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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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MRSA assay now CE marked in Europe
, /in Product News /by 3wmediaThe Panther Fusion MRSA assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion and Aptima assays, brings full automation, efficiency and excellent assay performance to MRSA screening. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable to any size laboratory. With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, the new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively.
The Panther Fusion MRSA assay accurately detects and differentiates Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from ESwab nasal samples. It has broad strain inclusivity including the Bengal Bay clone, and is able to correctly identify empty cassette variants.
The Panther Fusion MRSA assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine women’s health, virology, respiratory, hospital-acquired infections, and Open Access tests on the Panther Fusion system, running up to 32 different assays at the same time. In addition, MRSA samples can be loaded directly into the Panther Fusion, saving customers vital time and labour costs and delivering first results in 2.4 hours, considerably faster than commonly-used culture and lab developed tests. In addition, Panther Fusion offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.
Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry used in the company’s Aptima brand. Key benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. Its ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability, help reduce waste and the need for manual reagent preparation.
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Assay for monitoring of 6 antibiotics in serum/plasma
, /in Product News /by 3wmediaChromsystems has launched the first CE-IVD validated HPLC assay for antibiotics. It allows the quantitative determination of ampicillin, cefepime, ceftazidime, linezolid, meropenem and piperacillin in human serum and plasma. The assay is used to monitor the blood levels of these antibiotics and also provides qualitative data for sulbactam and tazobactam. The exceptional high stability of calibrators and controls as well as two internal standards ensure a precise quantification. The assay also includes a Priming Solution that increases the stability of the patient samples. The HPLC determination with subsequent UV detection is divided into two groups and requires only one column and one sample prep for all parameters.
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Combined detection of anti-Zika virus IgAM in acute infections
, /in Product News /by 3wmediaA new ELISA provides parallel detection of anti-Zika virus antibodies of classes IgA and IgM against the highly specific viral non-structural protein (NS-1). Anti-Zika virus NS-1 antibodies of class IgA are a novel alternative indicator of acute infection, and their detection is particularly useful in cases where IgM is not detectable. This can occur, for example, in patients who have had previous contact with a flavivirus through infection or vaccination (e.g. dengue, yellow fever, tick-borne encephalitis, Japanese encephalitis or West Nile viruses). When these individuals become infected with another virus of the genus Flavivirus, in this case Zika virus, the specific IgM response may be absent (secondary immune response). In these cases, determination of specific IgA can facilitate diagnosis of the acute Zika virus infection.
Studies have shown that although not all patients with an acute Zika virus infection exhibit specific IgM and specific IgA antibodies, all tested samples were reactive for at least one of the two parameters. Therefore, combined testing for IgM and IgA is beneficial for reliable diagnosis of acute infections.
In the study, serum samples of 31 patients with confirmed acute Zika virus infections from the Dominican Republic, where Zika and dengue viruses are endemic, and 40 patients from Vietnam with acute dengue virus infection were tested with the new ELISA. The Anti-Zika Virus IgAM yielded a sensitivity of 100% (31/31) and a specificity of 95% (38/40). In comparison, the Anti-Zika Virus IgM demonstrated a sensitivity of 29% (9/31) and a specificity of 100% (40/40). Thus, combined detection of both antibody classes instead of just IgM leads to a threefold increase in the sensitivity for acute Zika virus infections without a significant loss of specificity.
Early diagnosis of acute infections with Zika viruses is particularly important for pregnant women since the virus may interfere with the neurological development of the fetus and can cause microcephaly. However, also in adults the viral infection may have long-term neurological consequences. Therefore, timely recognition of this infectious disease is required.
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Expanded range of safety products for blood collection
, /in Product News /by 3wmediaThe VACUETTE SAFETY Winged Set is a new addition to Greiner Bio-One’s range of safety products and it is equipped with a safety mechanism. For greater flexibility, there are three different options for activating the safety mechanism immediately after blood collection. The clearly audible click confirms that the needle is safely and irreversibly locked in the safety shield. To give the user more choice, the safety blood collection set is available both with and without a pre-assembled blood culture holder. The transparent product design provides optimal blood flow visibility. Around a third of all occupational accidents in healthcare involve needlestick injuries. Nurses are at particular risk of being infected by blood-borne diseases such as hepatitis B, hepatitis C and HIV. It is therefore advisable to use safety products for taking blood samples in order to lower the risk of needlestick injuries. The first VACUETTE Safety Products were brought onto the market in 2003. The products have been developed and enhanced on an ongoing basis since then. In addition to the established VACUETTE Safety Blood Collection Sets, VACUETTE Safety Needles are also available, enabling users to select from a wide range to meet their specific needs.
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Continuous workforce education system enables addition of own learning content
, /in Product News /by 3wmediaAdvances in technology, and the constant competitive necessity to upgrade workforce skills mean that employees need to be trained continuously. For that reason, Siemens Healthineers expanded its premium subscription for workforce education management, PEPconnections, with a Virtual Library, which provides customers with the ability to add their own learning content to their group. With PEPconnections institutions can easily manage their workforce education, design learning plans, manage, assign and administer online training and professional development activities for employee groups in hospitals and laboratories. Importantly, it does not matter whether the learning activities were developed by Siemens Healthineers, the institution itself, or any other source. Customers now can easily upload their own content as PDFs, videos, documents or links to the Virtual Library. Following upload, items in the Virtual Library are available for general usage or can be assigned to group members through a new or existing learning plan. PEPconnections allows subscribers to manage staff competency and skills – supporting them in transforming care delivery for enhanced patient outcomes. Institutions can benefit from Siemens Healthineers trainings but also have the ability to individualize their learning experience and upload their own content. PEPconnections provides a connection to knowledge in digitalizing healthcare that is designed to increase staff competency, efficiency, and productivity.
The basis is PEPconnect – the industry’s first personalized education and performance experience for healthcare professionals worldwide. It provides medical professionals with customized training and professional development opportunities, with learning activities in topics on laboratory diagnostics, medical imaging and minimally-invasive therapy. The activities are designed at Siemens Healthineers by experts in key areas, such as application design, instructional technology and information security. Learners can also construct a learning experience personalized to their needs, and share their learning experience with others via a range of social media channels or groups they are members of within PEPconnect.
Almost 300,000 professionals are already using PEPconnect for their training and professional development needs in up to eight different languages.
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Single-sample freezing point osmometers
, /in Product News /by 3wmediaThe Osmomat 3000 single-sample freezing point osmometer is especially designed for routine measurements in the medical field and is also very suitable for measurements in research. The instrument determines the total osmolality of aqueous solutions. It requires very small sample volumes and can thus be applied for extreme measuring tasks. Its rapidity allows serial measurements in a very short time.
A basic version of this instrument is also available for simple handling and precise measurements rather than automatic documentation. Measurements on the Osmomat 3000 basic have to be recorded by the operator, as it is not equipped with a printer nor with data output.
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EKF Diagnostics’ Quo-Lab analyser is setting new standards in HbA1c measurement
, /in Product News /by 3wmediaA study published in the Journal of Diabetes Science and Technology found that “Quo-Lab met all criteria” and “has no bias compared to the mean of four secondary reference measurement procedures.”*
Quo-Lab is a semi-automated analyser designed to meet the needs of diabetes clinics and labs that demand low cost of operation and ease of use. It provides HbA1c results in four minutes using a small drop of blood.
EKF has developed Quo-Lab in conjunction with industry experts to deliver a product that meets the tightening requirements of NGSP certification and CAP EQA criteria.
Find out what Quo-Lab can do for your practice today.
https://www.ekfdiagnostics.com/quo-lab.html
*Lenters-Westra E, English E. Evaluation of Four HbA1c Point-of-Care Devices Using International Quality Targets: Are They Fit for the Purpose? Journal of Diabetes Science and Technology. 2018; 12: 762-770.
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2-reagent Vitamin D assay
, /in Product News /by 3wmediaDiazyme Laboratories, Inc. announced that the FDA has granted 510(K) clearance to market its two-reagent Vitamin D assay, the only fully automated two-reagent Vitamin D test for use on validated clinical chemistry analysers. Diazyme’s EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analysers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods.
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Flow cytometric casebook
, /in Product News /by 3wmediaFlow cytometric immunophenotyping is a rapidly evolving IVD technology which is establishing a place in the routine lab for the assessment of leukemia and certain lymphomas. At the heart of the test is a panel of antibodies that can detect markers or antigens on the cells. However, this depends on the accurate interpretation of complex patterns, determining whether a pattern is consistent (normal) or inconsistent with an expected population. To aid in this complex pattern recognition, Beckman Coulter has developed a unique educational resource, the ClearLLab CaseBook. Users can also download the data to continue their diagnostic practice.
The casebook is based on the ClearLLab 5C reagents which were the first preformulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be granted de novo authorization by the Food and Drug Administration (FDA) for in vitro diagnostic use. ClearLLab reagents simplify and standardize the process removing one of the limitations to flow cytometry gaining its place in the routine lab, and eliminating the need for a lab to manually prepare and design panels, a time- consuming process.
The ClearLLab 5C Casebook provides the clinical history of 16 patients, illustrating the progressive analysis of flow cytometric immunophenotyping data by means of numerous colour-coded illustrated scatter plots. These first assess and then assign the cells before giving a detailed characterization of the aberrant population according to the presence or absence of antigens. It includes patients with characteristic findings typical of various lymphoid and myeloid neoplasms as well as those with clinical and/or laboratory findings suggesting an underlying neoplastic process, but in which no immunophenotypic abnormality is identified. Specimen types include peripheral blood, bone marrow, and lymph nodes. Each case concludes with an assessment of the immunophenotypic findings as well as potential pitfalls.
Flow cytometry has several advantages over immunohistochemistry in cancer detection. This includes its ability to define distinct cell populations by their size and granularity, exclude weakly expressed surface antigens and measure several antigens at the same time with multi-colour analysis.
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Remote instrument service application
, /in Product News /by 3wmediaBeckman Coulter recently announced the European launch of DxONE PROService, a custom remote-service application that enables laboratories to help ensure fast turnaround times for important patient test results through continuous instrument monitoring. DxONE PROService allows Beckman Coulter to work in collaboration with laboratories to identify potential system issues with alerts that notify of possible workflow disruptions. This helps to prevent circumstances that could compromise delivery of critical patient results and maximizes instrument uptime. The service securely channels performance information through Beckman Coulter’s proprietary data pipeline to a dedicated regional private cloud.
Through the secure, proprietary connection capabilities of DxONE PROService, laboratories can give Beckman Coulter service teams remote access to their instrumentation. Applying intelligent diagnostics, service professionals can take a forward-looking approach to identifying potential issues in advance, and proactively address them. Should issues arise, laboratory technologists and Beckman Coulter experts can engage in real- time troubleshooting and, if possible, fix issues remotely. If a service call is necessary, Beckman Coulter will have the information needed to expedite a resolution of the issue, ensuring laboratory operations are up and running as quickly as possible.
DxONE PROService meets the standard for the EU’s newly implemented General Data Protection Regulation (GDPR), which governs how the personal information of EU citizens is gathered, transferred and stored within the European Union. DxONE PROService uses encryption, VPN and authentication services, and dedicated regional private clouds that are in compliance with the GDPR.
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