Beckman Coulter (Fullerton, California) reported adding an application to its Coulter LH 750 hematology analyzers that automates the analysis of body fluids for greater lab efficiency and labor savings. With the new application, laboratories using the LH 750 can analyze three types of body fluids: cerebrospinal fluid (CSF), serous fluids (pleural, peritoneal, pericardial) and synovial fluids (pretreated with hyaluronidase). The automated process improves test turnaround time and enhances overall lab productivity. The body fluid application also helps labs eliminate errors associated with manual cell counting, such as errors in fluid dilution, counting errors in samples with low cell counts, and calculation errors associated with the conversion of the manual chamber count to reportable results, Beckman Coulter said. The LH 750 with body fluid analysis performs automated cell counting and immediately displays results for red blood cells (RBCs), white blood cells (WBCs) or total nucleated cells. The system indicates if the tested sample is a body fluid or a whole blood sample. All other parameters are suppressed, which helps simplify reporting to patient charts. In addition, the system's standardized testing method performs calculations based on units used in complete blood counts and evaluates a large number of cells within an established linearity range. This helps reduce variability of low and high counts for WBC and RBC analysis. The LH 750 is a member of Beckman Coulter's line of LH 700 series hematology systems.
Bio-Rad Laboratories (Hercules, California) reported that it has received FDA clearance for its BioPlex 2200 system, a new immunoassay platform that uses multiplexing technology to analyze for multiple disease states from single patient samples. It is the first clinical diagnostics platform to offer multiplexing technology on a fully automated, fully integrated random access platform, according to the company. The company said the system would soon be available in the U.S.
Biosite (San Diego) reported that it has submitted a premarket approval application to the FDA for the Triage Stroke Panel. The test is a rapid immunoassay intended for use in conjunction with neuro imaging as an aid in the assessment and diagnosis of cerebral ischemia, or stroke. The Triage Stroke Panel is designed to measure multiple biomarkers and incorporates a panel index feature, which analyzes information from all the markers and presents a single composite index result.
BMD (BioMedical Diagnostics; Marne-la-Vall e, France) reported that the CARIS (Carrier for Assay Reagents and Immuno Samples) platform, its new module for the preparation of test samples for autoimmune disease diagnosis, has been CE-marked. CARIS has been incorporated into FIDIS FPX, the company's high-throughput diagnostic system. CARIS fully automates the entire preparation process. The modularity of the FIDIS FPX platform means that laboratories can choose the modules they require. BMD said it has designed the system around industry standards allowing easy interfacing of test operations, immunofluorescence, multiplex and ELISA with laboratory information systems.
Dade Behring (Deerfield, Illinois) said it will begin to offer laboratories the Dimension Xpand Plus System, a second generation integrated analyzer, building on its Dimension Xpand System, which it calls "the only chemistry analyzer to offer true integration of chemistry and immuno- chemistry testing for the low-volume laboratory." The Xpand Plus analyzer extends the Xpand system by offering more automated features. Enhanced instrumentation offers the clinical laboratory improved productivity and efficiency, while maintaining a simple, flexible, and highly capable design. The Xpand Plus integrated chemistry analyzer complements the productivity enhancement features found on the RxL Max analyzer, by offering more than 85 frequently ordered tests; programmable sample integrity analysis and documentation; and a flat touch screen monitor with a new articulating arm and keyboard tray for improved ergonomics and ease.
Gen-Probe (San Diego) reported receiving FDA clearance for its Aptima Chlamydia Trachomatis (CT) assay, an amplified nucleic acid test that detects, on a stand-alone basis, the bacterium that causes the most common sexually transmitted disease (STD) in the U.S. Gen-Probe's primary amplified STD test is the Aptima Combo 2 assay, which simultaneously detects Chlamydia trachomatis and Neisseria gonorrhoeae (GC). Like the Aptima Combo 2 assay, the Aptima CT assay was cleared to detect CT from a wide variety of sample types: clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The Aptima CT assay can be run on Gen-Probe's semi-automated DTS instruments. Gen-Probe also has filed for regulatory clearance of its stand-alone Aptima GC assay, expecting approval in 1Q05.
iCAD (Nashua, New Hampshire) reported the release of its ClearLook CAD (computer-aided detection) Image Characterization Package. ClearLook is used together with iCAD's Radiologist Review Station, which presents breast images marked to show suspicious features on a display screen typically located where mammographic films are read. ClearLook offers high-resolution zoom capabilities enabling enlargement of any area of the breast image presented, plus descriptive data related to masses and calcifications in the region of interest, helping the radiologist understand why a particular set of features was marked. The ClearLook package, available as an option for the company's Second Look 500 Mammographic CAD systems, also will be available as an option on iCAD's Second Look 300 system for early detection of breast cancer.
Sigma Medical (Irving, Texas), a division of Sigma-Aldrich (St. Louis), reported launch of a new genome amplification kit, GenomePlex Whole Genome Amplification (WGA). In October, Sigma entered into an exclusive licensing agreement with Rubicon Genomics to further develop and commercialize the GenomePlex WGA technology, a kit that utilizes a proprietary amplification method designed for robust amplification of limited-source DNA. In less than three hours, GenomePlex WGA amplifies nanogram amounts of starting DNA into microgram yields. The new kit is sufficient for 50 reactions and recommended to be used with Sigma's JumpStart Taq DNA Polymerase. Additions to the whole genome amplification product line for 2005 are expected to include a kit sufficient for 100 reactions and a kit with JumpStart Taq DNA Polymerase included, according to Sigma.
SonoSite (Bothell, Washington), a leader in hand-held ultrasound systems, said it has begun customer shipments of the SonoCalc IMT software, enabling physicians to quickly measure the wall thickness (IMT) of the common carotid arteries and assess a patient's risk of cardiovascular disease. Used in conjunction with the Titan system SonoSite's high-resolution, hand-carried ultrasound technology the SonoCalc IMT software enables physicians to identify disease at an early stage for more effective management. The PC-based software works with digital images downloaded from the Titan system. Introduced at the 2004 scientific sessions of the American Heart Association (Dallas) in November, the SonoCalc IMT automated edge-detection technology provides physicians with the ability to analyze the IMT of a patient's carotid artery and compare it with published population data to generate an individualized cardiovascular health profile report. The software provides fully automated, single-click IMT measurement capability; semi-automated, user-guided IMT sketch or trace measurements for difficult images; statistical analysis of multiple IMT measurements; patient-specific exam electronic file management; and professional report generation summarizing one or more IMT examinations for a particular patient.