C384 Thermo best open

Compact refrigerators for secure and sustainable clinical storage

A new series of compact refrigerators has been specifically developed to address the need of clinical laboratories and patient care facilities for cold storage equipment that enable secure and energy-efficient storage of vaccines, medicines, lab kits and breast milk, while offering quiet operation and a small footprint. Powered by Phononic’s solid state cooling technology, the new TSG refrigerators have been designed to provide uninterrupted temperature stability and cleanroom-compatible readiness for reliable storage of the most sensitive materials. Furthermore, the systems offer whisper quiet operation at less than 35 dbA, meaning they can be placed in clinical laboratories, nurse’s stations, and even patient rooms and intensive care units, without disrupting the work environment and patient comfort. With ENERGY STAR-rated performance, the TSG Series refrigerators consume significantly less energy than similar models, meeting clinical settings’ sustainability objectives and reducing operating costs. In addition, as they feature fewer refrigeration components compared to other available units, they require only minimal maintenance and offer increased storage capacity. The solid state technology used in the TSG Series allows for minimal impact on the clinical environment through reduced operational noise and heat output, while the systems’ small size maximizes working space. As with the Thermo Scientific TSX Series of freezers and refrigerators, the new TSG Series uses environmentally-friendly refrigerants in line with global initiatives aimed at minimizing greenhouse gas emissions. Additionally, the systems feature an alarm capability, notifying users of temperature fluctuations, door ajar and power failure, enabling for corrective action to ensure ideal storage conditions are always maintained throughout the internal chamber. The TSG Series refrigerators are available in undercounter (TSG505) and countertop (TSG205) configurations to suit varying application needs.

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C388 Awareness Technology copy

Automated RPR syphilis analyser

Awareness Technology, Inc. has announced FDA clearance and release of ChemWell RPR for reliable and cost-effective syphilis screening. ChemWell RPR replaces the manual labour-intensive and subjective visual rapid plasma reagin (RPR) reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. This allows laboratories to use the US CDC recommended traditional nontreponemal screening algorithm instead of the higher-cost and complicated reverse algorithm while reducing hands-on time by 92%, compared to a manual RPR test. RPR yields fewer false positives and is therapeutically useful unlike treponemal testing, The innovative system was developed in cooperation with Arlington Scientific Inc. (Salt Lake City, Utah USA) who is selling in North America and Europe under the brand name Evolution. Awareness Technology will supply the rest of the world through its distribution and technical service channels.

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C393 Buhlmann

Fully automated calprotectin testing

Fecal calprotectin testing has historically been a challenging test. Sample preparation is smelly and time consuming; and the assays have previously taken a long time to run.
The CALEX Cap from Bühlmann already eased the sample preparation, providing rapid, clean and consistent preparation, offering a simplified workflow solution for fecal calprotectin extraction without the need to decant or further dilute samples. Now modifications to the blue and white caps at either end of the CALEX device enable them to be used on laboratory track systems for a truly automated hands-off approach to fecal calprotectin testing.     The white cap has been rounded so that once the stool has been sampled the CALEX can fit easily into the racks and pucks of laboratory track systems for front loading or full random access mode. The CALEX is then automatically identified from the barcode and centrifuged. The modification to the blue cap enables automated de-capping after which the CALEX is transported on the track to the appropriate analyser for calprotectin analysis using the Bühlmann fCAL turbo before being moved to the automatic sealer and storage area. Results are then automatically reported on the laboratory LIM system. Combined with the speed of result and wide assay range (20 – 8000µg/g) of the fCAL turbo, the new Track CALEX completely transforms the approach to Calprotectin testing.

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C389 Coris crop

Carbapenemase variants detection test

Surveillance and control of resistance to beta-lactam among gram-negative bacteria remains nowadays a big concern for microbiologists worldwide. Descriptions of OXA-48 associated infections are still revealing huge impact on antimicrobial treatment and patient morbidity. For clinical laboratories, OXA-48 and its variants represent the most challenging resistance mechanism to detect and are often under-detected by routine diagnostic methods. Multiple allelic variants of OXA-48 have been described, with diverse hydrolytic profiles. As an example, the single amino acid substitution and four amino acid deletion described in OXA-163 confer an increased hydrolytic activity against cephalosporins, coupled to a loss of resistance to carbapenems. This particular hydrolytic profile makes detection confusing. Treatment failures can impede patient recovery and favour the selection of new resistant strains. Until recently, efficient identification of OXA-163-expressing strains relied on gene sequencing, which is not practical for a clinical laboratory daily routine. The recently available immunochromatographic lateral flow assay developed by Coris BioConcept to specifically differentiate OXA-163 from OXA-48 proteins, replaces costly and lengthy genotypic methods. This phenotypic test is an easy-to-use and instrument-free test that provides a fast (15 minutes) and accurate (100%) identification of variants. Precise detection of other carbapenemases will be included in the test to reach a 5-parameters assay. This up-coming “RESIST-5” test commercialized by the same company is the ideal tool to precisely identify the most prevalent carbapenemase-mediated resistance mechanisms on a single phenotypical assay. Its use on a daily routine in healthcare facilities will enable a broader surveillance of worldwide-disseminating new carbapenemase variants and help clinicians in the daily patient care.

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C387 Euroimmun

Microarray for detection of polymorphisms in lactose intolerance

A DNA microarray based on EUROArray technology provides parallel detection of the two main polymorphisms associated with primary lactose intolerance (13910 C/T and 22018 G/A) in one test. Genetically-caused deficiency of the digestive enzyme lactase affects around 20% of Europeans and almost all adults in large parts of Asia.  According to current knowledge, homozygous carriers of the wild type variant (13910 C/C or 22018 G/G) develop lactose intolerance, while heterozygous carriers of the polymorphisms (13910 C/T or 22018 G/A) only show corresponding symptoms in stress situations or with intestinal infections. Homozygous carriers of the mutant variant (13910 T/T or 22018 A/A) are lactose tolerant as adults. These latter gene variants prevail especially in population groups with a long tradition of pastoralism, for example in Europe.  Primary lactose intolerance needs to be distinguished from the secondary (acquired) form, which can develop as a result of other gastrointestinal diseases and is often only temporary. Molecular genetic determination is able to differentiate the two forms, in contrast to classical diagnostic procedures such as the hydrogen breath test or blood sugar test which cannot distinguish the primary and secondary forms.
The EUROArray Lactose Intolerance Direct provides simple and fast detection of the two polymorphisms 13910 C/T and 22018 G/A, allowing confirmation or exclusion of primary lactose intolerance with high probability. In the case of positive results, homozygous and heterozygous states are differentiated. The assay can be performed directly on pre-treated whole blood, eliminating the need for time- and cost-intensive DNA isolation. Numerous integrated controls ensure high reliability of results, for example, by verifying that there are no other rare mutations in direct proximity to the tested positions which could interfere with the analysis. Data evaluation, interpretation and archiving are fully automated using the EUROArrayScan software, ensuring standardized, objective results. All EUROArray processes from sample arrival to report release are IVD validated and CE registered.

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C391 Trimero

Nephelometric free light chain assays for IMMAGE immunochemical systems

KLoneus®, the TRIMERO’s new generation of Kappa and Lambda free light chain assays, for serum and urine samples, based on polyclonal specific antibodies, have been developed specifically for the Beckman Coulter’s IMMAGE® and IMMAGE® 800 immunochemical systems, using UDR particle enhanced non-competitive rate nephelometry method, with antigen excess control.
In order to ensure lot to lot traceability, values have been referred to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM).
Other available assays for IMMAGE® immunochemical systems include IgD Immunoglobulins, C1q Complement, C5 Complement, C1 (Esterase) Inhibitor, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, B2-Microglobulin for serum and urine, Serum Amyloid A (SAA),…
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C351 Gonotec osmomat auto

Osmomat auto Freezing point osmometer

The design of the Osmomat auto is based on ten years of experience with the measuring principle of the Osmomat 030, the first cryoscopic osmometer that was launched by Gonotec for clinical application.  The company was.able to automate the draining of the measuring system so that it is possible to reliably obtain a high sample throughput. The simple menu-driven operation requires a minimum of user interaction and allows automated operation of the Osmomat.
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C397 Hologic

Bordetella assay now CE marked Europe

Hologic’s Panther Fusion Bordetella 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 Bordetella detection. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable for any size laboratory.
The Panther Fusion Bordetella assay is a real-time PCR assay for the detection and differentiation of Bordetella pertussis (B.
pertussis) and Bordetella parapertussis (B. parapertussis) from nasopharyngeal swab specimens collected from symptomatic patients.Laboratories can combine cervical and sexual 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. The system 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 that powers the company’s Aptima brand. Key system 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.
The Panther Fusion assays utilize ready-to-use, unit-dose lyophilized reagents, which have 60-day on-board stability to help reduce waste and the need for manual reagent preparation. Diagenode, a leading diagnostics assay provider based in Liege, Belgium and New Jersey, USA, was a principal partner in developing the Panther Fusion Bordetella assay in collaboration with Hologic, and is the manufacturer of the kit.

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C399 Beckman Life Sciences

Flow cytometry data analysis system

Beckman Coulter has launched the Kaluza C Flow Cytometry Analysis Software, an advanced data analysis system for the clinical laboratory. The new software streamlines clinical QC reporting and addresses standardization issues in flow cytometry.  Both CE- marked and listed with the FDA, Kaluza C software improves the visualization and analysis of rare events.  It makes it possible to process large, multi-colour, files with up to 20 million events and set the plot resolution according to the gate level.  Further, it enables the operator to focus on a limited number of events to preserve the integrity of the scatter plot.   Tools such as easy Boolean gate formation and autogating are also incorporated to improve the analysis of complex data sets.  It takes less than a second to adjust the compensation and calculate compensation values. Kaluza C offers laboratories the opportunity to improve their clinical reporting.  It provides support at several levels, from quality control and regulatory compliance to ease of use and advanced user management tools. Complex, clinical reporting can now be done in minutes, helping to improve workflow and reduce turnaround time (TAT).
Kaluza C incorporates quality control visualization tools for regulatory and quality control compliance.  The software also offers a range of user management tools, from report page generation to auditing work levels and traceability, and enables easy exporting of data into the main laboratory information system. It can analyse clinical data from any cytometer that complies with the official Flow Cytometry Standard (FCS).  

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C398 EKF

Pocket-sized lactate analyser for sports performance monitoring

The new Lactate Scout 4 hand-held lactate analyser for fast and accurate sports performance monitoring is designed for use in the field as a training companion for individuals or sports teams. For both sports training and personal fitness,  measuring lactate helps to define workout intensities for maximum fat catabolism, increases in endurance, and avoiding critical over-exhaustion. Use of Lactate Scout 4 will help coaches and athletes to rapidly determine optimum training programs, define training zones, and avoid inefficient training regimes. The new analyser is ideal for field training since it is pocket-sized, weighing just 60g, with simple push-button navigation and an e-paper screen that can be read easily in any light conditions. Lactate Scout 4 is quick and simple to use, requiring no calibration and returns a result in 10 seconds with just a 0.2 µl capillary blood sample. Functionality of the Lactate Scout 4 is further enhanced by Bluetooth connectivity to all major brands of heart rate monitor. Heart rate data can now be collected and collated using the step test function to provide in-depth analysis of performance. Up to 500 lactate results can also be stored on the device, all of which are compensated for the influence of low and high hematocrit levels. Adding to its practicality and reliability, the Lactate Scout 4 can undertake 1,000 tests using just two CR2450 lithium batteries.
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