Nearly 600 exhibitors at the 2003 American Association for Clinical Chemistry’s Clinical Lab Expo featured the latest products, technologies, and services for the laboratory. The show took place July 22–24 at the Pennsylvania Convention Center. Following is a look at some of the products showcased.

Abbott Laboratories
Abbott Laboratories previewed AbbottLink™, a new system in development. The new system will allow its diagnostic instruments to automatically transmit product performance information to the company’s service operations through the Internet. This will enable the company’s service representatives to proactively identify technical issues from a remote location.

Using a high-speed, secure Internet connection, AbbottLink is designed to transmit instrument data, instrument logs, files, maintenance records, calibrations, and other key performance metrics. No patient data will be transmitted over the system.

AbbottLink will be available for use on the company’s line of automated instruments, including AxSYM®, ARCHITECT®, Aeroset®, and Cell-Dyn systems. It will be introduced on the AxSYM system in the United States in September and on the ARCHITECT family of instruments in 2004.

AxSYM, Abbott Laboratories

Abbott also introduced enhancements to its AxSYM® automated immunoassay system. AxSYM 5.0 features advanced computer software that allows quicker access to commonly used laboratory data, such as stored patient results, stored quality control results, and the status of test orders. The system also features enhanced hardware, including an optical sensor that automatically alerts operators when reagent bottle caps have not been properly removed.

Abbott’s CELL-DYN 1800 automated hematology analyzer was also showcased. The CELL-DYN 1800, designed to meet the needs of small to medium-sized clinical laboratories that run complete blood counts (CBCs), provides a combination of features for hematology analyzers. These include fast access to patient results and expanded data-management capabilities.

The CELL-DYN 1800 produces a CBC with 18 parameters, including histograms and a three-part differential in 60 seconds. This rapid turnaround allows physicians to see laboratory results in minutes so they can complete their evaluation of a patient during a single office visit.

Other features of the CELL-DYN 1800 include:

• Handheld bar-code reader to help eliminate data-entry mistakes;
• Low-glare LCD monitor;
• Data-management system capable of storing 10,000 specimens;
• Three reagents;
• Small footprint (17” x 26”) that enables the instrument to fit under standard cabinets and helps conserve laboratory space; and
• The ability to store complete patient demographics.

The CELL-DYN 1800 received marketing clearance from the US Food and Drug Administration (FDA) in May.

American Diagnostica Inc
American Diagnostica Inc (ADI) displayed its full line of research products for the clinical diagnostics, biomedical, and life science research markets. These products included chromogenic and fluorogenic substrates, enzymes, immunochemicals, plasma components. specific proteins, individual coagulation factors, specialized antibodies, reference and deficient plasmas, and a full line of reagents, assays, and test kits incorporating chromogenic, fluorogenic, clotting, and ELISA-based technologies.

ADI specializes in the research, development, and manufacture of assay systems and reagents for coagulation, fibrinolysis, hemostasis, and thrombosis; cardiovascular disease; cancer prognosis; and drug discovery.

Bayer HealthCare Diagnostics Division
Bayer HealthCare Diagnostics Division announced at the show that it recently received US Food and Drug Administration clearance for its BNP (B-type natriuretic peptide) assay, a fully automated test for use as an aid in the diagnosis of heart failure. The test is used on the ADVIA Centaur Immunoassay System, which provides testing for a broad range of conditions, including cancer, cardiovascular diseases, fertility, anemia, thyroid diseases, allergy, metabolic diseases, therapeutic drug monitoring, and infectious diseases.

The company exhibited its ADVIA IMS 800i, part of the ADVIA Integrated Modular System family of products. These products combine both clinical chemistry and immunoassay testing on a single platform. Through the use of modularity, automation of routine operational procedures, and Smart Access software, the Bayer analytical platform was designed to allow the labor-strapped laboratory the ability to process testing with one technologist.

Bayer also exhibited its ADVIA 120 csf Assay, an automated method that provides rapid leukocyte (WBC) and erythrocyte (RBC) counts as well as absolute and proportional counts for the CSF WBC differential. The method is performed on the ADVIA 120 Hematology Analyzer using direct cytometry.

BD.id, BD Medical Systems

BD Medical Systems
BD Medical Systems introduced the new BD.id™ Patient Identification System. The system is designed to enhance patient care and reduce overall health care costs by limiting the potential for medical errors that can occur while collecting, transporting, and storing blood, urine, and other specimens.

The BD.id System utilizes a handheld computer with a built-in scanner. Prior to the collection of a specimen, the system identifies the health care professional by scanning a user ID badge. Once the professional is confirmed, the patient’s bar-coded wristband is also scanned, at bedside, to confirm that the right patient is receiving the right tests.

Once the specimen is collected, the BD.id System matches the specimen collection orders stored in the handheld computer with the information scanned from the patient wristband and confirms that the specimen container is the correct one for the tests ordered. A new bar-code label for the specimen container is printed at the patient’s bedside with the time and date of collection. Last, when replaced in its cradle, the BD.id System synchronizes with the laboratory information system and confirms with the labs that the correct collection from the patient was completed.

Bio-Rad Laboratories
Bio-Rad showcased Evolis™, a self-contained microplate processor designed to completely automate microtiter plate–based EIA techniques for laboratories performing 5,000 to 150,000 EIA samples per year. The open architecture enables laboratory managers to select microplate assays with analytical requirements appropriate to their laboratory’s environment. Evolis processes four microplates (round and flat bottom) at a time, with up to 12 assays per plate.

Bio-Rad also exhibited its Autoimmune PhD System, an integrated robotic liquid-handling unit with data management and microplate-reader control options. It provides patient sampling, reagent pipetting, incubation, and washing for EIA microplate-based assays.

Bio-Rad’s booth also provided information on TOX/See™, the company’s one-step drug-screening test that gives results in as few as 3 minutes. New tests for TCA (tricyclic antidepressants) and MDMA (Ecstasy) have been added to a test menu of nine other drugs (amphetamines, methamphetamines, opiates, cocaine, PCP, THC, benzodiazepines, barbiturates, and methadone).

Bio-Rad had many other products on display, including its line of controls: Liquichek™ D-dimer, Hematology, Urine Toxicology, Blood Gas Plus CO-Oximeter, Amplichek™ CT/CG, and Lyphochek Hemostasis.

Triage Cardiac Panel, Biosite Inc

Biosite Inc.
Biosite exhibited its Triage® Cardiac Panel, which aids in the diagnosis of acute myocardial infarction; the Triage TOX Drug Screen, which aids in the diagnosis of drug overdose; the Triage BNP Test, the first rapid blood test to measure B-type natriuretic peptide (BNP); and the Triage Cardio ProfilER, which aids in the evaluation of chest-pain patients.

The Triage Cardiac System can be used at the point of care or in a central laboratory. It measures the presence of three cardiac marker proteins: CK-MB, myoglobin, and troponin I, which are typically released into the bloodstream following a heart attack.

The Triage Tox Drug Screen is a 15-minute, qualitative urine test that enables hospital physicians to perform toxicology screening simultaneously for eight classes of commonly abused drugs (nine assays), including opiates, barbiturates, marijuana, amphetamines, methamphetamines, benzodiazepines, cocaine, tricyclic antidepressants, and phencyclidine (PCP).

The test has two components: the disposable Triage TOX Drug Screen and the small, portable Triage MeterPlus. The Triage TOX Drug Screen is made of plastic that contains a network of micro capillary structures. The Triage MeterPlus is a portable, desktop fluorescence instrument used to quantify results of immunoassays manufactured by Biosite.

The Triage BNP Test is a portable, quantitative, rapid diagnostic test that can be used at the point of care (emergency department, critical care unit) or in a central laboratory. BNP is a protein marker that is present at elevated levels in patients with congestive heart failure.

Liquid QC Cardiac Marker, Cliniqa Corporation Laboratories

Cliniqa Corporation
Cliniqa Corporation displayed its Liquid QC Cardiac Marker Control. This three-level human serum is ready to use straight from the refrigerator. It has six analytes and a 2-year shelf life. Analytes include CK-MB, myoglobin, troponin I, hs CRP, and digoxin. Two additional controls are pending FDA approval: the combined ApoA1/ApoB Control (3 levels) and the Tumor Marker Control (3 levels with 13 constituents).

Immucor Inc
Immucor Inc showcased its line of instruments designed to automate the transfusion process and donor centers. The company manufactures blood serology and infectious disease products featuring patented Capture® solid-phase technology for red cell antibody detection and identification, platelet antibody detection, CMV, and syphilis screening for blood-donor samples.

The company’s new Galileo is a fast, fully automated instrument that is not yet available in the United States. It offers a broad assay menu coupled with features similar to a chemistry analyzer: continuous access, linear rack, and bidirectional interface. Multitasking and a high throughput allow the instrument to adapt to the lab’s workflow.

Galileo gives the operator continuous access to samples and reagents. The system has true multitasking capability. Tests are processed in any order presented, multiple tests can be performed on each sample, and results can be viewed while the system is running.

Unprecedented throughput is achieved by independent and simultaneous operation of instrument stations. To enhance speed and flexibility, Galileo utilizes two pipetting arms interchangeably for reagents and samples.

The touch screen, color monitor, keyboard, swivel workstation, and menu-driven software ensure ease of use. The system stores digital images of results for ease of review, and the bidirectional interface minimizes data-translation errors.

Olympus America Inc
Olympus exhibited a number of products, including its newly updated modular Olympus OLA2500™ laboratory automation solution (featured on our cover and in the Spotlight section, p. 8), the TANGO benchtop blood bank analyzer, and the DP70™ 12.5-megapixel cooled digital color camera.

The TANGO benchtop blood bank analyzer is expected to be available in the United States in late 2004. It is designed for medium to large transfusion services, donor centers, and reference laboratories performing ABO/Rh testing and antibody screening. It will perform a host of functions, including blood group determination; antibody screening, identification, and titration; and compatibility testing. With a throughput of 200 wells per hour, TANGO will be an efficient tool in areas where real estate is tight. The benchtop analyzer measures 4.2(L) x 2.2(W) x 2.4(H) feet, and weighs 286 pounds.

It will perform pipetting sequences of liquids and subsequent analysis of agglutination reactions. The fully automated process will include positive sample identification, process control through automated recording of reagents (lot numbers, expiration dates), sample dilutions, reagent addition and mixing, incubation, washing, centrifugation, and image analysis.

For greater flexibility, TANGO systems will also feature batch and random access operating modes and STAT sample interrupt. TANGO will use a Windows® NT operating system, Pentium processor, touchscreen interface, and image- analysis software.

Sysmex
Sysmex showcased its range of hematology, coagulation, urinalysis, and information systems solutions. The Sysmex XT-2000i, a recent addition to the Sysmex X-Series product line, is a compact, high-performance hematology analyzer. It provides CBC results, including a fully automated WBC 5-part differential, reticulocyte count, and fluorescent optical platelet. Fluorescent flow cytometry technology allows for rapid, reliable test results that are essential for effective patient diagnosis and therapeutic monitoring.

A new addition to the Sysmex urinalysis line is Sysmex UF-Alpha™, an automated urinalysis transport line that links the Sysmex UF-100™ Fully Automated Urine Cell Analyzer and the Bayer Clinitek Atlas® Automated Urine Chemistry Analyzer.

The company also exhibited Sysmex Information Systems Division products, including the K-Xpert data manager; the SIS work area manager; MOLIS, the modular open laboratory information system; and eCLAIR, the electronic clinical laboratory and information resource.

TOSOH
TOSOH spotlighted its AIA-450 random access immunoassay analyzer. At 16 x 16 x 20 inches and weighing slightly more than 55 pounds, the AIA-450 is ideal for small-volume hospital labs, physician office laboratories, and cardiac and special testing. TOSOH’S AIA-450 utilizes the same 10-minute incubation, ST reagents as TOSOH’s AIA-600II and AIA-NexIA, including tumor, anemia, and cardiac markers, as well as thyroid and reproductive hormones. FDA clearance is pending, and the product is expected to be available in November 2003.

The company’s AIA-1800 automated immunoassay analyzer utilizes TOSOH’s unique unitized test cup technology, providing standardization among all AIA systems. The AIA-1800 offers random access and continuous processing of samples at 180 tests per hour. The user-defined reflex testing, auto-rerun, auto-dilution, auto-pretreatment, and result review by exception helps maximize technician time.Other features include STAT capability, bar-coded primary tube sampling inventory management, and an online maintenance checklist. It is available in two models: ST and LA with NCCLS and international standards for laboratory automation.