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.
Laboratory Management Dashboard
Monitors activities in real time
The e.Dashboard module from Psyche Systems Corp, Milford, Mass, provides a live, real-time laboratory management dashboard and standard management reports. The module aims to empower managers with the ability to view and react to laboratory processes with a clear picture of their business from an operational perspective. It monitors the following key activities in real-time: open orders, cases accessioned, needs grossing, needs diagnosis, needs signature, needs correction, needs clinical results, needs add-ons, needs reprint, needs final report, work billed versus performed, and interface status. It is the latest addition to the company’s suite of laboratory information system products, which include NucleoLIS, WindoPath, and WPTox.
(508) 473-1500; www.psychesystems.com
Hospital Glucose Meter
Suited for critically ill patients
The StatStrip Glucose Xpress 2, along with StatStrip Glucose and StatStrip Glucose Xpress, from Nova Biomedical, Waltham, Mass, are the only three hospital glucose meters to be cleared by FDA for use throughout all hospital and professional healthcare settings, including with critically ill patients. StatStrip Glucose Xpress 2 utilizes the same glucose measurement technology as StatStrip Glucose and StatStrip Glucose Xpress. According to the company, StatStrip Glucose technology has been studied extensively, and is proven to be free of clinically significant interferences and to demonstrate excellent agreement compared to central laboratory reference methods.
(800) 458-5813; www.novabiomedical.com
Requires 2.5 µL sample
Chembio Diagnostic Systems Inc, Medford, NY, is now marketing and selling the Sure Check HIV 1/2 assay, which was previously marketed in the United States by Alere Inc as Clearview Complete HIV 1/2 assay, part #92111. This change is in name only; the product has not undergone any changes in format or formulation and does not require revalidation. The assay continues to be manufactured exclusively at Chembio’s FDA-registered, current good manufacturing practices compliant and ISO 13485-certified facility in Medford, NY. Sure Check is an easy-to-use, self-contained collection and test device for the rapid, visual detection of antibodies to human immunodeficiency virus 1 and 2. It requires only 2.5 µL of fingerstick or venous whole blood, serum, or plasma. The FDA-approved assay has waived status under the Clinical Laboratory Improvement Amendments of 1988, and has been prequalified by the World Health Organization.
Chembio Diagnostic Systems
(844) 243-6246; www.chembio.com/surecheck
Clinical Chemistry Analyzer Series
For mid-volume laboratories
Carolina Liquid Chemistries Corp, Winston-Salem, NC, offers a complete line of analyzers to meet the needs of every chemistry laboratory. Suited for mid-volume laboratories, the CLC 800 produces up to 400 photometric tests per hour and 800 tests per hour with ion-selective electrode (ISE). For high-volume laboratories, the CLC 1600 produces up to 1200 photometric tests per hour, while the CLC 6410 produces up to 6410 photometric tests per hour and is ideal for large core and reference labs. Multisite laboratories can benefit by using the same reagent cartridge on all platforms. The standardized barcoded cartridge simplifies the ordering process and standardizes results across sites.
Carolina Liquid Chemistries
(877) 722-8910; www.carolinachemistries.com
Sperm Count Quality Controls
Contains stabilized sperm
Streck, Omaha, Neb, offers Sperm-Chex, the only sperm count control on the market with stabilized sperm cells. Sperm-Chex has two clinically significant levels of control to simulate the sperm cell concentration that technologists encounter in patient samples. Sperm-Chex Post VC is a positive/negative control developed to monitor post-vasectomy sperm counts. Sperm-Chex and Sperm-Chex Post VC have the same chamber loading and optical characteristics as a patient sample. When used like a patient sample, the products validate the technologist’s proficiency in sperm cell quantification. The products are stable for 42 days open-vial and 12 months closed-vial when stored at 2°C to 10°C, and are packaged in plastic microtubes with screw-top caps.
(800) 843?0912; www.streck.com
Fully Automated Coagulation Analyzer
Improves sample management
The Sysmex CS-2500 system from Siemens Healthineers, Tarrytown, NY, is a fully automated coagulation analyzer now available in the United States and globally. The system offers mid-volume and multisite hemostasis labs smartly designed technologies, including preanalytical sample integrity, or PSI, technology, to improve sample management, increase efficiency, and streamline lab workflow. To minimize retesting, technologies include assay-based preanalytical checks for detection of hemolysis, icterus, and lipemia interference; underfilled primary-sample tubes; and clogs. Automated platelet aggregation, automated mixing studies, and clot waveform analysis enable cost-effective consolidation. Additionally, the system offers a wide spectrum of testing methodologies and sophisticated software to simplify lab operations, and provides an uninterrupted workflow delivered in a compact, affordable footprint.
(800) 242-3233; usa.healthcare.siemens.com
Hemostasis Testing Systems
Automate key preanalytical and postanalytical steps
The ACL Top family 50 series of hemostasis testing systems from Instrumentation Laboratory, Bedford, Mass, is designed for mid- to high-volume clinical laboratories, including sites using lab automation tracks. The systems offer preanalytical quality assurance, risk management, and laboratory accreditation benefits. Automated preanalytical sample integrity checks identify underfilled sample tubes, abnormal sample aspiration potentially caused by clots, and assay-specific interference from hemolysis, icterus, and lipemia. Additionally, the new systems offer enhanced laboratory accreditation tools to automate documentation for compliance with quality standards.
(781) 861-0710; www.instrumentationlaboratory.com
Automated Hematology System
Includes integrated slidemaker and stainer
The XN-3000 automated hematology system from Sysmex Corp, Kobe, Japan, is a benchtop unit that includes two coprimary hematology analytical modules and an integrated slidemaker and stainer. Users can select an optional floor-standing wagon for system and reagents. The unit provides advanced clinical parameters, including nucleated red blood cell count with every complete blood count, and a fluorescent platelet channel for immature platelet fraction. The unit’s compact design delivers a smaller footprint, while concentrated reagents simplify consumable inventory management.
(888) 879-7639; www.sysmex.com
Available in varying levels
Acusera Linearity sets from Randox Laboratories, Crumlin, UK, are designed to help users comply with Clinical Laboratory Improvement Amendments of 1988 requirements for calibration verification and assessment of linearity. The liquid, ready-to-use verifiers are available in varying levels and multiple configurations to meet specific instrument requirements while challenging the complete reportable range, ultimately ensuring accurate patient testing for cardiac, specific proteins, and therapeutic drugs on Beckman Coulter and Roche Diagnostics instruments. All linearity sets are supplied with complimentary data reduction software, which provides instant access to reports and real-time peer group data.
(866) 472-6369; www.randox.com
Special Protein System
Minimizes sample preparation time
The Optilite from Binding Site Inc, San Diego, enables users to optimize workflows with flexible, unrestricted access to samples, reagents, and cuvettes. Users can minimize sample preparation time by loading any combination of sample tubes and fluid type; the instrument redilutes to end result, thereby eliminating manual sample dilutions. The unit delivers results with three methods of antigen excess. Optilite simplifies data security through automatic lot number recognition and full traceability. System dimensions are 94 cm x 70 cm x 62 cm.
(800) 633-4484; www.bindingsite.com
Designated as moderately complex
The Cobas HIV-1 test from Roche Diagnostics, Indianapolis, is a dual-target, real-time polymerase chain reaction assay that provides precise, quantitative human immunodeficiency virus-1 RNA results with correlation to the Cobas Ampliprep/Cobas TaqMan HIV-1 test v2.0, which targets two unique, non-drug target regions of the genome. The Cobas HIV-1 test runs on the Cobas 6800 and Cobas 8800 systems, which are fully automated solutions designed for clinical and donor screening molecular testing. The systems are designed to transform the molecular workflow, delivering fully integrated automation, high throughput, and high flexibility for routine molecular testing. Both systems enable simultaneous processing of multiple assays, order automation, and direct tube sampling from a variety of tube types. The test has moderately complex categorization, and a reduced sample input.
(800) 428-5076; usdiagnostics.roche.com
Zika Virus Assay
Uses transcription-mediated amplification
The Aptima Zika virus assay on the Panther system from Hologic, Marlborough, Mass, is a qualitative nucleic acid assay with FDA-issued emergency use authorization (EUA) for the detection of Zika virus RNA. The highly sensitive, highly specific assay was developed in response to the Zika outbreak that is associated with clinical complications, including microcephaly and other birth defects in infants born to infected mothers. The Aptima Zika virus assay uses transcription-mediated amplification technology to detect Zika virus RNA in plasma and serum specimens with a fast turnaround time on the Panther system—3.5 hours to first patient result, and 5 minutes for each subsequent result—for the presumptive identification of Zika virus infection, to be managed in accordance with guidelines issued by the Centers for Disease Control and Prevention and state and local public health agencies.
(781) 999-7453; www.hologic.com
Quality Control Set
Consists of five levels
Audit MicroControls Inc, Eatonton, Ga, has added to its line of calibration verification and linearity and daily quality control products with the Linearity FD BNP (Extended) control set. The product 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 BNP-32 and NT-Pro BNP. The product has an open-vial stability of 2 days for BNP-32 and 5 days for NT-Pro BNP when stored at 2–8°C.
(866) 252-8348; www.auditmicro.com
Clinical Chemistry Analyzer Family
Drives down total cost of ownership
The AU chemistry platform from Beckman Coulter, Brea, Calif, delivers low total cost of ownership supported by proven uptime, scalability, and use of fewer consumables. Improved clinical effectiveness and patient care are achieved through a broad menu offering of Six-Sigma quality assays and consistent high rankings in reliability and service. AU chemistry systems are designed for use across the entire spectrum of testing environments, from small- and medium-sized hospital laboratories to high- and ultra-high volume core hospital and commercial laboratories.
(800) 526-3821; www.beckmancoulter.com
Diagnoses systemic lupus erythematosus
The Quanta Flash dsDNA from Inova Diagnostics, San Diego, is an FDA-cleared highly specific marker that, in conjunction with clinical and other laboratory findings, is used to diagnose systemic lupus erythematosus (SLE). This assay shows high sensitivity and specificity for SLE, strong correlation with disease activity parameters such as C3, C4, SLE Disease Activity Index, and total complement activity. Moreover, the marker shows correlation to the dsDNA-Ab RIA Farr assay from IBL International, part of the Tecan Group, Männedorf, Switzerland, with rapid, safe results. It is designated as moderately complex under the terms of the Clinical Laboratory Improvement Amendments of 1988.
(800) 545-9495; inovadx.com
Direct Enzymatic HbA1c Assay
No interference with hemoglobin variants
The International Federation of Clinical Chemistry-certified direct enzymatic HbA1c assay from Diazyme Laboratories, Poway, Calif, has no interference from hemoglobin variants including HbC, HbE, HbS, and caramylated acetylated Hb or labile HbA1c. With freedom from interference, and intra- and inter- CV values less than 2.6%, the assay provides performance advantages over conventional immunoassay and chromatography methods. Diazyme’s patented enzymatic method measures HbA1c directly using only a single instrument channel and completely eliminates latex particle cuvette contamination. The assay can be used on most automated chemistry analyzers, and reagent transfer can be eliminated for most chemistry systems with instrument-specific packaging options.
(858) 455-4768; www.diazyme.com
Multiplex PCR System
Requires 2 minutes of hands-on time
BioFire Diagnostics LLC, Salt Lake City, has received FDA premarket notification (510(k)) clearance to market its FilmArray Torch instrument for use with the FilmArray blood culture identification panel, gastrointestinal panel, and meningitis/encephalitis panel. Earlier this year, the system received FDA clearance for use with the company’s FilmArray respiratory panel. The high-throughput system is a fully integrated, random, and continuous access multiplex polymerase chain reaction system designed to meet the throughput demands of any size clinical laboratory. Integrating sample preparation, amplification, and detection into a single closed system, the system requires only 2 minutes of hands-on time and has a total run time of about an hour.
(800) 735-6544; www.biofiredx.com
GADAb ELISA Test Kit
For the determination of autoantibodies to glutamic acid decarboxylase
Kronus, Star, Idaho, offers the Glutamic Acid Decarboxylase Autoantibody (GADAb) ELISA kit for the accurate determination of autoantibodies to GAD in human serum. The GADAb ELISA kit is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). GAD autoantibodies are generally present and measureable several years prior to the clinical onset of disease. The measurement of GAD autoantibodies can help identify individuals at risk and provide essential information with regard to the autoimmune progression of diabetes.
(800) 457-6687; www.kronus.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
Integrated Urine Chemistry and Sediment Analyzer
Processes up to 200 chemistry tests per hour
The fully automated Aution Hybrid AU4050 analyzer system from Arkray USA, Minneapolis, integrates urine chemistry and flow cytometry technology into a small, space-saving footprint. 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 high capacity with minimal operator intervention for true walkaway capabilities. It also streamlines urinalysis testing with automatic reflex testing, no manual dilution, 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.
(877) 538-8872; www.arkrayusa.com
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.
(800) 495-5270; www.alcorscientific.com