Data Management Program
Automatically analyzes all QC data
Randox, UK, introduces Acusera 24.7 Live Online, a new Web-based interlaboratory data management program. It is designed to complement Acusera third-party quality controls, and aims to improve the effectiveness of quality control processes within the clinical lab while also helping to interpret QC results. Users have the ability to monitor analytical performance and access peer group reports online. Access to comprehensive charts, reports, and statistically relevant peer group data generated from thousands of labs worldwide enable users to identify any trends, system errors, and reagent issues. Acusera 24.7 automatically analyzes all QC data and applies user-defined QC multirules that highlight any rejected results. The audit trail report records all events leading to the creation, modification, and deletion of an electronic record.
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com
Biopsy System Gains FDA Approval
Organizes tissue samples
Mammotome revolve, a dual vacuum-assisted biopsy system from Devicor Medical Products Inc, Cincinnati, has received FDA approval. The system features a specimen management system capable of collecting and organizing individual tissue samples in numbered, specimen radiograph, and pathology-ready chambers that preserve tissue integrity. It also features DualVac vacuum technology, which gives clinicians the ability to secure larger contiguous tissue samples. These features, in combination with a physician-controlled variable aperture, allow clinicians to confirm or adjust sample acquisition in response to procedural situations to confidently access and acquire challenging lesions.
(513) 864-9000; www.devicormedical.com
Easy to operate, intuitive software
The A2O, an automated osmometer with intelligent liquid-handling technology from Advanced Instruments, Norwood, Mass, is a fully automated, multisample osmometer that incorporates 50 years of applied technology experience in the field of freezing-point osmometry. It combines a functional design, analytical performance, and an intuitive software control package that is user-friendly.
(800) 225-4034; www.aicompanies.com
Flexible system offers variety of features
The Whitley A95 Workstation from Don Whitley Scientific, UK, is the largest model in the company’s range of modified atmosphere chambers, with a capacity of up to 1,400 petri dishes. The chamber uses full-color, touchscreen technology. The integral 30-liter airlock with automatic internal door can transfer 90 plates in 5 minutes. Dual-gas operation contributes to low running costs. Remote monitoring allows access from any computer or mobile device with a secure Internet connection. The A95 features four oval, manual, sleeved ports that enable two people to operate simultaneously within the same workstation. These ports also act as mini airlocks for 10 plates each, so for smaller quantities of samples, users do not have to use the airlock.
Don Whitley Scientific
(800) 396-4276; www.dwscientific.co.uk
Mid-Volume Chemistry Analyzer
Size does not sacrifice features
Randox, UK, introduces RX daytona plus, a new solution for mid-volume clinical chemistry testing. RX daytona plus features familiar performance in a compact space. The benchtop, fully automated, random access clinical chemistry analyzer consolidates routine and specialized testing onto one platform. It offers a sample clot detection sensor and includes many of the features typically found on larger automated analyzers. The analyzer is capable of running 270 photometric tests per hour, or 450 tests per hour including ISE’s via the optional ISE unit. Water consumption of 5 liters per hour keeps costs to a minimum, and a loading hatch allows emergency samples to be analyzed quickly at any time. Remote access diagnostics allows for immediate access to the system, ensuring reduced down time.
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com
High-Volume Coagulation Analyzer
Automated preanalytical sample management
Siemens Healthcare Diagnostics, Tarrytown, NY, has introduced the Sysmex CS-5100 system, a random access, high-volume coagulation analyzer, in multiple markets across the world, including Europe, Africa, Canada, Latin America, Australia, and New Zealand. This addition to the Siemens Sysmex CS portfolio is equipped with simultaneous, multiwavelength Preanalytical Sample Integrity (PSI) technology, enabling high-volume labs to achieve first-run accuracy by identifying and managing unsuitable test specimens prior to analysis. Leveraging PSI technology, the system automates and standardizes sample management, detecting unsuitable samples prior to analysis. This technology enhances results reliability while improving efficiency by minimizing the need for manual sample inspections. The system also features third-generation cap-piercing technology, which contributes to reduced sample processing time and maintains the analyzer’s high throughput capability. With onboard capacity of up to 3,000 tests and up to 40 reagents, the system delivers extended walkway time to streamline workflow.
Siemens Healthcare Diagnostics
(888) 588-3916; www.healthcare.siemens.com
Guided Pipetting System
Software creates, saves, executes applications
Hamilton Co, Reno, Nev, introduces the Microlab 300 series pipettor, a guided pipetting system. The lightweight, handheld device enables labs to achieve quality assurance through reproducible and traceable methods and to reduce sample preparation time by eliminating inefficient steps. Users can dispense between 0.5 to 1,000 µL without needing to exchange pipettes. The pipettor achieves this range using one probe and two tip sizes. It meets GLP/GMP, RoHS, 21 CFR Part 11, and ISO-8655 regulations. The device also comes with user-friendly, proprietary software that allows technicians to create, save, and execute pipetting applications from start to finish.
(800) 648-5950; www.hamiltoncompany.com
Instructional DVDs, Drawing Blood Samples
Showing techniques and common errors
The Center for Phlebotomy Education, Corydon, Ind, offers videos for teaching health care professionals what they must know about drawing quality blood samples safely and properly. This series of five DVDs reflects current Clinical and Laboratory Standards Institute (CLSI) standards and OSHA guidelines. Three-dimensional animations illustrate nerve injury, arterial nicks, platelet clumping, hematoma formation, and hemoconcentration. Detailed demonstrations cover the critical aspects of venipuncture, skin puncture, and arterial blood gas collections. Errors that collectors can introduce during sample collection, transport, and storage that alter test results, along with the types of injuries patients suffer from poorly performed venipunctures that can lead to litigation, are discussed.
Center for Phlebotomy Education
(866) 657-9857; www.phlebotomy.com
Tumor Marker Control
Independently assess performance
The new Acusera multianalyte Liquid Tumor Marker Control from Randox, UK, covers a total of 12 commonly tested and esoteric cancer antigens and tumor markers. It includes AFP, beta-2- microglobulin, CA15-3, CA19-9, CA27-29, CA125, CEA, ferritin, hCG, PSA Free, PSA Total, and thyroglobulin. The liquid ready-to-use format requires no preparation. Open vials have a stability of 30 days for all analytes listed, which helps minimize waste. The serum is 100% human in origin, providing a matrix similar to the patient sample, but also reducing antibody cross reactivity and the possibility of control values shifting when reagent batch is changed. Three distinct levels of control are available with all analytes, including PSA present at desirable levels. Labs can use the Acusera liquid tumor marker control to independently assess analytical performance.
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com
Nicotine Metabolites and Nitrosamines Products
Used in a lab’s matrix of choice
Cerilliant, Round Rock, Tex, introduces its new Certified Spiking Solutions of nicotine metabolites norcotinine and trans-3-hydroxycotinine, as well as nicotine nitrosamines NNN, NNK, and NAB at concentrations of 1.0 mg/mL in methanol for each solution standard. These certified reference solutions can be used as Snap-N-Spike starting materials in the lab’s matrix of choice for preparation of calibrators and controls in nicotine testing and other clinical or diagnostic applications by LC/MS or GC/MS. Nicotine biomarkers are commonly monitored in patients who smoke cigarettes, use other nicotine products such as nicotine gum and electronic cigarettes, or are exposed to environmental tobacco smoke. Accurate patient results in clinical and diagnostic testing of nicotine use depend on accurate and consistent certified reference materials for the numerous nicotine metabolites.
(800) 848-07837; www.cerilliant.com
Simplified data reporting
Adaptive Biotechnologies, Seattle, introduces clonoSEQ, a clinical assay that measures minimal residual disease (MRD) in a range of blood-based cancers. It will be available for widespread clinical use by mid 2013. Minimal residual disease is the name given to small numbers of leukemic cells that remain in the patient during treatment, or after treatment when the patient is in remission. The number of these residual cells may be, in some cases, correlated with the risk of relapse. The company has simplified data reporting to make comprehension easier and quicker for hematologists. Enhancements include developing a proprietary set of immune receptor templates to eliminate PCR amplification bias, instituting a systematic chain of custody to handle customer samples, and building a bioinformatics platform to enable the measurement of MRD as a ratio of the malignant clone to the total number of nucleated cells in a blood sample as well as to the lineage-related cells.
(206) 659-0067; www.adaptivebiotech.com
Parasite and Worm Assays
Made for labs of all sizes
Gold Standard Diagnostics, Davis, Calif, offers a comprehensive line of assays for parasites and worms. Its portfolio of parasite tests provides labs with a reliable, single-source procurement option and access to a wide range of highly consistent and cost-effective serological and stool assays. The tests are designed for labs of all sizes. GSD partners with manufacturers from around the globe to offer a broad menu of parasitology products, including Acanthocheilonema viteae, Ascaris lumbricoides IgG, Echinococcus IgG, Entamoeba histolytica IgG, Leishmania IgG, Schistosoma mansoni IgG, and more.
Gold Standard Diagnostics
(530) 759-8000; www.gsdx.us
Evaluates for interference from five interfering substances
The Assurance Interference test kit and Dextran sulfate sodium salt are the latest products from Sun Diagnostics, New Gloucaster, Me. The Assurance kit evaluates assays for interference from five common interfering substances. It is made with human-sourced, triglyceride-rich lipoproteins to evaluate lipemia interference, human hemolysate to evaluate hemolysis interference, human albumin and gamma-globulins to evaluate protein interference, and conjugated and unconjugated bilirubin to evaluate icterus interference. The company also offers Dextran sulfate sodium salt for lab use. It has a variety of lab applications, including use in preparing a precipitating reagent for the determination of HDL cholesterol.
(877) 786-3424; www.sundiagnostics.us
Abbott, Abbott Park, Ill, has received FDA clearance for its new testosterone test. The ARCHITECT 2nd Generation Testosterone Assay is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma. It is more sensitive, accurate, and precise than previous versions. The new assay runs on the company’s fully-automated Architect family of analyzers (pictured) and is available in the United States. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens) including primary and secondary hypogonadism, delayed or precocious puberty, and impotence in males; and in females, hirsutism (excessive hair) and virilization (masculization) due to tumors, polycystic ovaries, and androgenital syndromes.
(800) 323-9100; www.abbottdiagnostics.com