October 2013 Clinical Laboratory News: Volume 39, Number 10
Expo Attendees Get First-Hand Look at the Future of Lab Medicine in Houston
Exhibitors dazzled visitors at the 2013 AACC Clinical Lab Expo at Houston’s George R. Brown Convention Center, July 29–August 1, with hundreds of new and innovative products for clinical laboratories. Everything from molecular tests for genetic mutations to large automated systems capable of processing thousands of samples per hour was on display. Presented here are snapshots of some of the product introductions.
AB Sciex Announces First CE Marked Kit for MS Analysis
The first Food and Drug Administration (FDA)-cleared kits for mass spectrometry (MS) analysis may be coming soon to U.S. laboratories.
AB Sciex announced a new family of IVD reagent kits CE-marked for Europe, which it hopes to bring to the United States. SCIEX IVD-MS kits are specifically designed for diagnostic analysis by MS. The first kit, available in most EU countries, targets high-demand vitamin D analysis. Using the company’s 3200MD CE-IVD series of MS systems, labs can quantitate both 25-OH-vitamin D2 and 25-OH-vitamin D3 in a single run.
Thousands of laboratory professionals visited the
2013 AACC Clinical Lab Expo to inspect the newest products
for clinical laboratories.
Abbott Launches Next Gen Lab Automation, HCV Genotyping Test
With labs feeling the pinch of staffing shortages, automation solutions continue to help meet the demand to process tests faster and handle increased volume. The new Abbott ACCELERATOR a3600 track system meets those needs by processing up to 3,600 samples/hour and handling multiple tube sizes and types simultaneously. To see how it could work in their practice settings, attendees had the opportunity to lay out their ideal lab with realistic replica instruments and tracks.
Abbott also debuted the first FDA-approved hepatitis C virus (HCV) genotyping test, now available on the m2000 platform. The test helps clinicians personalize treatments to a patient’s HCV genotype, leading to improved clinical outcomes.
AACC’s booth was a popular spot
for checking out membership benefits.
Sysmex Marks Milestones of Progress With New Introductions
Celebrating its 10th anniversary in the U.S. market, Sysmex America showcased its two new hematology offerings: the Sysmex XP-300, a big update for smaller labs, and the Sysmex DI-60 Integrated Slide Processing System, an automated slide making/staining and digital cell image pre-classification system.
The Sysmex XP-300 Automated Hematology Analyzer is the newest member of the company’s three-part differential analyzer portfolio, and features updated, user-friendly software. The XP-300 provides the convenience of a color touch panel for ease-of-use operation and time-saving barcode scanning, and is capable of storing up to 40,000 samples.
The Sysmex DI-60 Integrated Slide Processing System is a compact platform that provides integrated, scalable automation of the manual blood film preparation and WBC differential process. It integrates in a single work cell slide preparation, slide staining, and digital image pre-classification of cells. A more standardized differential result and extensive collaboration via network connectivity enhances the level of service laboratories can provide to clinicians and patients.
The latest innovations in laboratory automation
attracted lots of interest from attendees.
EKF Displays Novel End-Stage Renal Disease, ß-HB Tests
EKF Diagnostics showcased a novel test to accurately identify diabetic patients at high risk of progression to end stage renal disease (ESRD) up to 10 years in advance of currently available tests. EKF’s new Soluble Tumor Necrosis Factor receptor 1 (sTNFr1) test is an ELISA assay that has the potential to significantly improve diabetic patient management and outcomes. Recent research has demonstrated that high circulating levels of sTNFr1 are strongly associated with progression to ESRD in patients both with and without overt nephropathy.
The company also announced the worldwide launch of the STAT-Site M ß-HB following the test’s recent CE marking in Europe. The quantitative strip-based test for ß-hydroxybutyrate provides a quick and easy assessment of diabetic ketoacidosis in less than 80 seconds.
Tacrolimus Immunoassay, Cardiac Controls Among New Products From Thermo Fisher
Thermo Fisher Scientific Inc. featured specialty diagnostics products and analytical instruments designed to improve accuracy and productivity in clinical applications, including the QMS Tacrolimus immunoassay that recently received FDA 510(k) clearance. The liquid, ready-to-use immunoassay measures levels of tacrolimus on automated clinical chemistry analyzers, including the bench-top Thermo Scientific Indiko analyzer, to improve monitoring of kidney, liver, and heart transplant patients.
The company also debuted another FDA-cleared product, the Thermo Scientific MAS Omni•CARDIO controls, an assayed control serum comprising a combination of cardiac and associated critical markers to monitor assay conditions. This single test eliminates the need for separate quality control measures between tests and provides rapid results.
You can find more new products in CLN’s 2013 New Products Review.
Visit www.aacc.org, and go to the July issue of CLN under publications.
Beckman Coulter Moves Forward With Array of New Products
Featuring in its booth for the first time products from IRIS Diagnostics, Beckman Coulter and IRIS launched the Alifax automated erythrocyte sedimentation rate analysis system, a product available through a distribution agreement with Alifax. The system fits both large and small workloads, and automation delivers increased productivity and reduced turnaround times. The patented technology generates results in 35 seconds or less. IRIS’s automated urinalysis system was also featured.
Other products showcased included the newest, most advanced version of REMISOL Advance, a data management system that connects to a single server not only Beckman Coulter instruments but also up to 128 other instruments. The UniCel DxH600 Coulter cellular analysis system with advanced software provides improved first-pass accuracy and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes in mid- to high-volume labs. Assays making their debut were the AccuTnI+3 on Access 2 immunoassay systems and the HbA1c- assay on UniCel DxC systems, both of which recently received FDA clearance.
Siemens Introduces VersaCell X3 Solution
Siemens further expanded its automation portfolio with the new VersaCell X3. This platform features a small footprint and upright design to fit the needs of low- and mid-volume laboratories for which track-based automation is out of reach. It can connect up to three Siemens analyzers though a single robotic sample interface to help reduce operator sample handling, better prioritize work flow, and eliminate pre- and post-analytical processing. A new priority drawer above the routine sample drawer provides eight STAT positions and frees up to 50 sample positions for routine processing. A centralized screen gives the operator access to all connected analyzers for greater efficiency.
Intelligent Automation Management Featured in Roche’s Booth
Roche announced plans for the U.S. introduction of the cobas 8100 automated workflow series, an advanced system designed to automate many routine tasks and increase efficiency. The new system uses intelligent robotics to prepare blood samples from immediate testing and post-analytical processing, providing up to 1,100 samples per hour. Other products displayed included the ACCU-CHEK Inform II system, the first point-of-care blood glucose device to offer meter-level wireless technology; the CoaguCheck XS Plus system, a handheld PT/INR meter that recently earned a CLIA waiver; and the cobas 48000 system, a walk-away system that offers molecular tests such as BRAF V600 and EGFR.
Roche also announced that the FDA has approved a new, more efficient workflow process for Roche’s HPV test, for the first time allowing sample processing from the primary sample collection vial after it has been used for Pap testing.
bioMérieux Displays VITEK MS System for Bacterial ID
Recently named by The Cleveland Clinic as one of the top 10 breakthrough medical technologies of 2013, a new system for MS-based bacterial identification was one of the featured instruments in bioMérieux’s booth. The VITEK MS is a matrix-assisted laser desorption ionization time of flight mass spectrometer that can identify in minutes almost 200 disease-causing bacteria and yeast from plated colonies, a game-changing technology in patient care. The instrument analyzes material from microbial cultures and identifies anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae, and yeast.
Following the Expo, bioMérieux announced that it has been granted FDA 510(k) de novo clearance for the VITEK MS, which in a clinical trial produced an overall accuracy for bacterial identification of 93.6% compared to nucleic acid sequencing.