Originally Published IVD Technology October 2002
This Year in IVDs
Richard Park
In spite of economic hard times, IVD manufacturers continued to develop and launch an assortment of new products in 2002.
This past year has not been easy for IVD companies. The poor economic conditions that began the previous year spilled over into this year, with the economy continuing to soften, rising unemployment, and the falling stock market. And the recent uncertainties concerning a possible war with Iraq have made potential investors even more nervous about the economy and therefore hesitant about investing their money in the market.
Overall, 2002 has turned out to be yet another year that was full of challenges for many IVD companies. Despite these troubles, IVD companies managed to release some exciting and cutting-edge new products and technologies this year. This article examines the key areas of the IVD industry, highlighting trends and product launches in each segment.
Automation
Even though IVD manufacturers may have experienced some resistance from laboratories to buying automated laboratory systems, that has not deterred them from continuing to develop automated laboratory processes in order to minimize staffing requirements. Industry experts believe that market growth for these automated systems may be on the decline. Nevertheless, during the past year, a number of manufacturers have introduced new systems that offer significant advantages toward automating laboratory processes.
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| Olympus Diagnostic Systems Group: The AU640 provides continuous sample-rack feed with throughput of up to 800 tests per hour. |
These new systems provide random-access testing, pediatric sampling, and continuous sample-rack feed with throughput of up to 800 tests per hour (1200 with electrolytes) on the AU640, and 400 tests per hour (800 with electrolytes) on the AU400. The e-Class systems utilize enhanced hardware and Windows NT software that enables labs to reduce operator training time with customized menus, icons, and color-keyed graphics.
Olympus also released the OLA 2500, a modular laboratory automation system with aliquotting and pre- and post-analytical sample processing capabilities. As a front-end sample processor, the system automatically decaps, aliquots, and sorts tubes to any analyzer sample rack, saving time and labor, and eliminating sample-handling errors. The OLA2500 utilizes an on-board digital imaging system to check sample volume as well as identify tube size, cap type, and color.
As a modular system, the OLA2500 can be configured for expanded capability to keep pace with individual lab needs and growth. In a standard configuration, the system typically processes as many as 650 tubes per hour, making it suitable for peak work-load periods in medium- and large-volume labs. The system handles a variety of sample tube sizes including screw caps, rubber stoppers, and aluminum seals.
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| Abbott Laboratories: The AxSYM Plus has a pressure-monitoring system for detecting clot, air, or foam in samples or reagents. |
Abbott also has three other new automated immunoassay instrument systems: the Architect i2000sr, the Architect c8000, and the Architect ci8200. The Architect i2000sr is a next-generation automated immnoassay system designed to run up to 200 tests per hour and provide STAT and retest capabilities. The system gives laboratories the ability to better manage test samples and minimize operator handling with its automated rerun, dilution, and pretreatment capabilities. This system is pending U.S. marketing clearance.
The Architect c8000 and the first 36 reagents on the instrument were cleared for U.S. marketing earlier this year. The c8000 offers throughput of up to 1200 tests per hour, and has the ability to adapt to different work loads. It is also configured to handle up to 68 assays onboard, with 38 assays expected to be available at launch later this year.
The Architect ci8200 integrates both the i2000sr and the c8000 instruments to create a single immunoassay and clinical chemistry system on one platform. The ci8200 system can run up to 200 immunoassay tests and up to 1200 clinical chemistry tests per hour. The system allows one operator to interface with both chemistry and immunoassay testing, reduces the need for staff training, and delivers test results in one combined report.
Dade Behring Inc. (Deerfield, IL) launched the PFA-100 platelet function analyzer, which is able to detect platelet dysfunction. Unlike earlier testing, which must be conducted in specialty labs, the analyzer provides routine platelet function testing. This analyzer uses flow and shear stress to simulate the function of platelets in the body (both adhesion and aggregation), and the device enables platelet dysfunction to be detected in less than 5 minutes.
Dade Behring also released the StreamLab analytical work cell, which is designed for high-volume laboratories. The StreamLab system integrates fully automated instruments within a single lab in order to optimize their combined capabilities. This is achieved within an open system that can be configured and reconfigured to meet individual laboratories' requirements.
Tests that can be conducted with analyzers in the work cell include routine and specialty chemistry and immunochemistry, complete cardiac panel, therapeutic drug monitoring, drugs of abuse, and plasma proteins. On the work cell, both routine and STAT tests can be conducted in the lab simultaneously.
In addition, Dade Behring introduced the Sysmex CA-7000 coagulation analyzer, which enables laboratorians to continuously load samples, reagents, and reaction cuvettes without interrupting work flow. Up to 100 patient samples can be processed simultaneously in 10 racks that can be continuously fed as processing is completed.
The CA-7000 provides current technology in clotting, chromogenic, and immunologic methodologies, and can process both routine and specialty assays, using 20-parameter random-access capabilities. With up to 20 quality control files per parameter, lab customization and new lot crossover studies are simple to conduct.
BD (Franklin Lakes, NJ) launched the BD FACS sample prep assistant and the BD FACS lyse/wash assistant, which are automated sample-preparation instruments. These systems sample primary tubes, deliver monoclonal antibodies, and mix and lyse samples that are then analyzed on a flow cytometer. The software on these instruments offers preprogrammed panels, as well as the flexibility of creating user-defined panels to meet the laboratory's needs. Up to 40 samples can be processed at the same time on these systems.
Sysmex Corp. (Long Grove, IL) released the XT-2000i, a compact, high-performance hematology analyzer. The XT-2000i provides CBC results, reticulocyte count, and fluorescent optical platelet count. Enhancements in user-friendliness and flexibility have been achieved through the employment of Windows-based software. Integration into a computer network gives the XT-2000i the ability to access on-line quality control and remote diagnostic functions to accelerate and simplify service support.
The Sysmex UST is the first urinalysis system with a robotic transport system for very-high-volume laboratories. The UST includes the UF-100, which utilizes fluorescent flow cytometry to provide fully automated, unattended urine cell analysis. This modular system can be configured with up to four analyzers to meet the throughput of the laboratory. It also includes a robotic rack transportation system for continual loading of samples.
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| Agilent
Technologies: The 1100-series high-throughput liquid chromatography/mass
selective detector system is a fully integrated, single-vendor solution. (click to enlarge) |
Elementar Americas Inc. (Mt. Laurel, NJ) introduced its rapid N IIIc, a Dumas-type combustion nitrogen/protein analyzer. The analyzer has recently been adapted for clinical use for the determination of nitrogen in urine and fecal matter. The assessment of nitrogen balance, based on total urinary and fecal nitrogen measurement, is important for determining nutritional status in clinical situations such as for patients in a state of hypermetabolism or in conditions with extensive catabolism of connective tissue.
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| Tecan: The new clinical workstation provides a complete tracking process for a wide range of validated microplate-based assays. |
The 1100-series sample capacity extension is a small-footprint, pick-and-place robot that turns the 1100-series LC/MSD into an open solution, for high-throughput and multiuser laboratories. The 1100-series bar code reader includes a stationary bar code reader, used for positive plate identification during the run, and a handheld bar code reader for convenient editing. The 1100-series valve solutions offer dedicated valves for column regeneration, column and solvent selection, and on-line sample preparation.
Tecan (Research Triangle Park, NC) released a new clinical workstation designed to increase throughput and walk-away time for high-volume labs running a range of validated ELISA/EIA and infectious disease–based assays. This clinical workstation can process more than 12 microplates per run, and even notifies users via pager in the event of a problem.
This clinical workstation provides a complete tracking process, from samples to results, for a wide range of validated microplate-based assays, including ELISA/EIA and polymerase chain reaction (PCR), for forensic and infectious disease applications. Other functions include aliquoting, reagent addition, dilution, plate washing, and incubation.
Information Management
IVD manufacturers have continued to allocate more resources into developing their information management products as a vital part of their business. Interest in information management among companies demonstrates their recognition of the importance of this area to large customers, whose challenges in collecting, analyzing, storing, and transferring data have continually become more sophisticated and complicated. In the past year, a number of companies have introduced new systems designed to streamline information management for their hospital and laboratory customers.
Ortho-Clinical Diagnostics (OCD; Raritan, NJ) introduced the e-Connectivity Interactive System Management feature for its Vitros ECi, ECiQ, and Fusion product series. This real-time, two-way connection provides automatic data exchange between enabled systems and OCD for greater customer support and system uptime.
Using e-Connectivity, a Vitros operator can set up the system to establish a secure connection with OCD. Once connected, the system can begin reporting a wide range of systems performance and process control data to customer support, ready itself for new software versions, and allow remote-control access for troubleshooting purposes.
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| LabSoft Inc.: The Velocity LIS Web module allows users to check patient results, order lab tests, and review pending results. (click to enlarge) |
Dade Behring released the LabPro information management system for the company's line of MicroScan microbiology systems. LabPro uses the Windows NT operating system, offering features not possible on traditional DOS-based data management products. Benefits of LabPro include the ability to keep all patient information in one database, with Zip-drive backups easily scheduled.
LabPro also allows customization of formularies, data analysis, and results reporting for outside clients and resident physicians. It can perform an unlimited number of targeted laboratory information system (LIS) queries covering patient demographics, quality control results, and other records, and offers real-time flagging and storage of out-of-control results. It also tracks lot numbers, receipt dates, quality control corrective-action text, and analyzes results for surveillance and infection control.
Beckman Coulter Inc. (Fullerton, CA) introduced software version 6.2 for its DL2000 data manager, which operates with a hospital's LIS to simplify and streamline the flow of information. DL2000 with version 6.2 software offers networking capability, system administration, and advanced results and work-flow management functionality based on patient-specific demographics.
New features include enhanced validation rules, allowing labs to implement reflex testing and rerun patient samples based on initial test results and decision rules set by the laboratory. Further enhancements include automatic detection or archive after host upload, automatic database maintenance, more functional sample lists for easier requests and sorting, and improved data management viewing features.
Beckman Coulter also released new software versions to enhance the operating performance and test menu of the Synchron CX and Synchron LX clinical chemistry analyzers.
Software version 6.4 for Synchron CX and version 2.9 for Synchron LX systems update each instrument's chemistry database. New features include the P-Amylase (PAM), which is now a bar-coded liquid reagent with 30-day onboard stability. The assay features an analytical range of 7 to 600 U/L and from 480 to 1800 U/L using the out-of-range detection and correction (ORDAC) feature. PAM can be used for serum, plasma, and urine sample types.
Salicylate (SALY) is now offered as a liquid reagent in a larger 2 x 45 test configuration with 60-day onboard stability and 30-day calibration stability. The analytical range is from 4 to 100 mg/dl. SALY can be used for both serum and plasma sample types. Direct LDL cholesterol (LDLD) is now available as a liquid, ready-to-load, bar-coded 2 x 100 test kit with calibrator. The analytical range is from 10 to 550 mg/dl. LDLD can be used for both serum and plasma sample types and requires no pretreatment or calculation based on other lipid tests.
Bayer Diagnostics (Tarrytown, NY) launched a new data management system for use with its Advia family of systems, the Advia CentraLink network solution system. This system is a data manager that connects multiple instruments through a single server to the LIS. Advia CentraLink provides consolidated review and edit for those instruments, consolidated review of quality control, graphical cytograms for hematology, a single LIS connection, data management contingencies, and a simplified interface for laboratory automation systems.
Advia CentraLink is designed to consolidate data for up to 16 analytical systems, and can be configured with up to five client workstations, all providing identical functionality. The user has the option to review records for all connected instruments or any single connected instrument. Critical functions such as review, edit, quality control, and instrument warnings can be customized according to the needs of the laboratory to allow for optimal access to quality control and clinical data.
PerkinElmer Life Sciences (Boston) released its ArrayInformatics, a software solution for storing, organizing, and evaluating gene expression microarray data. The new ArrayInformatics database and visualization-tool product set can organize, track, and integrate data as a relational set of links, across every step in the gene expression work-flow process.
Using the ArrayInformatics software, researchers can capture and integrate microarray dataflow from instruments and other software packages. Researchers using gene expression tools for drug discovery, gene expression profiling, and other genomics-related efforts can publish results quickly and compare results with colleagues in a standardized format.
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| Enzyme-linked immunosorbent assay for hepatitis C virus | Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Anti-HCV Calibrator | Ortho-Clinical Diagnostics Inc. (Raritan, NJ) | Reagent pack is for qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) | Microbiology | No | 8/30/01 |
| Alpha-fetoprotein test kit for neural tube defects | Immulite AFP and Immulite 2000 AFP | Diagnostic Products Corp. (Los Angeles) | For the quantitative measurement of alpha-fetoprotein (AFP). | Immunology | No | 11/9/01 |
| Cell-mediated immunity test for Mycobacterium tuberculosis | Quantiferon-TB | Cellestis Ltd. (St. Kilda, Victoria. Australia) | Aid in the detection of infection with Mycobacterium tuberculosis. | Microbiology | Yes | 11/28/01 |
| Electrochemi-luminescence immunoassay for antibody to hepatitis B surface antigen | Elecsys Anti-Bs Immunoassay and PreciControl Anti-HBs | Roche Diagnostics Corp. (Indianapolis) | For qualitative determination of total antibodies to the hepatitis B surface antigen (HBsAg). | Microbiology | No | 2/28/02 |
| Solid-phase chemi-luminescent enzyme immunoassays for hepatitis B | Immulite Anti-HBc and Immulite 2000 Anti-HBC | Diagnostic Products Corp. (Los Angeles) | For qualitative detection of total antibodies against hepatitis B core antigen (anti-HBc). | Microbiology | No | 7/24/02 |
| Hepatitis B test | Immulite Anti-HBs and Immulite 2000 Anti-HBs | Diagnostic Products Corp. (Los Angeles) | For qualitative measurement of total antibodies to the hepatitis B surface antigen (anti-HBs). | Microbiology | No | 7/22/02 |
| Solid-phase chemi-luminescent enzyme immunoassays for hepatitis B | Immulite HBsAg, Immulite 2000 HbsAg, and Immulite HBsAg Confirmatory Kit | Diagnostic Products Corp. (Los Angeles) | The immunoassays are for qualitative detection of hepatitis B surface antigen (HBsAg). | Microbiology | No | 7/26/02 |
| Solid-phase chemi-luminescent enzyme immunoassays for hepatitis B | Immulite Anti-HBC IgM and Immulite 2000 Anti-HBC IgM | Diagnostic Products Corp. (Los Angeles) | For qualitative measurement of IgM antibody to hepatitis B core antigen (anti-HBc IgM). | Microbiology | No | 7/26/02 |
| Eight IVD products received FDA premarket approvals (PMAs) from August 2001 through July 2002. | ||||||
Point-of-Care Devices
During the past few years, the point-of-care (POC) market has undergone double-digit growth. While many industry experts agree that this segment will continue to grow, not everyone believes that double-digit growth can be maintained. Nonetheless, some experts continue to envision a variety of potential growth areas for POC diagnostics, including not only new types of tests but also new settings for testing. Despite such optimism, however, some POC instruments may not be appropriate for every setting. Moreover, others agree that the quality of POC tests remains an area of concern.
International Technidyne Corp. (Edison, NJ) introduced the Hemochron Jr. Signature+ whole-blood microcoagulation system that performs POC testing in minutes. This system has a quality control lockout feature that enables POC supervisors to monitor testing quality at predetermined intervals and also check operator compliance with FDA regulations and standard procedures.
LifeScan (Milpitas, CA) launched the InDuo system that combines blood glucose monitoring and insulin delivery, and is designed to help people better manage their diabetes. As a combined insulin doser and blood glucose monitor, this system offers insulin users the opportunity to make more-informed dosing decisions with the benefit of blood glucose test results.
The InDuo system offers less-painful blood glucose testing, requiring such a tiny drop of blood (1 µl) that it allows people to test on the arm. Additionally, the InDuo system remembers the amount of insulin injected at the last dosing as well as the time elapsed since that dosing. This system also helps build user confidence, as it is easy to dial the correct amount of insulin and inject the dosage required.
LifePoint Inc. (Ontario, CA) released the Impact test system, a saliva-based, on-site drug and alcohol testing system that delivers quantitative, simultaneous, blood-comparable results. This system consists of a small, transportable instrument and a fully contained disposable saliva test module, which serves as a sample collection device, test analysis, and optical-read chamber.
The Impact test system is designed to detect up to 10 molecules simultaneously (for panel testing) from one person's saliva sample in less than 5 minutes. The instrument manages all functions related to running a test, including automatic quality control and system validation, specimen collection, specimen adequacy test, specimen processing, reagent addition, optical readout, test result analysis, and generating a result printout with interpretation.
Instrumentation Laboratories (Lexington, MA) introduced the GEM Premier 3000. This active total process control system automatically quality controls the system, monitors its performance in real time, identifies failures and interferences, takes corrective action, and provides full documentation.
The GEM Premier 3000's disposable multiuse cartridge contains everything needed for critical-care testing: sensors, solutions, gases, pump tubing, and water container. With 13 different cartridge configurations, this system meets the demands of many testing locations, both high- and low-volume, and can be customized to meet changing needs by simply changing the cartridge.
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| Cozart Bioscience Ltd.: The RapiScan buprenorphine kit has cutoff points of 25 ng/ml for norbuprenorphine and 50 mg/ml for buprenorphine. |
The test procedure involves adding three drops of urine to the test cartridge, which evaluates the sample for the presence of buprenorphine and norbuprenorphine. The cartridge is then inserted into the handheld instrument which times, interprets, stores, and prints the results of the test in less than 10 minutes.
Quidel Corp. (San Diego) released its new urinalysis instrument, the UrinQuick urine chemistry analyzer. In addition to UrinQuick's software capabilities and its transport and optic systems, the user-friendly screens guide laboratory personnel through every aspect of operation, including a full on-board quality control program.
Bio-Rad Laboratories (Hercules, CA) introduced the D-10 hemoglobin testing system, which provides comprehensive hemoglobin testing in a compact footprint. This fully automated system combines diabetes monitoring, beta-thalassemia diagnosis, and screening for hemoglobinopathies on a single platform.
The D-10 offers simple and efficient operation for clinics, physician offices, or clinical laboratories. While whole blood primary-tube sampling eliminates sample preparation, the system's touch screen operation and automatic sample bar code reading increase ease-of-use.
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| Thermo Biostar: The PocketChem urinalysis analyzer is a POC test for the detection of the 10 common analytes found in urine. |
Immunoassays
There continues to be a considerable amount of activity in the area of immunoassays, which is also increasingly competitive. For example, according to the European Diagnostic Manufacturers Association (Brussels), European growth in rapid diagnostics (membrane-based lateral-flow and flow-through tests) reached 19% during 2001, up from 18% the previous year. IVD manufacturers are also continuing to look for ways to simplify and automate immunoassays, creating technologies that are faster, more accurate, and more cost-effective.
Beckman Coulter released Vanc, a test for the quantitative determination of vancomycin concentration in human serum and plasma. Vanc is available in a liquid, ready-to-use, bar coded reagent cartridge, which eliminates the need for laboratory staff members to mix, hydrate, or dilute the reagent before testing. Vanc measures vancomycin concentration using a particle-enhanced turbidimetric-inhibition immunoassay testing method.
Beckman Coulter also introduced CRPH, a new high-sensitivity C-reactive protein (CRP) assay to help physicians determine a patient's risk of coronary artery disease (CAD). In addition to CAD assessment, the CRPH test aids in the evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. The CRPH test can report CRP levels down to 0.02 mg/dl in serum or plasma samples including lithium heparin and sodium heparin.
In addition, Beckman Coulter launched two assays to help monitor thyroid conditions. The company's new Access Thyroglobulin (Tg) and Access Thyroglobulin Antibody (TgAb) assays are for the quantitative determination of Tg and TgAb in human serum and plasma. Access Tg provides a fast and accurate method to aid in monitoring local and metastatic thyroid tissues in patients, while Access TgAb aids in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, Graves' disease, and nontoxic goiters.
Quidel Corp. released two tests for the clinical evaluation of infectious vaginitis: the QuickVue Advance pH and Amines, and QuickVue Advance Gardnerella vaginalis tests.
The QuickVue Advance pH and Amines test contains two qualitative colorimetric tests for use in the characterization of vaginal fluid, a pH test, and a test that detects alkali volatilizable amines. Combined with the evaluation of the vaginal discharge, these tests provide three of the four clinical or Amsel criteria necessary for the evaluation of bacterial vaginosis.
The QuickVue Advance G. vaginalis test detects G. vaginalis Proline IminoPeptidase (PIP) enzyme activity from women suspected of having bacterial vaginosis. This test contains quality control on each test, and results are read within 5 minutes. This test is also an enzyme activity test for use in the detection of G. vaginalis PIP activity in vaginal fluid specimens from women suspected of having bacterial vaginosis.
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| Olympus Diagnostic Systems Group: The HDL and LDL cholesterol direct reagents are compatible with fasting and nonfasting samples. |
Olympus also launched its new high-sensitivity C-reactive protein (CRP) reagents. The test detects levels of C-reactive protein as low as 0.5 mg/L, and it has demonstrated minimal interference from lipemia, bilirubin, and hemolysis.
Thermo Biostar released its RSV OIA rapid immunoassay for the qualitative detection of respiratory syncytial virus (RSV) antigens from nasopharyngeal specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections.
Molecular Diagnostics
With the completion of the Human Genome Project, many industry experts predicted that the sequencing of the human genome would unleash a spate of new commercial diagnostics with corresponding therapeutic agents. Although the field of molecular diagnostics has not yet lived up to the expectations created by such predictions, many industry experts believe that the field still holds potential that has only begun to be tapped.
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| Pyrosequencing AB: The Vacuum prep tool prepares DNA samples for genetic analysis. |
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| Pyrosequencing AB: The PSQ 96MA system is a multiapplication sequence analysis system for applied genomics. |
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| Pyrosequencing AB: The PSQ HS 96A reduces costs for single nucleotide polymorphism and mutation analysis. |
The productivity of both the PSQ 96MA and PSQ HS 96A systems is enhanced by the ability to perform multiplex genotyping. Furthermore, the inclusion of integrated robotics and a 10-plate stacker (96-well format) delivers up to two hours of unattended operation. These systems' capabilities include automatic multiplex genotyping of polymorphisms such as SNPs, point mutations and insertion/deletions as well as the analysis of multiple SNPs on a short stretch of DNA and tri- and tetra-allelic polymorphisms.
PerkinElmer Life Sciences (Boston) introduced a full set of gene probes for use in genetic testing of type 1 diabetes. These probes provide a method for increasing daily sample throughput, enabling quicker, more-effective research. They are capable of handling large sample-volume throughput, and are less technically demanding than traditional solutions.
Agilent Technologies launched its Nanoflow proteomics solution, an integrated liquid chromatograph/ion trap mass spectrometer system optimized for proteomics applications such as the identification and characterization of proteolytically digested proteins. The Nanoflow proteomics solution is optimized to operate at the nanoliter-per-minute flow rates that yield better LC/MS/MS sensitivity.
The Nanoflow proteomics solution provides fully automated desalting and enrichment due to integrated column switching valves and enrichment and analytical columns specially designed for nanoliter flow rates. The Nanoflow proteomics solution features a new nanoflow LC pump optimized for nanoliter-per-minute flows.
Agilent also released its G2565BA microarray scanner. This device makes it easier for scientists to scan a wider variety of glass slide microarrays from third-party manufacturers as well as from those labs spotting their own microarrays.
The new microarray scanner delivers a number of features including: efficient scanning of most standard varieties of glass slides with differing thicknesses and widths so that researchers can freely use the Agilent microarray scanner to run both Agilent and non-Agilent microarrays; simple customization of microarray scan regions for non-Agilent microarrays, making it easy to run different microarray layouts; a laser-saver function that can be programmed to turn on and off according to a given lab's work-flow needs, thereby increasing the laser's life span while reducing instrument maintenance; Web-based monitoring of the status of microarray scanning, allowing researchers to check the completion status of a given scan so they can monitor their microarray analysis remotely; and enhanced instrument start-up diagnostics software that assesses scanner performance parameters and provides researchers with a status report prior to scanning.
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| Bayer Diagnostics: The Versant HIV-1 RNA 3.0 assay is a nucleic acid probe diagnostic assay for the direct quantification of HIV-1 RNA. |
Gen-Probe Inc. (San Diego) released the DTS 800 system, an automated nucleic acid pipetting system that can process up to 400 Aptima Combo 2 assay samples. With this system, the technologist can process both urine and swab samples simultaneously. The penetrable cap of the Aptima Combo 2 collection kit decreases the chance of contamination, increases throughput, and decreases the risk of repetitive motion injury to laboratory personnel. Detection and identification of both pathogens from one collection tube and one reaction tube reduces work load and frees laboratory resources for other testing.
Bayer Diagnostics received FDA approval for its Versant HIV-1 RNA 3.0 assay, a nucleic acid probe diagnostic assay for the direct quantification of HIV-1 RNA in the plasma of people with HIV. This assay is the first FDA-approved viral-load assay to detect significant changes in viral load across the entire assay range.
BD launched the BD Viper sample processor which can be used for amplified molecular testing. This system automates the sample handling associated with high-volume amplified molecular testing of chlamydia and gonorrhea that is performed on the BDProbeTec ET system. Together, these two systems provide efficiency through reduced labor, rapid time to results, high throughput, and minimal maintenance. Specifically, results from up to 552 patient specimens per 8-hour shift for combination chlamydia-gonorrhea screening may be reported.
Conclusion
While analysts do not expect the economy to spiral further down into recession, the current instability in the economy does not bode well for IVD companies in the near future. In addition, political developments in global hot spots, especially the Middle East, could bring unexpected shocks to the economy.
Despite such challenges, IVD manufacturers will continue to develop new products as well as new technologies for clinical diagnostics and other applications. And IVD Technology will certainly be here to cover them.
Richard Park is senior editor of IVD Technology.
Photos Courtesy Olympus Diagnostic Systems Group, Abbott Laboratories, Tecan, Agilent Technologies, Labsoft Inc., Thermo Biostar, Cozart Bioscience Ltd., Pyrosequencing AB, Olympus Diagnostic Systems Group, Pyrosequencing AB, Bayer Diagnostics
Copyright ©2002 IVD Technology
