C311 Bioysystems

Hematology system based on microfluidics technology

HA5, a new 5-diff hematology system based on microfluidics, complements Biosystems’ portfolio of products addressed to routine laboratories. Implementing state-of-the-art technology, microfluidics allows reducing reagent consumption up to approximately 75% compared to other analysers on the market. That means not only saving on handling, storage and transportation cost, but also advantages in reagent management as a 400-test single pack contains all the reagents required to perform the analysis, with a weight just slightly over 5kg. HA5 works in closed mode with standard vacuum tubes. Once the tube is loaded, a built-in rotor assures correct homogenization of the sample before proceeding with the analysis, with a throughput of 60 tests/hour. The measuring method uses laser-based flow cytometry with forward-scattered light detection and volumetric impedance; it provides a 26-parameter complete blood cell count report that includes RBC and PLT histograms, as well as a 5-part WBC scattergram. A large full-colour LCD touchscreen with an intuitive interface allows clear and easy operation, including reagent and controls management through QR codes, patient identification through barcode reader, LIS communication and personalized laboratory configuration. The small footprint (283 x 226 x 333 mm) of the instrument allows its installation even in very reduced spaces, making it especially suited for Emergency Departments, ICUs, private clinics, blood banks, or even in mobile care units.

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C316 LaCAR MDx Technologies

2-manipulation technique for SNPs detection without DNA extraction

The LAMP Human FII&FVL Duplex KIT (rs1799963/rs6025) allows every lab to perform the qualitative detection of the Prothrombin G20210A mutation (rs1799963) and the Factor V Leiden mutation (rs6025) by Loop-mediated isothermal amplification (LAMP) in an easy, fast and cost-effective way. LaCAR offers a wide panel of SNP detection kits requiring only two manipulations and without DNA extraction. The whole process including amplification, reading and results interpretation can be performed in approximatively 30 minutes. Every product developed by LaCAR has been validated and CE-IVD marked on its LC-Genie III (compact device for amplification, reading and results interpretation – see photo) but also on various high throughput platforms such as LightCycler 480 (Roche), LightCycler 96 (Roche), CFX96 (Biorad)… LAMP is a relatively new DNA amplification technique, using an isothermal nucleic acid amplification, which eliminates the need for expensive thermocyclers used in conventional PCR or qPCR and could provide major advantages due to its simplicity and ruggedness. In LAMP, the target is amplified at a constant temperature (+/- 65°C) using three sets of primers and a polymerase with high strand displacement activity. Detection of the different genotypes is performed by melting curve analysis after amplification. Both mutations are detected simultaneously by using a different fluorescent colour for each mutation.

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C321 Elitech

Viral meningitis panel

Recently launched is a high-performance real-time PCR assay: Meningitis Viral 2 ELITe MGB Panel for viral meningitis diagnosis, validated with ELITe InGenius, ELITechGroup’s fully automated sample to result system. Viruses are the most common causative agent of meningitis. Although presenting similar onset, viral and bacterial meningitis are associated with entirely different outcomes. Rapid and accurate diagnosis by molecular method is important to identify the viral agent, rule out a bacterial infection, and adapt patient management. Meningitis Viral ELITe MGB Panel 2 is a multiplex assay validated with cerebrospinal fluid samples, which combines reverse transcription and real-time PCR amplification for the detection and the differentiation of Enterovirus, Parechovirus and Adenovirus in one single reaction. The clinical studies have demonstrated excellent performance: 100% diagnostic sensitivity and 100% specificity for all targets. The validation with the ELITe InGenius system offers several advantages to laboratories: results in only 2h30 with limited hands-on time, emergency testing performed in parallel of any routine samples within the same run, and storage of extracted nucleic acid for an optimal use of precious CSF samples for retesting, additional molecular testing, or archiving. The ELITe InGenius menu for molecular diagnosis of meningitis will be further broadened in the coming months, with an additional real-time PCR multiplex assay for the detection of the main causative agents of bacterial meningitis.

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C319 Dynex crop

High throughput automated ELISA system

Based on an intelligent design and featuring SmartKit reagent loading technology, the Agility automated ELISA system emphasizes simplicity with an extremely intuitive, easy-to-use interface that enables effortless navigation. The system supports several major error-proofing advances, including a comprehensive monitoring system to measure consumable levels and extensive bar coding to eliminate manual data entry. The use of innovative direct-load reagent SmartKits streamlines front-end preparation and minimizes hands-on reagent loading, significantly reducing overall assay times and providing full walk-away freedom. Up to 16 SmartKits and 12 plates can be stored on-board for simultaneous runs. The system utilizes three precision robotic arms – one for sample pipetting, one for reagent pipetting and another for transporting plates and consumables – to obtain maximum process efficiency and unparalleled precision while eliminating nearly all manual steps and reducing the potential for human error. The Agility ELISA system combines ingenious design, total automation and an innovative approach to reagent loading that boosts productivity and minimizes hands-on time.

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C291 Streck

New multiplex real-time PCR kits detect clinically relevant β-lactamase genes

β-lactamase enzymes inactivate β-lactam antibiotics and render them ineffective for the treatment of clinically-important Gram-negative bacterial infections. Now, two new kits from Streck Inc. provide a comprehensive, cost-effective molecular method to detect the most clinically-important β-lactamases that confer resistance to penicillins, cephamycins, and in some cases, carbapenems. The antibiotic resistance monitoring and detection (ARM-D) kits, are multiplex real-time PCR kits that can quickly detect more than 450 β-lactamase gene variants. The ARM-D Kit, β-Lactamase detects 9 different carbapenemases, ESBLs and plasmid-mediated ampC gene families. The ARM-D Kit, ampC kit targets 6 plasmid-mediated ampC resistance gene families and can differentiate plasmid-mediated ampC β-lactamase resistance from chromosomal resistance. These genotypic detection methods identify the most prevalent types of β-lactamase-based antibiotic resistance and complement phenotypic methods for the detection of multidrug resistant organisms. They can be used with standard susceptibility tests to improve surveillance and epidemiologic tracking, for improved infection control and increased effectiveness of antibiotic stewardship programmes. AmpC β-lactamases are chromosomally encoded in many bacterial species. Their overexpression can lead to resistance to most β-lactam antibiotics, causing therapeutic failure. Transmissible plasmids with acquired genes for AmpC β-lactamases often cause increased β-lactamase production and can appear in organisms lacking or having low-level expression of a chromosomal ampC gene. Resistance due to plasmid-mediated AmpC enzymes can be broad in spectrum and often hard to detect. As Gram-negative organisms producing multiple or plasmid-mediated β-lactamases are difficult to identify phenotypically, more specific detection methods are essential for the identification of clinically important β-lactamases and selection of the appropriate antibiotic therapy. Detection and genetic identification of both plasmid-mediated and chromosomally expressed AmpC β-lactamases are crucial for a better understanding of these resistance mechanisms and, consequently, for active surveillance and infection control.
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C322 Siemens

Atellica Solution, advanced diagnostic analysers now available for sale

Siemens Healthineers announced recently the CE Mark and global commercial availability of its Atellica Solution – flexible, scalable, automation-ready immunoassay and chemistry analysers. The solution is now available across the globe in Europe, the United States, South America and Asia. The Atellica Solution is comprised of sample management, as well as immunoassay and chemistry analysers, and is an excellent fit for mid-and high-volume labs. It delivers unprecedented flexibility to adapt to changing testing needs and space constraints. The solution can combine up to 10 components into more than 300 customizable configurations – including linear, L and U shapes. It can operate as a stand-alone system or connect to Aptio Automation to provide a comprehensive, multidisciplinary testing solution that could include clinical chemistry, immunoassay, hemostasis, hematology, and plasma protein analysers. Further, with an immunoassay analyser that runs up to 440 tests per hour, the Atellica Solution delivers industry-leading productivity per square meter.
One key feature is the Atellica Magline Transport, the patented bi-directional, magnetic transport technology that is 10 times faster than conventional sample conveyors, and provides innovative and unique sample management capabilities. The transport technology, together with a multi-camera vision system, intelligent sample routing, and automatic quality control (QC) and calibration, give laboratories independent control over every individual sample – from routine to STAT – to deliver rapid, high quality patient results to clinicians. The Atellica Solution simplifies laboratory operations through intelligent sample management. It can process more than 30 different sample container types, including pediatric and tube-top sample cups that can be aspirated from the primary tube. Further, by using the same reagents and consumables across different analyser configurations, laboratories can streamline inventory and deliver consistent patient results no matter where patients are tested. Powering the Atellica Solution is a comprehensive menu of 170 assays, including 10-minute turnaround times for key cardiac, reproductive and thyroid tests, with 50 more assays in the pipeline. The immunoassay analyser features a patent-pending dual incubation ring design, temperature and humidity controls of the reaction environment, powerful magnets for relevant particle separation and robust washing protocols – all of which enable delivery of rapid, high precision results.
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C319 Siemens

Nephelometric protein testing added to Atellica series

Now available to laboratories, the Atellica NEPH 630 System is a low- to mid-volume nephelometric protein testing solution that simplifies laboratory operations by unifying instrument, assay, IT connectivity and remote service disciplines to deliver advancements in protein testing. Nephelometry is a laboratory technique used to quantify specific levels of proteins found in blood and other bodily fluids. Information on the concentration of these proteins is important in assessing and monitoring cardiovascular risk, kidney diseases, neurological disorders, nutritional status and other diseases, such as multiple myeloma. While many systems only support protein level assessment on plasma or serum, the Atellica NEPH 630 System offers the broadest menu of protein tests for assessment of urine, cerebrospinal fluid, plasma and serum, enabling enhanced quantification of certain health conditions. Proven nephelometric technology provides high precision, reproducibility and pre-reaction protocols for high antigen-excess security. These are essential components for result accuracy and minimize the need for repeat testing. Because advanced antigen-excess checks, single-use cuvettes and kinetic curve displays are incorporated into the instrument, labs can report
results with confidence. To accommodate different testing volumes, the Atellica NEPH 630 System offers multiple reagent package sizes, resulting in less waste for laboratories. Additionally, lot-to-lot reagent consistency ensures concordance between results, providing physicians with greater insight into the patients’ disease progression. The Atellica NEPH 630 System streamlines workflow with highly intelligent software for secure, smart and simple testing. The instrument’s ability to integrate with the company’s process-management software—Atellica PM 1.0 Software—will minimize operator intervention, while providing insight into individual and multi-site lab workflow, enabling labs to spot trends and implement process changes for enhanced clinical, financial and operational efficiencies. The system also connects to Siemens Remote Service to help labs minimize downtime via remote monitoring and to provide rapid, efficient technical support when needed. To support multi-site labs, the Atellica NEPH 630 System offers result correlation with the company’s BN II System. Standardized reagents and consumables across both platforms enable high-volume and multisite labs to realize significant improvements in labour efficiency and cost savings.

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C323 Fujirebio image2

CK-MB assay

The CE-marked Lumipulse G CK-MB immunoassay can be used as an aid in the diagnosis of acute myocardial infarction (AMI) or as a marker of reinfarction. The launch of this assay now completes the Lumipulse G Cardiac panel which also includes BNP, high sensitivity troponin I and myoglobin. These cardiac assays provide high sensitivity, high precision and a wide dynamic range. Added to this, the single test cartridge concept helps eliminate reagent waste for cardiac markers such as CK-MB and myoglobin, assays that will tend to be run in lower volumes. Creatine Kinase (CK) is an enzyme found in high amounts in muscle tissue due to its role in muscle contraction.  CK-MB is found mainly in cardiac muscle, where it comprises 15-40% of the total CK activity, with the remainder being CK-MM.  Trace amounts of CK-MB are found in skeletal muscle (2-3% of the total CK activity); therefore, patients with skeletal muscle injury will have increases in the absolute concentrations of CK and CK-MB. Furthermore, release of CK-MB only occurs upon death of myocardial cells and it is not released in the setting of ischemia.  CK-MB was therefore considered to be the most useful biomarker for detection of myocardial injury before the introduction of high sensitivity troponin assays.

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C318 Diatron

3-part differential hematology analyser

The Aquila 3-part differential hematology analyser (60 samples /hour throughput) can be used in many testing locations where high-quality complete blood count (CBC) results are desired. The instrument provides an optimal testing solution for both the experienced and inexperienced user, and practices which require a high-quality hematology analyser. Specifically designed for the decentralized laboratory and near-patient testing situations, this small analyser has low reagent consumption (<12ml), requires only a small sample size (20µl) and has a unique on-board reagent pack (sufficient for approximately 200 measurement cycles). With a small footprint, the analyser can be used in many locations, including small laboratories and in point-of-care applications. The low instrument reagent consumption coupled with its on-board reagent pack ensure that the shipping, storage and usage of reagents deliver enhanced ease of use as well as significant cost reductions. The newly available analyser, while requiring little bench space, features a large touch screen, an intuitive user interface, an optional back-up battery pack and extended connectivity options.
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C324 Interscience

Real-time incubator and colony counter

The ScanStation is a real-time incubator and colony counting station designed for the pharmaceutical, agro-food and cosmetic industries as well as research. It provides centralized incubation, detection and colony counting of 100 Petri dishes simultaneously. In classical Pasteurian microbiology, the Petri dish must be placed in an incubator for 24h and up to 5 days. Then a time-consuming reading operation is performed to count colonies. The operator may notice the presence of invasive or confluent colonies mixed with air bubbles or debris, increasing the margin of error on the final result. The ScanStation provides results as soon as 6 hours after the beginning of the incubation which is up to 3 times sooner, faster and with unequalled accuracy. The ScanStation detects and counts colonies as soon as they appear at the beginning of the incubation. It is a real-time process, providing anticipated results, saving time and allowing earlier release of production batches. With this new technology, microbiologists can actually see, in real-time, the video of bacterial growth on the Petri dishes. This innovation is a mix between classic methods with the Petri dish and the latest innovations in robotic and computing, providing analyses’ results with unequalled accuracy and much sooner. The major innovation of the ScanStation is the automatic counting of the colonies at an early stage of their development, starting at the beginning of the incubation cycle. Up to 100 Petri dishes are counted every 30 minutes throughout the process, delivering a video recording of the bacterial growth. Final results are known 3 times sooner and faster because up to 100 Petri dishes are processed simultaneously and with superior accuracy as colonies are detected before clustering or covering can occur.

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