During the annual meeting of the American Association for Clinical Chemistry (AACC), vendors will have the opportunity to showcase their latest products. Here is a sampling of technologies that will be on display in the exhibit hall.
Fully Automated Analyzer
For erythrocyte sedimentation rate testing
The iSed system from Alcor Scientific Inc, Smithfield, RI, provides fully automated erythrocyte sedimentation rate testing, delivering accurate results in 20 seconds. Using a blood sample of 100 uL, the system is particularly suited for pediatric and geriatric patients. The analyzer tests samples directly from standard ethylene diamine tetraacetic acid tubes, reducing testing costs as well as contaminated waste. In a controlled environment, quantitative photometry measures the formation of red cell aggregates during the most critical phase of red cell sedimentation. As a result, the patient’s inflammation status is reflected accurately, unaffected by variables such as mixing and temperature. With closed-tube sampling and no required disposables, the system aims to streamline processes and improve safety for clinical laboratorians. Random-access, continuous-feed operation enables throughput of up to 180 samples per hour.
Alcor Scientific
(800) 495-5270; www.alcorscientific.com
Integrated Urine Chemistry and Sediment Analyzer
Processes up to 200 chemistry tests per hour
The fully automated Aution Hybrid AU-4050 analyzer system from Arkray USA, Minneapolis ,integrates urine chemistry and flow cytometry technology into the smallest space-saving footprint in the market. Processing up to 200 chemistry tests per hour, the system provides a high level of bacteria detection while standardizing workflow and reducing tech-to-tech subjectivity. The unit is designed for a high capacity with minimal operator intervention for true walkaway capabilities. It also streamlines urinalysis testing with automatic reflex testing, no manual dilutions, and minimal maintenance. Allowing for easy training and competency retention, the system is user-friendly and designed to provide high-quality results and improved bacteria detection for better patient outcomes.
Arkray USA
(877) 538-8872; www.arkrayusa.com
Daily Quality Control
Open-vial stability of 3 days
The Linearity FD Cardiac Siemens Stratus from Audit MicroControls, Eatonton, Ga, is 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 creatine kinase MB, myoglobin, and troponin I. It has an open-vial stability of 3 days when stored at 2-8°C.
Audit MicroControls
(866) 252-8348; www.auditmicro.com
Hematology Connected Workcell
Features automated sample routing and data management
UniCel DxH v3.0 software from Beckman Coulter Inc, Brea, Calif, supports automated connectivity of the UniCel DxH 800 and DxH slidemaker stainer Coulter cellular analysis systems. Available for in vitro diagnostic use, the UniCel DxH connected workcell permits laboratories to connect up to three DxH 800 analyzers to a DxH slidemaker stainer to create a customized, scalable workflow solution. Featuring automated sample routing, data management, and analytical capabilities, the DxH connected workcell provides low review rates and first-pass accuracy in results’ reporting. The integrated system utilizes the company’s automated intelligent morphology, a multidimensional, high?definition flow cytometry technology.
Beckman Coulter
(800) 526-3821; www.beckmancoulter.com
Diabetic Biomarker Test
Serves as intermediate marker of glycemia
The Stanbio LiquiColor glycated serum proteintest from EKF Diagnostics, Cardiff, United Kingdom, provides a 2- to 3-week indicator of a patient’s average blood glucose level. Closing the information gap between daily blood glucose testing and the 2- to 3-month HbA1c reading, the test serves as an intermediate marker of glycemia in instances where HbA1c may be of limited value, such as pregnancy, reduced red blood cell lifespan, and hemodialysis. The test utilizes the specificity of fructosyl-amino oxidase to eliminate inaccuracies caused by non-glycated protein-reducing substances, which significantly interfere with the fructosamine nitroblue tetrazolium method. Available as a liquid-stable kit and calibrator, it is suitable to use on a variety of clinical chemistry analyzers, with onboard stability of up to 4 weeks.
EKF Diagnostics, via Stanbio Laboratory
(800) 531-5535; www.ekfdiagnostics.com
Enzyme Immunoassay
For the qualitative detection of antibodies to Coxiella burnetti
The ImmunoDot Coxiella test from GenBio, San Diego, is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetti, or Q fever. It is used as an aid in the diagnosis of Coxiella infection in persons suspected of having the infection. The assay utilizes an enzyme-linked immunosorbent assay dot technique for the simultaneous detection of IgG and IgM antibodies to C. burnetti. The test is performed using 10 µl of serum, which may be stored at 2–8°C for up to 5 days and frozen below -–20°C for extended periods. The ImmunoDot test format allows individual patients to be tested for multiple parameters simultaneously.
Innominata dba GenBio
(800) 288-4368; www.genbio.com
Respiratory Viral Panel
Detects 14 respiratory virus types and subtypes
The respiratory viral panel from GenMark Diagnostics Inc, Carlsbad, Calif, uses the eSensor XT-8 molecular diagnostics system to detect 14 respiratory virus types and subtypes, including adenovirus, human metapneumovirus, human rhinovirus, influenza, parainfluenza virus, and respiratory syncytial virus. It requires less than 60 minutes of hands-on preparation time, including DNA extraction, and just over 3 hours of walkaway time. In clinical trials, the sensitive panel had 99.2% agreement with quantitative polymerase chain reaction. The eSensor instrument features a touchscreen user interface, customizable reports, and an expanding menu of multiplex in vitro diagnostic tests that can all be addressed on the same platform.
GenMark Diagnostics
(800) 373-6767; genmarkdx.com
Autoantibody ELISA
Determines autoantibodies to glutamic acid decarboxylase
Kronus, Star, Idaho, presents the glutamic acid decarboxylase autoantibody (GADAb) enzyme-linked immunosorbent assay (ELISA) kit for the accurate determination of autoantibodies to GAD in human serum. The kit is used as an aid in the diagnosis of type 1 diabetes mellitus, or autoimmune-mediated diabetes. GAD autoantibodies are generally present several years prior to the onset of clinical disease; measurement of GAD can help identify individuals at risk and provide essential information with regard to the autoimmune progression of diabetes. Kits contain 96 wells.
Kronus
(800) 457-6687; www.kronus.com
Chemistry Analyzer
Includes general chemistry test menu
MedTest, Canton, Mich, offers a general chemistry test menu on the Mindray BS-480 chemistry analyzer, which meets the testing needs of mid-volume laboratories. The analyzer produces 400 photometric test results per hour and 240 ion-selective electrode (ISE) tests per hour with an overall throughput of 560 tests per hour. Advanced features include automatic processes such as automatic start-up, ISE calibration, quality control, pre- and post-dilution, probe cleaning, probe collision recovery, reagent blank checks, and rerun, among others. The exclusive distributor of the analyzer in the United States, MedTest is handling the manufacturing and distribution of reagents, calibrators, and quality control products for the general chemistry and drugs of abuse testing markets. The analyzer’s full menu includes drugs of abuse reagents for urine drug screening and a range of chemistry tests, including specialty tests such as HbA1c and vitamin D.
MedTest
(866) 540-2715; www.medtestdx.com
Benchtop Clinical Chemistry Analyzer
450 tests per hour
Randox Laboratories, Kearneysville, WVa, has developed the RX series of clinical chemistry analyzers for high-quality testing. The RX Daytona+ is a fully automated, random access, benchtop clinical chemistry analyzer that provides rapid comprehensive routine and specialized testing with emergency stat sampling functionality. Suited for mid-volume chemistry testing, the system has a throughput of 450 tests per hour, including ion-selective electrode testing. The analyzer’s test menu includes routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, and diabetes testing.
Randox Laboratories
(866) 472-6369; www.randox.com
Strep A Test
Provides results in approximately 15 minutes
The Cobas Strep A test from Roche Diagnostics, Basel, Switzerland, recently received FDA waived status under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The test uses polymerase chain reaction technology on the on the Cobas Liat system, which fully automates the testing process, simplifies workflow, and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability, and minimal training. The Cobas test is the first CLIA-waived test to detect Strep A in throat swab specimens in approximately 15 minutes. It is also CE marked and FDA cleared.
Roche Diagnostics USA
(800) 428-5076; usdiagnostics.roche.com
Coagulation System
400 PT tests per hour
Sekisui Diagnostics, Lexington, Mass, offers the CP3000 coagulation system, which boasts a compact footprint and high throughput of 400 prothrombin time tests per hour. Its broad menu of dedicated reagents, the majority in liquid format, seeks to meet the needs of laboratories of all sizes. Abbott will be the exclusive distributor of the coagulation instrument in the United States, Europe, and other regions that recognize CE mark, with nonexclusive distribution in China, Hong Kong, Japan, and Macau. The system is expected to connect seamlessly to Abbott’s Accelerator a3600 lab automation platform and middleware solutions.
Sekisui Diagnostics
(781) 652-7800; www.sekisuidiagnostics.com
HPLC Medical Device
For general clinical use
The Prelude LX-4 MD high-pressure liquid chromatograph from Thermo Fisher Scientific, Waltham, Mass, is listed with FDA as a Class I medical device for general clinical use. The device features four parallel channels, which can deliver up to four different separations to a single mass spectrometer to enhance sample throughput. The channels can run identical or different methods simultaneously. Ensuring accurate, reproducible flow and gradient formation with concise design, the device offers enhanced productivity and confidence when providing laboratory-developed test results to healthcare professionals. It is designed and manufactured in a Thermo Fisher Scientific facility certified to ISO 13485, the quality systems standard for medical device manufacturing compiled by the International Organization for Standardization. For in vitro diagnostic use.
Thermo Fisher Scientific
(800) 678-5599; www.thermofisher.com
Hematology Systems
Run up to 60 samples per hour
Siemens Healthcare Diagnostics, Tarrytown, NY, offers three scalable hematology systems: the Advia 360, Advia 560, and Advia 560 AL systems. As lower capacity systems, they provide complete blood count testing capabilities for small- to mid-sized laboratories, while serving as back-up systems for larger laboratories. Features include options for open- or closed-tube sampling, customizable result printing, automatic anti-clogging, and automated maintenance. Other capabilities include options for manual or automatic calibration procedures, a cap-piercing function for safe and accurate sampling, a multilingual operating menu, and bidirectional communication to laboratory information systems. The systems run up to 60 samples per hour.
Siemens Healthcare Diagnostics
(800) 242-3233; www.healthcare.siemens.com
Risk Management Tool
Determines risk management index
Mission: Control from Bio-Rad Laboratories, Irvine, Calif, is an objective risk management tool for quality control (QC) in clinical laboratories. The software platform enables users to assess their risk of reporting incorrect patient results. Users can determine their lab’s risk management index, evaluate test method performance based on QC results, assess how much they can reduce their risk based on their instrument performance, and select QC rules and frequencies that fit their lab’s risk tolerance. The company also offers a consulting service that provides expertise from a dedicated QC specialist, assigned to help customers select assays to evaluate as well as determine a particular lab’s optimal QC rules and frequencies.
Bio-Rad Laboratories
(800) 424-6723; www.bio-rad.com
