AbbottLink is an award-winning* integrated care system that allows real-time communication between Abbott, you, and your Abbott instrumentation. Laboratories with AbbottLink will experience greater efficiency and an increase in productivity because of the AbbottLink customer portal. Labs can quickly obtain valuable workflow reports that document instrument utilization and assay efficiency in a convenient, timely, and secure manner via the Internet from anywhere around the world. *Abbott Diagnostics received the Innovation in Technology Award presented by the Aberdeen Group for maximizing technology solutions and solving pressing service chain issues in October 2007. AbbottLink is a trademark of Abbott Laboratories in various jurisdictions.
ARCHITECT HE4 Assay
The FDA has cleared Abbott’s new fully automated ARCHITECT HE4 test for in vitro diagnostic use. The ARCHITECT HE4 assay is a chemiluminescent microparticle assay for the quantitative determination of HE4 antigen in human serum. The assay is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. The addition of HE4 to the ARCHITECT’s full range of tumor markers shows Abbott’s ongoing commitment to oncology testing. ARCHITECT HE4 assay should not be used as a cancer screening test. ARCHITECT is a trademark of Abbott Laboratories in various jurisdictions.
Announcing the ARCHITECTPlus—the same quality you expect from the ARCHITECT family of immunochemistry analyzers, but with a new look and even more capability. The system control center has a large 17"-monitor mounted on a moveable arm to increase convenience and decrease required floor space. An updated CPU means faster screen response and improved processing speed. The v7.0 Premium software offers increased screen resolution and improved graphics, and a new “plan-my-day” tool helps you complete testing with fewer interruptions. Refer to the operations manual on our Website for operational precautions, limitations and hazards. ARCHITECT is a trademark of Abbott Laboratories in various jurisdictions.
ARCHITECT Folate Assay
The ARCHITECT Folate assay is a chemiluminescent, microparticle, folate-binding protein assay for quantitatetively determining folate in human serum and plasma on the ARCHITECT i System. This assay is FDA cleared. Folate measurements are used in the diagnosis and treatment of megaloblastic anemia. Low ARCHITECT folate values from patients with renal impairment or failure should be confirmed by an alternate folate method. ARCHITECT and i Systems are trademark of Abbott Laboratories in various jurisdictions.
PathFinder 350S Workcell
The PathFinder 350S, a component of Abbott’s High Efficiency Hematology program, is an automated robotic workcell designed for use in the laboratory environment and intended to sort specimen tubes into sample racks based on barcode identification and without the need for a track system. The PathFinder 350S can help address many of the challenges associated with specimen management, including reducing manual sorting errors, processing samples at up to 350 tubes per hour, and simplifying sample handling with flexible configurations. See the user manual for warnings, precautions, and limitations for proper use of the instrument. PathFinder is a trademark of Aim Lab Pty, Ltd.
Alere™ PBP2a Assay
The Alere™ PBP2a is a rapid, lateral-flow assay that detects the PBP2a protein found in MRSA directly from Staphylococcus aureus isolates. It is a cost-effective, targeted approach to identifying methicillin-resistant Staphylococcus aureus. The Alere™ PBP2a test provides results in 5 minutes, uses samples from culture (wound, skin, urine, etc.) and has built-in quality controls on every test strip.
ALFRED 60 Automated AST
A new application is available on the ALFRED 60 for rapid antibiotic susceptibility testing, starting from positive hemoculture bottles with results in only 3 hours. ALFRED 60 is the first fully automated system for bacterial culture, residual antimicrobial activity testing, and AST. It offers rapid, reliable results, sample traceability, and standardized working protocols. The patented technology detects intense bacteria replication activity by plotting growth curves in real time and indicates quantitative results expressed in CFU/mL. The positivity threshold is customizable according to laboratory needs. Culture now includes the new automated application, the McFarland Monitor, improved analysis speed and reduced manual errors.
ORAL-VIEW® Saliva Drugs-of-Abuse Rapid Test*
Simply place the collection part of the device inside the mouth for 3 minutes—then obtain your results in about 10 minutes through a visual read or through a portable electronic reader. No additional handling is required. This one-step, rapid immunoassay test can detect up to eight drugs in oral fluids including amphetamine, benzodiazepine, cocaine, methamphetamine/ecstasy, opiates, marijuana, phencyclidine, and methadone. Alfa’s one-step drug assay system has a clear advantage in road-side check point applications where the reliability of the test and quick turnaround time is critical. The test is for forensic use only in the U.S. or international export. *Pending FDA clearance.
Barcoded Magnetic Beads for 128-plex Assays*
Barcoded Magnetic Beads (BMB), using digital technology instead of conventional analog methodology, offer unmatched decoding accuracy, excellent fluorescence detection, and precision multiplex tests. When BMB technology marries biotechnology, it becomes a very flexible platform for routine clinical immunoassays and molecular diagnostics, companion diagnostics, biomarker validation, and pharmacogenomics. The new Biocode-1000 BMB Analyzer rapidly scans a 96-well microplate, decodes barcodes, measures label fluorescence, and displays the results of 128-plex testing within 1 minute per microwell. The Biocode-1000 BMB Analyzer makes multiplex assays very simple and offers high throughput, high accuracy, and affordability. *For research use only.
ARK™ Levetiracetam Assay
ARK Diagnostics Inc., the leader in the next generation of TDM assays, is pleased to introduce the ARK™ Levetiracetam Assay— a new, FDA-cleared, homogeneous enzyme immunoassay to measure levetiracetam (Keppra) in serum or plasma. ARK’s liquid-stable, ready-to-use formulation delivers convenience for routine use. ARK produces assays of choice—high-quality, rapid, and reliable—for precise results on a variety of automated clinical chemistry analyzers. Specificity is excellent, and the reportable range extends from 2–100 µg/mL. Levetiracetam is the latest member in ARK’s family of FDA-cleared assays for newer AEDs. Lamotrigine and gabapentin are pending FDA clearance.
IVT ALLERGY™ SYSTEM
ASI’s enhanced system combines the established science of the IVT Allergy™ Screen with the newly developed IVT Allergy™ Reader to provide digital recording of results with standardization of interpretation. The IVT Allergy™ Screen is an ELISA procedure that detects simultaneously, in a single test, IgE antibodies specific to multiple allergens in standard or customized allergy panels. Using state-of-the-art digital photo analysis, the IVT Allergy™ reader-enhanced system quickly screens multiple panels accurately. The IVT Allergy™ System combines the accuracy, convenience, and cost effectiveness of ASI’s in vitro testing with the precision of digital technology. Available outside of the U.S.
INFINITI HPV-HR QUAD*
With the recognition that virtually all cervical cancers, both of the squamous and of the adenocarcinoma histologic types, are related to cervical infections by 14 oncogenic human papillomavirus (HPV) genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), the need for high-risk genotyping is on the rise. The INFINITI® HPV-HR QUAD assay is a comprehensive panel that detects 14 high-risk HPV types. The test is automated on the INFINITI® Analyzer with simplified Load-N-Go automation, processing four patient samples on one microarray. *For research use only.
INFINITI CYP450 2C19+*
CYP450 2C19+ is an important liver enzyme involved in the metabolism and elimination of 5–10% of drugs in current clinical use. 2C19 polymorphisms are commonly seen in approximately 30% of Caucasians, 40% of African-Americans, and 55% of Asians. The INFINITI® CYP450 2C19+ is a comprehensive panel designed to detect 10 genetic mutations in the CYP450 2C19 gene: *2; *3; *4; *5; *6; *7; *8; *9; *10; and *17. The test is automated on the INFINITI® Analyzer with simplified Load-N-Go automation. *For research use only. Pending FDA clearance.
Studies have shown patients to be unresponsive to anti-EGFR drugs during metastatic colorectal cancer treatment when afflicted with KRAS- and BRAF-positive tumors. Major organizations like the American Society of Clinical Oncology and the National Cancer Institute are now recommending KRAS- and BRAF-mutation detection prior to anti-EGFR therapy. The INFINITI® KRAS-BRAF assay is a comprehensive panel designed to detect mutations in KRAS codons 12, 13, 61 and BRAF codon 600. The test is automated on the INFINITI® Analyzer with simplified Load-N-Go automation. *For research use only.
ChemWell®-T Automatic Chemistry Analyzer
At 100 tests per hour, cost-effective ChemWell®-T makes fully automatic biochemistry and turbidimetric analysis economically feasible for lower-throughput labs, specialty applications, and backup. ChemWell®-T’s PC-controlled, random-access, open system includes powerful easy-to-use software for programming and running assays, panels, and indices with high-level options such as custom-designed reports, patient data base, and complete QC package. Labs will also benefit from the outstanding value of unique features such as ChemWell®-T’s flexible reagent and sample platform with removable and interchangeable sections that can accommodate many types of common bottles, vials, and primary tubes required for a wide variety of workloads.
Custom Gold Colloid Molecular Conjugates*
BBI introduces a robust and efficient custom service for production of oligo-gold colloid conjugates used in molecular diagnostic testing and life science research applications. Extending from our expertise in immunoassay reagents for lateral flow, the BBI oligo-conjugation process improves on established thiol-coupling chemistries, resulting in more stable reagents with enhanced performance in DNA and RNA detection platforms. Amenable to a wide range of molecular formats, including array detection, aptamer studies, oligo-mediated agglutination, and nucleic acid lateral flow, this service is available on all the standard colloid sizes from 10–100 nm and may be used with both modified and unmodified DNA/RNA chemistries. *In development.
Dr. G Glucometer
This blood glucose monitoring system features: symbolic display; 28-test memory; large LCD screen; auto power on/off; switchable mg/dL and mmol/L; results in only 8 seconds; easy operation in three steps; compact and portable size; and state-of-the-art biosensor technology. The system only requires a 1.5-µL blood sample.
CR Series Immune Monitoring Systems*
Blue Ocean Biomedical introduces the CR Series—the first fully integrated, fluorescence-based, cellular analysis research system dedicated to running standardized immune monitoring panels. The CR Series Immune Monitoring Systems combine automated sample preparation and analysis in one instrument that communicates with the laboratory’s information system. The CR 300, shown here, features “Load & Go”™ technology, with an autoloader capable of handling up to 40 samples at once (eight cassettes of five tubes each). Just load the samples and go; the system does the rest. Two panels are available for lymphocyte subset analysis (T/B/NK) and Blue Ocean will customize other immune monitoring panels to your specifications. *For research use only.
UniCel® DxH™ Connectivity and Slidemaker Stainer*
The addition of connectivity and a slide-maker stainer to the UniCel® DxH™ family of Coulter® Cellular Analysis Systems takes the hematology lab a step further in the transformation that began with the DxH 800. These additions offer a scalable workcell solution that can address the specific testing needs of your laboratory.Trackless automation decreases the use of valuable space, intelligent workload distribution and specimen tracking maximizes workflow efficiency, and user-definable slidemaking and staining improves productivity, all using small sample volumes. *For research use only.
DxH™ 300/300C Coulter® Cellular Analysis System*
The DxH™ 300/300C Coulter® Cellular Analysis System is a new three-part differential instrument that delivers the unparalleled quality of results that you’d expect from a member of the DxH family. The DxH 300 user interface incorporates data management features only available on high-volume systems: large data storage capability, several quality control programs, and multiple search and storage options to streamline your lab’s workflow. High-quality results are assured by the advanced DxH algorithm technology that provides standardized flagging and accurate results the first time. *Pending FDA clearance.
REMISOL Advance v1.4
The Clinical Information Systems Business Center of Beckman Coulter, Inc. is pleased to announce the availability of the next software version update v1.4 to the laboratory data manager, REMISOL Advance. This version offers many new features, functions, and instrument connections to enhance your laboratory’s efficiency and efficacy. The new software includes: REMISOL Advance connections to new instrumentation; expanded rule applications; enhanced window displays and screens; new software applications. REMISOL Advance is a product of Normand-Info SAS.
DxLab Workflow Manager*
Beckman Coulter’s DxLab Workflow Manager is the new clinical information systems solution developed with quality management and laboratory workflow efficiency in mind. DxLab uses a graphical approach to creating rules, offering the ability to use powerful tools to manage instruments, quality control, and patient testing. User-friendly screens and robust functionality makes it suitable for low-volume and high-volume laboratories. *In development.
Chemclin 100 Immunoassay System
An easy-to- use, semi-automated, chemiluminescent analyzer, the Chemclin100 with U.S.technology and broad dynamic range is designed to read chemiluminescent signals in 96-well microplates. The analyzer’s detection method is more sensitive than RIA and ELISA. It reads an entire 96-well plate in 45 seconds, and the software is straightforward and easy-to-use. Supporting reagents are stable and ready-to-use, including tumor markers, infectious diseases, thyroid, fertility, diabetes, and other panels.
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. The high concentration of the BAW nanoparticles 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.
Myla™ Microbiology Middleware
Myla™—intelligent microbiology middleware—was designed by microbiologists for microbiologists. New innovations provided by the Myla software will change the way laboratory directors, managers, and technologists manage microbiology information. The software’s applications provide information that gives more visibility to your workflow, improving efficiency and saving time. The goal is to provide results to the physician sooner, ultimately making a stronger impact on patient care. Myla is the name of your new lab partner that provides a revolutionary way of working that will simplify your life. Now you can recapture time through improved connectivity, workflow, and information management.
PREVI™ Color Gram Automated Staining System
PREVI™ Color Gram is an automated Gram staining system that provides rapid, standardized results for all types of specimens and streamlines the workflow of microbiology labs. The automated spray technology of PREVI™ Color Gram saves time and enables standardization and accuracy of results. Traditional Gram staining is a cumbersome procedure that lacks reliability and reproducibility. This small-footprint system helps save on lab technician time while economically reducing reagent usage. Intelligent design features include standardized results, ready to read in 5 minutes, and no cross contamination.
PREVI™ Isola System for Specimen Processing
PREVI™ Isola is a revolutionary system for microbiology specimen processing that expands bioMérieux’s portfolio of automated solutions and streamlines the workflow of microbiology labs. This automated pre-poured media (PPM) streaker offers improved workflow efficiency through a patented robotic system that manages 90% of the steps required to process liquid microbiology specimen samples. The Previ™ Isola provides more isolated colonies per plate than manual methods. It inoculates, streaks, and labels PPM. Features include: pre-analytical microbiology automation; automated microbiology specimen processing instrument; and improved efficiency, workflow, and standardization.
RapidFRET® Oral Fluid 7-Drug Test System*
Biophor Diagnostics has advanced lab-based, oral-fluid drug testing with a breakthrough homogeneous technology that offers unparalleled benefits and sample throughput. The technology is automated, easy-to-use, and offers dramatic time and resource savings compared to competing technologies, while meeting proposed SAMHSA oral-fluid drug screening guidelines. Benefits include: test time <10 minutes for 70 test results once sample is added; automated, homogeneous-assay format that can also be run manually; ready-to-use, stable reagents (mix and read), eliminating washing or predilution steps; and dramatic improvement of drug recovery from samples. *Pending FDA clearance.
The NGAL Test*
NGAL is a novel biomarker for diagnosing acute kidney injury (AKI). Measuring NGAL in urine or plasma on your clinical chemistry analyzer gives information on patients’ AKI status, especially in situations that require rapid clinical decision making, such as monitoring critically ill patients in intensive care or triaging patients in the emergency room. The marker also aids in predictive evaluation of renal transplant patients and provides information on damage caused by nephrotoxic contrast agents. The NGAL Test is based on the principle of turbidimetry and will be available for a wide range of automated chemistry analyzers. *In development.
APC-PCI ELISA Kit*
BioPorto Diagnostics’ APC-PCI ELISA Kit measures the activated protein C-protein C inhibitor (APC-PCI) complex in human plasma. Severe sepsis has a mortality rate of 30–50% and kills about 1,400 people every day. Treatment options are limited to support, antibiotics, and recombinant human-activated protein C (rhAPC). APC-PCI may be a relevant tool to: aid management of severe sepsis patients by identifying critically ill sepsis patients at high risk of mortality; detect deep vein thrombosis and aortic aneurysms; and aid research into predicting acute myocardial infarction.*For research use only.
BioPlex™ 2200 Anti-CCP*
The BioPlex™ 2200 Anti-CCP kit is a multiplex, flow immunoassay intended for the semi-quantitative detection of IgG antibodies to cyclic citrullinated peptide (CCP) in human serum and EDTA or heparinized plasma. The assay range is 0.5–300 U/mL, with supported on-board dilutions of 1/4, 1/10, and 1/100. The BioPlex™ 2200 is a fully automated, random-access system that allows consolidation of routine anti-CCP testing and features more specialized assays, such as antinuclear antibodies (ANA) and vasculitis antibodies (MPO, PR3, and GBM). *Pending FDA clearance.
Liquichek™ Hematology and Reticulocyte Controls
Liquichek™ Hematology (X) Control and Liquichek™ Reticulocyte (X) Control are designed for the Sysmex XE-2100, XE-5000, XT-1800i (no reticulocyte), XT-2000i hematology instruments. Liquichek™ Hematology (S) Control and Liquichek™ Reticulocyte (S) Control are designed for the Siemens Advia 60 (no reticulocyte), 120, 2120, and 2120i hematology instruments. Liquichek™Hematology (A-I) Control Liquichek™ Reticulocyte (A-I) Control are designed for Abbott CD 4000 and Sapphire hematology instruments. The Unity™ Interlaboratory Program, with peer group comparison, is available for use with all of the new products. Data entry to the Unity software can be conveniently automated with UnityConnect™ or WebConnect™ connectivity solutions.
Liquichek™ Opiate Control
Liquichek™ Opiate Control is a urine quality control that contains popular drugs or drug metabolites commonly measured in pain management, addiction therapy, or drug abuse. Routine use of Liquichek™ Opiate Control provides laboratories the ability to monitor the precision of opioid drug testing procedures and to help ensure quality on an ongoing basis. This product is supplied as a frozen liquid and is available in two levels at concentrations above and below most assay cutoffs. Recovery of drugs or drug metabolites has been tested by EIA and confirmed by GC/MS or LC/MS/MS.
Type 6650 Flipper Isolation Valve
Burkert, the world’s leading partner for fluid control systems, introduces its Type 6650 Flipper isolation valve, setting industry standards for both size and performance. With its 4.5-mm width, the Type 6650 Flipper isolation valve is a significant step towards miniaturization, outperforming 10-mm designs. It allows equipment and instrument manufacturers to pack more valves into the same space for greater functionality or helps reduce laboratory costs by shrinking the size of the equipment or instrument. It is the perfect choice for clinical, life science, analytical, and fluid-handling equipment manufacturers with valve applications requiring fast response times, high reproducibility, no pumping, and excellent flushing characteristics.
CDS M Series Hematology Analyzer
The Medonic 16-parameter, three-part differential analyzer performs unlike any other hematology instrument. It is simple, accurate, reliable, and economical. The analyzer delivers excellent patient outcomes by providing accurate CBC’s in less than 1 minute from whole-blood tubes or from our patented 20-µL, finger-stick technology. It’s also easy to operate and maintain. Economics make sense and will help generate additional revenue for your practice. Let us show you how!
Human IgG Subclass Determination Kits
Abnormalities in serum levels of IgG subclasses have been observed in autoimmune diseases, neurological disorders, and HIV infections. Low serum levels of IgG2 or IgG3 have been reported in patients with recurrent upper- and lower-respiratory tract infections. The possibility of an IgG subclass deficiency should be considered in all children with recurrent infections and obstructive bronchitis. CEDARLANE® offers a broad range of kits for detection and quantitative determination of total levels of IgG subclasses. These kits are available in various formats such as nephelometry, radial immunodiffusion, and ELISA.
With the launch of the new CellaVision® DM1200 system, CellaVision has now expanded its product line into the smaller hospital market. CellaVision systems for the hematology lab combine slide handling robotics, high-speed auto focusing, and advanced artificial neural networks to find, focus, and pre-classify blood cells on a stained smear. This leads to vastly improved efficiency and consistency of WBC differential, RBC morphology, and body fluid procedures. The ability to network with other CellaVision systems provides connectivity for any health care system that wants to save labor, standardize differential results, reduce turnaround time, and improve patient care.
CLSI Method Evaluation Software
Introducing new method evaluation software that follows the exact protocols found in CLSI documents. As the lab industry’s mosttrusted standards organization, CLSI introduces an innovative, user-friendly program that helps you maximize the power and protocols of the CLSI documents. The software usability allows you to produce reports on analytical accuracy, precision, linearity, recovery, reference intervals, and diagnostic performance. It empowers labs to accelerate their performance, reach the highest level of compliance, and transform the way they deliver patient care.
Liquid QC® Cardiac Marker Control Complete
CLINIQA has channeled its proprietary liquid stabilization technology to produce the first “True Liquid” Cardiac Marker Control that is stored at 2–8°C and has a 2-year shelf life from the date of manufacture. This unique, true, liquid-stable control covers nine analytes (BNP, CK-MB, d-Dimer, homocysteine, hsCRP, myoglobin, NT-proBNP, troponin I, and troponin T) in three levels to suit instrument system requirements. With an open-vial stability of 30 days when refrigerated, Liquid QC Cardiac Marker Control Complete is intended for use in clinical laboratories as a quantitative control for monitoring test procedures used to assay human specimens for cardiac markers.
Human Triglyceride Fraction
The Human Triglyceride Fraction is a lipoprotein material isolated from human serum and stored as a frozen liquid. The preparation has a triglyceride to cholesterol ratio >3 and may be used as a triglyceride additive to adjust triglyceride concentration in control products. The Hemoglobin A1c (HbA1c) product is a lyophilized powder produced from human hemolysates that may be used as a control or standard for HbA1c assays. Individual lots of HbA1c product are custom made specifically for each customer. The hemoglobin concentration and percent HbA1c of the material varies with the specifications of the individual customer.
Diagnostica Stago, Inc. introduces STA Coag Connect™, a new coagulation-specific data manager. STA Coag Connect™ comple-ments our existing family of instruments with enhanced features, including auto-verification, reflex testing, metering manager, and a QC package. Being sensitive to labor shortages, turnaround time, test volumes, and maintaining high data quality helped to guide Diagnostica Stago, Inc. in developing Coag Connect™. *In development.
Calibrated Automated Thrombogram® CAT*
Calibrated Automated Thrombogram®, or CAT, is an exciting new technology incorporating a fluorogenic substrate in an easy-to-use, automated platform that measures the initiation, burst, and subsequent inactivation of thrombin in clotting of platelet-poor or platelet-rich plasma. It is a global hemostasis assay for investigating hypo- and hyper-coagulability and the effects of anti-thrombotics and other pharmaceuticals on thrombin generation. A unique thrombin calibrator, it eliminates potential sample specific interferences, such as the inner-filter effect, substrate depletion, and variability in sample color and light intensity. Diagnostica Stago, Inc. represents Thrombinoscope as the exclusive distributor in the U.S. *For research use only.
STA®-Staclot® dRVV Screen and Confirm
The 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 that neutralizes the LA present in the plasma, resulting in a shortened clotting time. The tests are not affected by contact factor deficiencies, factor VIII, and IX deficiencies. or other specific inhibitors. The assay is not affected by samples containing therapeutic levels of heparin. STA Staclot dRVV Screen and Confirm, in conjunction with Staclot LA, are complimentary in fulfilling the recommendations establishing by ISTH. Both products are FDA cleared.
Ecarin Chromogenic Assay (ECA)*
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 in order to minimize dangerous side effects. Most widespread methods, such as aPTT, ACT, PT, or TT, are not suitable for monitoring due to a lack of specificity, narrow range, and the plateau effect. Due to important advantages over the previous tests, the ECT is a superior method for the determination of DTIs. *For research use only.
CY-Quant VASP/P2Y12 by Stago is an 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. Research on how patients respond to these drugs, as well as what other factors affect patients’ responses, will be extremely useful for future efforts to treat patients using this class of drugs. *For research use only.
SMART Point-of-Care Testing System*
Diazyme’s new SMART point-of-care testing system provides a simple, rapid, and accurate platform for an ever-growing number of general and special chemistry assays. The SMART requires minimal operator training and is easy to use and maintain. Calibration is by a lot-specific RFID card that is included with each test kit for maximum convenience and accuracy. The enzymatic HbA1c assay is 501(k)-cleared and NGSP-certified and is not affected by Hb variants such as S, C, E, and D. The system also provides accurate low-cost assays for hsCRP*, homocystine*, and cystatin C*. *Pending FDA clearance.
epoc® Blood Analysis System
Introducing lactate* on the epoc BGEM Test Card. epoc® is healthcare’s first, cost-effective, wireless, and easy-to-manage, point-of-care solution that delivers lab-quality blood gas and electrolyte results at the bedside in about 30 seconds. The epoc System is comprised of single-use epoc BGEM Test Cards, portable epoc Reader with Host Mobile Computer, and a web-based Data Manager. System features include: room temperature storage of barcoded test cards; internal, automated quality control; and wireless transmission of patient and quality test records that are easily interfaced to the hospital’s LIS/HIS system via HL7, healthcare’s interface standard. *Pending FDA clearance.
Xplorer® Electronic Pipette*
People 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, you 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.
Building upon its well-known Estapor® superparamagnetic microspheres, EMD Chemicals/Estapor is pleased to launch its new Bio-Estapor® product line. This new line includes streptavidin-, anti-mouse IgG-, anti-human IgG-, protein A-, and protein G-coated microspheres, allowing researchers to optimize any bioseparation, biopurification, or biodetection applications without sacrificing sensitivity and ease-of-use. In anticipation of the researchers’ expanding needs for biotools that meet precise assay requirements, our new line integrates several innovative technologies, including sizes, surface properties, and ferrite content.
GAS-ISE Hct QC
GAS-ISE Hct QC, the new combination QC for i-STAT with hematocrit, is the first all-in-one control product of its kind with pH, blood gases, electrolytes, metabolites, and hematocrit target values. Designed for i-STAT analyzers, the product eliminates the need to use two separate cartridges with each control check and cuts QC time in half. The product is available as a three-level QC, as well as a five-level AMR/linearity panel.
pO2 AMR Validation Control
A new pO2 AMR Validation Control, Hypoxic QC™ is the first pre-tonometered product of its kind to validate extra-low (15 mm Hg) pO2 values. Hyperbaric QC™ is designed to validate the high (710 mm Hg) pO2 range. Together, these two products validate the full pO2 analytical measurement range (AMR) of blood gas analyzers. Hypoxic QC features active hemoglobin buffering with 10-minute, open-ampule stability, making it well suited for method comparisons as well. Hyperbaric QC is an aqueous formulation that validates ultra-high, recovered values that are ideal for cardiac catheterization labs and OR suites.
EuroDiagnostica, inventor of anti-CCP testing for rheumatoid arthritis, announces the newest members of our autoimmune testing portfolio. EuroDiagnostica provides the world with more than 90% of anti-CCP testing products: CCPlus ™ anti-CCP, the most specific marker for diagnosing and tracking rheumatoid arthritis; Cap-ANCA™ PR3 and Cap-ANCA™ MPO, the only ANCA tests available using capture ELISA technology with unmatchable sensitivity; and Complement Screen™*, the only assay available today that measures all three complement pathways. We also manufacture the Diastat, Immunoscan, and Wieslab autoimmune product lines. With new products, 37 FDA- cleared products, and important RUO products, EuroDiagnostica is the choice for autoimmune testing kits. *For research use only.
SealMate™ System for Microplate Sealing
Excel Scientific, maker of sealing films for microplates, exhibits the new SealMate™ applicator, a unique system that reduces cost and simplifies application of adhesive sealing films, along with its complete line of films for ELISA, PCR, storage, cell culture, and protein crystallization.
The X45 is a system suitable for small products and whenever compact integration of conveyors to machinery and equipment is required. Product handling is gentle and stable, contributing to high product quality standards and high efficiency. The X45e drive- and puck-handling units offer unique solutions for easy and efficient control of your single-piece flow system. The X45e modules allow simplified controls design and easy modification of performance. Integrated RFID functionality makes it easy to control the process and product QA.
Fluid Handling System Engineering
Gems Medical Sciences offers complete fluid handling system design from concept through product realization. Gems engineers have the experience and expertise to take an idea at any stage in its development cycle and work with you to develop a small assembly or a complete fluid handling system. Services include: design documentation; validation; verification; supply chain verification; and design for manufacturability to reduce the overall cost of product production. Our hands-on experience and unique array of intelligent sensors provides medical OEMs and start-up companies with the resources needed to reduce development costs and speed time to market. ISO 13485 certified.
ThunderBolt ELISA Platform*
The GSD ThunderBolt is a 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 on-board 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 cost-effective, powerful, flexible, compact, and highly efficient laboratory automation solution. *In development.
Interlab G26 Agarose Gel Analyzer
The Interlab G26 is the most compact and fully automated agarose gel electrophoresis analyzer available today. Interlab G26 offers a fast, secure range of high-clarity electrophoresis assays. The analyzer features complete walk-away automation. It automates electrophoresis phases from sample application to gel reading with no operator intervention and has automated sample application. Operators can load up to eight gels for the same test or a range of assays. Operation is fast and easy with: minimal mouse clicks to start analysis; initial 26 results within 38 minutes; complete gel analysis every 20 minutes; and automated data transfer. Footprint: 34" x 20" x 21". Grifols USA, LLC is the exclusive distributor for Interlab in the U.S.
Parasep SF—Solvent Free Fecal Concentrator
The Parasep® SF parasite concentrator offers fast (2 minute) centrifugation, clean recovery of samples, and an optimal concentration of ova, helminth larvae, protozoan cysts, and coccidial oocysts without the use of toxic solvents such as ether or ethyl acetate. It is a totally closed system (no contact with samples) and free of toxic solvents. The three-dimensional filtration device is patented by DiaSys and pre-filled systems are available. It is designed to use with a standard centrifuge and has four easy steps: sample preparation; emulsification; centrifugation; and examination. Parasep SF is distributed in the U.S. by Grifols USA, LLC.
Zeus Pipetting Module
Hamilton Company, the world leader in fluid measurement OEM, introduces the ZEUS Pipetting Module for IVD instruments. The unique, self-contained Z-Excursion Universal Sampler (ZEUS) aspirates volumes from 1–1,000 µL and features Hamilton’s proprietary air-displacement pipetting technology that delivers superior levels of accuracy and reproducibility. The ZEUS module with Z-motion movement is ideal for any IVD instrument that requires on-board pipetting.
Antibodies for the New Type of BNP Immunoassay
BNP is an acknowledged marker of heart failure (HF). It presents in multiple forms in HF patients’ plasma: truncated from both the N- and C-terminus, with only a small portion of BNP circulating as a full-size molecule. Immunoassays using at least one MAb specific to the terminal epitope could underestimate the real BNP content. HyTest offers an antibody combination for development of single-epitope sandwich (SES) immunoassays. The assay uses MAb 24C5 as the capture antibody and MAb Ab-BNP2 as the detection antibody. MAb 24C5 is specific to the central part of BNP molecule (epitope 11–17) and MAb Ab-BNP2 recognizes only the immune complex of MAb 24C5 with BNP. The SES assay is not susceptible to proteolytic degradation of BNP molecule terminal fragments and shows the highest sensitivity (0.4 pg/mL) among all BNP assays described in the literature.
ABO and RhD Blood Grouping Kits
ABO and RhD Blood Grouping Kits use unique, visual testing technology to detect ABO and RhD blood groups based on immune response principles of antigens and antibodies. They are suitable for onsite blood collection, medical laboratory testing, and urgent pre-transfusion testing. With rapid accurate results, good performance in specificity, and excellent stability (stored at 2–30ºC for 2 years), these kits offer detection of ABO and RhD blood groups simultaneously in one test without any additional equipment. This product has obtained an international patent: International Patent No. PCT/CN2009/000322.
Hicera Series Precision Dosing Systems
Iwaki’s new precision dosing pumps are designed to accurately dispense critical fluids. The Hicera Series provides 0.1% repeatable performance for volumes as small as microliters per sample. Much smaller than traditional syringe pump designs, Iwaki piston metering pumps eliminate the need for re-calibration while providing more than 40 hours of no-touch maintenance-free service life. The APN Series is built to handle the most aggressive fluid handling requirements on the analyzer. APN’s molded diaphragm maintains the pump’s accuracy whether handling fluids or gas. The solids-handling valve design ensures dependable performance under adverse operating conditions. Custom designs and prototype quantities are available.
Power. Speed. Flexibility. NEO is a fully automated, walk-away instrument for the high-volume laboratory. Its features include: continuous access; STAT priority; fast TAT and high-throughput. This analyzer offers all of the benefits and features you’ve come to expect from the transfusion diagnostics company, IMMUCOR. Find out how to change the way you think about blood bank automation. *Pending FDA clearance.
The next generation automated urinalysis workcell features: Edit-Free Release Technology; accreditation support; identification of clinical, urine-culture candidates; and iWARE™ Expert System. *Pending FDA clearance.
iWARE™ Software features expert-system application for real-time, clinical concordance, and validation and LIS connectivity that facilitates communication between urinalysis and microbiology laboratories.
ProTime InRhythm System for PT/INR*
The ProTime InRhythm™ System is an IVD device for quantitative measurement of prothrombin time (PT/ INR) from fingerstick or venous whole blood collected with no additives. The test system is intended for professional use in the management of patients treated with oral anticoagulants. Product features include: total test time <1 minute at <2.0 INR; improved precision and accuracy from 0–10 INR range using duplicate patient test channels; easy-to-use, color, touch-screen interface; room temperature reagents; capacity to add patient and operator ID; 10-µL sample size; state-of-the-art connectivity and data management functionality; optional two-level external liquid QC; user-rechargeable and replaceable battery; and ability to store up to 1,200 results. *Pending FDA clearance.
Acetylcholine Receptor-Binding Antibody Kit
The AChR Binding Ab Kit is for determining anti-acetylcholine receptor antibody levels in human plasma and serum. Sample antibodies bind to receptors in a liquid phase (test tube). The antibody-antigen complexes are precipitated and radioactivity measured. There are two incubation times: 30 minutes and 120 minutes. The assay range is 0.2–7.5 nmol/L. The detection limit is 0.058 nmol/L, and the cut-off control is 0.25 nmol/L. The assay has a clinical sensitivity of 100% and clinical specificity of 97.7%, and is FDA cleared.
Free T4 RIA by Equilibrium Dialysis Kit
The Free T4 RIA by Equilibrium Dialysis Kit provides a sensitive assay for measuring free T4. There is an overnight dialysis step andtwo incubation times. The 100 test kit includes 80 QD-Cells™, disposable, single-use dialysis cells. Kit features include: small sample volume (100 µL or 200 µL); 0.2 ng/dL sensitivity; and standard range of 0.2–12.8 ng/dL.
Voltage-Gated Potassium Channel Antibody RIA 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 voltage-gated potassium channel (VGKC – Kv1.1, 1.2 and 1.6). This new RIA allows accurate and specific determination of VGKCAb. Measurement of antibodies to VGKCs may be useful in select indications. *For research use only.
Aquaporin-4 Autoantibody (AQP-4Ab) ELISA 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). AQP-4 is the most abundant water channel protein in the central nervous system and is expressed extensively within the brain and spinal cord regions. This new ELISA allows accurate and specific determination of autoantibodies to AQP-4. *For research use only.
OMNI Cell Culture Bag
Lampire is proud to launch its’ new line of Lampire OMNI™ Cell Culture Bags that support the rapid and safe expansion of cell cultures from 50 mL to 2 L or more. The bags can be used alone or coupled with micro-carriers and cell scaffolds for optimal growth of many cell types, including mammalian stem cells, CHO, HEK293 and Jurkat, as well as insect and plant cells. The Lampire OMNI™ Cell Culture Bag is prepared from a USP class VI-certified, highly gas-permeable material. Inclusion of Luer-lock ports provides easy culture access and permits connection of many bags in series, turning your standard cell culture incubator into a bioreactor-scale production system. Let us customize a cell culture bag to meet your production needs.
Horizon Lab™ Analytics
McKesson’s Horizon Lab Analytics solution provides essential management decision support tools and scorecards to quickly measure the 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 to empower 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 measures key safety and operational metrics with standard out-of-the-box content. McKesson has been providing laboratory information systems for more than 30 years.
EasyRA Chemistry Analyzer
The EasyRA is a fully automated, random-access chemistry analyzer for use in low- to moderate-volume hospital and physician-office laboratories. An expanded test menu and open channels enhance the flexibility of the EasyRA. Combined with its unprecedented ease-of-use, the EasyRA sets a new standard in its class.
illumigene™ Molecular Diagnostic System
illumigene™ puts molecular diagnostics within the reach of every lab. illumigene™ delivers the power of molecular technology in a simplified and affordable format. Meridian Bioscience has combined Loop-Mediated Isothermal Amplification (LAMP) technology with a simple assay process and a compact amplification and detection system, the illumipro-10™, to provide laboratories with illumigene. Designed and manufactured based on the feedback from literally hundreds of laboratory professionals, and providing molecular accuracy with rapid turnaround, low labor requirements, and true cost effectiveness, illumigene is the molecular diagnostic system the market needs.
BS-800M Automated Chemistry Diagnostic System*
BS-800M, an innovative clinical chemistry diagnostic system manufactured by Mindray Corporation, incorporates Mindray’s suggested reagents, calibrators, and controls and can be adapted to the customer’s desire by integrating between one (BS-800M1) and four (BS-800M4) modular units, creating throughputs of 1,200–4,800 tests/hour. The100-µL minimal reagent consumption, up to 860 sample capacity, 2–8°C reagent cooling, reagent bubble detection, and user-friendly operating software, are all features that focus on cost-effectiveness, result accuracy, operator safety, and technology advancement. BS-800M provides a brand new experience in laboratory practice and lets you explore the cutting-edge instrumentation of modern technology. *Pending FDA clearance.
The Celltac coag CGM-6100 Analyzer
The Celltac coag CGM-6100 is the newest in a long line of Nihon Kohden’s IVD analyzers. The CGM-6100 is an advanced coagulation analyzer that is easy to use, convenient, and reliable. One unique feature is automatic registration and management of sample ID and material information with the built-in barcode reader. The calibration curve is loaded just by reading the barcode. With this comprehensive data handling and system management, CGM-6100 reduces labor costs and risks of operator error. Nihon Kohden is a Japanese company well known worldwide for its innovative and reliable medical equipment. Distributor inquiries welcome.
StatProfile® pHOx Blood Gas/Critical Care Analyzer
Nova introduces a redesigned family of pHOx blood gas/critical care analyzers with test menus including pH, PCO2, PO2, NA, K, Ca, Cl, glucose, BUN, creatinine, lactate, hematocrit, hemoglobin, oxygen saturation, and co-oximetry. The StatProfile® pHOx design features include: bright, color, touch-screen user interface; simplified operation; snap-in reagent cartridges; auto-calibration; fully-automated quality control, and test results in as fast as 45 seconds. The combination of StatProfile pHOx long-life sensors plus time-saving features for the user creates the most cost-effective way for hospitals to provide blood gas assays. StatProfile pHOx analyzers are used in the OR, ED, ICU, and STAT labs.
Automated Oral-Fluid Assays for Drugs-of-Abuse*
Roche Diagnostics and OraSure Tech-nologies, Inc. introduce drugs-of-abuse, oral-fluid assays for amphetamine, opiates, methamphetamine, PCP, and cocaine for use on automated clinical chemistry analyzers. These fully automated assays were developed in conjunction with the Intercept® Collection Device from OraSure Technologies, providing a convenient method for oral-fluid, drugs-of-abuse testing. Oral-fluid testing may reduce problems with unobserved adulteration and substitution and offer a more convenient collection. *Pending FDA clearance.
VITROS® Intact PTH Assay*
Ortho Clinical Diagnostics introduces a new diagnostic assay, the VITROS® Intact PTH Assay, for the quantitative detection of parathyroid hormone. The assay is designed to be run in a fully automated, random-access format on the VITROS® 5600 Integrated System, the VITROS® 3600 Immunodiagnostic System, and the VITROS® ECi/ECiQ Immunodiagnostic System, all with Intellicheck® technology. Results are expected to be readily available in 18 minutes to allow for use in the intra-operative setting. The VITROS® Intact PTH Assay is expected to have a wide measurable range (up to 5000 pg/mL), thereby avoiding the need for dilution. *Pending FDA clearance.
VITROS® 5600 Integrated System
Ortho Clinical Diagnostics VITROS® 5600 Integrated System is uniquely designed to integrate clinical chemistry and immunoassay testing, increasing laboratory productivity and performing more than 100 different chemistry, immunoassay, and infectious disease tests on a single, high-quality system. One patent-pending innovation is its “sample-centered” processing approach. Each individual sample is accessed independently and in parallel for chemistry and immunoassay testing. Turnaround time and productivity is optimized by intelligently accounting for variable sample and test mixes. The VITROS® 5600 Integrated System incorporates market-proven VITROS® technologies into one of the easiest-to-use and most compact integrated systems on the market.
VITROS® 3600 Immunodiagnostic System
Ortho Clinical Diagnostics VITROS® 3600 Immunodiagnostic System high-capacity immunoassay system provides laboratories with an innovative solution to address quality, labor, and cost challenges. The system combines three proven VITROS® technologies into a single system designed to consistently produce highly accurate test results. VITROS® 3600 Immunodiagnostic System uses the same reagents as other VITROS® Systems, thereby maintaining the same degree of accuracy and efficiency. MicroSensor Technology automatically performs sample quality indices checks for the first time ever on an immunoassay system. The broad menu of immunoassays covers disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic and anemia.
VITROS® HBeAg* and Anti-HBe* Assays
Ortho Clinical Diagnostic announces the VITROS® HBeAg and Anti-HBe assays for use on the VITROS® ECi/ECiQ Immunodiagnostic Systems. The presence of HBeAg in serum is a strong indication of high infectivity of HBV. The presence of Anti-HBe is an indication of the convalescent stage of HBV infection. Anti-HBe is found in carriers of HBV who are able to clear HBeAg from the circulation. HBeAg/anti-HBe are important in the diagnosis of HBV infection. These assays will complement the current nine hepatits, HIV, and Rubella infectious disease assays as well as 29 routine immunoassays. *Pending FDA approval.
Homocysteine Reagent Set
Pointe Scientific has introduced a new homocysteine assay two-part, liquid-stable reagent set for automated chemistry analyzers. This two-part liquid reagent incorporates SRM 1955. The assay shows excellent correlation with HPLC and immunoassay methods. An accuracy study of Pointe Scientific homocysteine and Catch, Inc. three-part homocysteine showed a correlation coefficient of 0.999. Precision studies conducted using the CLSI: EP 15 protocol yielded excellent precision with CVs below 2%.
OC-Sensor Diana® Analyzer
An automated iFOBT analyzer, the OC-Sensor Diana® is the first FDA-approved, high- throughput FIT analyzer. Capable of performing 280 tests per hour, this compact instrument is ideal for small workstations (24.8"w X 22"d X 22"h, 133 lbs). Its immunoturbidimetric method offers superior assay performance and enhanced patient outcomes. The patient collects one sample from one stool instead of three separate specimens. The patient collects and closes the sample device. The instrument measures closed sample collection devices, so the laboratory technician never comes in contact with the sample. The novel collection device and personal packs result in increased patient compliance.
Introducing ProMag™ Bind-IT™ pre-activated magnetic microspheres for reagent development. ProMag™ Bind-IT™ are highly uniform 3-μm magnetic microspheres with a revolutionary surface that allows fast (≤60 minutes) and stable binding of antibody. Our novel Bind-IT™ chemistry is designed to immobilize protein in a manner that preserves tertiary structure for optimal activity. The resulting highly active surface provides significant improvements in the sensitivity and dynamic range of immunoassays. Bind-IT™ chemistry also offers exceptional reproducibility between coating batches, translating into an expedited reagent development process.
Thyretain™, TSI Reporter BioAssay
Thyretain™ is the only commercially available IVD device that specifically detects thyroid stimulating immunoglobulin (TSI). TSI is linked to the autoimmune thyroid disorder, Graves’ disease. In this disease, TSI binds to the thyroid stimulating hormone receptors (TSHR) of the thyroid gland, causing an over-production of thyroid hormones. This can lead to a number of different symptoms, making the initial diagnosis of thyroid disorders difficult. With a procedure for easy handling, a patented testing technology, specific TSI detection and quick turnaround time, Thyretain offers a superior product coupled with accurate results that improve patient care and laboratory workflow.
Random-Access Multiplex Analyzer*
This analyzer offers advances in diagnostic testing. A multimarker, disease-orientated menu offers laboratories cost savings through consolidation, reduced reagent consumption, and walk-away capabilities. The biochips allow simultaneous measurement of clinically related markers, both routine and novel, from a variety of sample types. It takes laboratory testing to the next level with many unique features such as STAT and deadline capabilities, a throughput of up to 1,000 tests per hour, and secure remote diagnostics. Arrays available include: cytokines; cerebral; metabolic; adhesion molecules; cardiac; thyroid; drugs-of-abuse; fertility; tumor monitoring; colorectal cancer SNP; synthetic steroids; endocrine; STIs; and respiratory pathogens. *In development.
The Roche Elecsys Anti-HAV IgM immunoassay is intended for the in vitro, qualitative determination of IgM antibodies to the hepatitis A virus in human serum and plasma. The assay is used as an aid to detect an acute or recently acquired hepatitis A virus infection. The electrochemiluminescence immunoassay is intended for use on four immunoassay platforms: the Elecsys 2010; MODULAR ANALYTICS E 170; cobas e 601; and cobas e 411 analyzers. This product is not available for use in the U. S. *Pending FDA clearance.
CoaguChek XS Pro System
The right tools to control PT/INR testing in your environment. This system’s exclusive, smart technology uses built-in quality controls to help ensure the accuracy of every result, and its data management features help you with compliance and practice management. This system provides: accurate results in 1 minute with 97% correlation to the lab method using the Sysmex CA-560 analyzer and the Dade Innovin; flexible QC options for any testing environment (automatic, on-board controls and optional liquid controls); a bar code reader that automatically captures employee and patient ID information; operator- and QC-lockout capabilities; and storage of 1,000 patient and 500 optional liquid QC test results.
Rubella IgM Immunoassay
The Roche Elecsys Rubella IgM immunoassay is for the in vitro, qualitative determination of IgM antibodies to rubella virus in human serum and plasma. This assay may be used as an aid in the presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence Rubella IgM assay is available for use on four immunoassay platforms: the Elecsys 2010; MODULAR ANALYTICS E 170; cobas e 601; and cobas e 411 analyzers.
ACCU-CHEK® Inform II with RALS®-Plus DMS*
The new ACCU-CHEK® Inform II system is designed to enable wired and wireless connectivity with the RALS-Plus data management system from Medical Automation Systems (MAS). RALS-Plus provides one, simple, POC-solution to facilitate improved efficiencies, compliance, and outcomes across the continuum of care. Together the ACCU-CHEK® Inform II system and RALS-Plus help hospitals streamline POC testing, provide two unique patient identifiers, and manage operators anywhere, anytime. *Pending FDA clearance.
Cardiac 200 Analyzer
Expanding the Roche Diagnostic cardiac portfolio, the Roche Cardiac 200 is a lateral-flow, immunofluorescent analyzer designed for rapid (approximately 10–19 minute turnaround time depending upon the cardiac assay) and flexible cardiac marker mix testing. The test cartridges use a patented, internal-standard measurement technology focused on performance (precision and correlation) consistent with laboratory system expectations. Offering a menu that includes NT-proBNP, troponin I, CKMB, and myoglobin, the Cardiac 200 can process up to 36 tests per hour, when 10-minute tests are performed on six samples using a Cardiac 200 configuration with three test modules. Two other module configurations are available.
The Elecsys Anti-HCV Immunoassay is intended for in vitro, qualitative determination of total antibodies to hepatitis C virus in human serum and plasma. Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemiluminescence Anti-HCV immunoassay is intended for use on three immunoassay platforms: the MODULAR ANALYTICS E 170; cobas e 601; and cobas e 411 analyzers. *Pending FDA clearance. Not available for use in the U.S.
Recapper RC 1200 S Unit
The Sarstedt Recapper RC 1200 S is a benchtop or stand-alone unit that safely and rapidly recaps up to 1200 screw-cap tubes per hour, reducing the risk of repetitive motion injuries and accidental exposures. The Recapper places a screw cap onto 15-mm Sarstedt tubes for storage. The RC 1200 S can be adapted to accommodate most linear analyzer racks, eliminating additional transfer of opened tubes. Multiple tube lengths and styles may be processed simultaneously with no prior sorting. Caps are available in convenient bulk packaging. /Minimal routine maintenance is required.
CAPILLARYS™ 2 FLEX Piercing for Whole-Blood Hb*
Introducing whole-blood hemoglobinopathy testing by capillary electrophoresis (CE). Fully automated CE technology now has cap-piercing capabilities with the CAPILLARYS 2 FLEX Piercing system. Whole-blood plasma samples are automatically inverted before sampling to ensure thorough homogenization of the sample and accurate Hb results. High-resolution Hb separation takes place concurrently in eight capillaries with a fast sample throughput of 37 results/hour. The CAPILLARYS 2 FLEX Piercing is a continuous-feed system that provides full traceability from barcoded, primary sample tube to final result. A comprehensive test menu is available, including serum and urine protein electrophoresis, immunotyping, and chronic alcohol abuse marker.*Pending FDA clearance.
ASSIST and GELSCAN™ Systems*
Bringing automation, positive sample ID, and new visualization technology to traditional agarose gel electrophoresis testing. Sebia offers front-end automation with the ASSIST system, eliminating manual pipetting (samples, dilutions, and antisera) and providing full traceability from primary tube to final result. The GELSCAN densitometry system, a high-resolution, image- capture technology, provides direct visualization of the electrophoretic gel and a precise quantification of all fractions. GELSCAN is optimized for use with SEBIA HYDRAGEL™ electrophoresis gels. The system performs an automatic self-calibration and is operated by user-friendly (PHORESIS) software with extensive curve-editing capabilities and customized report options. *Pending FDA clearance.
Volume-Verified Pipetting technology by Seyonic provides real-time validation of the liquid handling functions over a wide dynamic range, from sub microliters to milliliters. By using an integrated flow sensor at the pipetting site, the system measures the volumes, reports on pipetting actions, and provides a complete volume verification in real-time. Further pipetting functions, such as tip-clogging and liquid-level detection are also available. The pipetters are designed to meet a variety of applications, from single-channel to eight-channel versions, handling samples from vials and microtiter plates.
syngo® Lab Process Manager
syngo® Lab Process Manager simplifies laboratory workflow with an integrated technology platform that consolidates and visualizes critical information from a single, central location. The Lab Process Manager: optimizes staff utilization with customizable applications that push real-time, relevant information to operators; provides advanced management of patient and QC data for higher levels of compliance across multiple systems; and transforms workflow intelligence, managing information by exception.
IMMULITE® 2000 XPi Immunoassay System*
The IMMULITE® 2000 XPi Immunoassay System offers enhanced hardware and software features that combine proven reliability with the largest automated immunoassay menu available. This system includes: sophisticated software, including AutoStart for daily maintenance and QC; more than 90 immunoassays with broad dynamic ranges for routine, esoteric, allergy, inflammatory, and bone testing; AutoRack for continuous sample loading and reduced turnaround time; and up to 200 tests/hour. *Not available for sale in the U.S.
Sysmex® CS-2000i/CS-2100i Automated Blood Coagulation Analyzer*
Our newest hemostasis systems—Sysmex CS-2000i /CS2100i—are innovative, robust analyzers designed for total system reliabi-lity, less downtime, and greater productivity for mid- to high-volume laboratories. The systems feature: automated, pre-analytical sample quality checks; four measurement principles for broad reaction analyses testing; and Intuitive Windows®-based software. Sysmex is a trademark of Sysmex Corporation. Windows is a trademark of Microsoft Corporation. *Not available for sale in the U.S.
ADVIA Centaur® CP Immunoassay Systems: New Assays
Our newest additions to the ADVIA Centaur CP immunoassay systems are: a fully automated hepatitis panel, including HBeAb* and HBeAg*; an automated HBsAg confirm-atory testing that saves time and reduces the risk of transcription errors; Rubella IgG (qualitative and quantitative) and IgM (qualitative) for detecting rubella virus in human serum or plasma; and the new, fully automated procalcitonin* chemiluminescent immunoassay. *Not available for sale in the U.S.
IMMULITE® Immunoassay Systems: New Assays
The new, fully automated syphilis screen qualitatively detects antibodies to Treponema pallidum. It eliminates the risk of manual transcription errors associated with traditional syphilis testing. Forty newly FDA-cleared ASR allergens underscore the continual development of the Siemens allergy menu and the first, third-generation specific allergen assay. Random-access testing of allergy with other immunoassay testing on a single platform enhances workflow efficiency.
CLINITEK Status® Connect System
The CLINITEK Status® Connect System, along with the Multistix® family of urinalysis testing strips, provides flexible connectivity, data integration, and operational control to reduce risk in point-of-care environments. The system features: advanced operational control and operator management to prevent unauthorized access; automatic test lockout if QC fails for enhanced quality control; optional bar-code capability for accurate entry of patient and operator information; and flexible connectivity options for data integration into EMR/DMS/LIS/HIS. Multistix is a trademark of Bayer Healthcare LLC.
Dimension Vista® 1500 and ADVIA® Automation
ADVIA® Automation now offers connectivity to integrated systems, including the Dimension Vista® 1500 Integrated Chemistry System. The automation upgrades include: streamlined flow of data and QC management information between all connected systems; maximum menu consolidation, including LOCI advanced chemiluminescence and plasma protein assays; and efficient point-in-space sampling design.
VERSANT® kPCR Sample Prep
The VERSANT® kPCR Sample Prep provides a single system for DNA/RNA extraction supporting multiple applications. It offers enhanced sample identification and quality extraction for confidence in your PCR results. Its features include: one platform and a single reagent set for different sample types and workloads; target amplification by a variety of molecular technologies, including sequencing, PCR, kinetic PCR, SNPs (single nucleotide polymorphisms), and line probe hybridization. It allows fast, easy setup with walk-away operation and the capability to run up to 96 extractions in under 3 hours.
ADVIA® Automation Centrifuge Module
The ADVIA® Automation Centrifuge Module is designed for peak performance, with its 72-tube capacity and ability to process up to 300 tubes/hour. The module can be used in multiple disciplines, including chemistry, immunoassay, and coagulation. Features include: variable tube sizes; customizable operational settings; and multiple modules on the same automation track.
Dimension® Clinical Chemistry Systems: New Assays
A full menu of immunosuppressive drug (ISD) assays is now available on one platform with no manual pretreatment required. Cyclosporine, cyclosporine extended range, tacrolimus, and sirolimus assays are the only fully automated ISD tests available. Dimension systems offer fully automated myeloperoxidase (MPO) immunoassay. Plasma MPO concentration in patient samples acquired during the period of assessment of acute coronary syndrome predicts the risk of major adverse cardiac events, such as myocardial infarction, need for revascularization, or death over a 30–180 day interval.
Refrigerated Storage Module for StreamLAB® Automation Solution
The Refrigerated Storage Module improves management of post-analytical processes by providing automatic on-track storage and archival of completed samples. The system also offers: 15,000-tube storage capacity; auto-disposal of tubes; and storage for multi-ple tube types and sizes.
LabPro Information Manager
LabPro Information Manager expands microbiology data analysis and reporting capabilities with a single database and interface connection for multiple LabPro system configurations. LabPro is accessed directly from bench computers, optimizing workflow through simultaneous, multi-user access. Features include: alert-resolution history for confirmation of atypical results; tailored programs with pre- and user-defined alerts; user-definable comments for laboratory-specific corrected actions; customizable rules for susceptibility interpretations and organism identifications; and enhanced product support through remote diagnostics.
UA-Cellular™ for UF Micro Urinalysis 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 cap 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 Blood Collection Tube*
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 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 to14 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.
Cell-Free RNA™ BCT Blood Collection Tube*
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 cell-free RNA in plasma and prevents release of cellular RNA during sample processing and storage, reducing background RNA levels. 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.
ESR-Auto Plus® Analyzer
The ESR-Auto Plus® is a 10-position automated ESR analyzer. The instrument accurately and precisely measures sedimentation rate of erythrocytes in 1.2-mL ESR-Vacuum Tubes. Results are measured in millimeters per hour (Modified Westergren Method) and are available in 30 minutes. The instrument features: random access; a built-in printer; sample ID capability; barcode scanner; and a 15-minute prediction mode. The ESR-Auto Plus incorporates a QC system for monitoring the laboratory’s QC program and data can be downloaded to a laboratory information system.
UA-Cellular™ for IQ Micro Urinalysis 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 exact amount of control needed into sample tubes without waste. UA-Cellular for IQ offers an open-vial stability of 30 days and a closed-vial stability of 105 days.
CD4 Count Quality Control
CD4 Count is an assayed, whole-blood quality control for verifying the accuracy of the BD FACSCount™ flow cytometer. The easy-to-read assay includes absolute counts and percent positive ratios for CD3, CD4, and CD8 T lymphocytes. CD4 Count is available in two levels of CD4 positive cells. The normal level provides a normal CD4 count, which is found in healthy individuals, and the low level provides a depressed CD4 count, which is monitored by clinicians for HIV/AIDS disease progression and therapy decision-making. Both levels offer an open-vial stability of 30 days and a closed-vial stability of 90 days.
Cell-Chex™ is a spinal and body fluid control with distinct white blood cell and red blood cell populations for manual counts. When stained in the same manner as a patient sample, the white blood cells can be differentiated. The two-level control is assayed for total RBC and WBC counts, a five-part WBC differential, as well as a two-part polymorphonuclear and mononuclear differential. Level 1 now contains crystals to help assess lab technicians’ skills in identifying urate crystals in synovial fluid samples.
Direct TIBC Reagent
The Thermo Scientific Direct TIBC reagent offers a fully automated, direct measure of total iron-binding capacity (TIBC). This liquid-stable, ready-to-use reagent decreases turnaround time by as much as 15 minutes by eliminating cumbersome manual processes and increases accuracy of results by as much as 20% over UIBC+iron methodologies. For use on most chemistry analyzers, this assay has excellent correlation with alumina column, magnetic, and transferrin TIBC methodologies, and it is unaffected by lipemia, bilirubinemia, hemolysis, and other interfering compounds. It streamlines your laboratory testing by maximizing lab productivity, minimizing operator error, improving turnaround times, and removing the need for sample splitting.
Sera-Mag Streptavidin Blocked Magnetic Particles
Thermo Scientific Sera-Mag SpeedBeads Blocked-Streptavidin Magnetic Particles use a non-surfactant, non-protein surface blocking approach to provide low, non-specific binding and high-binding capacity for biotinylated target molecules. These uniform, colloidally stable, monodispersed, nominal 1-µm particles contain two layers of magnetite and a surface encapsulated with a unique polymer to provide much faster separation in a magnetic field. They increase binding capacity, improve assay precision, and lead to shorter assay times. Typically supplied at 1% solids (10 mg/mL) in a 0.05% sodium azide water solution, Sera-Mag Blocked-Streptavidin Magnetic Particles are ideal for automated immunoassays, immunoprecipitation and protein purification applications.
ClinSpec™ Immunosuppressants Test Kit*
The Thermo Scientific ClinSpec Immunosuppressants Test kit is designed for use with liquid chromatography/mass spectrometry (LC/MS) systems in clinical research applications. The first in a series of LC/MS kits, the ClinSpec Immunosuppressants Test provides a quick out-of-the box solution for monitoring immunosuppressant drugs during clinical research. This kit will enable standardization of LC/MS results from different laboratories, independent of location, and allow laboratories with limited technical staff to perform routine LC/MS analysis. While this test kit is optimized for use on Thermo Scientific TSQ Quantum Ultra and Exactive LC/MS systems, it can be used on other LC/MS platforms. *For research use only.
MAS® PTH QC Control
The Thermo Scientific PTH Control is offered as a tri-level, multi-pack to provide effective coverage of the PTH assay range on automated methods. Assigned PTH values are provided for laboratory staff to expedite the setup process for a new QC product. Access to the LabLink xL peer-comparison program is available for PTH control data submission and direct comparison to a worldwide-user base. This human serum-based, liquid QC product is designed to monitor parathyroid hormone tests available on many automated PTH methods including Abbott, Beckman Coulter, Roche, Siemens, and Tosoh Bioscience.
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 is combined with the unique low-volume cuvette design, reducing 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.
Three new assays will be introduced for use on the Tosoh AIA Systems, including RBC folate, cystatin C, and HbA1c. The cystatin C and HbA1c assays will be available in the 10-minute incubation (ST) format. *Pending FDA clearance.
AIA-900 Automated Immunoassay Analyzer*
Introducing the AIA-900 Immunoassay Analyzer, a new addition to Tosoh’s family of AIA Analyzers. The AIA-900 has a throughput of 90 tests per hour and is available in three different models: the bench model; the AIA-900 bench model with the nine-sample loader; and the AIA-900 floor model with the 19-sample loader. Tosoh continues to provide the same unit-dose, test-cup technology on the AIA-900. *Pending FDA clearance.
UTAK’s Methotrexate Serum Controls are unique. Every batch of Methotrexate Controls is custom-made due to interlab calibration range choices. UTAK’s ability to spike-in any methotrexate concentration allows each lab to accurately measure methotrexate at all levels, even the low end of the calibration curve. All Methotrexate Controls are supplied as a lyophilized powder with a 24-month shelf life and 25 days of reconstituted stability. At UTAK, we manufacture your controls, your way.
UTAK’s Busulfan Controls are unique. Every batch of Busulfan Controls is custom-made due to interlab assay differences. Therefore, each lab builds its own busulfan controls by selecting either straight plasma or plasma with an anti-coagulant, the specific busulfan concentrations, and the volume fill size per vial. All Busulfan Controls are supplied as a frozen liquid with a 12-month shelf life and 25 days of thawed stability. At UTAK, we manufacture your controls, your way.
MassTrak™ Immunosuppressants XE Kit*
Waters Introduces MassTrak™ Immunosuppressants XE-CE/IVD for in vitro diagnostic use. MassTrak Immunosuppressants XE allows clinical laboratorians and transplant physicians to provide quality health care and effectively monitor immunosuppressant drug levels in transplant patients. MassTrak Immunosuppressants XE is intended for quantifying levels in whole blood samples of the immunosuppressive drugs Everolimus® in adult kidney and cardiac transplant patients and Tacrolimus® in liver and kidney transplant patients. Waters MassTrak Immunosuppressants XE Solution is a total system solution offering quality controls, calibrators, and internal standards from a single source with robust, validated methods, and LC/MS/MS instrumentation for therapeutic drug monitoring. *Pending FDA clearance.
CryoELITE™ Cryogenic Vial
With the new Wheaton CryoELITE™ Cryogenic Vial, sample integrity is secure. Sample tracking is simple and permanent with the unique CryoELITE™ 2D Data Matrix barcode insert. The CryoELITE line provides both externally and internally threaded options and is available in 1.2-, 2-, 3-, 4- and 5-mL volumes, in either free-standing or round-bottom configurations. Caps come in seven colors: blue, green, pink, red, white, yellow, and natural. All vial lots are certified DNase- and RNase-free, non-pyrogenic, and endotoxin-free and provided sterile or non-sterile. Caps and vials are made from low-binding, cryogenic, radiation-grade, virgin polypropylene.