-dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. Diazyme's D-Dimer Assay is based on a latex-enhanced immunoturbidimetric assay. D-dimer proteins in the sample bind to the specific anti-D-dimer antibody, which is coated on latex particles and causes agglutination. Booth No. 4613


Dynex Technologies Inc.

Dynex Agility: Revolutionizing ELISA Processing

Dynex invented the microplate 50 years ago and continues to innovate with ELISA technology with the release of the Agility™ automated microplate processing system. This revolutionary open system uses state-of-the-art robotics and automated data entry, processing up to 12 microplates at once and delivering unparalleled precision while eliminating nearly all manual steps. Up to 16 bar-coded SmartKit™ assays can be loaded onboard, greatly improving throughput without sacrificing extra bench space. These pioneering advances reduce technician time and the potential for costly data entry errors, while improving ease-of-use and enhancing the product offerings of ELISA reagent kit manufacturers. Booth No. 2753




The MEDICA® Pro EDI is specifically designed to meet the water needs of high-performance, high-volume single or multiple clinical diagnostic analyzers and incorporates electrodeionization (EDI) technology. The system delivers 4 L/minute of CLSI CLRW water with up to 60 or 120 L/hour productivity. The single system design incorporates all the water purification components plus a 50-L storage reservoir to ensure a very quick and cost-effective installation. Space-saving design plus economic and guaranteed performance at all times, including self-monitoring software with built-in emergency by-pass, allows uninterrupted operation 24 hours/day. Booth No. 5450



CueSee® BGEM LVM/Hypoxic Complete

CueSee® BGEM LVM/Hypoxic Complete is designed to verify the reportable range of blood gases, electrolytes, and metabolites on any blood gas instrument. It includes five levels of an aqueous quality control material as well as an extra-low pO2 control, with all target levels spanning clinically significant ranges. The pO2 and pCO2 ranges are further optimized to achieve levels higher than any traditional blood gas controls. With the Hypoxic level, the extreme low end of the reportable range is also validated. This product also includes CueSee Online, a free online data submission program for peer comparisons, statistics, and graphical presentations. Booth No. 2424


CueSeeVeriSTAT® all-in-one quality control products with pH, blood gases, electrolytes, metabolites, and hematocrit contains an added blue dye for ease-of-use. Designed for i-STAT analyzers, the products eliminate the need to use two separate cartridges with each control check, cutting time and costs. The product line is available in three levels of QC as well as a five-level AMR/calibration verification panel. CueSee VeriSTAT has optimal target ranges, long shelf life, and room temperature stability, all with extremely competitive pricing and personal customer service. A free online data submission program is also included for peer comparisons, statistics, and graphical presentations. Booth No. 2424

ACU-Drop® II

ACU-Drop® II is a unique, patented packaging form that is revolutionizing quality control in the IVD market. The dual-chambered device keeps various fractions separated, preventing reactions between components of the desired matrix. When ready, the user simply pushes a button to allow the fractions to combine. Then the user mixes the fractions and the sample is ready to use, either from the built-in dropper bottle or by attaching a syringe. This concept is ideal for creating liquid matrices that mimic human specimens as closely as possible and are suitable for quality control, calibration verification, proficiency testing, competency assessment, method validations, and lot comparisons. Booth No. 2424


GG&B Company

MGS-80 Fully Automated Gram Stainer

Place one to 80 fixed slides on the slide carrier, push a button, and walk away. The slides exit automated staining chambers dry and ready to view. The MGS-80 features a self-cleaning cycle and calibrates after every test. It includes a patented electro-optical eye for accurate decolorization of any biological material regardless of sample thickness or type. Currently, the platform is designed for gram staining with a throughput of 70+ slides/hour, but it can be adapted for all other staining formats using a modified decolorization step. Available August 2013 for hospital and reference labs. Booth No. 4524


Gilson, Inc.


PIPETMAX provides multichannel, automated sample preparation using disposable tips in a compact footprint. Gilson PIPETMAX is a revolutionary, automated liquid-handling platform that addresses training issues, procedural variability and errors, operational costs, and preparation time. Unlike traditional automation platforms, PIPETMAX comes at a size and price appropriate for many clinical assays. It is suitable for preparing genomic and cell-based assays in a small, affordable pipetting station. *Not for use in diagnostic procedures; for research use only. Booth No. 5335


Gold Standard Diagnostics

Borrelia burgdorferi B31 Lyme Confirmation Blots

Improve Lyme disease confirmation testing with easy-to-use Borrelia burgdorferi Lyme Line Immunoassay (LIA) blots from Gold Standard Diagnostics! The FDA-cleared line blots offer excellent specificity and consistency for detection of both IgG and IgM Borrelia antibodies. Highly purified Borrelia antigens are precisely printed on each strip allowing easy and accurate interpretation using manual processing or automated digital pattern recognition software. Compared to traditional Western blots, the GSD LIA strips offer easy automation, simple procedure, intuitive interpretation, large lot sizes, easy handling, and sharply-defined antigen strips. Experience the benefits that GSD's Lyme blots will bring your laboratory today! Booth No. 4411


IMRA America, Inc.

i-colloid: Surfactant-Free Colloid Gold*

IMRA America, Inc. introduces i-colloid, a high-purity gold nanoparticle colloid fabricated with a laser material-processing method free of surfactant and other chemical reagents. The naked gold nanoparticle surface and high-purity solvent enable high-efficiency bio conjugation with controllable loadings of multiple ligands including PEG, peptide, and other biomolecules. Available in both water and organic solvents, this product is suitable for immunoassay, SERS, and in vivo application research. *Not for use in diagnostic procedures; for research use only. Booth No. 3867



ProTime InRhythm*

The ProTime InRhythm™ System is an in vitro diagnostic device for the quantitative measurement of prothrombin time international normalized ratio (PT/INR) from fingerstick whole blood or fresh venous whole blood collected with no additives. The test system is intended for professional use in the management of patients treated with oral vitamin K antagonist therapy. The ProTime InRhythm System employs a proprietary multi-channel analysis and clot detection technology designed for superior accuracy and reliability across the reportable range, strengthening clinician confidence in test results. *Pending FDA clearance. Available only outside the U.S. Booth No. 5427


Kawasumi Laboratories America, Inc.

Winged Blood Collection Set

The K-Shield® Advantage Winged Blood Collection Set with pre-attached tube holder provides a safe collection environment for both clinicians and patients, with an integrated safety device that eliminates any extra steps for disposal. It has a fast and simple one-step activation with an audible click, ensuring that the needle is covered during removal, as well as ensuring confidence in safety. With a siliconized-coated needle for easy insertion and one of the sharpest needles in the industry, it is significantly more comfortable for the patient than competitive products—as well as being extremely cost-effective! Booth No. 5651



Voltage-Gated Calcium Channel Antibody RIA Kit

KRONUS® has been a leading provider of specialized immunoassay test kits to clinical and research laboratories for more than 25 years. The company's product offerings include the Voltage-Gated Calcium Channel Antibody (VGCCAb) RIA Kit for the semi-quantitative determination of antibodies to voltage-gated calcium channels in human serum (P/Q type). The VGCCAb RIA Kit is FDA cleared and useful for measuring VGCC antibodies to distinguish between Lambert-Eaton myasthenic syndrome and myasthenia gravis. The assay result is intended to be used in conjunction with other clinical and laboratory findings. Booth No. 3934

Steroid 21-Hydroxylase Antibody RIA Kit

KRONUS® has been a leading provider of specialized immunoassay test kits to clinical and research laboratories for more than 25 years. The company's product offerings include the 21-Hydroxylase Antibody (21-OHAb) RIA Kit for the semi-quantitative determination of antibodies to steroid 21-hydroxylase in human serum. The 21-OHAb RIA Kit is FDA cleared and may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune polyglandular syndrome type I or II. The assay result is intended to be used in conjunction with other clinical and laboratory findings. Booth No. 3934


Lampire Biological Laboratories, Inc.

Customized Human Plasma

Lampire Biological Laboratories, Inc., global supplier to the healthcare industry, announces the addition of custom human sera panels, bulk sera panels, and normal and disease-state plasma and sera to our products and services catalog. Materials may be purchased singly or through standing orders per customer requirements and specifications. Primary sources are through our contracted FDA-approved collection centers nationwide. Booth No. 4607


LGP Consulting, Inc.

KapSafeAutomated Recapper

The new KapSafe™ Automated Recapping System, now available to recap tubes in ADVIA Centaur® racks, is an automated, pneumatics-free, high-speed bench-top recapper that safely and automatically recaps tubes for storage or archiving. The small footprint KapSafe System (24" w. x 24" d. x 33" h.) automatically recaps standard vacuum collection tubes (13–16 mm diameter, 75–115 mm height) at speeds up to 1,200 tubes/hour. The KapSafe protects lab workers from repetitive motion injuries and provides walk-away operations with an input capacity up to 20 multiple types of racks, including Beckman AU®, Roche Cobas®, Abbott Architect®, or ADVIA Centaur, with various-sized tubes. Booth No. 1543


LipoScience, Inc.

Vantera® Clinical Analyzer

Your lab's advantage in a new era of NMR diagnostics, the Vantera® Clinical Analyzer measures the number of low density lipoprotein particles (LDL-P) in serum and provides actionable information to manage cardiovascular disease risk. It is the first FDA-approved NMR-based analyzer designed specifically for the clinical laboratory. Vantera simultaneously reports out multiple lipoprotein analytes without any assay-specific reagents, requires no special knowledge of NMR to operate, and is designed for low maintenance and seamless lab integration. It uses clinically proven technology backed by more than 9 million NMR LipoProfile® tests. Vantera provides a scalable platform to drive future assays for diabetes and other metabolic disorders. Booth No. 5535


Luminex Corporation

xTAG® Gastrointestinal Pathogen Panel on MAGPIX® System

Current testing to diagnose the many potential causes of infectious diarrhea is spread across multiple laboratories and testing methods often lead to long turnaround times that hamper proper patient care. The xTAG GPP assay is a 5-hour comprehensive molecular test that rules out >90% of the infectious causes of diarrheal disease. Laboratories can obtain results for 11 pathogens using a streamlined workflow that eliminates the complexity of managing multiple samples and test methods. The assay is cleared for use on both the Luminex 100/200™ and the new MAGPIX systems. Booth No. 4539

xTAG® CYP2D6 Kit v3 on Luminex® 100/200System

Genotyping of the cytochrome P450 2D6 gene allows physicians to consider a patient's unique genetic information in selecting the right medications and appropriate doses for a variety of common conditions, such as cardiac diseases, pain, depression, and cancer. The xTAG® CYP2D6 Kit v3 is a comprehensive genotyping assay that offers reliable testing for CYP2D6 genotypes. The test is used as an aid to clinicians in determining treatment strategy for therapeutics that are metabolized by the CYP2D6 gene product. The assay is FDA-cleared for in vitro diagnostic use on the Luminex® 100/200™ xMAP® system, a multiplexing analyzer that provides users throughput advantages and menu flexibility. Booth No. 4539


MediaLab, Inc.

InspectionProof Web-Based System

With InspectionProof from MediaLab, you'll be ready for an inspection no matter when it happens. Upload your inspection checklists and provide your responses with our easy-to-use web-based system. There's no software to download and no hardware to maintain. Complete your inspection checklists by providing text responses, uploading supporting files, and linking to policies and procedures in Document Control. By inspection time, you're organized, up-to-date, and 100% prepared. Booth No. 4558

Document Control System

Document-related errors are the most commonly cited CAP deficiency, and a paper-based system is inconvenient and prone to costly errors. Make it a priority to start using MediaLab's web-based Document Control system in your laboratory. Document Control automates the tedious tasks associated with procedure approval, revision, and signoff, leaving you and your employees free to focus on your primary duties. Never miss an important deadline or signature—Document Control doesn't let anything fall through the cracks. Document Control is affordable for any size laboratory, starting at just $695/year. Booth No. 4558


Medica Corporation

Competency Review Software for EasyCell® Assistant

EasyCell® Assistant Competency Review software is now available on the EasyCell® assistant. This new software provides hematology supervisors with a built-in tool—no additional software or internet connection required—to evaluate technologists' expertise in classifying WBCs and evaluating RBC morphology. Instructors can now create a set of slide files from the laboratory's own slides for competency assessment. 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. Booth No. 1324

Full-Range C-Reactive Protein (frCRP) Assay*

The new Full-Range C-Reactive Protein (frCRP) Assay for the EasyRA® Analyzer measures C-reactive protein. The extended reporting capability of the frCRP Assay improves efficiency and saves time using one method for both low and elevated CRP concentrations. The frCRP Assay is the first of several specific protein assays in development for use on the EasyRA®, a fully automated clinical chemistry analyzer used in low-to-moderate volume hospital and physician office laboratories. The EasyRA® features an intuitive icon-driven user inter-face, touchscreen monitor, and onboard RFID technology that simplifies reagent inventory management. The EasyRA® sets a new standard in its class with a combination of unprecedented ease-of-use, intuitive UI, and limited maintenance. *Pending FDA clearance. Booth No. 1324

ISE Cartridge System Na+/K+Cl/Ca++

The ISE Cartridge System Na+/K+Cl/Ca++ for clinical chemistry analyzers is an electrode measurement system for the determination of sodium, potassium, chloride, and ionized calcium. All electrodes are in one sensor cartridge for easy, rapid replacement. The integral sample cup is changed automatically with the sensor cartridge for greater reliability. The disposable ISE cartridge can be configured for small-to-medium-to-high throughput chemistry applications. Medica's experience and expertise are unmatched, with over 5,000 modules in use on more than 30 clinical chemistry analyzer platforms from over 15 manufacturers worldwide. Medica Corporation's OEM ISE Module is considered to be the standard for integrated electrolyte systems. Booth No. 1324


Operon, S.A.

HLA B27 Strip*

Based on a reverse dot blot technique, the HLA B27 Strip test allows the determination of the HLA B*27 alleles. All the reagents are included in the kit, even the Taq polymerase. A visual determination with the help of a template allows easy interpretation of the results. The kit should be transported and stored at 2–21ºC. The HLA B*27 group of alleles has been associated with a wide range of pathologies, such as ankylosing spondylitis in 88–95% of patients, acute anterior uveitis in 50–60% of patients, reactive arthritis in 60–85% of patients, and inflammatory bowel disease in 50–60% of patients. *Available only outside the U.S. Booth No. 2551

Norovirus Lateral Flow Test (Strip & Cassette)*

Norovirus is a rapid immunochromatographic test for the qualitative detection in independent bands of genogroup I and genogroup II in human feces. Compared to other tests on the market, it's extremely quick, requiring 10 minutes for sample preparation plus 15 minutes for reading results. The easy procedure does not require special equipment, and involves dissolving the stool sample in a buffer and adding a quantity of the supernatant to the strip. Colored bands also make result interpretation easy. *Available only outside the U.S. Booth No. 2551


Ortho Clinical Diagnostics

ORTHO Lx SolutionsSM

Lx SolutionsSM unites two well-established product offerings—the value and productivity of VITROS® Products and Services working in concert with ValuMetrix® Consulting Services. Together, they represent a unique customer offering that differentiates Ortho Clinical Diagnostics as a provider of products and services to enable clinical laboratories the ability to take more control of their destiny in a challenging and evolving healthcare world. Our guaranteed outcomes approach can include focus on ROI, turn-around times, space-savings, construction cost avoidance, and total operating cost, in addition to improved productivity, reductions in tech time, and capacity for growth. Learn more at the Ortho Clinical Diagnostics booth. Booth No. 4229

ORTHO PLUSSM Inventory Management

What is it? An innovative software product designed to help customers optimize the planning and replenishment of VITROS® system reagents and consumables. Thesoftware remotely monitors reagent use and tracks on-hand inventory, automates reagent and consumable order recommendations, and proactively alerts you about potential inventory shortages. ORTHO PLUSSM Inventory Management transitions the supply chain activity from a reactive and unpleasant experience to an efficient and predictive state. Learn more at the Ortho Clinical Diagnostics booth. Booth No. 4229

VITROS® 25-OH Vitamin D Total Assay

VITROS® 25-OH Vitamin D Total Assay is intended for the in vitro quantitative measurement of total 25-OH Vitamin D in human serum using the VITROS® ECi/ECiQ Immunodiagnostic Systems, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 5600 Integrated System. The assay provides an accurate, complete Vitamin D test that provides healthcare providers with confidence in patient results while providing laboratories with a test that can be easily integrated into their current workflow on a single, broad menu system. Results are used in the assessment of a patient's vitamin D sufficiency. Booth No. 4229


Parker Hannifin, Precision Fluidics Division

Parker Smart Syringe Pump

At one third the size and less than one fourth the weight of standard 30 mm-syringe pumps, the Parker Smart Syringe Pump improves the performance and accuracy of clinical diagnostic and analytical chemistry systems. This long-life pump is rated to a minimum of 5 million cycles, which improves system reliability and reduces costly downtime. Its lightweight and compact size enables smaller instrument designs, decreasing instrument costs and footprint. Engineers can simplify their fluidic controls by mounting a probe directly on the pump, which they can then mount on a motion system. This removes any transfer tubing between the pump and probe and eliminates performance losses due to long transfer lines. Booth No. 1511



Laboratory Courier Management Solution

Path-Tec™ has developed a low-cost, user-friendly, laboratory-specific courier management solution that addresses all the unique challenges that laboratories face in tracking samples, supplies, and couriers. This web-based solution assists laboratories in effectively managing all of the critical specimen collection functions, such as courier scheduling, route management, supply tracking, specimen tracking, and reporting. This convenient software includes an intuitive mobile application that provides real-time information to track couriers and improve courier routing, tracking, and communication. Laboratories can improve client service, tracking, and courier performance using a solution that is cost-effective and built specifically for them. Booth No. 1322


PlexBio Co., Ltd.


Maximize lab resources by leveraging PlexBio's cutting-edge multiplex bioassay platform. Not only will our innovative IntelliPlex™ suspension array technology help researchers make the most of precious samples, but it will also save labor and reagents by generating more data points at a time. Probes or antibodies can be conjugated to bar-coded magnetic beads (BMB) with different bar code numbers corresponding to different analytes. The BMB are then mixed together and reacted with samples and fluorophores. The DigiPlex™ analyzer quickly and accurately decodes each BMB in a 96-well plate, combining the bar code information with reporter intensity to produce biomolecular reactivity of each analyte for up to 96 samples at a time with up to 128 available bar codes. *Not for use in diagnostic procedures; for research use only. Booth No. 1907


Pointe Scientific

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 400/480/640 chemistry analyzers. The Pointe Scientific reagents are liquid-stable and 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. Booth No. 3837

NEW HbA1c Reagent, Stabilized R2 Component

Pointe Scientific introduces an improved reagent for the determination of HbA1c on general chemistry analyzers. The methodology still uses a highly specific monoclonal antibody to HbA1c with HbA1c determined by immunoturbidimetric analysis. The R2 has been stabilized so that it is now ready to use, eliminating the need to mix two separate R2 components. Automated hemolysis can be performed on many chemistry analyzers providing a totally automated test system. The Pointe Scientific reagents are liquid-stable and have been shown to be accurate and precise. NGSP-certified calibrators and HbA1c controls are also available. Booth No. 3837


Polymedco Cancer Diagnostic Products, LLC

OC-Sensor IO*

The latest in automated FIT analyzers, the OC-Sensor IO is used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps, and colitis. Its features include: full automation; the ability to run 88 tests/hour; a 5,000-sample memory; sample bar code reader; a 5.7 inch touch panel LCD display; closed sampling bottle; and LIS capability. Increase your lab's productivity, remove subjectivity in reading results, and automatically update patient records with the OC-Sensor IO. The compact design is ideal, with a 14.2 inch width, 22.1 inch depth, and 16.7 inch height, and is easy to implement. Samples are completely closed and laboratorians will never come in contact with the patient sample. *Pending FDA clearance. Booth No. 4204


Polymedco, Inc.

Sedimat® 15 Plus Reader

The Sedimat 15 Plus is an automated 15-minute ESR reader. This random access ESR reader has eight tube positions and the capability to perform 32 tests/hour. The small footprint is ideal for any workstation. A bar code reader is also available. Results can be printed or transferred to the LIS system. Booth No. 4207



Simoa HD-1 Analyzer*

Quanterix' Simoa™ HD-1 Analyzer is a fully automated, ultra-sensitive immunoassay platform. The proprietary single molecule array (Simoa) technology at the heart of the instrument's operation uses a digital form of ELISA, in which target analyte molecules are individually trapped and counted, delivering a 1,000-fold increase in sensitivity over existing immunoassays and routinely reaching femtomolar limits of detection. The Simoa HD-1 Analyzer can run multiplex panels up to 10-plex, and also can accommodate sample volumes as low as 1 µL. The instrument is designed for extreme ease-of-use, with an intuitive user interface and true walk-away capability, and can run 500 samples/day. *Not for use in diagnostic procedures; for research use only. Booth No. 1504


Roche Diagnostics

cobas® KRAS Mutation Test RUO*

This research-use-only real-time PCR test is for the qualitative detection of mutations in codon 12/13 sequence in exon 2 and codon 61 sequence of exon 3 of the KRAS gene in DNA derived from formalin-fixed, paraffin-embedded tissue samples of human tumors. For use with the cobas® 4800 system, the test provides up to 45 results in 8 hours, with automated result interpretation and test reporting for consistent, objective, and reproducible results. It has broad mutational coverage and minimal tissue requirements. *Not for use in diagnostic procedures; for research use only. Booth No. 4049

cobas® EGFR Mutation Test RUO*

This research-use-only real-time PCR test is used for the qualitative detection and identification of mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor gene in DNA derived from formalin-fixed, paraffin-embedded tissue samples of non-small cell lung cancer. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection. The test provides up to 30 results in 8 hours, with automated result interpretation and test reporting for consistent, objective, and reproducible results. It has broad mutational coverage and minimal tissue requirements. *Not for use in diagnostic procedures; for research use only. Booth No. 4049

cobas® PIK3CA Mutation Test RUO*

This research-use-only real-time PCR test is for the qualitative detection and identification of mutations in exons 1, 4, 7, 9, and 20 of the phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene in DNA derived from formalin-fixed, paraffin-embedded tissue. For use with the cobas® 4800 system, the test provides up to 30 results in 8 hours, with automated result interpretation and test reporting for consistent, objective, and reproducible results. It has broad mutational coverage and minimal tissue requirements. *Not for use in diagnostic procedures; for research use only. Booth No. 4049

Roche Elecsys HE4 Assay

An immunoassay for the quantitative determination of HE4 in human serum and plasma, this test is used as an aid in monitoring the recurrence or progression of disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 values should be used in conjunction with other clinical findings used for monitoring ovarian cancer. This assay is intended for use on the cobas e 411, cobas e 601, cobas e 602, Elecsys 2010, and MODULAR ANALYTICS E 170 analyzers. Booth No. 4049

Roche cobas c Homocysteine (HCYs) Assay

Designed for the in vitro quantitative determination of total L-homocysteine in human serum and plasma, this test can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria. The total homocysteine represents the sum of all forms of homocysteine including oxidized, protein-bound, and free. This assay is intended for use on the cobas c 311, cobas c 501, and cobas c 502 analyzers. Booth No. 4049

Tina-quant lipoprotein(a) (Lp(a))

An in vitro test for the quantitative determination of lipoprotein(a) in human serum and plasma, this assay is intended for use on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. Booth No. 4049

HbA1cDx Gen 3*

This test is to be used as an aid in the diagnosis of diabetes and identifying patients who may be at risk for developing diabetes. The HbA1cDx, Gen 3 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the cobas c 501 clinical chemistry analyzer. HbA1c determinations are useful for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. This new claim is pending FDA clearance. *Pending FDA clearance. Booth No. 4049

ACCU-CHEK® Inform II System

Roche introduces the first POC blood glucose device to offer meter-level wireless technology for accurate, real-time patient data transfer. The test strip and meter deliver accurate, reliable test results in 5 seconds with no maltose, xylose, or oxygen limitations and have an expanded hematocrit range of 10% to 65%. The meter has a touch screen and features enhanced patient ID, Other Test Entry, under dose protection, and centralized control of strip lot data. The easy-to-clean, durable housing meets the new FDA-, CMS-, and CDC-recommended guidelines for POC blood testing, cleaning, and disinfection. Booth No. 4049

cobas b 123 POC System

Roche introduces its next generation in blood gas technology, uniquely designed to provide optimal reliability for hospital point-of-care settings. The mobile analyzer features a four-level clot protection system that helps prevent downtime caused by the introduction of clots that lead to reagent pack failures, taking time away from the patient and wasting usable reagents. The reagent pack requires no refrigeration and includes smart chips that allow the packs to be easily transferred between like devices and help hospitals control material and labor costs. It has a broad assay menu including lactate and fast sample processing time for laboratory class results. Booth No. 4049

CoaguChek® XS Plus System

Roche announces CLIA-waived status for its handheld meter for PT/INR testing at the point-of-care. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing. The system offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities or through the POCT1A standard data transfer protocol. Implementing connectivity enables data transfer and reporting capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve organizational efficiency. Booth No. 4049

COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is the first FDA-approved, standardized, fully automated cytomegalo virus test capable of delivering accurate and reliable CMV viral load results to clinicians for use in critical treatment decisions for solid-organ transplant patients. It can quantitate CMV DNA over the range of 137–9,100,000 IU/mL with full traceability to the first WHO International Standard for CMV. The Roche test provides clinical value for baseline testing and therapeutic monitoring of patients with CMV disease based on clinical data generated from studies utilizing a well-characterized transplant patient population. Booth No. 4049

COBAS® AmpliPrep/COBAS® TaqMan®HCV Test, v2.0

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 is a next-generation viral load test designed to accurately determine the amount of hepatitis C virus RNA and to help clinicians assess a patient's response to antiviral therapy. The new Roche test uses a novel dual-probe design with built-in redundancy that provides an additional layer of protection to keep pace with the rapidly changing hepatitis C virus and treatment landscape. In addition to broad genotype coverage, the test also offers tight precision at clinically relevant decision points and efficient workflow for laboratories on a proven, fully automated platform. Booth No. 4049

HbA1cDx Gen 2

This test is to be used as an aid in the diagnosis of diabetes and identifying patients who may be at risk for developing diabetes. The HbA1cDx, Gen 2 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the COBAS INTEGRA 800 clinical chemistry analyzer. HbA1c determinations are useful for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. This is the first HbA1c test that FDA has allowed to be marketed for this use. Booth No. 4049


SCC Soft Computer

Holomic Rapid Diagnostic Reader HRDR-200

The Holomic Rapid Diagnostic Reader HRDR-200 is an economical handheld reader that enables more reliable lateral flow immunoassay tests, instant access to electronic health records, and real-time, wide-area diagnostic data collection. It is ideal for point-of-care, telemedicine, and public health monitoring, and available for qualitative, quantitative, and fluorescent applications. For rapid test manufacturers and vendors, HRDR-200 will improve accuracy of your tests and make them more attractive to your customers. For clinical, point-of-care labs and field testing, HRDR-200 can be used as a small footprint laptop reader and handheld field reader. Booth No. 1411



CAPILLARYS2 FLEX Piercing—Whole Blood Hb

Fully automated, whole blood hemoglobinopathy testing by capillary electrophoresis is now available with cap piercing capabilities on the CAPILLARYS 2 FLEX Piercing system. Whole blood 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 and includes serum and urine protein electrophoresis, HbA1c, immunotyping, and CDT (a chronic alcohol abuse marker). This instrument is now FDA cleared. Booth No. 3453

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 testing 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 the addition of samples at any time. True positive sample ID is achieved with full traceability. A complete test menu is available and includes protein electrophoresis, HbA1c, immunotyping, and CDT (a chronic alcohol abuse marker). *Available only outside the U.S. Booth No. 3453

HbA1c Next Generation by Capillary Electrophoresis

The next generation of HbA1c assay, based on the principle of capillary electrophoresis, provides high resolution and clear-cut, precise separation of HbA1c and HbA0 fractions. Capillary electrophoresis eliminates direct interferences on the A1c fraction (carbamylated, acetylated, labile, and common Hb variants such as HbS, HbD, HbE) as well as the 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. This assay is now FDA cleared. Booth No. 3453



Seralite®* Diagnostic Device

Seralite® is a rapid diagnostic device for the diagnosis and monitoring of myeloma and related B-cell dyscrasia. The test provides quantitative measurement of κ and λ immunoglobulin free light chains (FLCs) in blood, serum, and urine. Using a portable reader, the results are presented on screen as concentrations of the FLCs with the calculated κ/λ ratio. This rapid test provides the clinician with an accurate picture of disease status within minutes rather than days, supporting faster decision making. The speed, efficiency, and accuracy of Seralite ensures peace of mind for clinicians and patients and may lead to better outcomes. *Not for use in diagnostic procedures; for research use only. Booth No. 5749


Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

CL-2000i Chemiluminescence System*

The CL-2000i Chemiluminescence System from Mindray is a newly launched fully automatic, random-access system for immunoassays. The system can provide a high throughput up to 240 tests/hour, with reaction time within 18–60 minutes. A total of 36 onboard reagents and 300 onboard samples together with continuous loading gives you the capacity to set, start, and walk away for up to 4 hours. User friendly software interface and novel functions such as maintenance guide make it simple to use. With flexible, modular connection possible to Mindray's BS-800/BS-2000 Modular System, the CL-2000i can be expanded into a scalable, integrated solution for chemistry and immunoassay analysis in core labs with large sample volumes. *Available only outside the U.S. Booth No. 3321


Siloam Biosciences, Inc.


Siloam Biosciences presents TROVA™—the first-ever, universal open-source point-of-care test (POCT) system. Unlike other POCT systems, any existing ELISA can be rapidly converted to a POCT assay using Siloam's Optimiser™ technology platform and TROVA POCT system. Assays can be developed and exhaustively validated using lab-automation systems, and optimized assays can be migrated to the TROVA POCT system within 3 months. Demonstrated model assays include a 20-minute hs cTnI POCT with a detection limit of 0.04 ng/mL and a 15-minute, 4-log beta-hCG POCT. TROVA is available to diagnostic assay providers under a simple licensing model. To discover the simplest pathway for your assay as a POCT, visit Siloam. *Available only outside the U.S. Booth No. 4165


Streck, Inc.


CD-Chex™ Select is the first and only commercially available flow cytometry control with the selected group of CD markers used for immunophenotyping. Assayed for BD Bioscience and Beckman Coulter® flow cytometry systems, it functions as a positive procedural control for reagent staining, erythrocyte lysis, sample preparation, and instrument performance. CD-Chex Select eliminates the need to hold and validate patient samples for use as a control with the evaluated markers. Available as a two-sample set, Sample 1 provides % positive values for CD26, CD41, CD57, CD64, FMC7, TCR α/β, and TCR γ/δ, and Sample 2 provides % positive values for CD58, CD61, and intracellular CD79a and MPO. CD-Chex Select offers 90-day closed-vial and 30-day open-vial stability. *Not for use in diagnostic procedures; for research use only. Booth No. 2144


CD-Chex™ CD117 is a positive procedural control used to monitor reagent staining, erythrocyte lysis, sample preparation, and instrument performance. The first and only commercially available flow cytometry control for CD117, it is designed to represent abnormal peripheral blood leukocytes similar to a hematolymphoid neoplastic patient sample. CD-Chex CD117 possesses surface CD117 detectable with fluorescent mono-clonal antibodies by flow cytometry. The CD117 positive abnormal leukocytes are distinguishable from normal leukocytes on the basis of light scatter properties, a low level of CD45 expression, and heterogeneous CD117 expression. CD-Chex CD117 eliminates the need to hold and validate patient samples to use as a control for CD117. *Not for use in diagnostic procedures; for research use only. Booth No. 2144

A1c-Cellular® Linearity

A1c-Cellular® Linearity is the only commercially available HbA1c linearity/calibration verification material with intact red blood cells. It is a five-level assayed linearity material used to assess instrument accuracy and verify 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. With no reconstitution required, A1c-Cellular Linearity offers 7-day open-vial stability and 105-day closed-vial stability. The cap-pierceable vials offer convenience of auto sampling for analyzers with those capabilities and bar codes are provided for instruments capable of bar code scanning. Booth No. 2144


LBC-Chex™ is the first and only lamellar body count control on the market. Lamellar bodies have been analyzed as an indirect estimate of fetal lung maturity and potential indicator of respiratory distress syndrome. LBC-Chex verifies instrument accuracy by testing the lower platelet limits that standard CBC controls and calibration material fail to assess. Developed for use on automated hematology analyzers, LBC-Chex is available in three clinically significant levels, requires no dilution, and can be used like a patient sample. It is assayed for Sysmex® and Beckman Coulter® instruments. LBC-Chex provides technicians with confidence their instrument counts are accurate for patient samples. *Not for use in diagnostic procedures; for research use only. Booth No. 2144


SurModics IVD

StabilZyme® Protein-Free Stabilizer*

For true protein-free stabilization, there is now a high-performance choice. The new SurModics StabilZyme® Protein-Free Stabilizer eliminates unwanted interference and cross-reactivity. This breakthrough solution offers performance comparable to SurModics's market-leading StabilZyme® HRP Conjugate Stabilizer, only in a protein-free formulation. It is designed for use with conjugated proteins, antibody-coated particles, and general protein stability. Testing indicates excellent activity retention—86% for more than 2 years. Manufactured in ISO 13485:2003 and 9001:2008 certified facilities, SurModics StabilZyme® Protein-Free Stabilizer will meet your most stringent quality and manufacturing requirements. Rely on SurModics for stabilization success. *Not for use in diagnostic procedures; for research use only. Booth No. 1434


Swisslog Healthcare Solutions

RoboCourier Autonomous Mobile Robot*

RoboCourier™ is the best-of-breed solution for automated light payload transport. For both intra-departmental and inter-departmental use, it provides on-demand and scheduled transport of payloads weighing up to 100 pounds. Available only in North America, from the leading provider of automated transport solutions for healthcare applications. *In development. Booth No. 4408


Sysmex America, Inc.

Sysmex® XN-Series Automated Hematology Analyzers

The Sysmex® XN-Series Automated Hematology Analyzers enable laboratories of any size to implement advanced clinical parameters, including NRBCs with every CBC, immature granulocytes with every differential, RET-He within the reticulocyte profile, and an all-new fluorescent platelet channel for immature platelet fraction. The compact design delivers a smaller footprint for increased physical productivity. Scalable options exist for auto-validation from onboard decision rules to Sysmex WAM™ middleware. The XN-9000™ integrates up to nine hematology units with the option of slide making/staining, tube sorting and archiving, and HbA1c to automate up to 90% of lavender top tubes the lab receives. Booth No. 2149

Sysmex® DI-60 Integrated Cell Image Analyzer*

The Sysmex® DI-60 Integrated Cell Image Analyzer completely automates the manual WBC differential process. The Sysmex DI-60 connects to the Sysmex XN-9000™ or XN-3000™ systems. Each allows hands-free sample processing with an automated CBC, slidemaking/staining, and digital scanning with cell pre-classification. The DI-60 is also available as a standalone workcell connected to the Sysmex SP-10™ Automated Slidemaker/Stainer. Automated Cell Image Analysis provides more standardized results and streamlines collaboration with real-time access to cell images. Sysmex WAM™ middleware provides auto-validation options, paperless workflow, and management reports designed to help improve the quality and efficiency of your hematology laboratory. *Available only outside the U.S. Booth No. 2149

Sysmex WAMv5.0 Decision Support Software

Sysmex WAM uses hematology-specific decision rules to help achieve paperless workflow and auto-validate more than 85% of samples. An extensive rules library helps laboratories maximize efficiency by increasing capacity, minimizing sample handling, and eliminating processing steps. Sysmex WAM is delivered with your rules completely configured. WAM 5.0 introduces a smear status report for tracking smear creation and results, an Alert Bar with near real-time "results" display, extended delta rules, and a rules tester suite. Additional QC and management reports modules give detailed information to help streamline workflow, improve turnaround time, and standardize high quality results. Booth No. 2149


The Lee Company

LPM Inert Solenoid Pump

The Lee Company's new LPM Series Inert Solenoid Pump was designed to offer greater design flexibility, and significant cost savings to the medical and scientific industries. The LPM Pump features a revolutionary port head design that allows tubing connections and manifold mounting. This enables the designer to test the fluidic system using connections to soft 1/16 inch tubing, and then once the system design has been finalized, the same pump can be manifold mounted using standard O-rings. Available in 10-μL and 25-μL models, the LPM Pump features low power consumption and a contoured end cap that provides secondary connector retention and is compatible with standard AMP connectors. Booth No. 1839


Thermo Fisher Scientific

Thermo ScientificLabLink xL Cloud Communicator

Avoid transcription errors. The new LabLink xL Cloud Communicator provides an efficient way to directly transfer QC data from Data Innovations Instrument Manager™ to LabLink xL via the cloud in real time. Developed in partnership with Data Innovations, the Cloud Communicator eliminates the requirement for additional hardware or software installation through the use of innovative internet-based technology. The Thermo Scientific LabLink xL web-based quality assurance program, used in conjunction with MAS Quality Controls, provides peer comparison, as well as internal QC review and Westgard rule validation real-time, when you need it. Contact Thermo Fisher Scientific Clinical Diagnostics at 800-232-3342 or email Booth No. 5140

Thermo ScientificMAS® Omni•CARDIO Controls

Space for controls on your analyzer is at a premium. The Thermo Scientific™ MAS™ Omni•CARDIO Controls is the next in the series of MAS Omni products offering consolidation of QC. The MAS Omni•CARDIO Controls are a comprehensive cardiac marker panel with the new generation of STAT analytes, including D-dimer, hCG, myeloperoxidase, and procalcitonin. Value assignment is provided for key instrument systems well known in the industry. The MAS Omni Controls offer a true third-party control solution aligned with the next generation of integrated instrument systems, streamlining the lab QC testing, decreasing costs, and improving overall lab efficiency. Contact Thermo Fisher Scientific Clinical Diagnostics at 800-232-3342 or email Booth No. 5140

Thermo ScientificQMS® Tacrolimus*

Intended for the quantitative determination of tacrolimus in whole blood samples, the Thermo Scientific QMS Tacrolimus Immunoassay is the newest aid in the management of patients receiving tacrolimus therapy post-kidney, -liver, or -heart transplantation. The QMS Tacrolimus assay uses the Quantitative Microparticle System technology. This liquid-stable, ready-to-use reagent offers superior performance with excellent low-end sensitivity and minimal interference with common metabolites and endogenous substances. For convenience, reagent bottles are bar-coded to run on the Indiko benchtop analyzer. Applications are also available for a wide variety of general chemistry analyzers. *Pending FDA clearance. Available only outside the U.S. Booth No. 5140

Thermo ScientificQMS® Everolimus

Everolimus is used in transplant patient therapy to prevent organ rejection. Thermo Scientific QMS Everolimus is the only immunoassay available for the quantitative determination of everolimus in whole blood samples and compares well to the gold standard LC-MS/MS method. The assay uses the Quantitative Microparticle System technology based on a competitive inhibition principle. Calibrators and controls are also available for this liquid-stable, ready-to-use reagent system. This assay rounds out the full ISD menu available on the Indiko and Indiko Plus benchtop analyzers. Applications are also available for a wide variety of general chemistry analyzers. Contact Thermo Fisher Scientific Clinical Diagnostics at 800-232-3342 or email Booth No. 5140

Thermo ScientificIndiko Plus Benchtop Analyzers

With a small footprint and large menu of assays, from therapeutic drug monitoring to drugs-of-abuse screening, the Thermo Scientific Indiko and Indiko Plus benchtop analyzers offer a complete solution to clinical and specialty testing labs. With bar-coded reagents and consumables, these systems provide savings in labor, time, and cost. Various automated features help perform analysis in an efficient way, providing quick results and enhancing patient care. An intuitive user interface and flexibility to load samples and reagents without interruption helps to manage the daily workflow. Contact Thermo Fisher Scientific Clinical Diagnostics at 800-232-3342 or email Booth No. 5140

Thermo ScientificPreludeSPLC Sample*

Economical, easy LC-MS/MS analysis: Thermo Scientific™ Prelude™ SPLC Sample Preparation and Liquid Chromatography system. Combined with a Thermo Scientific mass spectrometry system, the Prelude SPLC system enables clinical researchers to use LC-MS/MS for fast detection of immunosuppressant and oncology drugs, steroids, metabolites of vitamin D, and a variety of other drugs and their metabolites. The Prelude SPLC is designed to be easy to use for those not familiar with LC/MS. Economical to operate, the system is stingy with consumables and long on durability. Other cost-saving features include automated on-line sample preparation using Thermo Scientific™ TurboFlow™ technology and multiplexing two HPLC analyses to one mass spectrometer. *Not for use in diagnostic procedures; for research use only. Booth No. 5140

Thermo ScientificTSQ Quantiva & Endura MS*

Clinical research scientists and forensic toxicologists are constantly challenged by the need to accurately detect and quantify very low levels of compounds in complex biological samples such as blood, urine, and oral fluid. The new Thermo Scientific™ TSQ Quantiva™ and TSQ Endura™ triple-stage quadrupole mass spectrometry systems meet the demands of the most challenging quantitative experiments through their design—built from the ground up for the ultimate in performance, reliability, and usability. TSQ Quantiva and TSQ Endura systems transform your clinical and toxicology research by delivering the fastest, most sensitive, and robust systems for your most difficult biological samples. *Not for use in diagnostic procedures; for research use only. Booth No. 5140

Thermo ScientificTraceFinder3.1 Software*

Designed specifically for clinical research labs that employ liquid chromatography-mass spectrometry (LC-MS), Thermo Scientific™ TraceFinder™ 3.1 software offers simple workflow method setup with fully automated data acquisition, processing, and reporting. With TraceFinder 3.1 software, implementing LC-MS in the clinical laboratory is now easier than ever before. Targeted screening methods are now a simple three-step process: select screening type, select the compound database, and choose the identification and confirmation settings. Methods can be shared easily between instruments and labs. A range of preconfigured methods allows quick productivity. *Not for use in diagnostic procedures; for research use only. Booth No. 5140

ImmunoCAP® Allergen Components

Thermo Fisher Scientific recently received FDA clearance for nine new ImmunoCAP Allergen components with 10 additional components under FDA review. These components are among the more than 90 individual allergen components offered by Thermo Fisher Scientific. ImmunoCAP Allergen component tests quantitatively measure specific IgE to unique proteins of the whole allergen (foods, tree pollens, grass pollens, animal proteins, and others). This enhanced level of detail strengthens the clinical utility of IgE testing by identifying IgE antibodies to those allergen components that cause allergic symptoms. Allergen components, when used as a complement to whole allergen testing, provide vital information about risk, specificity, and cross-reactivity. Booth No. 5140


Tosoh Bioscience

ST AIA-PACK 25-OH Vitamin D

The ST AIA-PACK 25-OH Vitamin D (in vitro diagnostic use only) is designed for the quantitative measurement of total 25-hydroxyvitamin D (25-OH Vitamin D) in human serum or Na-heparinized or EDTA plasma on Tosoh AIA System Analyzers. The ST AIA-PACK 25-OH Vitamin D assay has equimolar affinity to 25-OH vitamin D3 and D2 and aligns well with the vitamin D status. It uses Tosoh's unit-dose test cup technology and the assay time is approximately 40 minutes. Available on all Tosoh AIA analyzers except the AIA-360, the 90-day calibration stability makes it feasible to run this assay with all testing volumes. Booth No. 4642



AUTION HYBRID AU-4050 Urine and Sediment Analyzer

"Its size is the power." U.S. ARKRAY, Inc. introduces the AUTION HYBRID AU-4050, a world-first fully integrated urine chemistry and sediment analyzer in a space-efficient unit. The AUTION HYBRID AU-4050 combines the proven ARKRAY urinalysis strip technology with fluorescent flow cytometry sediment analysis. The compact size of the AUTION HYBRID AU-4050 does not compromise performance that laboratories of all sizes demand. The continuous sample loading of the AUTION HYBRID AU-4050 improves sample throughput, averaging 150 samples/hour with time-to-first result in approximately 2.5 minutes. The full-reflex testing capabilities allow laboratories to complete urinalysis with minimal interaction. Booth No. 3653

AUTION ELEVEN AE-4020 Urine Chemistry Analyzer*

The AUTION ELEVEN AE-4020 from U.S. ARKRAY, Inc. is a compact, semi-automated urine chemistry analyzer. It streamlines your workflow with auto start, auto calibration, and a throughput of 514 tests/hour. Strips can easily be placed every 7 seconds with the right or left hand. The analyzer automatically corrects misaligned strips, eliminating the need for precise placement. The AUTION ELEVEN offers increased user control capabilities such as QC and operator lockout functions. It can be used as a stand-alone or backup analyzer to the AUTION MAX AX-4030 and AUTION HYBRID AU-4050. It uses the proven AUTION sticks 10EA. *Pending FDA approval. Booth No. 3653

ADAMS A1c HA-8180V Fully Automated HPLC Analyzer*

The ADAMS A1c HA-8180V analyzer delivers fully automated glycohemoglobin (A1c) testing and is the latest advancement of ARKRAY's industry-leading HPLC A1c lineage. The ADAMS A1c HA-8180V analyzer requires only 90 seconds to perform an A1c test, yielding results for HbA1c and HbF in the presence or absence of HbS and HbC, providing physicians peace of mind that their A1c test results are accurate and removing worry regarding HbS or HbC variant interferences. For patients without hemoglobinopathies, the analyzer delivers results in just 48 seconds, the fastest in the industry. *Pending FDA approval. Booth No. 3653

iSED® Automated ESR Analyzer

Introducing iSED, a fully automated ESR analyzer that has transformed ESR testing! A first of its kind, iSED provides results in 20 seconds, requires a 100-µL sample and brings true random access and walk-away convenience. Simply insert the primary tubes and iSED will handle the rest with features like onboard sample mixing, a built-in bar code reader, direct through-stopper sampling, auto eject, and LIS interface capability. The 20-position sample wheel accommodates single or multiple samples in any order received. For added convenience, Seditrol® bi-level quality controls remain onboard and ready for testing 24/7. iSED truly is the perfect ESR system! Booth No. 3653


Watson Bio Lab

Nexty Single & Multichannel Pipettors

The Nexty Series is the Next Generation of Micro-Pipettors developed through our years of experience and knowledge gained in the field. We offer a full line of single pipettors with volumes ranging from 0.2 µL to 5000 µL, and multichannel pipettors with volumes ranging from 1 µL to 200 µL. Our unique ergonomic design incorporates features like our "Turbo-Dial" for FAST volume changes and our rounded mushroom-shaped push button to ease stress on the thumb. We also offer a line of low-cost fixed-volume and petite-style pipettors. Booth No. 5848


West Medica

Vision Hema®

Vision Hema® is a blood cell identification and pre-classification system. Its aim is to automate and simplify a complex procedure of blood smear analysis. You work with a sys-tem where priority is given to efficiency and workflow standardization. All stages of blood smear analysis are optimized: automatic scanning, identification and pre-classification of blood cells, validation of analysis results, and data archive and report generation. Thanks to correct ergonomics, working time of experienced and qualified professionals is used more effectively. Accurate diagnosis, tactics, and strategy for further examination will ensure correct treatment of the patient. Booth No. 5428


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