Advances in instrumentation were everywhere at this year’s Clinical Lab Expo, the annual meeting of the American Association for Clinical Chemistry (AACC), held July 28th through August 1st in Orlando, Fla. All around the trade show floor were new platforms that integrate testing disciplines, improve random access capabilities, automate sample movement, tracking and analysis, and make sample identification, on-board testing and instrument management more foolproof. While not quite ready for a full prime time schedule, molecular diagnostics is clearly living up to the promise of moving into more labs and more testing modes. More instruments, large and small, now incorporate touchscreen user interfaces, e-training, Web-access and remote reporting. And, manufacturers are clearly mindful of the issues of worker safety and patient data security.
Abbott Laboratories
Abbott previewed three new analyzers, all members of the growing line of Architect automated instruments: the Architect i2000sr immunoassay analyzer, the c8000 chemistry analyzer, and the ci8200 combined platform product. All Architect systems utilize common software and a touchscreen icon-driven interface for standardization of training and user competence. In addition, this product line offers online help with video clips to help troubleshoot common problems, and computer-based training to assist in new system implementation.
The c8000 chemistry analyzer, which is based on the Aeroset platform, received FDA clearance earlier this year with 36 reagents. Both systems utilize the same probes, cuvettes and interchangeable reagents. The c8000 offers 200 open channels and performs up to 1200 tests per hour, with 68 onboard assays including three ion selective electrodes (ISEs). Currently, the system offers 150 routine and 35 STAT positions, and a 32-position auxiliary carousel for use with samples, calibrators and/or controls (common to all Architect systems). Abbott expects to launch the c8000 later this year. A total of 49 total assay applications are in the pipeline for this product.
The i2000sr is a closed system that offers 25 onboard assays, and can accommodate 100 routine and 35 STAT samples. The product is designed to run up to 200 tests per hour in a stand-alone scenario, with retest capabilities. Product launch in the U.S. is expected in the fourth quarter of this year.
The Architect ci8200 is an integrated platform consisting of both the i2000 and c8000. The ci8200 offers a throughput of up to 200 immunoassays and 1200 clinical chemistry tests per hour on one system. In addition, the combined platform provides for an onboard capacity of 93 immunochemistry reagents.
Abbott also featured the newly launched Axsym Plus automated immunoassay system at the Lab Expo. This system is the newest product in the Axsym product line, and features a larger flat-screen monitor and articulated keyboard for a more flexible user interface. A new in-line pressure monitoring system aids in clot, air or foam detection in reagents and samples. The advanced software developed for this system includes a STAT rerun capability, an enhanced auto-diagnostic capability, and a new foam avoidance feature that ensures probe dive depth is below foam or bubbles.
AutoGenomics’ Infiniti
In molecular diagnostics, Abbott discussed its newly formed alliance with Celera Diagnostics, which will accelerate the company’s gene sequencing product line. The company is investigating applications for ASRs in infectious disease, cardiovascular and autoimmune disease, central nervous systems and cancer.
American Diagnostica Inc.
ADI announced the recent FDA licensing and availability of Actichrome Heparin anti-fXa for the determination of unfractioned and low molecular weight heparins in human plasma. Recent studies indicate that use of low molecular weight heparins may provide numerous clinical and economic advantages over the standard unfractioned form. According to the company, applications for a wide range of automated coagulation instruments are currently available.
ADI’s product pipeline includes a full line of ELISAs for measurement of anti-phospholipid antibodies. Called Imuclone, these assays are currently awaiting licensing by the FDA. The company also discussed the development of a new Imuclone ELISA for CRP in serum or plasma. This assay is limited to research use only in the U.S.
AutoGenomics
This new company in Carlsbad, Calif., founded by a consortium of industry veterans, had its first demonstrations of the Infiniti, a continuous flow, random access, fully automated microarray system. This new system is designed to simplify and automate complex genetic testing, and integrates genomic and proteomic analyses. The system can perform sample to test results without manual intervention, utilizing advanced microarray methodology, microfluidic and robotic process automation, reagent management and advanced bioinformatic software. The system’s open architecture design allows it to be adapted to multiple methodologies, such as hybridization assay, primer extension assay, competitive and sandwich format immunoassays to perform Single Nucleotide Polymorphisms (SNPs), Short Tandem Repeats (STRs), gene expression analysis and protein determinations. AutoGenomics’ BioFilmChip microarray uses patent-pending thin film technology; the Qmatic operatic software provides users with the versatility to perform multiple testing methodologies simultaneously; and the Intellipac reagent management module has on-board microchip design features to enable the operation of the system by a minimally trained technologist.
The automated process will identify samples and query the LIS for assays to be run, indicating which Intellipac reagent module and BioFilmChip magazines to load. The system will quantify the amount of reagent and buffer, and the number of pipette tips needed to complete the run, and indicate when test results will be available. Results are delivered in real time and can be sent to a remote PC terminal or hand held device. Initial focus for test applications will be in women’s health, newborn screening, cardiovascular disease and cancer screening.
Axis-Shield Diagnostics
Axis-Shield announced the FDA 501k clearance of Diastat anti-CCP EIA, a new assay for diagnosis and management of patients with early-onset rheumatoid arthritis. The assay detects autoantibodies against cyclic citrullinated peptide (CCP) containing modified arginine residues in human serum or plasma. According to the company, studies have shown that patients who are anti-CCP positive at disease onset are more likely to have poor prognosis than patients who are anti-CCP negative at presentation. In addition, there is a growing body of evidence suggesting that early detection and treatment with new disease-modifying anti-rheumatic drugs can prevent major joint damage.
Axis-Shield also launched two educational websites for health professionals to learn more about homocysteine, an emerging risk factor for cardiovascular disease, and holotranscobalamin, a new marker for vitamin B12 deficiency. The websites for these two analytes may be accessed at www.homocysteine.net and www.holotc.net, respectively.
BD Diagnostic Systems’ BD Viper Sample Processor
Boston Biomedica, Inc.
BBI announced the availability of a new HCV RNA genotype panel that allows test kit manufacturers and users to evaluate the ability of assays to detect or distinguish HCV genotypes. Called the PHW 201, this panel is comprised of 10 members including nine distinct genotypes and one negative. The company also introduced PHD 801, a HBV DNA linearity / sensitivity panel that allows users to assess quantitative HBV DNA assays over a broad range of sensitivities. This panel is comprised of nine positive diluted specimens and one negative, and is calibrated to the WHO International Standard for HBV DNA.
BD Diagnostic Systems
BD announced the launch of the BD Viper Sample Processor, a new automation solution for use with the company’s BDProbeTec ET real-time amplification/detection system. The BDProbeTec, first marketed in 1999, is a real-time DNA amplification assay cleared by the FDA for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. The Viper employs an industrial-grade robot to perform pipetting transfers without the use of syringe pumps and tubing. Up to 564 samples for Chlamydia trachomatis alone or 552 samples for Chlamydia trachomatis and Neisseria gonorrhoeae combined may be completed in a single eight-hour shift using the BD Viper Sample Processor with the BDProbeTec ET System reader.
Beckman Coulter’s Access 2 Immunoassay System
Bayer Diagnostics
Bayer showcased the Advia 2400 clinical chemistry analyzer, an enhancement of its current high volume model, the Advia 1650. The 2400 provides for higher throughput than the 1650: cycle times have been decreased from three to two seconds; and throughput has increased from 1,200 photometric tests and 450 ion-selective analyses (ISEs) per hour, to 1,800 photometrics and 600 ISEs per hour for a total throughput of 2,400 tests per hour. Other new features include a new sample access port, a larger wash station on the dilution tray, an increase of cuvettes from 221 to 303, and a decrease in sample aliquot from 28 to 22 microliters for ISEs. Like the 1650, the 2400 uses small sample aliquots and reagent volumes, and may be interfaced with other testing disciplines using the Advia WorkCell. Bayer expects the product to be available the fourth quarter of this year.
Beckman Coulter, Inc.
Beckman Coulter showcased the Synchron LXi 725 Clinical System, a new product that consolidates chemistry and immunoassay tests onto a single platform. Designed for high volume settings, the system is scheduled for availability this fall and will feature data management software to help labs manage sample tubes, workflow and patient results. The LXi 725 also features closed-tube sampling and aliquoting, which allows tubes to be loaded without decapping. The system accommodates both STAT and routine workloads with parallel processing, and in the event of a single sample requiring both immunoassay and chemistry testing, the LXi725 automatically creates a daughter tube and then releases the original sample for chemistry analysis. All system functions are monitored from a single user interface.
Beckman Coulter’s Synchron LXi 725
Also demonstrated was new enhancements to Beckman’s line of automation modules, including the Power Processor preanalytical automation system, which performs sample login, barcode reading, centrifugation, cap removal, serum level measurement, and sample sorting into sample tube racks. New enhancements to Beckman Coulter’s automation line include aliquoting and refrigeration modules.
The Access 2 Immunoassay System was also featured in the Beckman booth. This system features networking capabilities that can link up to four systems with a single LIS interface, permitting a throughput of up to 400 tests per hour. A flat-panel touchscreen, a Windows NT software platform, and access to onboard and remote diagnostics simplify and enhance system operation. Onboard refrigeration as well as continuous random access and STAT capability with 24 onboard assays add to reagent stability and system efficiency.
In hematology, the company showcased the Coulter LH 750 high-volume analyzer. The LH 750 delivers random access by profile type, including CBC, CBC/diff, CBC/diff/retic, CBC/retic or retic only. In addition, the LH 750 performs automated nucleated red blood cell (NRBC) enumeration. The analyzer can be combined with integrated slide preparation modules to form a trackless automation workstation called the Coulter LH 755 workcell.
The company also offered live demonstrations of Lab Accreditation Tools, which include Quality Link and Lab Accelerator Software. Developed by laboratory management and quality experts, Quality Link is a software solution that provides the laboratory with an expansive platform to manage data and documentation necessary for regulatory and quality accreditation requirements. Lab Accelerator provides sample policy and process documents, operator manuals, diagnostic and troubleshooting guides, and instrument logbooks that are customizable to meet the specific needs of the laboratory.
Beckman Coulter’s Quality Link software
Bio-Rad Laboratories
Bio-Rad introduced four new products including two microplate automation solutions, a new hemoglobin test system, and QC OnCall, a novel approach to daily laboratory quality control. QC OnCall provides daily QC comparisons from a worldwide peer group, and includes not only conventional statistical-based validation, but also validation based upon biological variation. Designed to improve laboratory quality control operations, the data and comparative reports are available online, 24/7.
A modular design allows the new PhD Workstation to provide the ability to efficiently process low to high volume workloads. Through networking, one to ten workstations may be controlled by a single computer, providing the flexibility to process from 2 to 20 plates simultaneously. With a 192 well capacity, each Workstation is capable of running up to eight assays at one time. A proprietary volumetric pump provides accurate delivery volumes down to one microliter. The system also includes an online dilution capability, and a graphical template for assay set-up.
Evolis is a self-contained microplate processor designed to automate EIA microplate techniques. Featuring an open architecture and walkaway operation, thesystem can process four microplates simultaneously, with up to 12 assays per plate. The system is able to process up to 180 patient samples per run, and additional samples may be loaded without run interruption. The Evolis includes four independently controlled incubators, four light-protected ambient incubators, and three different wash buffers.
The D-10 Hemoglobin Testing System, currently under development, provides HbA1c, percent HbA2 and percent HbF results on a fully automated compact HPLC platform. The system features whole blood primary tube sampling, a touchscreen user interface, and automatic sample barcode reading. The system also includes an HbA1c program with chromatographic Schiff base removal.
bioMérieux Inc.
bioMérieux highlighted a new diagnostic test system called the NuciSens EasyQ, featuring real-time amplification and detection in a single closed-tube format. The product, which combines NASBA amplification and Molecular Beacon based probe detection, was designed to reduce technical hands-on time, time to result, and cross contamination. NASBA technology selectively amplifies RNA sequences in a DNA background, and is used to detect RNA targets, confirm viral replication, and measure gene expression. In the EasyQ System, newly generated RNA molecules from NASBA are hybridized to molecular beacons and detected real-time by continuous monitoring of fluorescence with the NucliSens Analyzer. The EasyQ operates on an open platform to accommodate customer-developed protocols, and can amplify and simultaneously detect up to 48 samples in one hour.
The company also showcased the MDA II, a fully automated analyzer for clotting, chromogenic assays and immunoassays in a high-volume setting. The MDA II’s advanced optical system flags interfering substances, corrects lipemia, and ensures proper volume delivery and optimal performance of assays. The product’s “Waveform Analysis” technology alerts the operator to abnormal waveform patterns. A new optional feature, called MD/Alert Tools, flags the operator to the presence of a biphasic waveform. This atypical waveform has been associated with potentially serious coagulopathy seen in sepsis and other clinical conditions. Called the A2 flag, this tool can provide an early alert to the need for further clinical and diagnostic investigation.
Dade Behring
Dade Behring showcased a variety of new products ranging from new analyzers to new assays. Introduced at the Expo, the Dimension RxL Max and RxL Max Suite analyzers combine chemistry and immunochemistry onto a single platform. Targeted for the high volume market, the RxL Max is an enhancement of the current Dimension product offering. System highlights include a flat touchscreen user interface and enzymatic carbon dioxide, reducing maintenance while increasing processing from 72 to 100 samples per hour. The essence of this system is an enhanced software platform that provides flexible options for sample quality checking without impacting throughput or TAT. Also included is an enhanced STAT sample alert function, data download capabilities, and a higher level of user-definable system information. The Max RxL Suite is a modular solution for upgrading to higher system capability.
Designed for high volume laboratories, Dade Behring showcased the new Sysmex CA-7000 coagulation analyzer. System highlights include a five times increase in speed over the CA-1500, barcoded reagents with continuous access to reagent management, and dual integrated patient barcode readers that reduce errors while increasing security. The analyzer produces 550 results per hour when testing PT and aPTT simultaneously. Up to 100 samples may be processed in ten racks, with continuous loading of samples, reagents and reaction cuvettes without workflow interruption. The system performs both routine and specialty assays, and offers up to 20 QC files per parameter for less complex user customization and new lot crossover analyses. Optional cap-piercing without impacting processing speed, the ability to perform system calibration while running routine specimens, an automated reagent handling system, and automated repeat and reflex testing also add to the system’s performance level. The company is expected to launch this product in the U.S. this fall.
For microbiology, the company highlighted several new panels, including the MICroStrep plus that provides antibiotic susceptibility testing across a range of 18 antibiotics. The panel utilizes minimum inhibitory concentration testing, which may be valuable in managing serious infections. Besides helping to provide clinicians with information to aid in more accurate prescription decisions and therapeutic regimes, the panel may prove useful in studying resistance and emerging infectious disease. The company also launched KnowIT, a web-based training tool for customers with MicroScan LabPro Information Manager. The coursework is modular in design, and allows students to conduct sessions individually and at their own pace. While providing CEU credits, the training tool also gives laboratorians skills to optimize the efficiency and obtain maximum utilization of the LabPro Information Manager.
Luminex
Luminex announced the development of a new product designed for high-throughput applications. Based on the Luminex 100 platform, the new Luminex HTS features a 384 well capability, an increase from the 96 well capacity of the current model. The HTS will also feature an eight well pipetter, a liquid handling system, and software/hardware support for installation of customer-supplied robotic arm assemblies. The HTS, which is designed to perform hundreds of thousands of individual bioassays per day, is slated for availability in the fourth quarter of this year.
Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics unveiled the Vitros 3,1 FS, its second product offering in the upcoming Vitros Fusion series. Developed with Six Sigma Process Excellence strategies, the new Vitros Fusion analyzers are designed to address staffing efficiencies as well as increasing concern for sample security and integrity. Designed for medium volume scenarios, the compact 3,1 FS utilizes the same engineering as the Vitros 5,1 FS showcased at the 2001 Lab Expo. This high degree of standardization will permit consistency in training and operations for laboratories with multiple systems and/or multiple sites. Using MicroSlide technology, both systems can perform general and special chemistry assays, including TDMs, proteins, and DATs. The addition of new MicroTip chemistry technology enables special chemistries to be performed without plumbing, drains, fixed probes or mixing assemblies. Currently under development, both products are expected to be available to the U.S. market in 2003.
Ortho-Clinical Diagnostics’s Vitros ECiQ2
Ortho also exhibited the new Vitros ECiQ Immunodiagnostics System. Upon availability, the product will provide several enhancements over current models including an expanded menu, flat panel operator interface and several software enhancements for higher levels of productivity and performance. To expand the use of Intellicheck technology – a software feature that provides verification of key processing steps – three new procedures are planned for inclusion in the ECiQ product: reagent aspiration verification, a direct technique that will help to ensure proper reagent volume; sample/reagent verification that certifies proper reagent and sample volume within the well; and well wash dispense verification that confirms addition and removal of wash reagent in the well. Along with these procedures, a total of 13 checks that are automatically performed without impacting throughput are planned to be available with this system.
Ortho also introduced the e-Connectivity Interactive System Management feature for the ECi, ECiQ and Fusion line of products. Allowing a real-time, two-way connection between systems and the company, this tool will provide access to software downloads, remote diagnostics and remote system monitoring by technical support personnel. The system operator maintains control over the transfer of data, including when and what data is accessible. In addition, firewalls prevent access to patient information and data connection to other laboratory systems, computers, or networks. All new Vitros systems will include the e-Connectivity feature. Upgrades for existing ECi systems is expected to become available in the fourth quarter of this year.
Ortho also discussed the status of several assays currently under development, including myoglobin, anti-HAV total and the TORC family of assays. Assays currently available outside the US include anti-HIV 1/2, anti-HAV IgM, anti-HBc, anti-HBc IgM, anti-HBe and HBeAg. In the US, clinical trials are underway for the anti-HBc and anti-HBc IgM assays, and preparation for filing an anti-HIV 1/2 assays is also in progress. During this past year, the company received PMA for anti-HCV, anti-HBs, and HbsAg, and tests for B12, folate and PSA are now also available.
Olympus Diagnostic Systems Group
In addition to its new LabModel workflow simulation product, Olympus showcased two new analyzers at this year’s Lab Expo. The new chemistry-immuno systems, the AU400 and AU600 e-Class analyzers, are enhancements of their current AU product line. Designed to optimize workflow, the e-Class systems incorporate new hardware and a Windows NT-based software platform that will allow labs to reduce training time through the use of customized menus, icons and color-keyed graphics. Olympus is offering an upgrade program for existing AU400 and AU600 customers to bring them to the e-Class level platform.
Olympus AU400e
Olympus announced the market release of a new modular lab automation solution, the OLA2500, designed for use in mid to high volume laboratories. This front-end sample processor automatically decaps, aliquots and sort tubes to any analyzer sample rack, and utilizes a digital imaging system to check sample volume as well as identify tube size, cap type and color. In the standard configuration, the system can process up to 650 tubes per hour. The system may be configured for expanded capability to address future increases in sample processing demands. The Olympus OLA2500 uses a Windows operating system, Pentium processor, a graphic user interface, and image recognition software.
The company highlighted LabModel, a new solutions-based service that aids clinical laboratory managers and administrators in identifying the best instrument configuration for greater productivity and faster ROI for their departments. Called Olympus LabModel, the service provides managers with fact-based computer aided simulation to evaluate current workflow, assess multiple options, and determine the best laboratory configuration to meet real world needs. LabModel uses state-of-the-art software to track and document projected efficiencies over short- and long-term periods, providing an objective view of all operational areas including throughput, maintenance, turnaround time, labor, training, and workstation consolidation.
Quidel Corporation
Quidel announced the launch of two tests for the clinical evaluation of infectious vaginitis. Based upon the company’s proprietary Layered Film Technology (LTF), both tests are designed for use in the physician office. The CLIA-waived QuickVue Advance pH and Amines test identifies vaginal pH greater than or equal to 4.7, and detects volatile amines associated with anaerobe overgrowth. Each assay resides on separate colorimetric test cards. Results are available within two minutes as a plus/minus readout. The QuickVue Advance G. vaginalis test uses LTF to detect Gardnerella vaginalis Proline IminoPeptidase (PIP) enzyme activity in vaginal fluid specimens. Called “Rub n Read”, this test produces results directly on the swab: positive results are indicated by a peach to red color. Quality control is also contained on every test card to assure assay performance.
Roche Diagnostics Sysmex XT-1000
Quidel also introduced the UrinQuick Urine Chemistry Analyzer, marking the company’s entry into the instrumentation market. This semi-automated urinalysis system can perform over 360 tests per hour, including 11 chemistries and color determination. It features onboard quality control, and storage of up to 2,000 urine test strip results. With the PC keyboard and barcode reader, the operator may also incorporate and store microscopic observation with patient data.
Roche Diagnostics
At the Lab Expo, Roche Diagnostics announced FDA marketing approval for the Amplicor HIV-1 Monitor assay, version 1.5. This assay allows for measurement of HIV-1 RNS over the range of 50 to 750,000 copies per mL, and can detect Group M subtypes A-G. Both viral load and genotyping have been shown to aid in therapeutic decisions and can help to achieve optimal positive response to therapy.
Roche showcased the XT-2000i, a new compact, high performance hematology analyzer. The XT-2000i, which shares the same technology platform as the XE-2100, provides CBC results including a fully automated WBC five-part differential, reticulocyte count and fluorescent optical platelet count. Windows-based software, and access to online quality control and remote diagnostics improve the efficiency and performance of the system. Because the XT and XE products use common reagents, controls and data management systems, the XT can be used either as a stand-alone system or as a viable back-up to the XE in high volume settings.
The Urisys 2400, launched in the U.S. in May 2002, is a fully-automated urinalysis system designed for use in medium to high volume laboratories testing approximately 100 urine samples per day. The successor of the Supertron Urine Analyzer (SUA), this system is currently in use at five sites in the US. The cornerstone of the product is a new 400-strip cassette with an inherent onboard stability of two weeks, a significant enhancement over SUA 200-strip cassette, which has an onboard stability of ten hours. Sample capacity has also been increased from 45 to 60 with the SUA, to 75 with the 2400. Other enhancements include a touchscreen operator interface, simplified daily maintenance, and increased calibration stability from two weeks to one month.
Roche also showcased the Cobas TaqMan 48, an automated PCR system that performs simultaneous amplification, detection and quantification of amplified product. Currently under development, this new system is designed to address throughput issues in a medium-sTized molecular laboratory. The TaqMan48 amplifies two sets of 24 samples, for a total of 48 samples in one cycle, doubling the capacity of the current TaqMan model. Cycle times vary from 1.5 to two hours, and two onboard ASRs for HCV and HBV with ten open channels for user-defined assays are available at this time. The product is expected to be launched in the fourth quarter of this year.
Other new product offerings for this company include Accu-Check Pocket Compass Software, which allows a patient’s Accu-Chek Compact or Active Meter to connect with PDAs over a wireless network. Advantages of this connectivity include different ways for patients to manage their disease by access to charts, graphs, and trending data that may have otherwise been overlooked. Assays in the Roche development pipeline include D-Dimer, HBcAg, and Pro-BNP, which is scheduled for U.S. availability this fall.
In collaboration with Gen-Probe, Tecan launched a new automated nucleic acid pipetting system, the DTS 800. This system processes up to 400 Gen-Probe Aptima Combo 2 Assay swab or urine samples on one platform. The assay, which uses target amplification and nucleic acid probe detection, detects and differentiates Chlamydia trachomatis and Neisseria gonorrhoeae, two of the most common causes of STDs. By using the Tecan Genesis 100/4 RSP (Robotic Sample Processor), the DTS 800 processes both urine and swab samples simultaneously. The assay eliminates centrifugation of urine specimens, and allows for detection of both pathogens from one collection tube. The DTS 800 complements the currently available DTS 1600, which processes up to 800 samples per shift.
Tecan also announced a new relationship with OraSure Technologies to launch a fully automated system designed for drugs of abuse testing. Based on the new Tecan Clinical Workstation (TCW), this system will utilize OraSure’s Intercept assays to detect nine commonly abused drugs. The TCW, which is based on Tecan’s Genesis platform, is designed for high volume laboratories running validated ELISA/EIA and infectious disease assays. Complete sample tracking, aliquoting, reagent addition, dilution, and incubation are all features of this new system. For very high volume settings, multiple TCWs may be linked together to share processing functions. A walk-away feature pages an operator should the system require intervention.
Abbott Diagnostics and Tecan teamed up to introduce the Genesis FE500, a front-end automation workcell that processes up to 300 primary and 500 total tubes per hour.
