Advanced Instruments, Inc.
Alfa Scientific Designs, Inc.
Applied BioCode, Inc.
ARK Diagnostics, Inc.
Arlington Scientific, Inc.
AVE SCIENCE & TECHNOLOGY INDUSTRY CO., LTD.
Awareness Technology, Inc.
Beijing Chemclin Biotech Co., Ltd.
BioPorto Diagnostics A/S
BPC BioSed srl
Burkert Fluid Control Systems
Carolina Liquid Chemistries Corp.
Diagnostica Stago, Inc.
Dynex Technologies, Inc.
Escalon Clinical Diagnostics/Drew Scientific Inc.
Escalon Clinical Diagnostics/ JAS Diagnostics
Fujirebio Diagnostics, Inc.
Gold Standard Diagnostics, Inc.
InBios International, Inc.
InTec PRODUCTS, INC.
Iris Diagnostics, a Division of IRIS International
Iris Sample Processing
IVAX Diagnostics, Inc.
Iwaki America Inc.
Jokoh Co., Ltd.
McKesson Provider Technologies
Micropoint Bioscience, Inc.
Microscan Systems Inc.
m-u-t America, Inc.
Nanjing Liming Bio-products Co., Ltd.
Ortho Clinical Diagnostics
Phadia US Inc.
Pointe Scientific, Inc.
Sekisui Diagnostics, LLC
Shanghai Tellgen Life Science Co., Ltd.
Shenzhen Mindray Bio-medical Electrionics Co.,Ltd.
Siemens Healthcare Diagnostics
Thermo Fisher Scientific
TriLink Biotechnologies, Inc.
UTAK Laboratories, Inc.
Wiener Laboratories SAIC
ARCHITECT HIV Ag/Ab Combo Assay
ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay for simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. It is intended for use as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects age ≥2 and pregnant women, including acute/ primary HIV-1 infection. The test does not distinguish between HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody and is not intended for blood screening. Results should be interpreted with the patient's presentation, history, and laboratory results. *For in vitro diagnostic use only in the U.S.; for sale by or on order of physician or to clinical laboratory only.
i-STAT 1 Wireless
On February 14, 2011, Abbott Point-of-Care received FDA clearance in the U.S. to market its i-STAT 1 Wireless. The i-STAT 1 Wireless is a new wireless version of the i-STAT point-of-care testing system that is widely used in hospitals, emergency rooms, and physicians' offices. The new system allows for the real-time transmission of diagnostics test results wirelessly from the patient's bedside via 802.11 technology. The wireless, handheld device can potentially save precious time by allowing caregivers to perform critical tests at the bedside and then transmit test results immediately.
A2O ™Advanced Automated Osmometer
The A2O from Advanced Instruments is a fully automated, multi-sample osmometer that incorporates more than 50 years of applied technology experience in the field of freezing-point osmometry. The A2O combines a functional design, exceptional analytical performance, and an intuitive software control package that is both powerful and elegantly simple to operate. Every aspect of the A2O has been intelligently engineered to fully automate osmolality testing with ease and simplicity. It is ideally suited for today's busy laboratories that are being asked to achieve more results faster but with fewer resources.
GNR Traffic Light® PNA FISH®
GNR Traffic Light PNA FISH provides rapid, molecular identification of E. coli, K. pneumoniae, and P. aeruginosa from positive blood cultures in just 90 minutes. The test is the latest addition to AdvanDx's easy-to-use PNA FISH (peptide nucleic acid fluorescence in situ hybridization) platform for rapid, reliable, and highly accurate identification of bloodstream pathogens from positive blood cultures. PNA FISH tests enable microbiology laboratories to report identification results 1–3 days sooner and to help clinicians ensure early, appropriate, and effective antimicrobial therapy for patients with bloodstream infections.
Alere™ PBP2a—MRSA Test
The Alere PBP2a is a rapid, lateral-flow assay that detects the PBP2a protein found in methicillin-resistant Staphylococcus aureus (MRSA) directly from isolates. It is a costeffective, targeted approach to identifying MRSA. The Alere PBP2a test provides results in 5 minutes, uses samples from cultures, including wounds, skin, and urine and has built-in quality controls on every test strip.
AlfaLYZER Saliva Parent THC Low-Cutoff System
Alfa Scientific Design announces our new breakthrough in parent THC detection for our rapid drugs-of-abuse tests. Stop by our booth to hear about this exciting, new breakthrough in THC testing that is a quantum leap ahead of the competition. It didn't take a genius to realize that up until now, rapid drug testing products that were on the market were really not detecting parent THC. This year we will be showing a new product at our booth that will make it relatively easy to detect parent THC at levels that previously were not achievable.
T Module System*
The T Module System is a revolutionary multi-parameter instrument based on latex technology that simultaneously performs tests such as CRP, ASO, RF, and Hb1Ac in a few minutes. The modular configuration allows laboratories to run the instrument with a customized panel of tests according to the needs of each laboratory. The instrument analyzes the kinetic reaction and recognizes the prozona effect, recovering the sample with appropriate dilution. The calibration curves of each reagent kit are recorded into a volumetric card that enables the analysis. *In development.
AliFax Test 1 and Roller 20 Analyzers
Excalibur Lab Specialists, Inc. announces the U.S. introduction of the Test 1 and Roller 20 lab analyzers from Alifax® Italy. These new analyzers offer a unique new approach to measuring erythrocyte sedimentation rate (ESR). Both the Test 1 and Roller 20 provide results in as little as 20 seconds. This is made possible by a novel approach that uses the kinetics of red-cell aggregation. The test's fast turnaround time and the system's ability to use only a 150-µL sample from standard, primary blood-collection tubes enables improved batch processing that establishes a new benchmark for ESR automation.
Barcoded Magnetic Beads (BMBs), a digital multiplex platform, are encoded with a highcontrast pattern that simplifies multiplexed diagnostic and molecular diagnostic assays while offering high throughput, high accuracy, and cost savings. Each bead contains one of 4,096 digital barcodes. Up to 4,096 immunoassay or nucleic acid analytes/ sample can be tested simultaneously in a 96-microwell plate. Biocode-HP Analyzer rapidly scans the BMBs, decodes the barcode, detects label fluorescence, and displays the results. The system provides a wide variety of applications, including infectious diseases, cancer diagnostics, HLA, autoimmune, companion diagnostics, gene expression analysis, micro RNA, genetic testing, and biomarker validation. *For research use only.
Aution Max AX-4030 Urine Chemistry Analyzer
The Aution Max AX-4030 is the latest advancement from U.S. ARKRAY, Inc. The Aution Max AX-4030 is a high-capacity, fully automated, urine chemistry analyzer with true walk-away capabilities. The Aution Max AX-4030 can hold up to 100 samples and 400 test strips, meeting your workflow demands. The Aution Max AX-4030 allows for batch, continuous loading, and STAT capabilities and provides a throughput of 225 samples/hour. Key technological features include: a refractometer for specific gravity and a test strip feeding mechanism with a sensor that ensures a single strip is dispensed and in the correct position, eliminating waste.
ARK™ Methotrexate Assay*
ARK Diagnostics, Inc., the leader in the next-generation of TDM assays, introduces the new ARK Methotrexate Assay, a homogeneous, enzyme immunoassay to measure methotrexate in serum or plasma. Compatible with a variety of automated clinical chemistry analyzers, ARK's liquid-stable, ready-to-use formulation delivers an assay with a limit of detection below 0.05 μmol/L. Specificity in the presence of 7-hydroxymethotrexate is excellent. The calibration range extends from 0–1.20 μmol/L and high concentrations may be tested after dilution with a provided buffer. Calibration-range and high-range controls are available. Methotrexate is the latest member in ARK's family of assays for therapeutic drug management. *Pending FDA clearance.
ARK Next 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 (AEDs). 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®) are also available. ARK produces high-quality, liquid-stable, ready-to-use assays that deliver 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.
ASiManager™ Digital Agglutination Analyzer
The ASiManager AT is an integrated digital particle analyzer that objectively interprets slide agglutination tests manufactured by Arlington Scientific Inc. Laboratory managers perform qualitative and semi-quantitative tests using the ASiManager AT to provide standardized test interpretation using criteria that define positive- and negative-agglutination reactions. The ASiManager AT also delivers an initial predictive titer analysis for the ASI-RPR Card Test for syphilis. It also provides tools that enable creation, storage, retrieval, and transmittal of the test results. This innovative technology provides a lowcost, state-of-the-art, digitally enhanced, integrated system for objective interpretation of proven particle agglutination immunoassay tests.
AVE-76 Series Urine Formed Element Analyzer*
AVE Science & Technology has taken the lead in implementing machine vision technology into microscopic morphology examination and has successfully developed 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 urineformed elements. With advanced target locating and tracking technology, threshold sample concentrations of 3–5 cells/μL can be detected without centrifuging or staining. As a result of the fast screening and recognition technology, the throughput is up to 200 tests/ hour. Positive samples only need verification, and there is no re-examination needed. The analyzer's identification accuracy is more than 95%. *Available for sale outside the U.S.
ReQuest™ Immunoassay Kits*
ReQuest Immunoassay Kits are manufactured in the U.S. and provide outstanding sensitivity, specificity, accuracy, and precision, thereby meeting the productivity needs of a wide range of laboratories. In today's highly competitive environment, ReQuest Immunoassay Kits assures reliable, user-friendly, and cost-effective diagnostic test methods for TORCH, autoimmune panels, infectious disease markers, and more. *Available for sale outside the U.S.
ProbeTec™ Herpes Simplex Viruses 1 & 2 Qx Assays
ProbeTec™ Herpes Simplex Viruses 1 & 2 Qx Assays The new BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) run on the BD Viper™ System with XTR™ Technology that uses strand-displacement amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA. The new BD ProbeTec HSV Qx Assays offer excellent sensitivity and specificity and a significant improvement in the time-to-results over culture methods that often take 2-10 days for results. BD's new automated HSV assays also provide laboratories with the capability to read up to 96 positive or negative results in about 2 1/2 hours. Using the BD Viper System with XTR Technology, laboratories also will be able to test other samples for chlamydia and gonorrhea on the same automated run used for the BD ProbeTec HSV1 and HSV2 Qx Assays.
MAX™ Open System*
Announcing the BD MAX Open System for molecular testing—the first and only system capable of performing user-defined protocols, IVD assays, and life science research with full automation. The BD MAX offers laboratories the possibilities of walkaway automation, standardized workflow, and consolidation of a broad range of molecular tests on a single platform in order to build programs that meet both current and future molecular testing needs. BD MAX—offering The Power of Choice. *Available for sale outside the U.S.
Chemiluminescence Immunoassay for TB
The Anti-TB kit is a chemiluminescence immunoassay (CLIA) test for detecting specific antibodies to Mycobacterium tuberculosis (TB) in human serum or plasma. In conjunction with Chemclin®100, a semi-automated CLIA analyzer, and Chemclin®600, a fully automated CLIA instrument, this assay provides high throughput and reliable detection. This assay offers laboratories higher sensitivity and is more user-friendly than other ELISA and RIA-based anti-TB assays. *Available for sale outside the U.S.
Ultra-Sensitive Gold Sol
BioAssay Works has developed unique colloidal-gold nanoparticle manufacturing technology, producing 15- to 100-OD concentrated gold particles in sizes ranging from 10–120 nm. These higher concentrations confer demonstrable performance advantages, especially increased test sensitivity, when applied to immunoassays. BAW's nanoparticles are used to develop ultra-sensitive, point-of-care rapid tests, molecular circuitry, evanescent wave backscatter technologies, and forward, light-scattering, flow cytometric immunoassays. BAW nanoparticles' high concentration allows the user to rapidly coat the surface of the particles with biomolecules and use the coated particles in various testing formats without further concentration or purification.
The NGAL Test™*
The NGAL Test, a particle-enhanced turbidimetric assay for the quantitative determination of NGAL in human urine or plasma, is designed for routine diagnostic use on chemistry analyzers from numerous manufactures, such as Roche, Abbott, Siemens, and Beckman Coulter. NGAL is a novel biomarker for diagnosing acute kidney injury (AKI). The test effectively gives almost any laboratory immediate access to a fast and easy method to measure NGAL. This test is intended for in vitro diagnostic use in select countries only. Check for availability in your country on our website. *For research use only.
Human epididymis protein 4 (HE4) is a secreted glycoprotein that is expressed by ovarian carcinomas. HE4 is an FDA-approved biomarker for monitoring the recurrence or progression of ovarian cancer. Bioprocessing, Inc. has been providing the diagnostic market with high-quality tumor marker antigens for clinically approved and novel immunoassays for 20 years. We now offer HE4 Antigen from cell culture sources to add to your control, calibrator, or standard. Available as either a highly purified or a partially pure product with low cross-reactivity, Bioprocessing, Inc.'s HE4 products will be a valued addition to your multi-analyte control. *For research use only.
BioPlex® 2200 APLS IgG, IgM, and IgA Kits
The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgG, IgM, and IgA kits are the first and only fully-automated, randomaccess multiplex flow immunoassays for the semi-quantitative detection of IgG, IgM, and IgA antibodies to cardiolipin (CL) and beta-2 glycoprotein I (β2GPI). Combined with clinical findings, these kits aid in the diagnosis of antiphospholipid syndrome (APS). These kits consolidate six traditional single-analyte tests into one disease-state panel. From a patient serum or plasma sample as small as 5 μL, workflow efficiency is enhanced with throughput up to 200 tests/hour. These kits also offer results in 45 minutes. The BioPlex 2200 APLS IgG, IgM, and IgA kits join an expanding menu of autoimmune and infectious disease tests on the BioPlex 2200 system. *Pending FDA clearance. Available for sale outside the U.S.
BioPlex® 2200 Anti-CCP Assay
The BioPlex 2200 Anti-CCP assay is a multiplex, flow immunoassay intended for semiquantitative detection of IgG antibodies to cyclic citrullinated peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results.
Liquichek™ Specialty Immunoassay Control
Liquichek Specialty Immunoassay Control is the first and only liquid, human serumbased control with a comprehensive menu that includes 25-OH vitamin D, iPTH, anti- TPO, and anti-Tg. The 25-OH vitamin D insert listing has been expanded to include all major automated methods, as well as LC-MS/MS values for vitamins D2 and D3. The control's long, open-vial stability and multi-analytes provide convenience and cost savings to laboratories. When using Liquichek Specialty Immunoassay Control with our powerful Unity™ software, you join more than 17,000 laboratories worldwide that already benefit from Unity's superior analytical capabilities and the most comprehensive inter-laboratory comparison.
Unity™ Alert QC Software*
Unity Alert is a new add-on module for Unity Real Time®, an expert QC data management solution from Bio-Rad. The software module continuously monitors QC status and alerts laboratories if QC data is missing or rejected against statistical process control rules such as the Westgard rules. Alert notifications can be provided by email or visually through taskbar icons. Unity Alert runs in the background as a service and operates even when Unity Real Time is closed. *Available for sale outside the U.S.
Assayed VIROTROL® I Controls
Assayed VIROTROL I Controls are liquid, human serum-based controls, providing laboratories with the ability to monitor assay precision. With a long shelf-life and openvial stability, these products are packaged in a convenient dropper bottle. These products include anti-CMV, anti-HBc, anti-HCV, anti- HIV-1, anti-HTLV-1, and HBsAg analytes with expected values provided for major instrument platforms.
VIROCLEAR Control is a liquid, human serum-based control designed as a negative control for 18 commonly tested analytes for hepatitis, retrovirus, syphilis, and antibodies to CMV. With a long shelf-life and open-vial stability, these products are packaged in two convenient dropper bottle sizes and primary tube.
Clinical Chemistry Analyzer Global 4500DR*
BPC BioSed srl is very proud to inform all customers and end-users of the new Analyzer Global 4500DR launch. The main features meet the needs of the market, including two arms and others main features on the right side for medium-to-high-volume hospital labs. The new analyzer is the latest development from our company and is based on recent customer requests. BPC BioSed is an Italian company founded in 1986 that produces markets and services automatic and semi-automatic chemistry analyzers for the human, veterinary, water analysis, oenology, and drugs analysis markets. *In development.
Bruker's MALDI Biotyper identifies microorganisms using MALDI-TOF mass spectrometry by measuring the unique, characteristic molecular fingerprint of the proteins that are found in all microorganisms. The resulting patterns of these proteins are used to reliably and accurately identify a broad range of microorganism down to the species level. The MALDI Biotyper is very accurate, highly reproducible, extremely costeffective, fast, and easy-to-use. It is especially designed to meet the demands of the microbiology laboratory. This new technology has changed and modernized the way microbial identification is done in clinical laboratories around the world. *For research use only. Pending FDA clearance. Available for sale outside the U.S.
TwinPower Dual Solenoid Valve System
The TwinPower patented, dual-solenoid coil system cannot be found anywhere else on the market. It offers the flexibility to increase flow, pressure, throughput, and safety, without increasing the size of the solenoid valve. The technology provides flexibility to decrease the size of the valve and instrument, saving space and time and cutting costs while maintaining performance of valves twice the size. Burkert's high-quality and reliable rocker valves were re-engineered to increase the robust nature of the fluid separated diaphragm, decrease internal and dead volume, reduce the manifold footprint, and add power-saving electronics, LED, latching and other special features now available as a standard. Burkert's Twin Power technology comes in three valve sizes: 10mm, 16mm, and 22mm.
CLC 720 Chemistry Analyzer
Carolina Liquid Chemistries' CLC 720 is a discrete, random-access, fully automated, floor-model chemistry analyzer. The CLC 720 is capable of running up to 100 different tests from CMPs, DAUs, and lipids to specialty tests such as cystatin C and 1,5 AG (GlycoMark®). The CLC 720 can run 560 tests/hour with ISE. It is an excellent fit for hospital, start-up, and small reference laboratories, as well as satellite laboratories, large reference laboratories, or large physician clinics. *Pending FDA clearance.
Qualiris by Stago Hemostasis QA Program
Qualiris by Stago is the new hemostasis quality assessment program. The program offers the broadest range of routine and specialty parameters for proficiency testing with the flexibility to meet the needs of your laboratory. The Qualiris program is an easy-to-use, web-based system, with thousands of participants worldwide, ensuring the maximum statistical comparison of your results. With Qualiris, Stago is pleased to provide real-time, peer-group reports, advanced technical support, and diagnostic challenges—an additional level of confidence for your hemostasis lab.
STA®-Staclot® dRVV Screen and Confirm
The FDA-cleared STA-Staclot dRVV Screen and Confirm are fully automated assays for detecting lupus anticoagulants (LA) in patient plasma by the diluted Russell viper venom method. Each reagent is barcoded for ease-of-use on the STA line of analyzers. The STA Staclot dRVV Screen uses a reagent with a low phospholipid concentration, enhancing its sensitivity and prolonging the clotting time. The STA Staclot dRVV Confirm uses a reagent with a high phospholipid concentration that neutralizes the LA present in the plasma, shortening the clotting time. The tests are not affected by contact factor deficiencies, factor VIII, and IX deficiencies, or other specific inhibitors, as well as by samples containing therapeutic levels of heparin. STA Staclot dRVV Screen and Confirm in conjunction with Staclot LA are complimentary in fulfilling the recommendations established by ISTH.
CY-Quant VASP/P2Y12 by Stago is a ELISA-based assay for measuring patient responsiveness to thienopyridines or other drugs that target the platelet P2Y12 receptor. Responsiveness by patients to these drugs exhibits bell-shaped curve behavior, with low responders at risk of ischemic injury due to clot formation. Due to this fact, research into how patients respond to and factors that affect this response will serve extremely useful for future efforts to treat patients using this class of drugs. *For research use only.
Ecarin Chromogenic Assay*
The Ecarin Chromogenic Assay (ECA) is an enhancement of the Ecarin Clotting Time (ECT), the reference method for determining direct thrombin inhibitors (DTIs) such as argatroban (Argatra®). Although general monitoring of these drugs is not recommended, many high-risk patients require an adapted dosage to minimize dangerous side effects. *For research use only.
STA Coag ConneXion
STA Coag ConneXion is an easy-to-use, Windows® 7-based user interface that offers comprehensive QC management, remote QC capability, and standardized result reporting with the use of expert rules for autovalidation. Automatic re-runs reflex test capability, and delta checks also are included in the Coag ConneXion system. Coag ConneXion gives you the flexibility of a completely paperless solution with the ability to record all of your patient samples, quality control samples, service calls, reagent logs, and maintenance logs. Future features, such as automated lot conversion templates, will further enhance your lab's ability to automate and simplify time-consuming processes. STA Coag ConneXion is the perfect compliment to any Diagnostica Stago analyzer and provides the highest level of data automation in the industry.
LIAISON® Measles and Mumps IgG Assays
The LIAISON Measles and Mumps IgG Assays use chemiluminescent immunoassay technology on the LIAISON Analyzer for detecting IgG antibodies to measles and mumps viruses in human serum to aid in determining serological status to measles and mumps virus. With first result in 35 minutes and throughput of 90 results/hour, these chemiluminescent immunoassays for measles and mumps IgG complete the MMRV IgG assay panel. DiaSorin is a worldwide specialty immunoassay leader in vitamin D and infectious disease testing with a history of expertise that spans more than 25 years.
25-OH Vitamin D Assay
Diazyme's 25-Hydroxy Vitamin D assay is an innovative homogenous assay that measures the true total 25-hydroxy vitamin D, the sum of both D3 + D2. The new assay introduces a number of enhancements, including a wide dynamic range with improved precision, while eliminating time-consuming washing steps found in conventional EIA methods. The assay is both fast and flexible with reduced testing time and cost compared to some competitive products that recommend running patient samples in duplicate. The test is user-friendly and can be run manually or easily adapted for use on a wide range of fully automated microtiter plate readers, making it suitable for use in laboratories of all sizes and testing needs.
Enzymatic 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 chemistry analyzers and is more specific and accurate than the current non-enzymatic NBT-based fructosamine test. Serum GSP concentrations in conjunction with HbA1c can be used to determine the "glycation gap" that offers improved diagnostic value by more reliably predicting complications of diabetes, including 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, which closes the existing information gap between daily blood glucose testing and the 2-3 month snapshot provided by HbA1c testing.
DYNEX Agility™ System
Magellan Biosciences has redefined ELISA processing with the new DYNEX Agility—an ingenious, state-of-the-art system featuring the most advanced walkaway automation in the category. Agility allows up to 12 microplates to be loaded on-board as they are prepared and can process 16 assays simultaneously. Agility also minimizes hands-on time thanks to revolutionary reagent loading technology, eliminating nearly all liquid transfer steps with Agility SmartKits™. SmartKits contain all the reagents needed 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.
Eppendorf Xplorer® Electronic Pipette*
Laboratorians who give 100% every day deserve the best tool to achieve the best results. The new Eppendorf Xplorer electronic pipette is synonymous with simplicity, precision, and reproducibility. That means no more delays due to complicated programming or inflexible processes. Instead, users get precisely adjustable parameters, maximum reproducible results, fatigue-free work, and consistent, full control over the pipette. No matter where you are in the world or which liquid you're using, the Eppendorf Xplorer can be individually adjusted to your environment and requirements, like altitude or specific liquid density. The Eppendorf Xplorer is simply better pipetting. *For research use only.
DS360™ HbA1c Analyzer*
Escalon Clinical Diagnostics and Drew Scientific Inc. introduce the latest in a long legacy of hemoglobin analysis systems offered by Drew Scientific: the DS360 HbA1c Analyzer. The DS360 HbA1c Analyzer uses ion-exchange HPLC to accurately determine HbA1c in minutes and is NGSP-certified and traceable to the IFCC reference method. The system provides automated testing with on-board patient demographic database, sample run management, and complete QC capabilities. The DS360 HbA1c Analyzer is fully compatible with laboratory information systems and provides a touch-screen interface with multiple language capabilities. The DS360 HbA1c Analyzer has been introduced recently in Europe. *Pending FDA clearance. Available for sale outside the U.S.
Reagent Line for Olympus 400/640 Analyzers*
Escalon Clinical Diagnostics™ and JAS Diagnostics™ are pleased to offer laboratories a reagent line of general and specialty reagents designed for the Olympus AU400™ and AU640™ series chemistry analyzers. Thisreagent line is supplied in barcoded Olympus reagent containers for easy customer use. Additionally, these reagents provide quality performance in terms of results and stabilities, along with significant cost savings for the laboratory. Dedicated technical and customer service is available, including on-site conversion and validation programs. *Pending FDA clearance. Available for sale outside the U.S.
Hypoxic/Hyperbaric QC: pO2 AMR Validation Controls
Hypoxic QC is the first pre-tonometered product of its kind to validate extra-low (15 mm Hg) pO2 values on any blood gas analyzer in the lab or at the point-of-care. Hyperbaric QC is designed to validate the high pO2 range (710 mm Hg). Together, these two products validate the full pO2 analytical measurement range of blood gas analyzers. Hypoxic QC features active hemoglobin buffering with 10-minute, open-ampule stability, making it well-suited for method comparisons. Hyperbaric QC is an aqueous formulation that validates ultra-high recovered values, making it ideal for cardiac catheterization labs or operating room suites.
GlucoTrol-WB Real Blood Glucose Control
GlucoTrol-WB real blood glucose control is a new product packaged with ACU-CAP, a device that enables separation of red blood cells from the plasma fraction containing glucose, thereby eliminating glycolysis. GlucoTrol-WB is highly commutable and compatible with all point-of-care glucose devices with minimal matrix effects. All levels of GlucoTrol-WB performance yield very low imprecision and are very comparable with the imprecision of human whole blood. ACU-CAP also eliminates the need for pipetting. GlucoTrol-WB can be used as a QC for method comparisons or validations and for proficiency testing.
Tumor Marker Control*
Fujirebio Diagnostics, Inc., the industry leader in biomarker assays, presents its solution for accurate precision monitoring of laboratory tumor marker assays. The Tumor Marker Control is intended for use as a quantitative, assayed serum control. This is the only multi-constituent control to contain the novel biomarker HE4 used to monitor progression and recurrence of epithelial ovarian carcinoma. It contains clinically relevant proportions of free PSA and PSA-ACT. Analytes include AFP, CA 15-3, CA 19-9, CA 125, CEA, ferritin, HE4, total PSA, and free PSA. Reconstituted, open-vial stability is 14 days at 2–8ºC with the following exception: Free PSA is stable for 7 days. The control sustains nine freeze/thaw cycles at ≤–20ºC. *Available for sale outside the U.S.
Vitamin D Control*
The Fujirebio Diagnostics, Inc. Vitamin D Control is an assayed, tri-level vitamin D control containing both 25(OH) vitamin D2 and 25(OH) vitamin D3. The control contains clinically relevant concentrations of 25(OH) vitamin D, as well as excellent reconstitution stability. Manufactured to the highest quality standards and value assigned across platforms, the Vitamin D Control ensures accurate precision monitoring of in vitro diagnostics laboratory testing procedures and techniques. Reconstituted, open-vial stability is 14 days at 2-8ºC. All analytes are stable for 60 days when stored at ≤ -10ºC. The control sustains nine freeze/thaw cycles. *Available for sale outside the U.S.
APTIMA® Trichomonas vaginalis Assay
The Gen-Probe APTIMA Trichomonas vaginalis Assay is the first NAAT to be FDA-cleared for the 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.
ThunderboltTM ELISA Platform
The GSD ThunderBolt is a powerful, compact, multi-language, fully automated, completely open, user-friendly, ELISA platform. The features of the instrument include: three microtiter plates; intelligent sample racks for positive patient identification; LED reader; built-in barcode scanner; bi-directional interface; orbital shaker; incubator; and onboard optics for remote troubleshooting. Up to 192 results can be generated in one run on a combination of up to eight different assays. The innovative design provides customers with a flexible, cost-effective, highly efficient, automated laboratory solution.
Interlab G26 Agarose Gel Electrophoresis Analyzer
The INTERLAB G26 is a compact, benchtop, fully automated agarose gel electrophoresis analyzer that delivers precise walk-away electrophoresis with simplified robotics, primary tube sampling, positive sample ID, simultaneous assay processing, and automated sample dilutions. The robotic arm, with its electromagnetic head, controls all the automated steps. Simply load barcodelabeled sample tubes for positive sample identification from tube to completed result. Neat samples, and those requiring dilutions, are prepared with ease using the on-board sampler. The migration chamber peltier uses vacuum-controlled gel adhesion with disposable electrode sponges for precise band focalization and easy set-up and maintenance.
MICROLAB® 600 Diluter and Dispenser*
Hamilton Company, the world leader in fluid measurement, introduces the MICROLAB 600, the next-generation in its line of semiautomated laboratory diluters and dispensers for pre-analytical sample preparation. Based on Hamilton's leading syringe technology and positive-displacement dispensing, the new instrument has been designed for easeof- use and offers flexibility for more routines and smaller sample volumes. The MICROLAB 600 is ideal for a range of applications, including blood alcohol and metals analyses. The new MICROLAB 600 features an internet- enabled controller with an icon-based, graphical touch screen for increased ease-ofuse. *Available for sale outside the U.S.
The Labmaster Automatic Balancing Compact Benchtop Centrifuge with refrigeration features a built-in, auto-balancing mechanism that measures imbalance and corrects it automatically. It has a maximum RCF of 19,839 x g and a maximum speed of 13,000 rpm. The centrifuge is very stable and operates silently. You can choose from four different rotors. Redesign your lab with Labmaster Auto Balancing Centrifuge and save yourself time and money.
Cascade Abrazo™ System*
The Cascade Abrazo system represents the next-generation in point-of-care hemostasis testing. The Abrazo analyzer features a handheld design with an intuitive touchscreen interface, wireless connectivity, and 2D barcode reader for capturing patient and reagent data. The administrative software and docking station allow remote management and quality control with customizable lockout features. The unique dry chemistry reagent platform is incorporated into barcoded assay cards the size of a driver's license. Analytes will include routine PT, aPTT, celite, ACT, plus low-range ACT, heparin management (heparin and protamine response), ENOX (enoxaparin), fibrinogen-LR, and direct thrombin management for monitoring bivalirudin, dabigatran, and DTIs. *For research use only.
HemoCue® Glucose 201 RT Analyzer*
HemoCue Glucose 201 RT is the newest addition to the HemoCue line of point-of-care glucose analyzers. If refrigerated cuvettes have kept you from using HemoCue® to measure glucose at the point-of-care, the new HemoCue Glucose 201 RT system is for you. HemoCue Glucose 201 RT retains our easy testing method and the lab quality results so vital in patient care, but it uses room-temperature cuvettes. *Pending FDA clearance. Available for sale outside the U.S.
hema-screen SPECIFIC is an immunochemical, fecal, occult-blood test specific for human hemoglobin. hema-screen SPECIFIC's distinguishing feature is our patented DEVEL-A-TAB collection slide, allowing two specimens to be tested at the same time. The new enhanced version of hema-screen SPECIFIC contains an additional 10 collection system/mailing envelopes. This feature allows doctors or labs to hand out additional collection system/mailing envelopes to compensate for non-compliance. Look for our new packaging. *In development.
DENV Detect IgM Capture ELISA
InBios is pleased to announce the first FDAcleared test manufactured in the U.S. for diagnosis of dengue infection. The DENV Detect IgM Capture ELISA is a qualitative enzyme immunoassay that detects IgM antibodies to dengue virus in human serum. This easy-to-use kit contains all the readyto- use reagents and controls. Storage is at 2–8ºC. The sensitivity and specificity was thoroughly evaluated with clinically confirmed cases of dengue 1-4 serotypes with excellent results. This product is CE Marked and represents the latest product offering by InBios for the detection of flaviviruses.
ABO & RhD Blood Grouping Kit*
INTEC ABO & RhD Blood Grouping Kit uses unique visual testing technology to detect ABO and RhD blood groups based on the immune response principle of antigens and antibodies. The kit is suitable for on-site blood collection, medical laboratory testing, and urgent pre-transfusion testing. With rapid accurate results and good performance in specificity and stability, the kit can be stored at 2–30ºC for 2 years. The kit offers detection of ABO and RhD blood groups simultaneously in one test without any additional equipment. This product has international patent: No.: PCT/CN2009/000322. *Pending FDA clearance.
iRICELL 1500 Automated Urinalysis System
The iRICELL 1500 consists of the iQ 200SELECT Automated Urine Microscopy Analyzer connected to the iCHEM® VELOCITY ™ Automated Urine Chemistry analyzer.
iRICELL®pro Automated Urinalysis System
The iRICELL pro consists of the iQ®200 Series Automated Urine Microscopy analyzer and the iCHEM®VELOCITY™ Automated Urine Chemistry analyzer with iWARE® Integrated Urinalysis Software.
Automated Laboratory Assistant*
The Iris Automated Laboratory Assistant automates a variety of protocols for FISH, WISH, Western Blot, as well as many other slide-based applications that are labor-intensive, time- consuming, and require multiple washes and incubation times. The new unit is a small, highly flexible platform consisting of a fluid-exchange system that delivers reagents sequentially with temperature agitation and control. It frees lab personnel from time-consuming, repetitive procedures and improves data reliability. A flexible user interface allows labs to store and save multiple protocols and modifying them as needed. *In development.
MAGO® 4S Analyzer
The MAGO® 4S is the only analyzer capable of providing laboratories infinite possibilities in ELISA and IFA testing. By allowing ELISA and IFA samples to be processed simultaneously, the MAGO 4S offers multiple solutions to increase laboratory productivity. Additionally, with an expanded menu, the MAGO 4S introduces a level of automation that is in a class by itself. This analyzer also performs serial, two-fold dilutions, self-cleans and calibrates daily, and performs pre-assay plate/ reagent volume checks. Windows®- based software adds inverse curve capability and a full-color screen simplifies setup. Diamedix provides a one-stop solution that increases productivity, efficiency, and economy.
Acetylcholine Receptor Blocking Antibody Kit*
The Acetylcholine Receptor Blocking Antibody Kit is a radioimmunoassay for in vitro determination of acetylcholine receptor blocking antibody levels in serum. We offer 30- and 120-test kits at prices competitive with 25- and 100-test kits. The assay procedure involves allowing blocking antibodies from samples to complex with acetylcholine receptors. Then the antibody-receptor complexes are allowed to complex with 125I-labeled bungarotoxin. The complexes are then precipitated, washed, counted, and determined. There are two 1-hour and one 2-hour incubations for the procedure. *For research use only. Available for sale outside the U.S.
Acetylcholine Receptor Binding Antibody Kit*
The Acetylcholine Receptor Binding Antibody Kit is a radioimmunoassay for in vitro diagnostic determination of acetylcholine receptor binding antibody levels in serum. We offer 30- and 120-test kits at prices competitive with 25- and 100-test kits. The assay procedure involves allowing acetylcholine receptor binding antibodies from samples to complex with 125I-labeled acetylcholine receptors. Then the complexes are precipitated, washed, counted, and determined. The procedure involves 30- and 120-minute incubation times. The kit features an assay range of 0.2–7.5 nmol/L, a detection limit of 0.058 nmol/L, a cutoff of 0.25 nmol/L, clinical sensitivity of 100%, and clinical specificity of 97%. *Available for sale outside the U.S.
Direct Free T4 Coated Beads Equilibrium Dialysis Kit*
The Direct Free T4 Coated Beads Equilibrium Dialysis Kit is a highly sensitive and specific radioimmunoassay for the in vitro direct measurement of free T4 in serum. The assay procedure involves dialyzing samples overnight and running a radioimmunoassay for free T4 using coated beads on the dialysates. The 100-test kit comes with 80 disposable cells (QD-CellTM) for dialysis, making dialysis of samples easier and more convenient. The radioimmunoassay uses coated beads that make measurement of free T4 by equilibrium dialysis easier and less labor-demanding. *For research use only. Available for sale outside the U.S.
Iwaki's new precision dosing pumps are designed to accurately dispense critical fluids. The Hicera Series provides 0.1% repeatable performance for volumes as low as microliters/ sample. Much smaller than traditional syringe pump designs, Iwaki piston metering pumps eliminate the need for re-calibration while providing more than 40,000 hours of no-touch, maintenance-free service life. The APN Series is built to handle the most aggressive fluid handling requirements on analyzers. APN's molded diaphragm maintains the pump's accuracy whether handling fluids or gas. The solids-handling diaphragm ensures dependable performance under adverse operating conditions. Custom designs and prototype quantities are available.
Electrolyte Analyzer with Ion Selective Electrode
The EX-D is a fully automated electrolyte analyzer with ion-selective electrode for measuring sodium, potassium, and chloride in whole blood, serum, and diluted urine. It also offers a solution for hemodialysis applications, allowing acid concentrates and sodium bicarbonate to be balanced. Twenty samples can be processed in one run and results are available within 36 seconds. The newly developed high-sensitivity electrodes allow calibration to be performed only once a day. The electrode produces very accurate results with a CV of <0.5%. An auto retest function allows for automatic retesting of samples with abnormal values. Emergency samples can be tested at any time during routine measurement.
Aquaporin-4 Antibody ELISA Test Kit*
KRONUS, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new ELISA test kit for measuring antibodies to aquaporin-4 (AQP-4Ab). Aquaporin-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 allows for accurate and specific determination of autoantibodies to AQP-4. *For research use only.
Voltage-Gated Potassium Channel Antibody RIA Test Kit*
KRONUS, a leading provider of specialized autoimmune diagnostic test kits, is pleased to announce the availability of a new RIA test kit for measuring antibodies to the voltagegated potassium channel (VGKC–Kv1.1, 1.2 and 1.6). This new RIA allows for accurate and specific determination of VGKCAb. Measurement of antibodies to voltage-gated potassium channels (VGKC) may be useful in select indications.*For research use only.
Horizon Lab™ Analytics
McKesson's Horizon Lab Analytics solution provides essential management-decision support tools and scorecards to quickly measure a laboratory's performance. This unique application integrates clinical and operational data into visual intuitive displays to monitor laboratory initiatives, optimize performance, and enhance regulatory compliance. This graphical tool produces meaningful information, empowering the organization to measure, manage, and improve care. It monitors the performance of laboratory operations and provides alerts so managers can quickly address issues. It also measures key safety and operational metrics with standard outof- the-box content. McKesson has been providing laboratory information systems for more than 30 years.
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 EasyRA sets a new standard in its class with a combination of unprecedented ease-of-use, intuitive user interface, and limited maintenance.
illumigene® Group B Streptococcus (GBS) Assay*
Meridian Bioscience announces the illumigene® Group B Streptococcus (GBS) assay. This latest offering to the illumigene® molecular portfolio utilizes the power of LAMP (Loop Mediated Isothermal Amplification) technology, and runs on the compact illumipro-10™ instrument allowing flexibility in operation (1-10 samples per run). Running from an enriched sample, in accordance with CDC guidelines, illumigene® GBS provides highly accurate results in less than an hour in a simple 7-step procedure. Its superior operational and cost efficiency makes it feasible for any size facility. Meridian Bioscience continues to exhibit that illumigene® is the molecular system designed by labs, for labs. (Not cleared for use in the U.S.) *In development.
mLabs® D-Dimer Test*
Micropoint's mLabs D-Dimer test is designed for point-of-care applications. The mLabs D-Dimer test is a quantitative microfluidic immunoassay that provides rapid test results for evaluation of pulmonary embolism or deep vein thrombosis. Patented mLabs microfluidic control technology enables high precision and highly reliable D-Dimer testing, featuring wide measureable range, fool-proof operations, and excellent correlations with central lab equipment, such as the mini-VIDAS. The test uses 250 μL of citrated whole blood or plasma. Testing time is <15 minutes and the measurable range is 100–10,000 ng/mL. *Pending FDA clearance.
Vision MINI Ultra-Compact Smart Camera*
Microscan's new Vision MINI ultra-compact, smart camera is designed for reliable vision performance in embedded identification and inspection applications. As the world's smallest fully integrated vision system, the Vision MINI's small size, autofocus lens, and wideangle optics provide the best performance available for vision tasks, such as cap presence/ absence, cap type, and cap color. The Vision MINI delivers both excellent results and reliability, along with Microscan System's assurance of long-term availability and support. This is essential for OEMs that require uninterrupted availability throughout the life-cycle of their products, and it enables them to focus on new development instead of obsolescence issues. *Available for sale outside the U.S.
Pluggo™ RH Decapper System
The Pluggo RH Decapping System for ADVIA® Centaur racks is an automated, bench-top decapper designed to use instrument-specific, sample-tube racks for the ADVIA Centaur or ADVIA Centaur XP System. The small footprint Pluggo RH System (22" w x 24" d x 14" h) automatically decaps all standard vacuum collection tubes at speeds up to 35 tubes/ minute. The Pluggo RH is designed to protect lab workers from repetitive motion injuries and from exposure to biohazardous material. The system provides walk-away operations with input capacity of up to 15 racks and output of up to 15 racks of uncapped tubes.
StrongStep® Candida albicans /Trichomonas vaginalis Antigen Combo Rapid Test*
Vaginitis is one of the principal reasons women see an obstetrician or gynecologist. Candidiasis and trichomoniasis are responsible for most cases of infectious vaginitis, but they need different treatment. StrongStep Candida albicans/Trichomonas vaginalis Antigen Combo Rapid Test is an immunochromatographic assay for qualitative presumptive detection of these two pathogens from vaginal swabs. Samples can be self-collected by patients. In addition, compared with wet mount and culture, the results from this antigen test are less influenced by vaginal local drug treatment before the patient's clinic visit. The test offers a simple testing procedure and fast results at the time of patients' clinic visit. *Pending FDA clearance. Available for sale outside the U.S.
StrongStep® N. gonorrhoeae/C. trachomatis Antigen Combo Rapid Test *
N. gonorrhoeae and C. trachomatis are closely related, and patients are often co-infected with the two pathogens. Patients should therefore be tested for gonorrhea and chlamydia simultaneously. StrongStep N. gonorrhoeae/C. trachomatis Antigen Combo Rapid Test is an immunochromatographic assay for qualitative presumptive detection of N. gonorrhoeae and C. trachomatis in female cervical-swab and male urethral-swab specimens. Unlike culture, the results from this antigen test are seldom influenced by patient's self drug treatment before a clinic visit. The test offers convenience for clinicians and provides patients with rapid results at the time of their clinic visit, thereby allowing early treatment and preventing further complications. *Pending FDA clearance. Available for sale outside the U.S.
StrongStep® HSV 1/2 Antigen Rapid Test*
Diagnosing herpes by visual examination of a lesion does not give an accurate diagnosis because many other infections or irritations can look just like herpes. Testing for the virus directly from the skin is useful if genital symptoms are present during the patient's clinic visit. StrongStep HSV 1/2 Antigen Rapid Test is an immunochromatographic assay for qualitative presumptive detection of HSV 1&2 antigens in mucocutaneous specimens. The test is intended for confirmation of HSV symptomatic infection but also differentiates other genital ulcer diseases with herpes easily and quickly. Because the test detects antigen, it yields much higher sensitivity and specificity than antibody tests. Compared to PCR or culture, the test offers wider feasibility. *Pending FDA clearance. Available for sale outside the U.S.
NextSlide Imaging has created an integrated, digital-imaging toolset for laboratory microscopy. NSI Review is a digital workflow solution used to examine and review smear slides of blood, body fluids, and cultures. The system makes and uses full-resolution images of the entire reviewed portion of every slide. Applications in hematology include: WBC diff count; Kleihauer-Betke; LAP; and reticulocyte counts. Automation tailored for each application includes cell location and classification. NSI Review reduces the cost of smear review, while delivering improved quality control and remote review capability. The system integrates a 100x slide scanner, a hosted data center, and a web-based review workflow. *Pending FDA clearance.
HALIA Middleware for Lab Automation*
HALIA instrument middleware provides a complete web-based, lab-computerization solution. HALIA allows central management of all IVD devices, supporting global control of processes and guaranteeing a complete response for the connectivity demands of modern analysis labs. The core component of HALIA is a user-configurable, inferential engine for evaluating autoverification, sample routing, and real-time QC rules. The new interactive rules building and testing tool streamlines rules configuration. A clear drill down structure gives immediate access to all essential parameters such as TAT, test status, and alarms. Thanks to its autoverification and monitor functionalities, HALIA allows lab managers to improve performance and efficiency, addressing the challenging lab automation environment. *Available for sale outside the U.S.
StatProfile® pHOx®—Critical Care Analyzer*
Nova introduces a new family of pHOx blood gas/critical care analyzers featuring the largest selection of critical care tests including pH, PCO2, PO2, Na, K, Cl, iCa, iMg, glucose, BUN, creatinine, lactate, hematocrit, hemoglobin, SO2%, and co-oximetry. StatProfile pHOx design features include: robust connectivity and on-board data management system; bright, color touchscreen user interface; simplified operation; snap-in reagent cartridges; auto-calibration; fully automated quality control; and test results in 45 seconds. The combination of the pHOx long-life sensors and cartridge-based technology provides the most cost-effective way for hospitals to provide blood gas/critical care testing. *Pending FDA clearance. Available for sale outside the U.S.
The new AWEL range of centrifuges has been launched, including the multifunction format. Bringing practical innovation to our customers, each model in the MF series offers a large sample capacity for its class and accepts a variety of swing-out, microplate, and angle rotors. New features include the AWELight™ system that displays blue lid lights at the end of the run, indicating the samples are ready to be removed. This not only increases operator efficiency, but it also improves process results. The AWELock™ system permits rotors to be exchanged and safely locked in position without using tools. A low profile adds to the convenience. *Available for sale outside the U.S.
Clostridium difficile Immunochromatographic Test*
A-B diff is a rapid immunochromatographic test for Clostridium difficile detection. Its main innovations compared to other tests in the market are detection of toxin A and toxin B in independent bands. This fact is important for making treatment decisions and isolating infected patients. It's extremely quick, 10 minutes for sample preparation plus 15 minutes for reading results. It's a very easy procedure, and it does not require special equipment, merely dissolve the stool sample in a buffer and add a quantity of the supernatant to the strip. HYPER diff is a rapid immunochromatographic test that can detect suspected hypervirulent strains of C. difficile as the ribotypes O27 or O17. *Available for sale outside the U.S.
VITROS® Syphilis TPA Assay*
Ortho Clinical Diagnostics announces the pending availability outside of the U.S. of the VITROS Syphilis TPA Assay. The VITROS Syphilis TPA assay is intended for in vitro qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum-specific antigens in human serum and plasma (heparin, citrate and EDTA). The presence of antibodies to T. pallidum-specific antigens in conjunction with non-treponemal laboratory tests and clinical findings may aid in diagnosis of recent, past, or treated syphilis infection. The assay is expected to be available for use on the VITROS 5600 Integrated Chemistry System, the VITROS ECi/ECiQ and VITROS 3600 Immunodiagnostic Systems. This product's availability is subject to fulfillment of regulatory requirements in each market. *Available for sale outside the U.S.
VITROS® Intact PTH Assay
Ortho Clinical Diagnostics introduces a new immunodiagnostic assay, the VITROS Intact PTH Assay, for quantitative detection of parathyroid hormone. The assay measures intact parathyroid hormone levels and uses one protocol for both routine and intraoperative testing with results available in 18 minutes. The VITROS iPTH Assay runs in a fully automated, random-access format on the VITROS ECi/ECiQ and 3600 Immunodiagnostic Systems and can also run on the VITROS 5600 Integrated System. Equivalent analytical results are generated across all three systems.
VITROS® Anti HBe and HBeAg Assays*
Ortho Clinical Diagnostic announces the pending FDA approval of the VITROS Anti-HBe and HBeAg assays for use on the VITROS ECi/ECiQ Immunodiagnostic Systems. These fully automated, random access assays will complete the full hepatitis panel and compliment HIV and rubella infectious disease assays, as well as 29 routine immunoassays. HBeAg in serum is a strong indicator of high infectivity of HBV. Presence of Anti-HBe indicates the convalescent stage of HBV infection and is found in carriers of HBV who are able to clear HBeAg from the circulation. HBeAg/anti HBe assays are important to define the specific HBV disease state. *Pending FDA approval.
VITROS® 4600 Chemistry System
The VITROS® 4600 Chemistry System is Ortho Clinical Diagnostics' most recent addition to the VITROS® Family of analyzers. Like its siblings the VITROS® 5600 Integrated System and the VITROS® 3600 Immunodiagnostic System, our newest analyzer offers standardized, high-quality test results using common technologies across the continuum of integrated and stand-alone systems. The VITROS 4600 System leverages our patented enabling technologies. These maximize quality of patient results as they continuously promote ease-of-use and productivity. The VITROS 4600 System answers the essential healthcare challenges you face everyday: improve patient care while balancing staffing, compliance, and total operating cost containment.
The world leader of in vitro diagnostics of allergy and autoimmune-related diseases introduces the Phadia 2500 instrument. This instrument is designed for cost-conscious, high-volume laboratories, and it offers efficiency and flexibility to meet a broad range of immunoassay testing needs. Phadia Laboratory Systems are optimized for the ImmunoCAP® Specific IgE blood test and EliA® autoimmune assays. Contact us today at (800) 346-4364.
The world leader of in vitro diagnostics of allergy and autoimmune-related diseases introduces the Phadia 5000 instrument. This instrument is designed for cost-conscious, high-volume laboratories, and it offers efficiency and flexibility to meet a broad range of immunoassay testing needs. Phadia Laboratory Systems are optimized for the ImmunoCAP® Specific IgE blood test and EliA® autoimmune assays. Contact us today at (800) 346-4364.
Enzymatic Creatinine Reagent Set
Pointe Scientific has introduced a new enzymatic creatinine assay for automated chemistry analyzers. This two-part, liquid-stable reagent eliminates endogenous creatine and ascorbic acid and offers 18-month shelf-life and up to 30-day, on-board stability. Hemoglobin to 500 mg/dL, conjugated bilirubin to 32 mg/dL, and unconjugated bilirubin to 40 mg/dL has been shown not to interfere with the assay. The assay shows excellent correlation to other creatinine assays. Precision studies conducted according to CLSI: EP 5 protocol yielded excellent precision with CVs below 2%.
Pulssar Technologies, a leading manufacturer of piston pumps and diluters, announces the launch of its new product, the PBC2 Pump. The PBC2 is a high-precision, dispensing pump that automates pipetting, diluting, and dispensing using a variety of piston sizes. Advantages of the PBC2 Pump include high precision (CV <1% for 2 μL dispensed volume) and high accuracy (>99.5%). The pump is maintenance-free, fully Cavro™ compatible (plug-in replacement) and has a guaranteed life of more than 15 million cycles without any loss of precision or accuracy. There is no need for syringes. The adapted design supports aggressive and abrasive liquids such as NaOH and NaCl. The pump has high speed piston movement (0.3 second/full stroke) and working pressure up to 100 psi or 6.9 bars Applications of the PBC2 Pump include IVD instruments, diagnostic analyzers, biochemistry, hemostasis, immunology, and biomedical and genomic research.
Dropper™ A1c - Diabetes Control*
We crafted the Dropper A1c Control to make your laboratory and point-of-care hemoglobin A1c quality control simple. Six months of refrigerated, open-vial stability reduces waste, and our dropper bottles make dispensing outrageously simple. The liquid, human blood-based matrix and 21 days of open-vial, room-temperature stability eliminates storage problems and provides maximum portability— perfect for sites without refrigeration. The Dropper A1c Control is designed for use with most major immunoassay and boronate affinity laboratory and POCT analyzers, including Siemens DCA 2000/2000+/Vantage and Dimension, Beckman Coulter Synchron, Roche Cobas Integra and Hitachi, Ortho- Clinical Vitros, and Primus PDQ/ultra2. The Dropper A1c Control offers longer stability and is super convenient. *Pending FDA clearance. Available for sale outside the U.S.
RX suzuka Clinical Analyzer*
The RX suzuka is a fully automated, random-access clinical analyzer capable of performing up to 1200 tests/hour including ISEs, providing laboratories with increased efficiency and productivity. The RX suzuka offers: unparalleled productivity via economic reagent handling; guaranteed flexibility with our comprehensive and diverse test menu, allowing for complete consolidation of routine and specialized tests on one platform; and unique system reliability, resulting in greater accuracy and efficiency. Unrivaled versatility and flexibility make the RX suzuka suitable for a variety of settings, including clinical chemistry, research, veterinary, toxicology, and food and wine testing *Pending FDA clearance. Available for sale outside the U.S.
RIDASCREEN® Calprotectin Test
The RIDASCREEN Calprotectin test is a new ELISA for quantitative measurement of fecal calprotectin with a one-point calibration for evaluation. RIDASCREEN Calprotectin shows highly distinctive and reliable quantification of calprotectin in stool samples within the entire measuring range. By using onepoint calibration, RIDASCREEN Calprotectin significantly increases the throughput of samples/microtiter plate. Measuring of fecal calprotectin provides reliable differentiation between chronic inflammatory bowel disease and irritable bowel syndrome. Furthermore, it is used for early detection of relapses and monitoring response to treatment of irritable bowel syndrome.
Histamine Release Assay*
The Histamine Release Assay is an in vitro cellular allergy diagnostic test that detects allergen-induced histamine release from basophil leukocytes using a glass-fiber method. The released histamine is bound selectively and permanently to the glass-fiber matrix in a microwell plate and can be measured within weeks. The Histamine Release assay primarily detects type I allergies against foods, drugs, and insect venoms. It can also be used for occupational, environmental, and inhalant allergens. About 90 allergens are available. Measurement requires a dedicated fluorescence reader, the Histareader 501. *Available for sale outside the U.S.
The RIDASCREEN Norovirus 3rd Generation Test
The RIDASCREEN® Norovirus 3rd Generation enzyme immunoassay (EIA) is the first FDA-cleared test for in vitro diagnosis of norovirus infections. The RIDASCREEN Norovirus 3rd Generation EIA test is a qualitative EIA intended for detecting selected genogroup I and genogroup II norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks. The assay is a solid phase sandwichtype EIA that uses a mixture of genogroup I and genogroup II norovirus-specific monoclonal antibodies. The RIDASCREEN Norovirus 3rd Generation EIA facilitates the possible diagnosis of norovirus outbreaks in less than 2 hours, thereby enabling faster implementation of outbreak control procedures.
Rheonix® introduces an automated microfluidic platform for the evolving molecular diagnostics industry. Rheonix CARD® technology automatically processes samples through purification, multiplexed amplification, and endpoint detection, offering true sample-to-result functionality with minimal technician hands-on time. The versatile system can be rapidly customized for a broad spectrum of diagnostic applications and incorporates low-cost consumables to analyze raw clinical samples such as blood, saliva, buccal and vaginal swabs. Successful pilot programs have applied a range of functional assays to the EncompassMDx platform, including SNP detection, pathogen identification, immunoassays, cell-based assays, and other molecular diagnostic applications. *For research use only.
cobas® HPV Test
The cobas HPV Test allows you to quickly and easily identify patients at highest risk for cervical cancer. It is the only assay that provides specific genotyping information for HPV genotypes 16 and 18 while simultaneously reporting the 12 other hrHPV types as a pooled result. One test in one run, from one patient sample (1mL) eliminates the need for reflex testing.
cobas® 4800 system
The cobas 4800 system reliably automates nucleic acid purification, PCR set up, and real-time polymerase chain reactions (PCR) for true walk-away automation that provides maximum laboratory efficiency. Because it requires less hands-on time than most comparable systems and needs minimal daily maintenance, the cobas 4800 system frees staff to spend more time on other critical tasks. This system is designed to deliver trustworthy results for high-demand tests when combined with our multiplex assays. The Roche standards for reagent development include the AmpErase® enzyme, internal control, and a unique kinetic algorithm to deliver consistent accurate test results.
cobas® CT/NG Test*
The cobas CT/NG Test is an in vitro nucleic acid amplification test for qualitative detection of Chlamydia trachomatis (CT) and/ or Neisseria gonorrhoeae (NG) in patient specimens. The test uses amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization to detect CT and NG DNA in endocervical swab specimens, clinician-collected vaginal swab specimens, clinician-instructed, selfcollected vaginal swab specimens, and male and female urine in cobas PCR Media and cervical specimens in PreservCyt® solution (Hologic, Inc.). *Pending FDA clearance. Available for sale outside the U.S.
LightCycler® MRSA Advanced Test
The Roche LightCycler MRSA Advanced Test offers a simple, flexible, and reliable way to incorporate molecular MRSA surveillance into hospitals' infection control programs.
COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0
Viral load testing remains the gold standard for managing HBV antiviral therapy. The COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 provides accurate and reproducible results at key medical decision points, allowing clinicians to optimize patient outcomes. The assay runs on the COBAS AmpliPrep/ COBAS TaqMan System, the first fully automated, real-time PCR, continuous load IVD platform featuring sample-in, result-out, and parallel-processing capabilities on up to three FDA-approved assays (HIV, HCV, and HBV) simultaneously.
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 is a dual PCR target test for optimal coverage of the evolving HIV genome. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 Test quantifies HIV-1 RNA based on co-amplification of two distinct regions of the HIV-1 genome— LTR and gag—providing broad coverage of the evolving HIV-1 genome. The assay runs on the COBAS AmpliPrep/COBAS TaqMan System, the first fully automated, real-time PCR, continuous load IVD platform featuring sample-in, result-out, and parallelprocessing capabilities on up to three FDAapproved assays (HIV, HCV, and HBV) simultaneously.
COBAS® TaqMan® HCV Test v2.0
With the introduction of the COBAS Taq- Man HCV Test version 2.0 for use with the high-pure system, Roche now offers HCV viral load tests for both automated and manual specimen preparation methods, further demonstrating Roche's commitment in providing workflow options and flexibilities for the diverse needs of laboratories.
MagNA Pure 96 System*
The MagNA Pure 96 System is the latest high-throughput, robotic workstation from Roche Diagnostics. The MagNA Pure 96 system purifies DNA, RNA, and viral nucleic acids from a wide variety of starting materials using proven magnetic glass particle technology. Preprogrammed software protocols are tailored to the laboratory's sample requirements and yield high-purity nucleic acids that are ideal for a broad range of downstream applications. This industry-first solution for automated, high-throughput nucleic acid purification processes up to 96 standard-volume samples simultaneously— in <1 hour— using barcoded, prefilled trays with ready-to-use reagents from up to 96 samples. *Pending FDA Clearance.
cobas® c 702 Module
The cobas c 702 module is the next-generation, high-throughput clinical chemistry module offering up to 2,000 tests/hour with enhanced reagent management. The onboard reagent manager intelligently schedules automated, reagent-cassette exchange without operator interaction, automating reagent decapping, loading, and unloading. Exchanges may also occur on the fly. The cobas c 702 module is a member of the cobas 8000 modular analyzer series and may be combined with mid-volume chemistry (cobas c 502 module) and immunoassay (cobas e 602 module) modules to create an integrated platform with 24 unique system configurations that meets the individual needs of high-volume laboratories.
cobas® e 602 Module
The cobas e 602 module is an immunoassay module offering up to 170 tests/hour/module and an initial menu of more than 50 assays. This module uses Roche's patented electrochemiluminescence (ECL) technology, which offers broad measuring ranges and low-end sensitivity (HCG+β: 0.10– 10,000 mIU/mL). The cobas e 602 module is a member of the cobas 8000 modular analyzer series and may be combined with two clinical chemistry modules to create an integrated platform with 24 unique system configurations to meet individual needs of high-volume laboratories. Combine the cobas 3 602 module with mid-volume chemistry (cobas c 502 module) and immunoassay (cobas e 602 module) modules to create an integrated platform with 24 unique system configurations that meets the individual needs of high-volume laboratories.
9-Minute STAT Cardiac Assays
9-Minute STAT assays for troponin T, troponin I, NT-proBNP, CK-MB, and myoglobin from Roche Diagnosticsprovide significant turnaround-time improvement on the cobas® 8000 modular analyzer series. On average, these STAT assays can produce the same critical results in half the time with only one, simple blood draw obtained via the sophisticated Roche OneTUBE® solution—a faster, more efficient way to deliver accurate results without sacrificing performance, precision, or sensitivity. Laboratories can run a comprehensive battery of cardiac STAT tests to provide accurate results faster than current testing methods.
Elecsys Anti-HAV Total Assay
The Roche Elecsys Anti-HAV Total Assay is an electrochemiluminescence (ECL) immunoassay for in vitro qualitative detection of total antibodies (IgM and IgG) to hepatitis A virus in human serum and plasma. The assay is intended as an aid in the laboratory diagnosis of past or acute/recent hepatitis A infection. The Roche Anti-HAV Total assay runs on the Elecsys 2010 system, MODULAR ANALYTICS E170 module, cobas e 601 analyzer, cobas e 602 analyzer, and cobas e 411 analyzer.
Elecsys Thyroglobulin (Tg) Assay*
The Roche Elecsys Tg Assay is an electrochemiluminescence (ECL) immunoassay for quantitative determination of thyroglobulin in human serum and plasma. Tg levels aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid ablation, either with or without ablative radioiodine therapy. The Roche Tg assay runs on the Elecsys 2010 system, MODULAR ANALYTICS E170 module, cobas e 601 analyzer, cobas e 602 analyzer, and cobas e 411 analyzer. *Pending FDA clearance. Available for sale outside the U.S.
Elecsys Human Growth Hormone (hGH) Assay
The Roche Elecsys Human Growth Hormone Assay is an electrochemiluminescence (ECL) immunoassay for quantitative determination of the biologically active 20-kDa and 22-kDa isoforms of human growth hormone in serum and plasma. The onestep, sandwich assay takes only 18 minutes and demonstrates excellent total precision of 1.7–2.5 CV% for the MODULAR ANALYTICS E170 module, cobas e 601 analyzer, and cobas e 602 analyzer. The high precision and reliability of the assay provide a solid base for a growth hormone assessment. The Roche Human Growth Hormone assay is available for all Roche immunoassay systems.
Middleware Solutions—Moving Averages
Roche Middleware Solutions offers Moving Averages, software that monitors the performance of assays and analyzers in between QC runs. The laboratory creates automated protocols within middleware to monitor the average of patient results on an assay-byassay basis and between multiple analyzers. If the average of patient results drifts above or below pre-defined threshold levels, moving averages will automatically stop autoverification and hold test results. The lab will be notified via email or screen pop-up. It empowers labs to detect potential assay or instrument degradation in between QC runs and offers the ability to intervene before experiencing QC failure.
Minivette® POCT Device
The new Minivette POCT device from Sarstedt is designed for precise and hygienic collection, transfer, and subsequent dispensing of small capillary blood samples for point-of-care tests. Blood is easily collected via capillary action into the end of the Minivette POCT device. The sample is held securely in the capillary without spills during transfer and then dispensed onto the test field with a slight push of the opposing integral piston. The Minivette POCT device is available for blood volumes of 20 μL and 50 μL, and the collection capillary is offered plain or prepared with EDTA or heparin.
13 x 75-mm Tubes for Automation and Analysis
The new 13 x 75-mm screw cap aliquot tubes with round bases from Sarstedt are designed for compatibility with common laboratory automation and analysis platforms. A full volume 13 x 75-mm tube accommodates 5 mL of sample, features printed writing block and graduations, and is available in clear or amber for light sensitive analytes. A 2.5-mL falsebottom version with an elevated conical base raises small sample volumes to an optimal height for analysis. The corresponding tall screw cap for improved gripping provides a leak-resistant closure that meets IATA requirements for transport. Alternatively, a flanged anti-evaporation push cap may be used to cover samples or to archive samples.
PVS 1625 with Screw-Cap Recapper
The Sarstedt PVS 1625 is a comprehensive, modular, laboratory automation system for pre- and post-analytical processing. Independent from an analytical platform, the PVS 1625 can be customized according to a laboratory's needs with available modules for loading, identification, decapping, sorting, aliquoting, and recapping. A new screw-cap recapper module is available that places a screw cap onto Sarstedt aliquot tubes. Aliquots can be made directly into compatible screw-cap tubes and immediately recapped for send-outs or capped post-analysis for archiving. The PVS 1625 is compatible with most analyzer racks and common tube types and dimensions.
MINICAP FLEX Piercing: Whole-Blood Hb Testing*
Whole-blood hemoglobinopathy testing by capillary electrophoresis (CE) with cappiercing 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 barcoded 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, including: protein electrophoresis, immunotyping, and CDT (chronic alcohol abuse marker). *Pending FDA clearance. Available for sale outside the U.S.
CAPILLARYS™ 2 FLEX Piercing: Whole-Blood Hb Testing*
Whole-blood hemoglobinopathy testing by capillary electrophoresis (CE) with cappiercing capabilities is now available 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 Hb separation takes place concurrently in eight capillaries with a sample throughput of 37 results per 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 CDT (chronic alcohol abuse marker). *Pending FDA clearance. Available for sale outside the U.S.
CAPILLARYS 2 Flex Piercing HbA1c *
This next-generation HbA1c assay, based on the principle of capillary electrophoresis, provides high-resolution, clear-cut, and precise separation of HbA1c and HbA0 fractions. Capillary electrophoresis eliminates direct interferences on the A1c fraction from carbamylated, acetylated, labile, and common Hb variants such as HbS, HbD, and HbE, as well as the analytical exclusion of HbA2 and HbF from the measurement. The method produces highly accurate results and extremely low CVs. CAPILLARYS 2 Flex Piercing HbA1c, with whole-blood, closed tube capacity, offers the best equilibrium in precision, robustness, and throughput along with the ability to run traditional electrophoresis testing. *Pending FDA clearance. Available for sale outside the U.S.
OSOM® C. difficile Toxin A/B Test*
OSOM C. difficile Toxin A/B is a rapid test to aid in the diagnosis of C. difficile infection. The assay requires just four simple steps, and results are available in 20 minutes or less. No incubation is required, and labs can run the test in batch or STAT. An accurate, easy-toread, two-color dipstick provides clear objective results. Each kit contains all the materials necessary to run the test, plus two additional test sticks for external QC. Online training is available anytime at www.osomtraining.com. *Made in the U.S.
FLAIR Microarray Scanner*
FLAIR, Sensovation's fluorescence array imaging reader, is a compact and affordable microarray reader designed for routine applications. It is used for multiplexed diagnostics in clinical research and routine analyses. FLAIR allows fast measurement of planar fluorescent microarrays with up to three colors. Originally designed for array-in well applications, FLAIR accommodates 96- well plates or four conventional slides on the four-slide holder. FLAIR is an easy-to-use, standalone instrument with integrated processor, including array analysis software and touchscreen. FLAIR offers the full performance of a microarray scanner for multiplexed diagnostics on an exceptionally small footprint. *For research use only. Pending FDA clearance. Available for sale outside the U.S.
Tellgenplex™ Tumor Marker Quantitative Assay*
Tellgenplex Tumor Marker Quantitative Assay is intended for simultaneous quantitative determination of multiple tumor markers based on xMAP technology, including AFP, CEA, CA242, CA125, NSE, CYFRA21-1, free-β-hCG, total-PSA, free-PSA, CA19-9, CA15-3, CA50, and SCCA. Laboratories can detect these tumor markers in single or multiplex formats to meet their needs. All these tumor markers have been cleared by State of Food and Drug Administration of China, and total-PSA/free-PSA has received CE certification. With a variety of tumor marker detection assays on the market, this in vitro diagnostic test can also be used as an aid in managing cancer patients *Available for sale outside the U.S.
BS-800 Modular System*
BS-800 Modular System, an innovative clinical chemistry diagnostic system manufactured by Mindray Corporation, incorporates Mindray's suggested reagents, calibrators, and controls. It can be adapted to customers' needs by integrating one to four modular units with various throughputs, ranging from 1,200–4,800 tests/hour. The systems uses only 100 μL of reagent, takes up to 860 BS-800 Modular System, an innovative clinical chemistry diagnostic system manufactured by Mindray Corporation, incorporates Mindray's suggested reagents, calibrators, and controls. It can be adapted to customers' needs by integrating one to four modular units with various throughputs, ranging from 1,200–4,800 tests/hour. The systems uses only 100 μL of reagent, takes up to 860 samples, has 2–8ºC reagent cooling, reagent bubble detection, and user-friendly operating software. The system allows labs to focus on cost-effectiveness, result accuracy, operator safety, and technology advancement. BS-800 Modular System provides a brand new experience in laboratory practice and lets labs explore the cutting-edge instrumentation of modern technology. *Available for sale outside the U.S.
Vitamin D Total Assay* on ADVIA Centaur® System
Laboratories can now meet the increased demand for vitamin D total testing with precise consistent results in as little as 18 minutes. The ADVIA Centaur Vitamin D Total Assay is an equimolar, fully automated vitamin D total assay that is traceable to LC-MS/MS, considered the gold standard in vitamin D testing. In addition, the assay measures the total 25-hydroxyvitamin D [25(OH)D] level (~100% D2 and D3) to ensure patients are evaluated for deficiency, sufficiency, or toxicity. *Available for sale outside the U.S.
VersaCell™ Connectivity to Dimension® EXL™ Systems
The VersaCell system's newest connectivity options include the Dimension EXL with LM, Dimension EXL 200, and RxL Max Systems. These Dimension platforms join the ADVIA® 1800 Chemistry, IMMULITE®, and ADVIA Centaur® Immunoassay Systems as VersaCell connectivity options. The Dimension EXL with LM systems combine the power of a uniform reagent system, 182 concurrent onboard assays, QuikLYTE® electrolytes, and LOCI® immunoassay technology. VersaCell provides unique preand post-analytical sample management and workload balancing. The new connectivity options create specific, needs-based workstations, combining two Dimension EXL systems or a Dimension EXL system with an immunoassay platform.
RAPIDPoint® 500* Blood Gas System*
RAPIDPoint 500 Blood Gas Analyzers provide the accuracy and reliability you have come to trust in an easy-to-use, maintenance- free solution. Designed to satisfy the unique demands of point-of-care testing, the cartridge-based system delivers a complete critical-care test menu from a single, wholeblood sample: pH and blood gases, electrolytes, glucose, total neonatal bilirubin, and full CO-oximetry. Engineered to maximize uptime, you can count on the RAPIDPoint 500 system to be ready to use without slowing down your staff with complex operating procedures and maintenance tasks. Longlasting cartridges, integrated automatic QC, and proven technologies free clinicians to focus on patient care as your workload and testing needs continue to grow. *In development.
Personalized Education Plan
The Personalized Education Plan (PEP) is a patent-pending, competency-based approach to customized laboratory education. Managed online, PEP blends the unique attributes of formal instruction, interactive training, state-of-the-art technology, and expert insight that help advance staff development and improve productivity. With a core system-based curriculum, PEP also provides ongoing guidance and educational support for a wide variety of professional and disease-management topics. In addition, PEP can be personalized to accommodate different needs, preferences, and learning styles through a multitude of convenient delivery vehicles.
LOCI® CA Assays on Dimension Vista® System
LOCI CA 125II, CA 15-3, and CA 19-9 assays for Dimension Vista systems are homogenous, sandwich, chemiluminescent immunoassays for the quantitative measurement of CA 125II, CA 15-3, and CA 19-9. LOCI CA assays integrate oncology testing into routine workflows on a consolidated platform and are the only CA assays to employ LOCI technology. When used in conjunction with other clinical and diagnostic procedures, serial testing with LOCI CA markers may be useful as an aid in managing previously treated cancers, for monitoring response to therapy, or for monitoring disease progress, recurrence, or residual disease.
INNOVANCE® D-Dimer Assay
The INNOVANCE D-Dimer Assay has been used by labs to aid in diagnosis of life-threatening venous thromboembolic events like deep vein thrombosis (DVT) and pulmonary embolism (PE). It is now available for use in conjunction with a non-high clinical pretest probability assessment model to exclude the presence of DVT and PE. Speed and performance make INNOVANCE D-Dimer a robust, cost-effective assay for both routine and emergency (STAT) use, capable of streamlining your laboratory workflow. The fully automated blood test runs on multiple coagulation systems offered by Siemens, including the BCS®, BCS® XP, and Sysmex® Coagulation Systems.
IMMULITE® 2000 XPi Immunoassay System*
The IMMULITE 2000 XPi Immunoassay System is a continuous, random-access analyzer that includes enhanced hardware and software features designed to handle many of today's immunoassay-testing challenges Enhancements include Auto Rack Load for no-pause sampling and AutoStart for automation of routine maintenance, and QC. Additionally, the IMMULITE 2000 XPi system features an extensive automated routine, allergy, and specialty immunoassay menu and processes up to 200 tests/hour. *Not available for sale in the U.S. Pending FDA clearance. Available for sale outside the U.S.
Dimension® EXL™ 200 Integrated Chemistry System
The Dimension EXL 200 Integrated Chemistry System is the latest addition to the Dimension family of analyzers. This new system features LOCI® advanced chemiluminescence technology, providing lowervolume laboratories with access to fast, sensitive immunoassay testing on a trusted, proven, and integrated platform. The test menu includes more than 90% of the critical methods ordered by physicians and features a cardiac STAT menu that delivers highsensitivity troponin I results in 10 minutes. Additionally, the Dimension EXL 200 system features technology new to the Dimension EXL line that helps increase productivity in the laboratory, such as a sample transfer module, sample clot check, and the capability to sample from pediatric tubes.
syngo® Lab Data Manager*
syngo Lab Data Manager is a new datamanagement system that links analyzers and StreamLAB® Automation Solutions to the laboratory information system (LIS) and Siemens remote services. This system provides a consolidated view of patient results and offers autoverification through which laboratories can automate release of test results, reduce errors, and increase consistency. The integrated quality control module ensures high quality result reporting through automated Westgard rules, custom rules, and real-time analysis of patient median statistics. syngo Lab Data Manager is future-ready, with a built-in growth path to process management the next generation of diagnostics IT. *Available for sale outside the U.S.
syngo® Lab Process Manager*
syngo Lab Process Manager integrates data management with process control to deliver next-generation diagnostics IT. This breakthrough IT solution provides a consolidated view of the lab's testing processes and equipment so the operator can quickly identify and resolve problems before they impact quality and turnaround times. *Available for sale outside the U.S.
EHIV Assay on ADVIA Centaur® CP Sys
The ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay is an immunoassay for qualitative determination of antibodies to human immunodeficiency virus (HIV) type 1, including Group O, and/or HIV type 2, in serum or plasma. Addition of the highperformance EHIV assay on the ADVIA Centaur CP extends the total available menu to 64 assays. The EHIV assay is developed, manufactured, and sold by Siemens Healthcare Diagnostics, Inc. for Ortho-Clinical Diagnostics, Inc.
LOCI® TPSA and FPSA Assays on the Dimension Vista®*
LOCI TPSA and FPSA for the Dimension Vista 1500 system consolidate PSA testing on a single platform and are the only PSA assays on the market to employ LOCI technology, a homogenous, sandwich, chemiluminescent immunoassay for quantitatively measuring total prostate-specific antigen (TPSA) and free prostate-specific antigen (FPSA). Measurements of TPSA and/or FPSA aid in detecting prostate cancer when used in conjunction with digital rectal exam in men ≥50 years, in management of prostate cancer, and with calculations of percent FPSA in distinguishing cancer from benign prostate conditions. *Pending FDA clearance.
LOCI® Free T3 Assay on the Dimension® EXL™ System
The Dimension EXL Free T3 Assay is a homogenous, chemiluminescent immunoassay based on LOCI technology. The LOCI free T3 methodology provides rapid turnaround, high analytical sensitivity, and excellent precision to assist physicians in diagnosing and treating thyroid patients. The free T3 assay completes the common panel of thyroidfunction assays on the Dimension EXL with LM system. This panel includes ultrasensitive, third-generation TSH, total T4, FT4, and FT3. Consolidation of these assays on a single, integrated platform enhances the laboratory's workflow efficiency without compromising on results.
BRAHMS PCT Assay* on ADVIA Centaur®
The ADVIA Centaur BRAHMS PCT (procalcitonin) Assay is a one-step, sandwich, chemiluminescent immunoassay used for determining PCT in human serum and plasma on the ADVIA Centaur Immunoassay System. This PCT assay provides additional, specific information that may be helpful in increasing the accuracy of sepsis diagnosis at an early stage to aid in risk assessment of critically ill patients. Sepsis is a serious medical condition caused by the body's response to an infection. Early detection and targeted clinical intervention have been demonstrated to be crucial for improved outcomes in septic patients. *Not available for sale in the US. Pending FDA clearance.
Cell-Chex is a spinal and body fluid control with distinct white (WBC) and red blood cell (RBC) populations for manual counts. When stained in the same manner as a patient sample, the WBCx 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 polymorph nuclear and mononuclear differential. Level 1 now contains crystals to help assess lab technicians' skills in identifying accurate crystals in synovial fluid samples.
UA-Cellular® for IQ Control
UA-Cellular for IQ is Streck's micro urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. UA-Cellular for IQ contains components at two clinically significant levels, providing thorough 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 has an open-vial stability of 30 days and a closed-vial stability of 105 days.
UA-Cellular® for UF Control
UA-Cellular for UF is Streck's micro urinalysis control designed specifically for the Sysmex® UF urine analyzers. UA-Cellular for UF contains cellular components at two clinically significant levels, providing thorough evaluation of the Sysmex UF analyzers' ability to qualify and quantify white 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.
Cell-Free DNA™ BCT Control*
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.
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 PCR tubes enable users to perform reliable PCR in less than 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.
CD-Chex® Plus BC Control
CD-Chex Plus BC is a whole blood assayed control for immunophenotyping on Beckman Coulter® flow cytometry systems. CD-Chex Plus BC determines the accuracy and reproducibility of all the steps involved in the process of immunophenotyping, including red blood cell lysis. CD-Chex Plus BC provides the most assayed CD markers in the industry, including T lymphocytes, B lymphocytes, granulocytes, monocytes, and NK cells. CD-Chex Plus BC CD4 Low offers a depressed CD4 absolute number often indicated in patients with immunodeficiency diseases. Each level has 30-day open-vial stability and 90-day closed-vial stability. CD-Chex Plus BC and CD-Chex Plus BC CD4 Low are available in plastic vials with pierceable caps containing 3 mL.
CD-Chex® Plus Control
CD-Chex Plus is a whole blood assayed control for monitoring immunophenotyping by flow cytometry. CD-Chex Plus determines the accuracy and reproducibility of all the steps involved in the process of immunophenotyping, including red blood cell lysis. CD-Chex Plus provides the most assayed CD markers in the industry, including T lymphocytes, B lymphocytes, granulocytes, monocytes, and NK cells. CD-Chex Plus 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. Compatible with most popular flow cytometry systems, CDChex Plus and CD-Chex CD4 Low are available in the 2.5-mL and 3-mL cap-pierceable fill volumes. Both levels have an open-vial stability of 30 days and a closed-vial stability of 90 days.
Cell-Free RNA™ BCT*
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 temperature. The patented preservative in Cell-Free RNA BCT preserves cellfree RNA in plasma and prevents the release of cellular RNA during sample processing and storage, reducing background RNA level. With Cell-Free RNA BCT, processing patient samples for detection and analysis of 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.
Streck Product Selection Guide
Streck, Inc., introduces a new feature on its redesigned website, www.streck.com. The Product Selection Guide is a quick reference to help customers 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 website also provides access to technical support from an experienced team of medical technologists and access to STATS, Streck's inter-laboratory 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.
Protein-Free Assay Diluent*
Introducing the newest member of SurModics' family of exceptional immunoassay products. This protein-free diluent is a proprietary buffer formulation that reduces matrix interference in samples, including heterophillic antibodies such as HAMA (human anti-mouse antibody) and RF (rheumatoid factor). The protein-free formulation removes any possible risk of BSA-related issues in sample quantitation. You can improve the true value of your sample results by simultaneously diluting false-positive samples and your standard curve with SurModics' assay diluent. More accurate results mean better patient outcomes. This reagent performs as an excellent diluent for samples, standard curves, and/or antibodies. *Available for sale outside the U.S.
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. The assay format makes administering sample collection easier during field visits or check-ins. Observing oral fluid collection also is noninvasive, reducing the risk of sample adulteration. Different size kits are available for a range of lab testing needs, and calibrators and controls are supplied as ready-to-use liquids. The CEDIA Oral Fluid Control Set is packaged at more than 50% of cutoff 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. Contact us at (800) 232-3342 or email us at email@example.com.
QMS® Teicoplanin Immunoassay*
The Thermo Scientific QMS Teicoplanin Immunoassay is intended for quantitative determination of teicoplanin in human serum or plasma as an aid in managing patients receiving teicoplanin therapy. The assay uses the Quantitative Microparticle Systems technology that is based on a competitive inhibition principle. Teicoplanin is used to treat moderate-to-serious infections caused by bacteria. QMS liquid-stable, ready-to-use reagents offer superior performance and are widely applicable to a variety of general chemistry analyzers. The assay offers excellent curve stability and low interference with endogenous substances. Contact us at (800) 232-3342 or email us at sales.diagnostics. firstname.lastname@example.org. *Available for sale outside the US.
QMS® Everolimus Immunoassay
The Thermo Scientific QMS Everolimus Immunoassay is the newest addition to a full menu of immunosuppressant drug monitoring immunoassays. There are applications for a variety of clinical chemistry analyzers. The QMS Everolimus assay was developed using the Quantitative Microsphere Systems technology, incorporating microparticle beads. The test is based on a competitive inhibition principle. This assay recently received FDA clearance for management of kidney transplant patients receiving everolimus therapy. Training and service is available by our highly trained field technical service team, and our 24/7 hotline provides on-going support for your lab. Contact us at (800) 232-3342 or email us at sales.diagnostics.fmt@thermofisher. com.
Indiko Clinical Chemistry Analyzer*
Introducing the new Thermo Scientific Indiko, a superior benchtop photometric analyzer. Indiko's compact design occupies a small footprint, is easy-to-install, and does not require external water or drainage connections. An easy-to-use graphic interface, combined with the unique low-volume cuvette design, reduces reagent usage and operating cost. A flexible loading system with combined sample and reagent disks allows for continuous access to samples, reagents, and cuvettes without interrupting the testing process. Once loaded, the analyzer automates all necessary steps, providing a walk-away time of up to 2 hours. Contact us at (800) 232-3342 or email us at email@example.com. *Pending FDA clearance.
MAS® Omni•IMMUNE™ Control*
Thermo Scientific MAS Omni•IMMUNE and MAS Omni•IMMUNE PRO consolidates immunochemistry QC testing. Combining the analytes for routine immunoassays, cancer markers, and newer specialty tests into a single, three-level QC material streamlines lab QC testing process by rolling three historically distinct products into a single vial. MAS Omni•IMMUNE PRO provides anti-Tg, anti-TPO, and SHBG in addition to assays provided in the standard Omni-IMMUNE. 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. Contact us at (800) 232-3342 or email us at firstname.lastname@example.org. *Pending FDA clearance.
MAS® Omni•CORE™ Control*
Thermo Scientific MAS Omni•CORE provides the highly requested consolidation of general chemistry and immunology QC products. Combining CRP, Rheumatoid Factor, and key serum protein tests with a general chemistry panel into a single, threelevel QC material streamlines lab QC testing, rolling two historically distinct products into a single vial. MAS Omni•CORE provides class-leading QC stability while maintaining distinct level separation. 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. Contact us at (800) 232-3342 or email us at sales.diagnostics. email@example.com. *Pending FDA clearance.
MAS® DOA Total Control
The new Thermo Scientific MAS DOA TOTAL Control is a multi-constituent urine toxicology control offering 19 analytes with four distinct levels at drug concentrations 25% above and below commonly used screening and SAMHSA cutoffs. A drug-free level and high-positive level are also available (six levels total). The MAS DOA TOTAL Control is a liquid, ready-to-use product available for use on a variety of instrument platforms. Each level of control is individually packed, which gives you the flexibility to choose your levels according to your drugscreen panel cutoffs while keeping the number of control vials to a minimum. Contact us at (800) 232-3342 or email us at firstname.lastname@example.org.
Fluoro-Max™ Fluorescent Particles*
Fluoro-Max Fluorescent Particles are internally dyed with europium chelate and come in carboxylate-modified and streptavidincoated versions. The particles produce a very broad Stokes shift so that any non-specific fluorescent interference can be avoided. This characteristic makes these particles ideal for lateral flow, diagnostic assay, nucleic acid hybridization, immuno/histological, research, point-of-care, membrane, and other timeresolved microfluorescent applications. Available in 0.1-, 0.2-, and 0.3- μ diameters, these particles excite at 333 nm and emit at 613 nm, and they do so for an extended lifetime of approximately 0.5 milliseconds. *Available for sale outside the U.S.
Sera-Mag® SpeedBeads™ Magnetic Protein A/G Particles*
Sera-Mag SpeedBeads Magnetic Protein A/G Particles provide a fast and convenient method for both manual and automated magnetic isolation of proteins using affinity binding. These nominal 1-μm diameter, uniform, colloidally stable, monodispersed, non-porous super paramagnetic particles can be used for isolating antibodies from serum, cell culture supernatant, or ascites, as well as for immunoprecipitation and co-immunoprecipitation of antigens from cell or tissue extracts. The particles are supplied at 1% solids (10 mg/mL) in 0.05% sodium azide and are available in 1-, 15-, and 100- mL bottles. Manufactured under strict quality and GMP controls in our medical device-registered, ISO 13485-certified facility. *In development. Available for sale outside the U.S.
ST AIA-PACK ACTH and ST AIA-PACK DHEA-S*
Tosoh introduces two new assays to add to its AIA test menu: ST AIA-PACK ACTH and ST AIA-PACK DHEA-S. ST AIA-PACK ACTH is designed for in vitro diagnostic use only for quantitative measurement of ACTH in human EDTA plasma on Tosoh AIA System Analyzers. ST AIA-PACK DHEA-S is designed for in vitro diagnostic use only for quantitative measurement of dehydroepiandrosterone sulfate (DHEA-S) in human serum, heparinized or EDTA plasma, on TOSOH AIA System Analyzers. Both ACTH and DHEA-S use Tosoh's unit-dose test cup technology, and the assay time is approximately 20 minutes. Both assays offer a calibration stability of 90 days. *Pending FDA clearance.
AIA-900 Automated Immunoassay Analyzer*
Tosoh introduces the highly anticipated AIA- 900 Automated Immunoassay Analyzer. This flexible new addition to Tosoh's respected family of AIA analyzers has a throughput of 90 tests/hour and is available in three different options: the AIA-900, the AIA-900 with the nine-tray sorter, and the AIA-900 with the 19-tray sorter. The three models present customers with a unique opportunity to grow with their testing volumes. For example, a laboratory that purchases the AIA-900 can add the nine-tray sorter to increase testing capacity without changing their instrument. The AIA-900 uses the same Unit-Dose Test Cup reagent technology as all Tosoh AIA immunoassay analyzers. The AIA-900 is being launched with the full AIAtest menu*. *Pending FDA clearance for ST AIA-PACK PA.
CleanAmp™ PCR Kits
CleanAmp PCR Kits are powered by TriLink's innovative, heat-activated dNTP chemistry. Activation of the CleanAmp chemistry occurs during the initial heat cycle of hot start PCR and each subsequent denaturation step, releasing just enough reagents to allow efficient amplification. CleanAmp PCR Kits benefit basic applications, as well as more advanced variants, such as real-time, multiplex, and reverse-transcription PCR. Customers can eliminate or reduce off-target amplification, significantly increase amplicon yield and specificity, and commercialize for less with reasonable licensing options.
Four-Level Methotrexate Controls*
UTAK's Four-Level Methotrexate Controls are manufactured in 100% human serum with no added preservatives to eliminate matrix effects and improve precision. The four methotrexate concentrations are 0.05, 0.075, 0.5, and 0.75 μmol/L. These lyophilized controls have a 30- month shelf life, 25 days of reconstituted stability, and are packaged in a 5 x 5-mL volume size.*Available for sale outside the U.S.
Bi-Level Antifungal Controls *
UTAK's Bi-Level Antifungal Controls are manufactured in 100% human serum with no added preservatives to eliminate matrix effects and improve precision. The analyte panel of antifungals includes Fluconazole, 5-Flucytosine, Itraconazole, Hydroxy-Itraconazole, Posaconazole, and Voriconazole at clinically relevant concentration levels. These lyophilized controls have a 30-month shelf life, 25 days of reconstituted stability, and are packaged in a 5 x 5-mL volume size. *Available for sale outside the U.S.
OVA1 is the first FDA-cleared test for aiding in pre-surgical evaluation of an ovarian mass for cancer, and also is the first protein-based in vitro diagnostic multi-variate index assay, a new class of state-of-the art, software-based diagnostics. The test uses five biomarkers— transthyretin, apolipoprotein A-1, beta2- microglobulin, transferrin (Tfr), and CA 125 II—and a proprietary software to determine the likelihood of malignancy in women with an ovarian mass for whom surgery is planned. OVA1 is indicated for women who meet the following criteria: >18 years; ovarian adnexal mass present for which surgery is planned; and not yet referred to an oncologist. Additional product information can be found at www.ova-1.com/.
Centrisart® Concentrator for Antigens and Antibodies
The Sartorius Centrisart centrifugal ultrafiltration device can be used for concentrating fungal antibodies in serum prior to complement fixation or immunodiffusion. The sensitivity of these tests for Coccidioides antibodies has been improved greatly by this method. The Centrisart may also be used for concentrating bacterial antigens in urine, serum, or cerebrospinal fluid. Antigens associated with H. influenzae and S. pneumoniae can be concentrated and tested with latex particle agglutination or other methods. This has been useful in the diagnosis of sepsis in newborns. The Centrisart features a unique design in which the ultrafiltration takes place in the opposite direction to the centrifugal force. This is effective in greatly reducing blockage of the filter and improving flow.
ACQUITY® Online SPE System*
Waters introduces the ACQUITY Online SPE System for general laboratory use. The ACQUITY Online SPE System couples powerful and enabling UPLC® Technology with automated, online, solid-phase extraction to streamline workflows and improve analytical performance for LC-MS/MS-based assays. This fully integrated system solution is designed to improve the flexibility of LC-MS/ MS testing by allowing multiple assays to be performed on a single platform. Singleuse cartridges are used to perform each and every extraction on the system, reducing the risks of analyte carryover and accumulation of matrix components that can compromise analytical performance. *For research use only.
Chagas Disease Detection Kits*
Wiener Labs has a complete line of kits for detection of Chagas disease, a parasitic infection produced by Trypanosoma cruzi. Commonly, the disease evolves towards a chronic phase. During the acute phase, the diagnosis is performed by detection of parasites in blood. During the chronic phase, serologic methods are used as screening tests. Today, blood donations in all endemic Latin American countries undergo Chagas screening, and testing is expanding to other countries like the U.S. The line is composed of: Chagatest ELISA recombinante v.4.0®, Chagatest ELISA recombinante v.3.0®, Chagatest ELISA lisado ®, WL Check Chagas®, Chagatest HAI®, Chagatest HAI A-V®. *For research use only.