The cobas m 511 combines a digital morphology analyser, cell counter and classifier into one streamlined instrument preparing, staining and analysing microscopy blood slides. By counting, identifying, isolating and categorizing white blood cells, red blood cells and platelets and finally presenting the digital images of all these cell types on the Viewing Station including a standard CBC and 5-part differential, the cobas m 511 helps medical technologists concentrate on finding and classifying abnormal cells within a patient sample. Significantly, the cobas m 511 requires only small sample volumes, so the blood requirements from vulnerable groups such as the elderly, intensive care patients and neonates are greatly reduced. The Bloodhound technology represents the core intelligence of the cobas m 511. It analyses the morphology of individual cells and presents the results of the analysis in detailed images for human interaction. Moreover, while medical technologists will continue to have the option of looking at slides under their microscopes, Bloodhound technology provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review. As opposed to the typical indirectly measured approaches used in blood analysis today – primarily impedance and flow cytometry – the Bloodhound technology images individual cells directly, analyses each cell’s morphology, counts it, and then classifies all the cells in the viewing area to provide a CBC, 5-part differential, and reticulocyte count. The cobas m 511 integrated hematology analyser has several quality control features built into the graphical user interface (GUI) software that are designed to help to reduce subjectivity of cell identification and standardize the quality of the results, sample after sample. The analyser uses the DigiMAC3 stain pack for a fully automated fix and stain of the microscopy slide and will process 1,000 cycles without replacement. Thanks to an internal reservoir, the analyser holds enough reserve reagents to process 25 samples after the DigiMAC3 stain pack empties. Using a proprietary “hot swap” process, technicians can quickly change the DigiMAC3 stain pack while the instrument is still processing specimens. An integrated Viewing Station provides medical technologists and hematologists with cell-by-cell viewing access. Going beyond what would normally be seen in a field-of-view through a microscope, Bloodhound technology allows to view individual white blood cells (WBCs), red blood cells (RBCs) and platelets on a high-resolution display and organizes them into cell-specific galleries. It also allows to sort RBCs by size, shape and hemoglobin concentration as well as platelets by size and granularity. All cell images from the various galleries can be enlarged to ensure an even closer examination of the cell’s structure and morphology. Most importantly, the Bloodhound technology identifies and isolates abnormal white cells from the population of the non-pathological white cells. These are any cells that cannot be classified due to morphologic or abnormal aberrations and require review by the medical technologist or hematologist.
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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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Lab-grade undercounter refrigerators use compressor-less technology
, /in Product News /by 3wmediaClinical and laboratory personnel with the need to store vaccines, pharmaceuticals and other molecular or biological samples safely can benefit from a new series of lab-grade undercounter refrigerators that are designed to minimize energy usage and noise, while maintaining high levels of performance and maximizing storage capacity. As the only current lab-grade undercounter refrigerators using thermoelectric devices in place of compressor technology for variable speed control, these refrigerators regulate their internal temperatures more effectively to provide ideal storage conditions for the most demanding applications. Powered by compressor-free V-Drive technology, featuring synchronized temperature management (STeM), internal conditions are actively monitored and maintained at the desired temperature. This includes constant monitoring of, and adjustments during, door-openings to minimize the negative impact of temperature fluctuations on samples. In combination, V-Drive and STeM provide uninterrupted temperature stability and uniformity throughout the internal chamber. Furthermore, the new TSX505 refrigerators consume up to 37 percent less energy than other models, translating to an average annual cost reduction of up to 30 percent. The compressor-less technology of the TSX 505 refrigerator also overcomes the common challenge of ‘humming’ experienced with many lab-grade refrigerators through its quiet operation at just 35 dBA. This means that the unit can be kept in work areas without disturbing personnel or nearby patients. In addition, with no internal protrusions, such as overhead fans, users can benefit from up to double the storage space compared to similar models. The undercounter refrigerators use environmentally-friendly refrigerants in compliance with the U.S. Environmental Protection Agency’s (EPA) Significant New Alternatives Policy (SNAP). Data logging capabilities are easily enabled through a USB port, allowing users to monitor storage conditions in a timely and efficient manner.
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Integrated hematology analyser
, /in Product News /by 3wmediaThe cobas m 511 combines a digital morphology analyser, cell counter and classifier into one streamlined instrument preparing, staining and analysing microscopy blood slides. By counting, identifying, isolating and categorizing white blood cells, red blood cells and platelets and finally presenting the digital images of all these cell types on the Viewing Station including a standard CBC and 5-part differential, the cobas m 511 helps medical technologists concentrate on finding and classifying abnormal cells within a patient sample. Significantly, the cobas m 511 requires only small sample volumes, so the blood requirements from vulnerable groups such as the elderly, intensive care patients and neonates are greatly reduced. The Bloodhound technology represents the core intelligence of the cobas m 511. It analyses the morphology of individual cells and presents the results of the analysis in detailed images for human interaction. Moreover, while medical technologists will continue to have the option of looking at slides under their microscopes, Bloodhound technology provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review. As opposed to the typical indirectly measured approaches used in blood analysis today – primarily impedance and flow cytometry – the Bloodhound technology images individual cells directly, analyses each cell’s morphology, counts it, and then classifies all the cells in the viewing area to provide a CBC, 5-part differential, and reticulocyte count. The cobas m 511 integrated hematology analyser has several quality control features built into the graphical user interface (GUI) software that are designed to help to reduce subjectivity of cell identification and standardize the quality of the results, sample after sample. The analyser uses the DigiMAC3 stain pack for a fully automated fix and stain of the microscopy slide and will process 1,000 cycles without replacement. Thanks to an internal reservoir, the analyser holds enough reserve reagents to process 25 samples after the DigiMAC3 stain pack empties. Using a proprietary “hot swap” process, technicians can quickly change the DigiMAC3 stain pack while the instrument is still processing specimens. An integrated Viewing Station provides medical technologists and hematologists with cell-by-cell viewing access. Going beyond what would normally be seen in a field-of-view through a microscope, Bloodhound technology allows to view individual white blood cells (WBCs), red blood cells (RBCs) and platelets on a high-resolution display and organizes them into cell-specific galleries. It also allows to sort RBCs by size, shape and hemoglobin concentration as well as platelets by size and granularity. All cell images from the various galleries can be enlarged to ensure an even closer examination of the cell’s structure and morphology. Most importantly, the Bloodhound technology identifies and isolates abnormal white cells from the population of the non-pathological white cells. These are any cells that cannot be classified due to morphologic or abnormal aberrations and require review by the medical technologist or hematologist.
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Automated washing device for IIFT slides
, /in Product News /by 3wmediaThe MERGITE! device from EUROIMMUN increases the efficiency and reproducibility of indirect immunofluorescence tests (IIFT) by providing automated washing of incubated slides. In the high-throughput washing procedure, up to 50 substrate fields are washed in parallel in approximately 40 seconds (instead of 5 minutes with manual washing). The direct and controlled liquid flow provides fast, meticulous washing which is gentle on the substrates. Cross contamination is prevented by separate washing of each field. The standardized, predefined wash programmes ensure a consistent washing quality and high reproducibility. Since manual drying of slides is no longer necessary, the risk of damage to the substrates is substantially reduced. The automated washing procedure reduces wash buffer usage by up to 50% compared to manual washing and eliminates the need for beakers, cuvettes and paper towels. Specially developed carriers provide efficient and safe handling of slides during incubation, washing and covering. The device has an intuitive user interface for easy use and minimal familiarization time. Its integrated touch screen enables independent operation without connection to a PC. The compact tabletop device requires very little standing space in the laboratory. MERGITE! is part of a complete package from EUROIMMUN for fully automated processing, microscopy and evaluation of IIFT.
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Unique manual on major components to IVD development
, /in Product News /by 3wmediaDoes your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be?
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you’re unsure of which regulatory pathway to pursue?
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market.
This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including:
To learn more about this manual, please click here
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