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November 2025
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
Prins Hendrikstraat 1
5611HH Eindhoven
The Netherlands
info@clinlabint.com
PanGlobal Media is not responsible for any error or omission that might occur in the electronic display of product or company data.
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Meningitis/encephalitis panel
, /in Product News /by 3wmediaBioFire Diagnostics’ FilmArray Meningitis/ Encephalitis (ME) Panel is now available in the countries which recognize CE marking. The ME Panel provides highly beneficial medical value, as it addresses the critical unmet need for quick and accurate identification of central nervous system (CNS) infectious agents. The comprehensive ME Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens (6 bacteria, 7 viruses and 1 yeast) responsible for community acquired meningitis or encephalitis in about an hour. Currently, testing CSF for multiple organisms can take days and is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests.
The ME Panel received a de novo clearance by the U.S. Food and Drug Administration (FDA) in October 2015. The ME Panel brings a unique opportunity to test simultaneously and rapidly for most bacteria, viruses and fungi found in those pathologies that can be extremely severe and sometimes lethal. Such an approach will positively impact the management of those patients by helping clinicians and biologists speed the diagnosis of these potentially severe conditions and make much faster decisions on appropriate therapy to prevent complications. More than 1.2 million people every year are affected by meningitis worldwide, resulting in 120,000 deaths globally from bacterial meningitis. Bacterial meningitis can occur suddenly in healthy people and even with prompt diagnosis and treatment, approximately 10% of patients may die and up to 20% or more may sustain permanent damage and disability. The ME Panel is cleared for the FilmArray and FilmArray 2.0 systems and is commercially available around the globe.
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Compact hematology system
, /in Product News /by 3wmediaThe DxH 500 hematology system with CE Mark is an openvial instrument offering a throughput of up to 60 samples per hour. It is the first analyser in a new range of workflowefficient hematology analysers able to deliver accurate, robust results from a finger prick of blood. The DxH 500 analyser has been specifically designed for low-volume hematology workloads and to promote rapid specimen turnaround and reduce patient wait times in small- and medium-sized clinics. Smaller than a standard microwave, the new instrument is able to provide a complete blood count (CBC) plus 5-part differential from as little as 12μL of whole blood or from 20μL of whole blood for pre-dilute analysis. This makes the DxH 500 ideal for pediatric and geriatric patients, for whom sample taking can be difficult. It is part of Beckman Coulter’s line of DxH hematology instruments (the DxH Workcell, DxH 800 Cellular Analysis System and DxH Slidemaker Stainer) incorporating the company’s multidimensional, high-definition flow cytometric technology. As part of the multi-site clinical reliability study to test its performance, uptime and workflow efficiencies, 36,000 samples were run across 26 sites in five continents. The DxH 500 exhibited less than or equal to one service call per year, providing uptime of more than 98%. In addition to high reliability, the system has several additional features to provide maximum uptime, with automatic start-up, fast reagent changes, no soft tubing, and minimum moving parts. It operates like a mobile phone, using touch screen technology so there is no need to add a PC and monitor. Low power consumption also reduces operational costs, with LED lighting replacing traditional lasers. The DxH 500 uses 50% less reagent volume per sample compared to other low-volume analysers so that a single set of reagent bottles can support hundreds of tests. Further, the DxH 500 needs only three reagents, which take less than two minutes each to replace, making better use of staff time and supporting a consistent workflow throughout the day. By providing non-toxic, cyanide-free and formaldehyde-free reagents, labs can reduce the cost of disposal and more easily meet environmental and regulatory compliance standards. Additionally, the DxH 500 supports laboratories’ paperless efforts with a bidirectional laboratory information system (LIS) interface for better data keeping. This integrated LIS interface can potentially help reduce data errors that occur during manual processes.
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New PTH Control for QC Portfolio
, /in Product News /by 3wmediaRandox Quality Control announces a further expansion to their comprehensive QC portfolio, the Acusera PTH Control. This new control has been designed with convenience in mind, providing the laboratory with a true third party solution for the measurement of PTH. The assayed liquid control has been developed with an extended open vial stability of 30 days and 2-year shelf life, reducing waste and ensuring consistency for this notoriously unstable assay.
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Zika Virus real time PCR detection kit
, /in Product News /by 3wmediaThe growing concern about the proliferation of Zika infections in the Caribbean, Central and South America, has turned the fight against the virus in a global health emergency. The infection is mainly transmitted through the bite of the Aedes spp mosquitoes and presents symptoms like mild fever, arthralgia, myalgia, asthenia, headache and maculopapular rash clinical symptoms, plus additional symptoms like conjunctivitis, retroorbital pain, lymphadenopathy and diarrhea. There is widespread concern about the association of the Zika Virus with increasing cases of congenital microcephaly. Other research indicate that the virus can cause brain damage. CerTest Biotec has developed a new kit for the identification of Zika virus in patients presenting symptoms of the disease. This new "ready-for-use" product contains all the necessary components and reagents to perform a test that detects viral Zika RNA using the real time PCR technique. It is very important to complete the identification of the virus in the early stages of infection; therefore, it is recommended that samples of blood, serum and/or saliva are collected during the first 5 days after the onset of symptoms. The VIASURE Zika Virus real time PCR detection kit is designed for specific identification and quantification of Zika virus in clinical samples from patients with signs and symptoms of Zika virus infection. This test is intended for use as an aid in the diagnosis of the Zika virus in humans in combination with clinical and epidemiological risk factors. RNA is extracted from specimens, amplified using RT-amplification and detected using fluorescent reporter dye probes specific for Zika virus.
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Prep automation in culture-independent pathogen PCR testing
, /in Product News /by 3wmediaMicro-Dx enables the culture-independent diagnosis of pathogens in various clinical samples. Micro-Dx is the first product combining walk-away automated human DNA removal and pathogen DNA extraction with broad-range rDNA Real-Time PCR and sequencing into a rapid diagnostic system for bacteria and fungi. Prominent advantages of molecular testing are the time gain compared to culturing and detection of pathogens that do not grow for reasons of fastidious nutrition requirements or growth inhibition due to antibiotic treatment of patients. Extraction of 1 to 12 samples is operated in the Select- NAplus instrument, which saves tedious manual handling and time. At the end of the procedure an exact differentiation of the species is obtained. Micro-Dx operates a wide range of specimens, including EDTA blood, CSF, BAL, aspirates from joints, swabs from wounds and abscesses and tissue biopsies from heart valves, liver and brain.
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Rapid test range for viral infections
, /in Product News /by 3wmediaMP Diagnostics’ newly launched MULTISURE Range consists of three separate devices for the diagnosis of diseases that are of major health concern: Dengue, HIV and HCV. The MULTISURE rapid tests are qualitative immunochromatographic assays intended for the screening of dengue, HIV and HCV infections and are equipped with MP Diagnostics’ patented reverse flow technology. The patented reverse flow technology enhances visual identification for easier interpretation of results. MP Diagnostics’ ASSURE Reader and ASSURE Palm Reader are developed for use with the MULTISURE range of rapid tests and are fully integrated instruments designed for the institution’s needs. The MP ASSURE readers complement the reading and documentation of results for both laboratory and point-of-care settings. With the latest upgrade in software, the MP ASSURE readers’ integration to management systems would be seamless for all users.
The new test range is for research use only in the United States.
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Immuno turbidimetric fecal CALPROTECTIN Assay
, /in Product News /by 3wmediaFecal calprotectin (fCAL) is the most important marker for in vitro diagnostic detection of gut inflammation. Immunological quantitation is well established and is used in the diagnostic process of inflammatory bowel diseases (IBD) and in the lifelong monitoring of these chronic conditions. fCAL testing today requires a significant level of lab resources including stool sample handling, extraction and the use of traditional immunological testing methods. The BÜHLMANN fCAL turbo assay is a big step towards full automation. It reduces the time to result as well as the total hands-on time significantly. It offers the possibility of random access and is independent of the clinical chemistry platform. Validated applications are available for the most common analysers. The combination with the proprietary extraction device CALEX Cap for pre-analytical sample preparation simplifies and accelerates stool diagnosis significantly. The BÜHLMANN fCAL turbo utilizes the well-established standardization of the BÜHLMANN fCAL ELISA to provide reliability and continuity of measurements.
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New reagent to measure dabigatran
, /in Product News /by 3wmediaStago completes its anticoagulant line with a new reagent, STA-ECA II, for the measurement of dabigatran plasma concentration in patients under treatment, in case of emergency (hemorrhage, urgent surgery or invasive procedure). STA-ECA II is an ecarin-based chromogenic assay which specifically measures the anticoagulant effect of direct thrombin inhibitors like dabigatran. The use of dedicated calibrators and controls is necessary. This assay is insensitive to lupus anticoagulant, heparin and variations in levels of coagulation factors and fibrinogen. Available on STA R Max, STA-R and STA Compact Max, STA-ECA II shows excellent analytical performances down to 15 ng/mL in the low range, with a high correlation to the reference technique for dabigatran measurement, LC-MS using “total dabigatran” protocol. With a long on-board stability (3 days) and at 2-8°C (28 days), this reagent is suitable for all types of laboratory activities.
In the USA and Canada this product is classified as “For Research Use Only”.
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Urine Oxalate assay
, /in Product News /by 3wmediaBioSystems launches a new reagent for the measurement of oxalate (oxalic acid) in urine. Oxalate is an end product of metabolism, predominantly derived from the breakdown of glyoxylate and glycine. It is eliminated entirely by urine and only about 15% of urinary oxalate is derived directly from dietary sources. Hyperoxaluria is a powerful promoter of calcium oxalate stone formation. An increased excretion of oxalate in urine may occur as a result of an excessive ingestion of oxalate-rich foods, because of malabsorption due to different gastrointestinal disorders (enteric hyperoxaluria) or because of an inborn error of metabolism (primary hyperoxaluria). Low oxalate values in urine are associated with hyperglycinemia or hyperglycinuria. BioSystems introduces this method (Oxalate Oxidase/Peroxidase – differential bireagent) in dedicated presentation for A15 and A25 analysers (code 12539: 1x25mL, 20 tests). It is calibrated using its own standard included in the kit. The kit also includes 20 pretreatment tubes which are also available separately in 100-unit packs (Oxalate Pretreatments Reagents: code 11839).
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HbA1c enzymatic assay
, /in Product News /by 3wmediaThe HbA1c value correlates with the average blood glucose level over the last 8-12 weeks and is used for monitoring and diagnosis of diabetes. DiaSys offers HbA1c net FS as a liquid-stable and ready-to-use 2-component assay. Due to the enzymatic test principle, excellent precision is ensured. Interference from a variety of hemoglobin variants like HbS, HbC, HbD, HbE, or HbF can be excluded. HbA1c net FS is characterized by a wide measuring range from 20 to 150 mmol/mol IFCC (4-6% DCCT/NGSP) and high on-board and calibration stability of up to 6 weeks. Moreover, this assay is standardized against the IFCC reference method and traceable according to the DCCT/NGSP network.
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