Now available for Horiba Medical’s Yumizen G hemostasis range of instruments, the new Yumizen G DDi 2 (D-Dimer) reagent kit offers a key measurement and reference exclusion test for the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE). It can also be used for monitoring the progress and effectiveness of treatment of Disseminated Intravascular Coagulation (DIC). HORIBA Medical’s new D-Dimer reagent kit is available for its full range of coagulation instruments which covers the needs of any laboratory. The dedicated hemostasis portfolio includes the fully automatic Yumizen G800, Yumizen G1500 and Yumizen G1550, as well as semi-automatic Yumizen G200 and Yumizen G400 analysers. Using antibody-coated latex particles and measured via the immuno-turbidimetric channels of these Yumizen G instruments, the new reagent kit delivers D-Dimer results consistency across the range.  The D-Dimer assay when used on very compact coagulation screening platforms such as the Yumizen G400DDi and Yumizen G200, which also have combined immuno-turbidimetric and chromogenic assay capabilities, is particularly suitable for small laboratories, hot labs and as backup. On these semi-automatic systems, the Yumizen G DDi 2 reagent kit offers an innovative combination of immuno-turbidimetric test capability and pre-calibrated ready-to-use reagent. Offering a cost-efficient solution, the new assay minimizes preparation time due to its ready-to-use liquid format. Furthermore, as the reagent is pre-calibrated it removes the need for a costly and time-consuming calibration step. Its high stability and optimized volume packaging also avoid wastage. HORIBA Medical’s new D-Dimer test kit is fully compliant with Gold Standard performances, having a Negative Predictive Value of 99% and an absence of hook effect up to 25 µg FEU/ml. It also offers slope check and post dilution function on both fully automatic and semi-automatic systems with a cut-off value at 0.5 µg FEU/ml.

HORIBA MEDICAL
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CE marking has been granted to one of the most comprehensive cartridge-based STI tests. The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology. Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling. Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented; “Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size. Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said: “We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
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Thermo Fisher Scientific has introduced several new products that build on its leading Orbitrap platform and expand research applications. The new Thermo Scientific Orbitrap Exploris 240 mass spectrometer is designed to give scientists working in proteomics, metabolomics, biopharmaceutical characterisation and small-molecules, the analytical performance required for research and high-throughput analyses. The company says the new system will advance discovery and identification with increased accuracy for confident scale-up, while providing operational simplicity and streamlining time-to-result.
Thermo Fisher Scientific pointed out that the new mass spectrometer delivers qualitative and quantitative capabilities synonymous with Orbitrap high-resolution accurate-mass (HRAM) spectrometry, with internal calibration that assures consistent data quality and decision making. These newest systems extend the Thermo Scientific Orbitrap Exploris portfolio of HRAM systems, which were introduced in 2019 with the release of the new-generation Thermo Scientific Orbitrap Exploris 480 mass spectrometer.
Software
Thermo Scientific Proteome Discoverer 2.5 software provides high confidence during peptide identification, accurate quantification and high throughput data analysis for proteomics researchers. Deep learning-based prediction of tandem mass spectra, facilitated through a new collaboration with MSAID, a software company transforming proteomics through deep learning, enables more scientists to benefit from major improvements in identification confidence and reproducibility.
To further enhance characterisation of protein biotherapeutics and oligonucleotide therapeutics, biopharmaceutical laboratories use the Thermo Scientific BioPharma Finder 4.0 software, which provides greater flexibility and customisation for this growing industry.
For small molecule researchers, Thermo Scientific Compound Discoverer 3.2 software further automates unknown compound identification performed on Thermo Scientific Orbitrap Gas Chromatography- Mass Spectrometry (GC-MS) systems to improve productivity.
In addition, the new Thermo Scientific Xcalibur 4.4 software brings the AcquireX intelligent data acquisition workflow to Thermo Scientific Orbitrap Exploris mass spectrometry platform users, enabling the fully automated acquisition of high quality MS/MS data and reducing manual input and repeat runs.
Collaboration
Thermo Fisher Scientific’s collaboration with Evosep, a leading provider of sample preparation technologies for protein-based clinical research, supports the development of high-throughput clinical research workflows for profiling large plasma sample cohorts for proteomics, translational research and pharmaceutical applications. This partnership recently led to the launch of an automated ultra-high throughput plasma protein profiling platform, combing the power of the new Thermo Scientific Orbitrap Exploris 240 mass spectrometer with the Evosep One liquid chromatography solution.
The company’s collaboration with Biognosys, a leading developer of next-generation proteomics solutions, resulted in the development of data-independent acquisition mass spectrometrybased workflows, which enhances sensitivity and coverage for proteomic research in translational and clinical labs. The collaboration includes a novel FAIMS-DIA method that features the Thermo Scientific FAIMS Pro interface, which improves selectivity, reproducibility and proteome coverage, as well as new methods that streamline discovery by combining Thermo Scientific SureQuant Targeted Assay Kits and the Biognosys PQ500 kit in a single workflow.
For more information, visit: www.thermofisher.com
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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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The EurobioPlex HSV-1, HSV-2 and VZV kit, which obtained the CE mark, is a real-time amplification test of viral DNA of each of these viruses, with specific detection, as well as a DNA extraction and PCR inhibition control. This ready to use test is performed from extracted DNA, or directly on cerebrospinal fluid (CSF) without extraction using a reaction in a single well/tube. The test is indicated to detect and specifically differentiate the DNA of these viruses, and thus to diagnose the occurrence of infection by these viruses in humans, or to supplement a proven or undetermined diagnosis. Time from sample to result is short: less than 35 min. on standard PCR instruments such as CFX96 (Bio-Rad) or LC480 (Roche), and 1h on the 8-well, single-patient testing TCOR8-IVD instrument (Tetracore), networkable (WiFi/Ethernet) for remote access and data download. The Eurobio-Plex HSV1-HSV2-VZV has been validated on the following specimens: plasma, blood, amniotic fluid, various biological samples with cellular components (skin, eye, pharynx, tongue, colon, penis, foreskin, anogenital and vaginal areas, naso-pharyngeal aspirations), and directly on CSF.
Human herpesviruses are enveloped linear double-stranded DNA viruses belonging to the family Herpesviridae. Their DNA replication and transcription of their genes occur in the nucleus of infected cells. They are subdivided into three groups: alpha-, beta – and gamma herpesviridae. Primary infection with herpes virus is common and most infections occur during childhood. Many Infections with varying degrees can occur at any age, resulting in various diseases: skin lesion (herpes eczema), encephalitis, neonatal herpes and disseminated herpes. A special case is that of VZV, responsible for chickenpox, characterized by moderate fever and a vesicular eruption. Generally benign for children, there is a risk of severe complications when it is contracted by adults, immunosuppressed people and pregnant women. The reactivation of the virus in the body leads to the appearance of zona. Fast direct detection from CSF with EurobioPlex HSV1-HSV2-VZV constitutes a powerful tool for the diagnosis of meningitis.
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