Compact Molecular Instrument
Uses isothermal technology
The Alere i platform from Alere Inc, Waltham, Mass, uses isothermal technology that amplifies nucleic acids at a constant temperature. Thermal cycling and sample purification steps are not required, enabling fast results. The instrument features a compact footprint, intuitive touchscreen, visual guides, and unidirectional connectivity to the user’s network. In 2014, FDA cleared the platform for the detection and differentiation of influenza A and B virus. The company also recently received FDA clearance for its Alere i Strep A test, which detects group A Streptococcus bacteria from throat swab specimens in 8 minutes or less. Other assays currently in development include tests for respiratory syncytial virus, Clostridium difficile, and a combined test for Chlamydia trachomatis and Neisseria gonorrhoeae.
(781) 647-3900; www.alere.com
Employs microfluidic technology
The Parsortix system from Angle Plc, Surrey, UK, is a cell separation technology that enables a simple blood test to capture cells of interest, such as circulating tumor cells (CTCs), for molecular profiling and analysis. The system uses a patented microfluidic technology in the form of a disposable cassette to capture and then harvest CTCs from blood, based on their less-deformable nature and larger size compared to other blood components. The disposable cassette is placed in a clamp, and the system then automatically processes the patient sample. Captured cells can be fixed and stained within the cassette to allow in-cassette identification and enumeration, or alternatively can be recovered to allow external staining or genetic analyses such as quantitative polymerase chain reaction or sequencing.
(215) 966-6240; www.angleplc.com
Clinical Chemistry Analyzer
Performs up to 480 tests per hour
EKF Diagnostics, Cardiff, UK, has unveiled the Altair 240 clinical chemistry analyzer, representing the company’s first fully integrated chemistry system designed for the global market. Available as a benchtop platform, the fully automated analyzer is equipped with bidirectional laboratory information system connectivity and is capable of performing up to 480 tests per hour. In addition to being supported by EKF’s broad menu of Stanbio Laboratory ready-to-use, barcoded, liquid reagents for routine and special chemistries, the Altair 240 also provides the flexibility to configure open-channel applications for many esoteric assays. The analyzer features a touchscreen menu, auto-rerun, auto-dilution, and stat interruption, while running on Microsoft Windows 7.
(800) 531-5535; www.ekfdiagnostics.com
Compact Clinical Analyzer
Quantifies blood lead levels
Magellan Diagnostics Inc, North Billerica, Mass, has released the LeadCare Plus blood lead testing system in the United States for the quantification of lead levels in blood. Developed to enhance the accessibility of blood lead testing, the single-channel system performs lead analysis in a compact footprint suited for space-constrained labs and clinics. Weighing approximately 3 pounds, the system requires a sample volume of 50 ?l of capillary or venous whole blood. Detection relies on the anodic stripping voltammetry electrochemical technique and takes 3 minutes. Designated as moderately complex, the test system is not intended for point-of-care use but rather for prescription use only. Magellan Diagnostics recommends that a minimum of two levels of quality control be performed each day or shift, before patient samples are tested.
(978) 856-2345; www.magellandx.com
Suitable for liquid nitrogen storage
Computer Imprintable Label Systems (CILS) Ltd, West Sussex, UK, offers a self-laminating CILS-8/91000 label range, which safeguards text against extreme temperatures and provides extra adhesion. Designed for liquid nitrogen storage, a computer-printable panel facilitates the addition of variable data using a standard laser or thermal transfer printer. Once printed and applied, labels will wrap around and self-laminate vials, flasks, and test tubes, providing secure adhesion and print protection against temperatures from –196ºC to 155ºC as well as abrasion, autoclave cycles, chemicals, moisture, and solvents. The product line is available in any size, and can be color-coded for immediate identification of samples and specimens.
(877) 512-8763; www.cils-international.com
Small, Dense LDL Reagent
Completes particle detection within 10 minutes
Randox Laboratories, Kearneysville, W Va, offers a reagent for the detection of small, dense low-density lipoprotein cholesterol particles (sd-LDL). The liquid, ready-to-use product has a measuring range of 0.189–22.2 mmol/L, comfortably detecting levels outside of the healthy limit of 4.9 mmol/L. Randox’s reagent utilizes the LDL-Ex Seiken method, which moves away from more time-consuming ultracentrifugation- and electrophoresis-based methods. Used on most automated biochemistry analyzers, the reagent completes particle detection within 10 minutes. It is stable to expiry when stored at 2°C to 8°C. For research use only.
(866) 472-6369; www.randox.com
Automated Sample Processing System
Uses intelligent routing
The Power Express from Beckman Coulter, Brea, Calif, is a high-speed automated sample processing system that processes samples for chemistry, immunoassay, and hematology testing. A dynamic inlet serves as a single high-capacity point of entry for samples. Intelligent sample management is designed to route samples among connected analyzers in an efficient manner. The system’s radiofrequency identification tube routing supports instrument connections on both sides of the track, optimizing specimen transport and leading to a smaller footprint without diminishing capacity. The system provides sample barcode reading at each sample aspiration while maintaining accuracy with positive patient identification. It also features refrigerated and ambient storage, and is finished with an automated specimen disposal unit.
(800) 526-3821; www.beckmancoulter.com
HbA1c Reagent Kit
Aids in the diagnosis of diabetes
The Vitros Chemistry Products HbA1c reagent kit from Ortho-Clinical Diagnostics, Raritan, NJ, can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c in human whole blood. The newly FDA-cleared HbA1c kit is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for monitoring long-term blood glucose control in individuals with diabetes mellitus. The kit offers operational and performance enhancements over the company’s currently marketed kit, including higher throughput and simplified calibration. The design of the Vitros HbA1c assay allows its use in patients with hemoglobin variants C, D, E, and S traits.
(800) 828-6316; www.orthoclinical.com/en-us
ZnT8Ab ELISA Kit
Aids in the diagnosis of type 1 diabetes mellitus
Kronus, Star, Idaho, offers a zinc transporter 8 autoantibody (ZnT8Ab) enzyme-linked immunosorbent assay (ELISA) kit for the semiquantitative determination of autoantibodies to zinc transporter (ZnT8) in human serum. The kit is used as an aid in the diagnosis of type 1 diabetes mellitus, or autoimmune mediated diabetes. ZnT8 is a member of the large cation efflux family and is one of the major targets of type 1 diabetes autoimmunity. ZnT8 autoantibodies may be present in patients diagnosed with diabetes and are useful as a marker for type 1 diabetes testing.
(800) 457-6687; www.kronus.com
Offer 3-year shelf life
New from Bio-Rad Laboratories Inc, Hercules, Calif, are human-serum based Lyphochek Allergen sIgE quality controls to monitor precision of in vitro allergy test procedures. Negative and panel A controls are multiconstituent controls that eliminate the need for multiple, single-analyte controls. The controls are analyzed for 15 frequently tested allergen-specific immunoglobulin E antibodies that include dander, dust mites, foods, grasses, and mold. Quantitative insert values are provided for three commonly used, fully automated test systems. The controls offer a 3-year shelf life and reconstituted open-vial stability of 28 days when stored between 2°C and 8°C.
(800) 424-6723; www.bio-rad.com
Software for Design of Experiments
Analyzes offline analytics
The newest versions of the advanced microscale bioreactor (AMBR) systems from Sartorius Corp, Bohemia, NY, will now be supplied with integrated BioPat Modde software for design of experiments (DoE), powered by Umetrics Inc, San Jose, Calif. The integrated DoE software enables bioprocess scientists to implement DoE into their workflow for simpler process optimization. Users can configure DoE experiments via work packets that are exported from the software to the AMBR system, configuring each microbioreactor with its own DoE-defined bioprocessing parameters. The data generated from AMBR, including offline analytics, are analyzed within the software to identify critical process parameters, optimize bioprocessing conditions, and define a robust design space for implementation in larger single-use Biostat pilot and manufacturing scale bioreactors.
(800) 368-7178; www.sartorius.us
Benchtop Immunoassay System
Performs up to 36 tests per hour
The Vidas 3 from bioMérieux, Marcy l’Etoile, France, is the latest version of the company’s benchtop immunoassay system. The FDA-cleared and CE-marked instrument incorporates enhanced preanalytical automation features, including automated scanning of reagents and barcoded primary sample tubes for improved traceability, automated calibration and onboard dilution, and new software capabilities. The low-throughput immunoassay system can perform up to 36 tests per hour, on demand, individually, or in series. Calibration can be completed every 14 or 28 days, depending on the parameter. Three separate racks each containing three configurable segments can hold a total of 27 samples, diluents, and calibrators. Users have access to more than 100 tests in a single-test format for the diagnosis of allergies, cancers, cardiovascular diseases, infectious diseases, infertility, pregnancy, and thyroiditis.
(800) 682-2666; www.biomerieux.com
Respiratory Pathogen Panel
Detects 22 respiratory pathogens
Luminex Corp, Austin, Texas, offers the NxTAG respiratory pathogen panel, a respiratory assay that detects 22 respiratory pathogens simultaneously. Features include a closed tube system that minimizes contamination risks; minimized hands-on time due to pre-plated reagents; a scalable throughput of 1–96 samples run at a time; and customization, with users afforded the ability to select any number of targets to customize their panel. The panel is designed to maximize productivity in centralized hospital and reference laboratories currently performing syndromic molecular respiratory testing. Not for use in diagnostic procedures. For research use only.
(877) 785-2323; www.luminexcorp.com
UIBC Quality Controls
Open-vial stability of 7 days
Linearity FD UIBC controls from Audit MicroControls Inc, Eatonton, Ga, are intended to simulate human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range. The lyophilized product consists of five levels that demonstrate a linear relationship to each other when assayed for unsaturated iron binding capacity (UIBC). Each level has an open-vial stability of 7 days when stored at 2°C to 8°C. The company also provides Auditor QC, a free online, real-time data reduction program that offers Levey-Jennings charts, linearity graphs, and peer-group analysis for daily quality control product users.
(866) 252-8348; www.auditmicro.com
H&E Staining System
Uses Lean methodology
Designed to automate the hematoxylin and eosin (H&E) staining process from tissue drying through coverslipping, the Ventana HE 600 system from Roche Diagnostics, Basel, Switzerland, detects slides by barcode scanning and dispenses fresh reagents on every slide, reducing the risk of tissue cross contamination. The system uses Lean methodology with minimum touch points and an intuitive operating system to improve workflow, and has a maximum throughput of 200 slides per hour. All reagents are ready to use, recyclable, color-coded, and individually numbered with radiofrequency identification technology for easy management and error prevention. No alcohol, deionized water, or xylene is used in the staining process, protecting lab technicians from exposure to harmful chemicals.
Roche Diagnostics USA
(800) 428-5076; usdiagnostics.roche.com