C314 Beckman image2

Flow cytometry platform offers ultraviolet and infrared lasers

Beckman Coulter Life Sciences has opened up the possibilities for cancer researchers with the launch of the first flow cytometer to offer excitation sources across the visible spectrum in a standard configuration. The CytoFLEX LX Blue-Red-Violet-Yellow Green-Ultraviolet-Infrared series incorporates excitation sources from ultraviolet 355 nm to infrared 808 nm alongside the existing Avalanche photodiode detectors (APD).  For the first time, this allows researchers to utilize the periphery of the visible spectrum. The CytoFLEX provides powerful analytical performance in a compact, benchtop instrument.  It leverages the effective use of Avalanche photodiode detectors to deliver the instrument’s advanced sensitivity. They work in conjunction with the different lasers, detecting the light emitted from the cells after excitation.  The addition of the new ultraviolet laser further expands the applications available to the researcher. While flow cytometry is recognized as a powerful technique for single cell analysis, traditionally it has focused on the centre of the visible light spectrum. The availability of the UV excitation source opens up research into cell-cell interactions under both normal and abnormal conditions.  For example, this will enable investigators to obtain separation of non-stained auto-fluorescing populations from positively stained populations. At the other end of the spectrum lie the infrared wavelengths, 808 nm. This is a field where more and more detectors are packed into an already crowded space.  The opening up of the infrared end of the spectrum sees an exciting expansion of the capabilities of flow cytometry.  Biologists will have space in the spectrum to simplify complex experiments, helping them tease apart subtle, but potentially meaningful, variations in their cellular analyses. The decision to incorporate Avalanche photodiode detectors, not available in other flow cytometers, in the design of the original CytoFLEX makes this expansion possible.  With their high and stable quantum efficiency from 400 to 1100 nm, they can enhance performance when using the new infrared laser.  In addition, the CytoFLEX includes an extensive set of repositionable band pass filters, the flexibility to upgrade by adding additional parameters and intuitive software to facilitate multicolour analysis.  

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Neurodegeneration biomarkers for diagnosis of Alzheimer’s and MND

A portfolio of CSF biomarkers corresponding to different stages of the neurodegenerative process aids the diagnosis of Alzheimer’s disease (AD) and motor neuron diseases (MND). The classic AD markers beta amyloid and tau measure aggregates like plaques and tangles. The most reliable measure of amyloid pathology is the ratio of beta amyloid 1-42 to 1-40, which takes into account the patient’s individual amyloid level. Total tau (T-tau) is an indicator of unspecific neuronal damage, while phosphorylated tau (P-tau) is AD specific. Determination of new synaptic biomarkers like BACE1 and neurogranin can indicate when synaptic integrity and hence cognitive function is impaired. In addition, analysis of the genetic risk factor APOE aids the differential and early diagnosis of AD. Neurofilament is an upcoming marker for MND, especially amyotropic lateral sclerosis (ALS). Analysis of the phosphorylated neurofilament heavy (pNf-H) or neurofilament light (Nf-L) subunit enables discrimination of MND from AD. The protein biomarkers beta amyloid 1-42, beta amyloid 1-40, T-tau or P-tau, BACE-1, neurogranin (truncated p75 form) and pNf-H can be determined in patient CSF using a panel of ELISAs developed by EUROIMMUN AG in collaboration with ADx NeuroSciences. The ELISAs use a matrix-independent approach which ensures high consistency in results. The protocols are aligned, require only four hours and are fully automatable. Lyophilized calibrators and controls provide convenient test performance, high precision and clinical accuracy. Genotyping in AD can be carried out using DNA microarrays such as the EUROArray APOE Direct, which determines the variants ε2, ε3 and ε4 in parallel in whole blood samples with fully automated data evaluation. Further tests for neurodegenerative diseases are on the horizon, including additional parameters for AD and MND, biomarkers for Parkinson’s disease (e.g. alpha-synuclein) and indicators of traumatic brain injury.

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C318 Hologic

Flu and respiratory assays CE-marked in Europe

Hologic has obtained a CE mark in Europe for its new Panther Fusion system and Panther Fusion assays for flu and respiratory testing. The Fusion module system offers laboratories the ability to extend the testing capabilities of the existing Panther system. The Panther Fusion module is an in‐lab upgrade to the Panther instrument. This addition adds the flexibility of PCR (polymerase chain reaction) to the proven performance of TMA (transcription-mediated amplification), which is used by the Panther system. Offering labs multiple chemistries on a single platform enables further consolidation of their testing portfolio. The Panther Fusion system retains all the key benefits of the Panther platform, including fully automated sample-to-result automation, multiple tests from a single sample, random access sample processing, continuous loading, and STAT capabilities. Additional benefits include a higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima tests. Flexibility is also improved with the addition of open access functionality to run laboratory-developed tests and protocols. This new capability allows laboratories to concentrate on developing assays, while the Panther Fusion system automates workflow and reduces overall hands-on-time. The addition of the flu and respiratory assays to the broad menu of Aptima tests already available for the Panther instrument further extends the range of diagnostic tests that laboratories can run on one Hologic system. The respiratory panel assays include the Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu, and Panther Fusion AdV/hMPV/RV tests. The respiratory assays offer a modular approach to syndromic testing via the ability to run one, two or all three assays from a single patient specimen depending on the needs of a given patient. The new Panther Fusion PCR assays, combined with the Aptima TMA assays, make the Panther Fusion system the only instrument worldwide that combines TMA, real-time TMA and real-time PCR with full sample to result automation. The Panther Fusion system and Panther Fusion assays have not been cleared for marketing by the U.S. Food and Drug Administration, and are not available for diagnostic use in the United States.
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C320 Beckman crop

Immunoassay system offers enhanced features

Built upon a 20-year legacy of reliable performance, the Access 2 immunoassay system is a compact, random-access benchtop analyser that delivers an extensive diagnostic-testing menu. The new features have been added to improve ease-of-use, workflow efficiencies, system reliability and customer satisfaction. Changes include the addition of an internal reagent barcode reader to minimize operating loading errors, an upgraded ergonomic workstation for operator comfort, improved fluidics tray for operational efficiency, a status light bar for notifying operators of instrument status, remote monitoring capability and a refreshed look. The Access 2 provides remote PROService connectivity, on-the-fly reagent and consumable loading, proven reliability and delivers up to 100 tests per hour. Together these features and benefits save laboratories precious time. Ideal for small- to medium-sized physician office laboratories, community hospitals and independent references labs or as a back-up to other primary immunoassay systems, the Access 2 is a reliable and robust system. It is designed with sample probe obstruction detection and remote monitoring capability for instrument diagnostics, maintains greater than 98 percent system availability and delivers less than 1.1 emergency service calls per year. An extensive diagnostic testing menu is available for use on the Access 2 immunoassay system, with tests that cover a range of disease states to fulfill patient care needs. These tests include, adrenal disorders, anemia, bone metabolism, cardiac-related conditions, diabetes, infectious diseases, reproductive health, endocrinology, thyroid and tumour markers.

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C309 Zivak

Carnitines/acylcarnitines LC-MS/MS analysis kit for dried blood spot

Carnitine/acylcarnitines screening is the most important part of the clinical laboratory diagnosis of amino acid, fatty acid or organic acid metabolism disorders. Carnitine / acylcarnitines screening allows the diagnosis of over 30 metabolic diseases from a drop of blood sample taken with a screening card. This screening test is performed by measurement of carnitine / acylcarnitines with isotope dilution tandem mass spectrometry. LC-MS/MS is a powerful tool that gives results for carnitine / acylcarnitines in 1.5 minutes. The screening can be performed by the Zivak Carnitine / Acylcarnitine LC- MS/MS Analysis Kit and Zivak NeoZin screening software. The main methods and procedures that have been selected are based on EN ISO 14971. The quantitative analysis of carnitine esters including free carnitine, C0, C2, C4, C6, C8, C10, C12, C14, C16, C16 OH, C18, C18 OH carnitine reveals disorders which are related to fatty acid oxidation. The quantitative analysis of carnitine esters including C3, C3DC, C4OH, C5, C5OH, C5DC carnitine reveals disorders which are related to organic acid metabolism.

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C315 Synabs image2

New rat monoclonals against aflatoxin with sub-ppb detection limits

Aflatoxins are poisonous carcinogens that are produced by certain molds (Aspergillus flavus and Aspergillus parasiticus) which grow in soil, decaying vegetation, hay, and grains. These small molecules are a worldwide health problem considering that as many as 5 billion people may be exposed. Children are particularly affected by aflatoxin exposure, which may lead to stunted growth, delayed development, liver damage and cancer.  In order to specifically detect and measure aflatoxin content in foods, in-vitro diagnostics companies have developed mouse monoclonal antibodies. Unfortunately, they were not able to quantify low levels of the toxin. SynAbs has demonstrated that Rat-LOU mAb displays  both a better affinity and sensitivity than the mouse monoclonal by a factor of 4, reaching  sub-ppb detection levels. Today, SynAbs has launched a generation of Guinea Pig monoclonal antibodies against aflatoxin. Guinea Pig monoclonals have already demonstrated superior affinity compared to rat monoclonals when applied to hormones.

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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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