[COMPUTERS/IT]
Bioinformatics System
Enables therapy monitoring
Qiagen, Hilden, Germany, has announced enhancements to its clinical decision support system, Qiagen Clinical Insight (QCI), which streamlines the annotation, interpretation, and reporting of next-generation sequencing (NGS) results for clinical laboratories. The QCI bioinformatics platform has been expanded from interpreting NGS data on somatic mutations in solid tumor cancers to add leukemia and lymphoma testing, as well as testing for hereditary cancer indications. For somatic cancer indications, QCI enhancements include insights for diagnostic testing as well as therapy monitoring and disease progression, support for copy number variations and fusion genes, and additional prognostics data from the literature. QCI now provides comprehensive coverage of drugs approved by FDA and the European Medicines Agency, professional clinical guidelines, and active genotype-related clinical trials.
Qiagen
(800) 426-8157; www.qiagen.com
[EQUIPMENT]
Cryogenic Carrier
Facilitates transport of specimens
The CryoPod carrier from BioCision LLC, San Rafael, Calif, is a hand-portable system for the safe transport of valuable biospecimens and temperature-sensitive therapeutics, including immunotherapies and vaccines. The result of a joint development project with Brooks Automation, Chelmsford, Mass, the liquid nitrogen vapor-based carrier is designed to provide reliable transport for biospecimens at a temperature of –150°C or less for more than 4 hours on a single LN2 charge. Onboard electronics display temperature, date, and time, and also provide user-settable audible and visual alarms. The instrument also features logging functionality, enabling operators to record and download the temperature and event history as needed. It can be manually filled or seamlessly integrated into an automated filling station that replenishes the LN2 charge in less than 15 minutes.
BioCision
(888) 478.2221; www.biocision.com
Dry Bath
Outfitted with temperature probe
Torrey Pines Scientific, Carlsbad, Calif, has introduced the EchoTherm model IC50, a Peltier-driven chilling and heating dry bath with exact sample temperature control. A temperature probe inserts directly into the sample or sample block, senses the temperature directly at the source, and sends that information to the unit to drive and control the temperature exactly where set. A sensor in the heater plate enables users to set the plate temperature and use the probe to monitor the sample temperature. The device can freeze, chill, or heat samples from –10.0°C to 110.0°C, and displays and controls temperature to ±0.1°C. The unit works with samples placed in assay plates, centrifuge tubes of all sizes, vials, test tubes, and other sample containers.
Torrey Pines Scientific
(866) 573-9104; www.torreypinesscientific.com
[MISCELLANEOUS]
Linearity Set of Special Diabetes Controls
Open-vial stability of 7 days
Audit MicroControls Inc, Eatonton, Ga, has added to its line of calibration verification and linearity controls with Linearity LQ special diabetes controls. The ready-to-use liquid product is designed to simulate human serum samples for determining linearity, calibration verification, and verification of the reportable. Linearity LQ special diabetes controls consist of five levels that demonstrate a linear relationship to each other when assayed for C-peptide, fructosamine, and insulin. The product has an open-vial stability of 7 days when stored at 2°C to 8°C. Along with the controls, the company offers Auditor QC, a free, online, real-time, data-reduction program. The package provides Levey-Jennings charts and linearity graphs, as well as peer-group analysis for daily quality control product users. Report results are produced immediately and stored on the Auditor QC Web site for future reference.
Audit MicroControls
(866) 252-8348; www.auditmicro.com
Flow Cytometry Control
Evaluates intracellular, surface antigens
The CD-Chex TdT Plus from Streck, Omaha, Neb, is a flow cytometry control assayed for terminal deoxynucleotidyl transferase (TdT), cluster of differentiation 1a (CD1a), CD34, and cCD3. It can be used in the evaluation of such intracellular and surface antigens as CD1a, CD2, CD4, CD5, CD7, CD8, CD34, cytoplasmic CD3, and nuclear TdT. When stained with fluorescent antibodies and analyzed by flow cytometry, CD-Chex TdT Plus provides reference values for abnormal cells often found in certain types of hematopoietic neoplasms. Designed for use on BD Biosciences and Beckman Coulter flow cytometry systems, the control has a 30-day open-vial stability and up to a 90-day closed-vial stability. For research use only.
Streck
(800) 843?0912; streck.com
Laboratory Labels
For curved surfaces
The CILS-8100X line of labels from Computer Imprintable Label Systems (CILS) Ltd, West Sussex, UK, is designed to stay secure on curved surfaces including dishes, flasks, tubes, and vials. Labels feature a high-performance adhesive that ensures critical data is not lost during such typical lab processes as freeze and thaw cycles, water baths, autoclaving, or storage in temperatures from –80°C to 135°C. Labels can be manufactured to precise requirements, in any shape or size, blank or with a professionally preprinted design, and ready to use with a laser or thermal transfer printer.
CILS International
(877) 512-8763; www.cils-international.com
Calibration Verifiers
Liquid, ready to use
The quality control division of Randox Laboratories, Kearneysville,? WVa, has launched new Acusera calibration sets for the AU clinical chemistry analyzer series from Beckman Coulter Inc, Brea, Calif, and the Cobas instruments from Roche Diagnostics, Indianapolis. All calibration sets are supplied in liquid, ready-to-use form, in varying levels to cover the full reportable range. Dedicated calibrator sets are available, comprising a wide range of cardiac markers, proteins, and therapeutic drugs. The sets deliver consolidation of up to 20 analytes and have an extended open-vial stability.
Randox Laboratories
(866) 472-6369; www.randox.com
[TESTING/DIAGNOSTICS]
Hydrocodone Assay
Meets SAMHSA guidelines
FDA has granted premarket notification (510(k)) clearance to a new immunoassay from Thermo Fisher Scientific Inc, Waltham, Mass, for specific detection of hydrocodone. The Thermo Scientific DRI hydrocodone assay has the requisite sensitivity to meet the newly proposed guidelines of the Substance Abuse and Mental Health Administration (SAMHSA). The assay is a homogeneous enzyme immunoassay that specifically detects hydrocodone at the SAMHSA-proposed 300 ng/mL cut-off and is crossreactive to the major metabolites hydromorphone and hydromorphone-glucuronide. The assay utilizes liquid, ready-to-use reagents that can be run in both qualitative and semiquantitative modes. Calibrators and controls are sold separately.
Thermo Fisher Scientific
(800) 678-5599; www.thermofisher.com
High-Volume Coagulation Analyzer
3,000-test onboard capacity
Siemens Healthcare, Erlangen, Germany, has received FDA premarket notification (510(k)) clearance of the Sysmex CS-5100 hemostasis system. The first analyzer in the Sysmex CS family of hemostasis systems to be available in the United States, the system enables automated, standardized sample management, as well as automated detection of unsuitable samples. It is equipped with simultaneous multiwavelength preanalytical sample integrity technology, enabling high-volume laboratories to achieve first-run accuracy. The system connects to Siemens’ automation and data-management offerings, including the track-based Aptio automation and Advia LabCell automation systems. Supporting an onboard capacity of up to 3,000 tests and up to 40 reagents, the system features third-generation cap-piercing technology and a wide optical spectrum.
Siemens Healthcare Diagnostics
(800) 242-3233; www.healthcare.siemens.com
Multiplex Polymerase Chain Reaction System
For syndromic infectious disease testing
The FilmArray system from BioFire Diagnostics, Salt Lake City, integrates sample preparation, amplification, detection, and analysis. Offering a syndromic approach to infectious disease diagnostics, the system requires hands-on time of just 2 minutes and produces results in approximately 1 hour. No precise pipetting is required, and FilmArray software guides users through the entire process. When the run is complete, the software analyzes and reports results in a simple format. The FilmArray system now has three FDA-cleared panels, including blood culture identification, gastrointestinal, and respiratory applications. Together, these panels test for more than a hundred pathogens, including antimicrobial resistance genes, bacteria, viruses, and yeast.
BioFire Diagnostics
(800) 735-6544; www.biofiredx.com
