Beckman Coulter announced early May that the latest addition to its automation portfolio, the DxA 5000 total laboratory automation solution, has achieved European CE Mark and China Food and Drug Administration approval. In today’s healthcare environment, laboratories are highly focused on enhancing patient care by driving faster turnaround time, delivering quality results and improving laboratory operations. The DxA 5000 helps laboratories meet these challenges through a collection of patented innovations that deliver rapid and consistent turnaround time, provide a new level of comprehensive pre-analytical sample quality detection, and reduce the number of manual processing steps to significantly improve laboratory efficiency.
Reporting results faster to physicians can positively impact patient outcomes. In the laboratory, specimen centrifugation is typically the most time-consuming pre-analytical activity. The DxA 5000 sets a new standard by utilizing a universal centrifugation protocol that significantly reduces the pre-analytical processing time by up to 73% for connected analysers across multiple disciplines.
Additionally, the DxA 5000 supports laboratories in delivering highly consistent turnaround time to their physicians. Leveraging first-of-its-kind dynamic system software, the DxA 5000 utilizes Intelligent Routing to bring automated patient-centric workflow to the laboratory. By understanding the tests requested, sample volume available and real-time analyser capacity and status, the DxA 5000 continuously calculates the most expeditious route for every patient sample – both STAT and routine.
Research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having adverse effects on patient care.  Moreover, a vast majority of the factors causing erroneous results occur outside the laboratory, including inadequate volume, mislabeled samples and incorrect tube type. The DxA 5000 is designed with a sharp focus on sample quality assessment, screening each sample at multiple points to help laboratories substantially reduce the risk of errors. In three seconds, the system detects patient tube parameters such as volume, sample identification, tube type, cap colour, orders pending and tube weight. The system is also designed to check for sample volume at three separate points: pre-centrifugation, post-centrifugation and prior to sample storage to continually ensure sufficient volume is available for the tests ordered. Together, these quality assessments reduce the potential for release of erroneous results and can help accelerate time to result by quickly alerting the laboratory when a new patient sample is needed.
In addition to improving sample quality, laboratories also require workflow solutions that help them manage high volumes of outpatient, outreach and network samples, while processing urgent requests for both patient wards and emergency departments. The DxA 5000 simultaneously manages high volumes of multiple discipline requests, with a large variety of patient sample tubes and sizes, without impact to overall system throughput or STAT turnaround time. By automating sample processing steps, the DxA 5000 supports laboratories in delivering a higher number of results per hour with the same staffing level.
Based on research and work performed with the company’s laboratory partners, sample processing steps are shown to make up approximately 70% of a laboratory’s labour hours. The DxA 5000 significantly reduces the number of manual steps in sample processing to as few as one. From sample accessioning and quality assessment to add-on test management and sample disposal, the DxA 5000 enables laboratory professionals to deliver high-quality results and improve efficiency, empowering them to focus their efforts and skills on managing patient sample exceptions.
The first in a suite of DxA systems currently in development, the DxA 5000 enhances Beckman Coulter’s comprehensive portfolio of scalable solutions and is a key component of its vision to bring workflow automation to laboratories of all sizes.
Beckman Coulter has received purchase orders for more than 20 DxA 5000 systems across multiple countries where regulatory clearance has been achieved.

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Urinary soluble CD163 (sCD163) is a novel non-invasive marker of renal inflammation, and its determination supports early detection and monitoring of active glomerulonephritis (GN). Studies by experts in the field led by Prof. Mark Little (Trinity College, Dublin, Ireland) showed that significantly increased sCD163 levels in urine are present in up to 87% of patients with active ANCA-associated vasculitis (AAV) with renal involvement. In contrast, only slight increases are detected in AAV patients in remission, patients with acute kidney failure or sepsis, and patients with AAV without kidney involvement (O’Reilly et al. Am Soc Nephrol 27: 2906–2916, 2016). Furthermore, urinary sCD163 is elevated in patients with non-vasculitic forms of GN, especially in patients with lupus nephritis class IV (Endo et al. J Nephrol Dial Transplant. 31(12): 2023-2033, 2016).  sCD163 is a macrophage activation marker. The sCD163 level in urine correlates directly with the kidney disease activity, reflecting the accumulation of CD163+ macrophages in the glomeruli in response to pro-inflammatory stimuli. The direct correlation with renal inflammation means that urinary sCD163 is superior in performance to standard urinary markers, which have limited value in identifying a renal relapse. Monitoring of urinary sCD163 values can help to predict renal flares before irreversible kidney damage occurs and might enable invasive kidney biopsies to be avoided.  sCD163 can be measured quantitatively in urine samples using a new ELISA from EUROIMMUN. The detection is based on monoclonal anti-sCD163 antibodies. Values are determined by means of a simple cut-off-based interpretation using 6 calibrators. The EUROIMMUN sCD163 ELISA will soon be available as IVD CE-marked assay.

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Built to meet the demands of repetitive routine microscopy, the BX46 microscope has features that help the user remain comfortable while working. The stage is fixed so it is close to the desk’s surface, keeping it nearer to the user’s hands. Samples are focused on using the movable nosepiece. The low-position handles and low-torque stage make it easy to move the specimen with a simple finger tap so that the arms and hands rest in a comfortable position. The tube moves up and down, tilts, and extends forward and back. With this one component, users of nearly any height can adjust the scope so that they’re comfortable. The BX46 microscope combines excellent ergonomics with energy efficient LED illumination, which makes it ideal for routine brightfield histology imaging.

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The BD COR System from BD (Beckton, Dickinson and Company) is an automated, high throughput molecular diagnostics system developed for large capacity laboratories. The modular and scalable design addresses lab needs to expand molecular testing offerings and increase test volumes by integrating and automating the complete molecular laboratory workflow. The system allows samples to be processed directly from liquid-based cytology vials and is capable of running the diagnostic workflow from pre-analytical processing to test result, unlike other automated molecular diagnostic platforms. As offerings expand, the system will provide a solution for a menu of clinically differentiated diagnostic assays for infectious diseases.  It has on-board capacity for reagents and samples to provide up to 360 results in eight hours of system processing, eliminating multiple technologist interactions per shift. Currently, the BD COR System is CE-IVD marked. It integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result. The system will be initially available with the BD Onclarity HPV Assay for the detection and extended genotyping of human papilloma virus (HPV). The system enables the processing of samples directly from liquid-based cytology vials, the creation of molecular aliquot tubes and assay testing, replacing labour-intensive and error-prone manual processes with automated ones. Over the coming years, the company plans to continue seeking regulatory authorizations to sell the BD COR System around the world while expanding the content menu to include many other assays for infectious diseases. The BD Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus (HPV) types and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Vial and in the Hologic PreservCyt Solution (not approved in the United States). Different configurations of the test are CE marked and FDA approved.
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