PRODUCT NEWS: June 2013

Performance Enhancements
Quicker results, automatic inventory
Abbott, Abbott Park, Ill, introduces a new capability for its RealTime m2000 system: enhancing the system’s flexibility and making molecular testing easier and more efficient. The new mPlus makes it possible for labs of any size to perform molecular diagnostic tests for infectious disease detection and therapy monitoring. It allow labs to process samples when they are ready rather than holding them for larger batch runs, providing faster results to physicians and patients. mPlus capability will also optimize reagent use, reduce lab cost of operations, and offer a new automatic inventory feature to improve system ease-of-use. mPlus capability is currently available for Abbott’s RealTime HIV, HCV, HBV, CT/NG, and CT assays outside the United States and for the RealTime CT/NG assay within the United States.
Abbott
(847) 937-6100; www.abbott.com

Lab Information Technology Gains Certification
Compliant with the ONC 2014 edition criteria
Sunquest Laboratory version 7.0.1003 from Sunquest Information Systems Inc, Tuscon, Ariz, is compliant with the ONC 2014 Edition criteria and was recently certified as an EHR Module by the Certification Commission for Health Information Technology (CCHIT), an ONC-ACB, in accordance with applicable hospital criteria adopted by HHS. The ONC 2014 Edition criteria support both Stage 1 and 2 Meaningful Use measures required to qualify eligible providers and hospitals for funding under the American Recovery and Reinvestment Act (ARRA). Adding the Meaningful Use 2014 Incorporate and Reportable module to Sunquest Laboratory provides a way to demonstrate Meaningful Use of the Reportable Results criteria by expertly implementing Public Health reporting from the laboratory.
Sunquest Information Systems Inc
(520) 570-2000; www.sunquestinfo.com

Courier Management System
Track status of deliveries
The Laboratory Courier Management module from Path-Tec, Columbus, Ga, represents part of a web-based solution that helps labs manage critical specimen collection functions, including courier scheduling, route management, supply tracking, specimen tracking, and reporting. The module shows the location of couriers, generates summary reports, and updated arrival/departure information. The module has an app for mobile devices as well.
Path-Tec
(706) 569-6368; www.path-tec.com

Iceless Cooling Container
Uses ceramic-coated aluminum beads
New from Dynalon, Rochester, NY, the DyNAQube is ideal for incubating up to 20 samples at 0°C to 4°C or ambient to 5°C for long periods of time. It chills while keeping everything dry and in place, removing the inconvenience of melted ice, contamination, or losing track of samples. The ceramic-coated aluminum beads provided with each DyNAQube help maintain the chilled sample temperature while supporting the vessels for as long as necessary. The beads are chemically resistant and, if required, can be autoclaved. The beads can also be prechilled by placing them in a Dynalon plastic beaker and incubated at refrigerated temperatures.
Dynalon
(800) 334-7585; www.dynalon.com

Thermal Cyclers
Designed for all lab sizes
Dynalon, Rochester, NY, introduces a new line PCR thermal cyclers, called DyNAcyclers, designed with today’s labs—small, medium, and large—in mind. DyNAcycler DCL with 20, 25, 30, and 48 array, has a small footprint and user-friendly programming. It holds 0.2-mL and 0.5-mL microtubes, and is backed with a 4-year warranty.
Dynalon
(800) 334-7585; www.dynalon.com

New Instrument/Gastrointestinal Pathogen Panel
Performs qualitative and quantitative analysis
Luminex Corp, Austin, Tex, has received FDA clearance for its Magpix instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on Magpix. xTAG GPP can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample. Based on the company’s xMAP technology, the Magpix instrument is a versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices. Its compact size makes it attractive to labs with limited bench space. This system can perform up to 50 different tests in a single reaction volume, reducing sample input, reagents, and labor while improving productivity.
Luminex Corp
(888) 219-8020; www.luminexcorp.com

Rapid Strip-Based Test for Hemoglobin
Quick, easy determination of anemia
EKF Diagnostics, UK, introduces a new strip-based test for quick and easy hemoglobin analysis for anemia determination. STAT-Site M Hgb, a handheld analyzer that combines low cost per test with portability, reliably delivers accurate hemoglobin analysis results within 30 seconds from 15 µL of finger-prick whole blood. Intuitive, step-by-step on-screen instructions minimize training and ensure ease of use.
EKF Diagnostics
(800) 531-5535; www.ekfdiagnostics.com

Fully Automated Integrated Urine Analyzer
150 samples per hour
US Arkray Inc, Edina, Minn, has received FDA clearance for the fully automated integrated urine analyzer. This latest addition to the company’s urinalysis portfolio combines the Arkray urinalysis strip technology with fluorescent flow cytometry sediment analysis in one space-efficient unit. It improves sample throughput capabilities with continuous sample loading averaging a rate of 150 samples per hour. The full reflex testing capabilities allow labs to complete urine analysis on the same platform with minimal interaction.
US Arkray Inc
(800) 818-8877; www.arkrayusa.com

Molecular Pathology Solution
Deliver integrated cell-capturing solution
Applied Spectral Imaging Inc (ASI), Carlsbad, Calif, and WaveSense Inc, Irvine, Calif, are integrating their platforms to provide a newly optimized molecular pathology solution. ASI’s GenASIs imaging and analysis instrument will be paired with WaveSense’s EpiSEP cell recovery and enrichment solution to deliver an integrated cell-capturing solution and computerized instrument to detect, image, and analyze the captured cells. The combined solution is effective in performing semiautomated FISH analysis of paramagnetic labeled target cells. Target cells may be retrieved, enriched, imaged, and analyzed in urine, bone marrow, blood, needle aspiration, abdominal ascites, lymph node, culture, and pleural effusion specimens. GenASIs is FDA-cleared for FISH clinical applications such as ALK, UroVysion, HER2/neu, CEP XY, and karyotyping.
Applied Spectral Imaging Inc
(800) 611-3466; www.spectral-imaging.com

Benchtop Hematology Analyzer
Reduces manual review rates and processes
Beckman Coulter Inc, Brea, Calif, a wholly owned subsidiary of Danaher Corp, introduces a new benchtop hematology analyzer for mid- to high-volume laboratories. The new UniCel DxH 600 Coulter cellular analysis system provides labs with quality results, improved first-pass accuracy, and automatic rerun and reflex testing. By reducing manual differential rates, the new analyzer frees labs to focus time on quickly and accurately reporting patient results. The software saves time by allowing labs to partially release patient results manually or automatically via decision rules. In addition, users now have the ability to create and edit decision rules during instrument operation.
Beckman Coulter Inc
(800) 526-3821; www.beckmancoulter.com

Immunochemical Fecal Occult Blood Test
Dry sample collection drives sample stability
The new rapid immunochemical fecal occult blood (iFOB) test from Sekisui Diagnostics, Lexington, Mass, detects hemoglobin in stool samples as an aid in the early detection of colorectal cancer. The OSOM Test provides better sample stability with its unique “dry sample” collection card. Value comes in the form of two patient sample collections on one collection card, allowing compliance with screening guidelines while using only one test cassette.
Sekisui Diagnostics
(800) 332-1042; www.sekisuidiagnostics.com

Synethetic Cannabinoid Test
Detects more than 55 types
Randox Toxicology, Kearneysville, WVa, has developed an ELISA targeting UR-144, XLR-11, and additional synthetic cannabinoid compounds commonly found in new Spice and K2 blends. Together with its JWH/AM2201 Synthetic Cannabinoids ELISA, the new UR-144/ XLR-11 ELISA provides a comprehensive solution for the rapid detection of more than 55 current synthetic cannabinoids in urine, blood, and oral fluid. UR-144 and XLR-11 are chemically different structures to earlier generations of synthetic cannabinoids such as JWH-018, JWH-073, or AM-2201.
Randox Toxicology
(866) 472-6369; www.randoxtoxicology.com

HTLV-I/II Assay
Tests blood and plasma specimens
The Avioq HTLV-I/II test from Avioq Inc, Research Triangle Park, NC, is an assay for the qualitative detection of antibodies to Human TLymphotropic Virus Type I (HTLV-I) and Type II (HTLV-II) in serum or plasma. It is intended for screening individual human donors, including volunteer donors of whole blood and blood components, and for use in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is also used in testing blood and plasma specimens to screen organ donors. The assay features a user-friendly microplate design suitable for various testing volumes and automation
Avioq Inc
(919) 314-5535; www.avioq.com

Inherited Cardiovascular Disease Genetic Test Menu
Available for individual and familial settings
Aviir Inc, Irvine, Calif, will be extending its offered services with a comprehensive inherited cardiovascular disease genetic test menu. The newly validated tests cover the major causes of cardiomyopathies, arrhythmia disorders, and other genetically transmitted diseases that affect the heart and vasculature. Each test is available for testing in both individual and familial settings. Two comprehensive panels are available to check for undiagnosed arrhythmia or cardiomyopathy.
Aviir Inc
(888) 287-4217; www.aviir.com

Beta-Hydroxybutyric Acid Linearity
Open vial stability of 7 days
Audit MicroControls Inc, Carlsbad, Calif, has added the Beta-Hydroxybutyric Acid Linearity, 5 levels, to its line of calibration verification/linearity products. It is intended to simulate human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range for Beta-Hydroxybutyric Acid. Packaged as 5 x 1 mL, this liquid product has a shelf life of 2 years and an open vial stability of 7 days when stored at 2°C to 8°C.
Audit MicroControls Inc
(866) 252-8942; www.auditmicro.com

Blood Culture Identification Panel
Provides automatic results
BioFire Diagnostics Inc, Salt Lake City, has submitted the FilmArray Blood Culture Identification (BCID) Panel to the FDA for 510(k) clearance. The panel provides automatic results for the most common infectious causes of sepsis, a significant cause of mortality and morbidity in adults, children, and infants. Using an easy procedure requiring only 2 to 3 minutes of hands-on time, the BCID Panel simultaneously tests positive blood cultures for approximately 90% of the gram-positive bacteria, gram-negative bacteria, and yeast microbes that cause bloodstream infections. The panel also tests for common antimicrobial resistance genes associated with Methicillin-resistant Staphylococcus aureus, Vancomycin-resistant Enterococci, and the newly emerging Carbapenem-resistant Enterobacteriaceae.
BioFire Diagnostics
(801) 736-6354; www.biofiredx.com

Multi-Biomarker Blood Test
Measures disease activity in RA
Crescendo Bioscience, South San Francisco, reports that the Wadsworth Center at the New York Department of Health issued a laboratory permit to the company to provide services to physicians in New York. Crescendo Bioscience offers Vectra DA, a multibiomarker blood test that measures disease activity in rheumatoid arthritis (RA) by integrating 12 key proteins consistently associated with the biology of RA into one single, objective, and quantitative score to help physicians make more informed patient management decisions. With this clearance, Vectra DA is now available in all 50 states.
Crescendo Bioscience
(877) 743-8639; www.crescendobio.com