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January 2026
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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17 OH progesterone ELISA with neonatal procedure
, /in Product News /by 3wmediaThe new 17 OH Progesterone Elisa (# KAP1401) uses a new polyclonal antibody and provides a validated extraction procedure for newborns serum samples. Extraction of the newborns samples is highly recommended in order to avoid any potential cross reaction with the 17OH-pregnenolone sulfate present in high concentration in very young infants. The DIAsource assay has the unique advantage to provide in the CE-IVD instructions for use a validated extraction procedure in addition to the corresponding expected concentration for newborns, men and women samples. Moreover the assay offers flexibility as it can be used on serum and EDTA/Heparin plasma samples and is easily adaptable for open-system ELISA analysers. Lastly, the 24-month shelf-life allows end-users to store the kits for a long term period with no impact on the stability, quality and performance characteristics of the assay.
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Alinity h-series hematology systems
, /in Product News /by 3wmediaSimplicity built in. Streamlined for your laboratory.
The Alinity h-series of systems integrates hematology workflow, from high-throughput Complete Blood Count (CBC) analysis to automated slide making and staining. With a bi-directional, internal conveyor and a throughput of 125 CBCs per m2, it delivers high performance in one of the most compact footprints available.
The system is composed of two Alinity hq modules and an Alinity hs module in a hq-hs-hq configuration. The Alinity hq analyzer delivers a CBC with an expanded 6-part White Blood Cell (WBC) differential that includes routine and several advanced parameters using Advanced MAPSS (Multi Angle Polarized Scatter Separation) technology. With the Alinity hs slide maker stainer and the integrated robotic sample management, the Alinity h-series of systems delivers unprecedented uniformity, flexibility, operational productivity and confidence to your customers.
Achieve integration that is built on user-focused design
With an emphasis on addressing needs articulated by you, the Alinity h-series of solutions offer an intuitive and uniform experience, aligned with other Alinity solutions. This commonality in user experience across multiple laboratory disciplines, allows for efficiencies in training, operation, and utilization of staff.
Deliver performance that comes from proven expertise in system and assay design
The Alinity h-series was designed from the ground-up with innovative technology and design elements that will address your need of managing a changing workload with existing resources. Alinity hq and Alinity hs have been designed to help you improve your laboratory’s operational productivity by automating routine processes, allowing your staff to focus on critical tasks.
Not commercially available in all countries, including the USA.
For invitro diagnostics use only.
ADD-00062367
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Immunochemistry processor
, /in Product News /by 3wmediaAP22 IF BLOT ELITE is a fully automated system for ELISA, IFA and BLOT methods. The instrument is able to run 2 ELISA microplates with 8 tests on line, 16 IFA slides or 24 blot strips, starting from the sample dilution and dispensing, reagent dispensing, incubation , washing through to dot imaging processing with assessment for each strip; the software provides the data record and patient report.
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Automated sample preparation module for LC-MS for research use
, /in Product News /by 3wmediaThe CLAM-2000 automates the pretreatment of blood or other biological samples before LC-MS analysis. The background for this development is to minimize variabilities caused by sample pretreatment and manual work. In recent years, there has been considerable progress in the use of mass spectrometers (MS) in the clinical research field due to their highly sensitive detection and high specificity as well as the possibility of multiplexing analysis without the risk of cross reactions inherent to immunoassays. Mass spectrometry enables direct detection of disease-related biological compounds in blood, urine or other biological samples, measurement of trace concentration levels of drugs as well as other applications. However, the bottleneck is still sample preparation which is often tedious, involves risk of errors and increases the risk of contamination of people dealing with sample preparation. By simply placing blood collection tubes in the system, the CLAM-2000 performs all processes through LC-MS analysis automatically. Unlike dispensing systems based on batch processing 96-well plates, the CLAM-2000 is completely automatic from pretreatment to analysis and processes individual sample successively in parallel. Consequently, it results in uniform pretreatment times between samples without slowing processing speed, while improving data reproducibility and accuracy. Pretreatment processes available include dispensing samples, dispensing reagents, stirring, suction filtration, incubation and automatic transfer of sample vials to an SIL-30AC autosampler after pretreatment. CLAM-2000 automates the sample pretreatment for LC-MS analysis. All necessary steps are automatically executed according to an existing method or a method to be developed. It also features excellent management functions providing a dramatically improved workflow with better safety for clinical research and higher reproducibility. It is compatible with the LCMS TQ systems LCMS-8045, LCMS-8050 and LCMS-8060, giving a large choice to adapt to sensitivity needs. The instrument is for research use only and not available in the USA, Canada and China.
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Assay for chlamydia and gonorrhea cleared for throat and rectal specimens
, /in Product News /by 3wmediaHologic’s Aptima Combo 2 Assay for Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) has received new CE-marked claims in Europe. These additional claims allow for testing of both clinician- and patient-collected throat and rectal swabs. These new samples, which can now be collected by the patient or the clinician using the Aptima Multitest Swab Specimen Collection Kit, broaden the range of patient-collected samples available. The excellent performance of the assay across sample types is reflected in throat and rectal samples, where Aptima Combo 2 demonstrates up to 100% sensitivity and specificity in detecting chlamydia and gonorrhoea. The APTIMA Combo 2 Assay can be used to test endocervical, throat, rectal, and male urethral swab specimens; female and male urine specimens; and cervical samples collected in PreservCyt Solution from symptomatic and asymptomatic individuals. The Aptima Combo 2 assay provides an upfront biological advantage compared to assays that detect DNA – up to 1,000-fold more rRNA than DNA per cell. The assay can be run as a standalone test or run simultaneously with other assays, providing clinicians with more flexibility. Chlamydia and gonorrhea are the most common notifiable sexually transmitted infections, and most chlamydial infections in the throat and rectum are asymptomatic. The European Centre for Disease Prevention and Control (ECDC) reported that in 2013, 384,555 cases of chlamydia infection were reported in 26 EU/EEA Member States, translating into an overall rate of 182 notifications per 100 000 population. Two-thirds (67%) of all chlamydia infections were reported in young people between 15 and 24 years of age, with the highest rates reported among women aged 20 to 24 years (1,717 cases per 100,000 population). The study also stated that the true incidence of chlamydia is likely to be considerably higher than the reported rates due to the asymptomatic nature of the infection. The ECDC also stated that in 2013, 52,995 gonorrhea cases were reported in 28 countries of the EU/EEA, with three times more cases in men than in women. Nearly half of all gonorrhea cases in 2013 (43%) were reported in men who have sex with men. Incidences of gonorrhea have increased 79% since 2008, a trend seen in most EU/EEA Member States.
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Leptin human ELISA
, /in Product News /by 3wmediaLeptin, the product of the ob (obese) gene, is a single-chain 16 kDa protein consisting of 146 amino acid residues. Leptin is produced mainly in the adipose tissue, and is considered to play an important role in appetite control, fat metabolism and body weight regulation. It targets the central nervous system, particularly the hypothalamus, affecting food intake. The primary effect of leptin appears to be mediated by leptin receptors expressed mainly in the hypothalamus. In humans, leptin levels correlate with body mass index (BMI) and percentage body fat, and are elevated even in obese individuals. Leptin has a dual action; it decreases the appetite and increases energy consumption, causing more fat to be burned. Leptin is secreted in circadian fashion with nocturnal rise in both lean and obese patients. Mutations of the ob gene resulting in leptin deficiency are the cause of obesity in the ob/ob mice. Endogeneous leptin can normalize their body weight. In contrast, high levels of leptin in obese human subjects point to an insensitivity to endogeneous leptin. Other factors in addition to the amount of body fat appear to regulate leptin action: insulin, glucocorticoids, catecholamines and sex hormones. Studies have shown that leptin may be linked to reproductive function.
The BioVendor Leptin ELISA is CE-marked, allowing in vitro diagnostic use in the European Union (research use only in the rest of the world). This sandwich ELISA uses a HRP-labelled antibody and has a total assay time of less than 2.5 hours. The kit measures total leptin in a 96-well assay format. Quality controls are human serum-based and standards are recombinant protein-based. Components of the kit are provided ready to use, concentrated or lyophilized.
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Cortisol and cortisone in saliva by mass spectrometry
, /in Product News /by 3wmediaChromsystems has launched the first CE-IVD assay for the quantitative determination of cortisol and cortisone in saliva by LC-MS/MS. MassChrom Cortisol, Cortisone in Saliva is a complete solution from sample to result, saving laboratories time and resources for in-house development. It represents a reliable, robust and proven CE-IVD assay that encompasses all required components for an efficient determination – from a fast sample preparation by filtration with clean-up tubes through to the analysis. Stable isotope-labelled internal standards for both parameters, 6PLUS1 Multilevel Calibrator Set and MassCheck controls ensure high precision of results. The parameters are determined directly by mass spectrometry, eliminating the risk of cross-reactivity as described for many immunoassays. Saliva sampling is easy, stress-free and non-invasive for patients. Stress-induced adrenal stress responses are removed, making salivary sampling more reliable, in particular in stress research and pediatric applications.
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STI multiplex assay panel
, /in Product News /by 3wmediaELITechGroup Molecular Diagnostics announces the CE-IVD marking of the STI ELITe MGB Panel: a multiplex assay for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG), three major bacteria involved in sexually transmitted infections. STIs are a global burden with more than 1 million infections acquired every day worldwide. Accurate and specific detection is important to reduce transmission and complications. In combination with the ELITe InGenius system, the STI ELITe MGB Panel makes it possible to simultaneously detect and differentiate in one single reaction Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Patient samples can be directly loaded into the system, which automatically performs all the steps of molecular diagnostics from extraction to result interpretation with minimal hands-on time. The clinical study has demonstrated excellent performance: respectively 96.4%, 100% and 100% diagnostic sensitivity and 100%, 98.4% and 98.4% specificity with C. trachomatis, N. gonorrhoeae and M. genitalium. STI ELITe MGB Panel is the 22nd CE-IVD assay of ELITe InGenius’ menu and the first one intended to diagnose sexually transmitted infections. Recently identified, M. genitalium is highly prevalent in the general population, and share similar symptoms with C. trachomatis and N. gonorrhoeae, but their specific antibiotic treatments are not fully efficient to cure M. genitalium and generate antibiotics resistance strains. Co-detection of Mycoplasma genitalium, along with Chlamydia trachomatis, Neisseria gonorrhoeae improves the efficiency of STI diagnosis and patient management. ELITe InGenius offers a unique menu with quantitative and qualitative assays for transplant pathogen monitoring, healthcare associated infections, respiratory infections, meningitis, sexually transmitted infections, and the testing of coagulation factors.
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LC-MS system for clinical diagnostics
, /in Product News /by 3wmediaThe SCIEX Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. The heart of the system lies within the innovative ClearCore MD software, a platform which simplifies and streamlines workflows and method development and incorporates features that enhance usability to help new users build proficiency quickly. In addition, the first FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the SCIEX Vitamin D 200M Assay, is for use on the SCIEX Topaz System. According to the Centered for Disease Control (CDC), LC-MS technology is the gold standard method for testing vitamin D, as it offers greater specificity and less cross-reactivity over immunoassay methods. The Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria established by the CDC’s Vitamin D Standardization-Certification Program (VDSCP). The assay individually quantitates both vitamin D2 and D3 while also separating out the D3 epimer, providing the specificity to deliver an accurate measurement of vitamin D status. The Topaz System offers both an open system for lab-developed tests (LDTs) and a closed system for running locked, pre-validated assays.
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Clinical information management tools
, /in Product News /by 3wmediaThe DxONE information management solutions is an integrated system of technologies and capabilities, designed to ease data access and usability. DxONE is designed in response to the increasing challenges faced by laboratory technicians to expedite result times, reduce costs, manoeuver personnel shortages and navigate network consolidations. The suite of next-generation technologies applies cloud-computing to provide remote-access functionality for an “answers anywhere, anytime” approach to care and laboratory activities. The strategic combination of tools is expected to help laboratories achieve greater operational excellence and efficiency, and empower more confident decision-making. The DxONE suite of information management solutions form a cohesive system of products designed to improve efficiency, give insight into operations throughout an entire network and create a more comprehensive understanding of laboratory performance. DxONE Inventory Manager eases inventory control functions to help laboratories minimize costs, ensure tight turnaround times, track trends and reduce administrative duties through automation and electronic capabilities.
DxONE Command Central gives personnel the ability to monitor multiple instruments in real-time from a single workstation and aids in counteracting personnel shortages. DxONE Insights streamlines workflow and efficiency by connecting instruments throughout a laboratory network: it provides greater access to actionable cloud-based analytics for closer monitoring of key performance indicators to aid in continuous improvement efforts.
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