C256 Biosystems 01

Ethanol test in serum, plasma and urine

BioSystems launches a new reagent for measurement of ethanol in serum, plasma and urine. Ethanol is a small molecule found mainly in alcoholic beverages, medical preparation and food. Their consumption is widespread but often abusive. Therefore, ethanol determination is one of the most common diagnostic tests in the toxicology and forensic laboratory and it is used for both medical and legal purposes. Ethanol acts as a central nervous system (CNS) depressant and can cause loss of attention, stupor, coma and possible death. BioSystems introduces this test in dedicated presentation for the A15 and A25 analysers (code 12789: 1 x 10mL + 1 x 7 mL) and for the BA400 analyser (21789: 2 x 20mL + 2 x 7mL). It is calibrated using Ammonia/Ethanol/CO2 Calibrator (BioSystems cod. 18065). The reagent offers an improved detection limit (8 mg/dL) and is optimized to work with the company’s analysers although it can also be adapted to other models. It is recommended to use the Ammonia/Ethanol/CO2 Control level I (cod. 18063) and II (cod. 18064) to verify the accuracy of the measurement procedure.
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waters spons. newsletter editorial Feb. 2017

MassTrak Vitamin D Solution

An LC-MS/MS-based clinical diagnostic solution that is CE marked to the IVDD 98/79/EC for quantitative assessment of vitamin D status in human plasma and serum.
The MassTrak Vitamin D Solution includes: instrumentation with the ACQUITY UPLC I-Class/Xevo TQD IVD System, reagents and consumables, services, and informatics. Obtain accurate, precise, linear, and sensitive results with the Waters MassTrak Vitamin D Solution.

*This kit is for in vitro diagnostic use. Not available for sale in all countries.
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DNA microarray for detection of eleven STIs

A new microarray based on state-of-the-art EUROArray technology provides parallel direct detection of eleven sexually transmitted infections (STIs) in one reaction, namely Chlamydia trachomatis, Neisseria gonorrhoea, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, Hemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis and herpes simplex viruses 1 and 2. STIs are often asymptomatic, but if left untreated they can lead to serious sequelae, for example infertility, fetal damage during pregnancy, and severe postnatal infections in newborns. PCR-based detection allows identification of both manifest and silent infections, and is thus suitable for diagnosis of symptomatic patients as well as for general screening. It offers a huge time advantage over culture and is especially useful for detecting sexually transmitted pathogens that are difficult or impossible to culture, e.g. C. trachomatis, Mycoplasma, Ureaplasma, T. pallidum. Due to amplification of the pathogen DNA, infections with a reduced pathogen number can also be reliably detected. A broad screening of STI pathogens is particularly important in asymptomatic or clinically ambiguous cases and for detecting multiple infections, which are often missed during single parameter testing. The EUROArray procedure is extremely easy to perform and does not require any in-depth molecular biology knowledge. Specific sections of pathogen DNA from patient samples are amplified and fluorescently labelled in one multiplex polymerase chain reaction (PCR). The PCR products are then hybridized to BIOCHIP microarray slides containing immobilized complementary DNA probes and detected by their fluorescence signals. The evaluation, interpretation and archiving of results is fully automated by EUROArrayScan software, and is thus highly standardized and objective. Meticulously designed primers, ready-to-use PCR components and integrated controls all contribute to the reliability of the analysis. The entire EUROArray process from sample to report release is IVD-validated and CE-registered. A human papillomavirus (HPV) microarray based on the same technology, which detects all thirty relevant high- and low-risk HPV subtypes, can be performed in parallel if required. 

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Zika virus assay

The Aptima Zika Virus diagnostic assay is now CE marked in Europe for the detection and diagnosis of the Zika virus in patients at risk of exposure to Zika or with signs and symptoms of the virus. The Aptima Zika Virus assay is a molecular diagnostic test that identifies the presence of Zika RNA in human serum, plasma and urine specimens, that can be used up to 14 days following the onset of symptoms. The Aptima Zika Virus assay is the latest Hologic test designed to run on the company’s Panther system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. By reducing hands-on time, the Panther system helps to minimize labour needs and the potential for manual errors. 

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C275 Orion JPG highres

Sensitive and rapid molecular detection of Campylobacter

Orion GenRead Campylobacter is a new molecular test intended for detection of Campylobacter species C. jejuni, C. coli and C.lari in patients suspected of having Campylobacter infection. The ready-to-use test kit is used together with the small Orion GenRead Instrument and is suitable for laboratories of various settings and sizes. Performing thetest requires neither special facilities nor expertise in molecular methods. An internal control is integrated into each test tube to contol for the reaction and ensure reliable results. The test, done directly from feces, has a simple sample handling procedure without a separate DNA purification step. The molecular test offers improved sensitivity over culture and allows detection also of nonculturable isolates. Results are provided in less than one hour which enables prompt diagnosis and treatment of compromised patients. The Orion GenRead system is based on SIBA technology, Orion Diagnostica’s proprietary isothermal nucleic acid amplification technique.

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C276 Reagena

Rapid test for determination of chemokine CXCL13

Chemokine CXCL13 is considered as a relevant biomarker of acute Lyme neuroborreliosis (LNB). Until recently, the laboratory diagnosis of LNB was based on cerebrospinal fluid (CSF) pleocytosis and the presence of intrathecal Borrelia specific antibodies. As shown in several studies, CXCL13 concentration is significantly elevated in CSF of LNB patients even before intrathecal production of Borrelia specific antibodies. Furthermore, CXCL13 rapidly decreases in CSF as a result of effective antibiotic therapy.  Reagena has developed a lateral flow rapid test, ReaScan CXCL13, for the detection of CXCL13 in human CSF. The ReaScan CXCL13 test procedure takes only 20 minutes and the intensity of the test line is read with the handheld ReaScan rapid test reader giving a numerical and objective result. ReaScan CXCL13 provides a new diagnostic tool for the rapid determination of CXCL13 near the patient and helps clinicians in the treatment decision for suspected LNB patients.

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C272 Randox crop

Upgraded online QC software

Following the successful launch of version 1.6, including new features like the automatic calculation of Sigma Metrics and Measurement Uncertainty, Randox Quality Control are announcing the launch of Acusera 24.7 Live Online Version 2.0.  Following extensive development based on customer feedback, Acusera 24.7 Live Online 2.0 is faster, with a simplified user interface and an enhanced user experience. In addition to the range of features offered in earlier versions, including QC multi-rules, interactive charts and the unique dashboard interface, the following new features have been added to the Acusera 24.7 Live Online software to speed up the review process and provide at-a-glance performance assessment:  
Peer data is updated instantly allowing real-time peer comparison, faster troubleshooting and identification of trends. Levey-Jennings charts now have even more functionality with the ability to add events such as calibration and reagent lot changes for advanced review of trends. The new user interface is faster and easier to use, enhancing user experience. Bi-directional communication with LIMS, new to Acusera 24.7 Connect, is now possible.  A new histogram chart provides a quick visualization of any test system bias.  Acusera 24.7 Connect and EDI is 100 times faster at importing QC results to the software, increasing efficiency in the lab. A new Exception Report provides a count of the number of results for a given time period that exceed 2SD, allowing corrective action to be taken.  Support for multiple devices based on responsive design that will scale to fit any platform including mobile, tablet and PC is also featured. Users can create a custom configuration that can be shared across other instruments in their lab and also other labs in their group, speeding up the configuration process for lab chains.  Performance limits, QC multi-rules and peer groups may now be customized depending on user preferences for each different analyte, instrument or lot of control. 

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C277 Fujirebio

Fully automated assay aiding in the early diagnosis of neurodegeneration

Fujirebio Europe recently launched the Lumipulse G ß-Amyloid 1-42 assay for its fully automated LUMIPULSE immunoassay systems. This CE-marked CLEIA (chemiluminescent enzyme immunoassay) kit allows the quantitative measurement of ß-amyloid in human cerebrospinal fluid within just 30 minutes. The Lumipulse G ß-Amyloid 1-42 assay is based upon Fujirebio’s well established, pioneering ELISA-based INNOTEST assay (the first neurodegeneration testing kit launched in 1995) and the know-how of Fujirebio in robust and automated CLEIA testing since the first LUMIPULSE instrument was released in 1992. The Lumipulse G ß-Amyloid 1-42 assay is the first fully automated testing solution for early detection of Alzheimer’s disease. It gives clinical laboratories access to more precise and reliable neurodegeneration testing and, of course, significantly faster results. Alzheimer’s disease starts silently, and develops several years before clinical symptoms appear. Until recently, it has been difficult for physicians to predict which individuals with memory problems will eventually develop AD, and which ones will not. New diagnostic tools to help detect AD as early as possible, and make early diagnosis with the highest level of certainty are of fundamental importance for both physicians and the patients and families involved. This is because memory complaints can result from several causes and may be reversible. Another reason that early detection tools are urgently needed is because it is believed that the treatment of diseases such as AD ideally should begin as soon as possible. Pharmaceutical companies trying to develop new AD treatments need reliable tests to establish clear-cut treatment groups, and means of monitoring the effectiveness of candidate treatments. 

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West Medica

Automatic analysis of bone marrow cells

Vision Hema® Bone Marrow is the first system worldwide for automatic analysis of bone marrow cells. The system automatically scans slides, identifies and pre-classifies bone marrow cells. After that the specialist validates the results using a PC.  
The main characteristics of the system are:  automatic scanning of slides; automatic identification and pre-classification of bone marrow cells: Blasts, Basophils, Eosinophils, Promyelocytes, Myelocytes, Metamyelocytes, Band neutrophils, Segmented neutrophils, Lymphocytes, Erythroblasts and others; bone marrow examination, marking of areas showing pathology, database for archive management; remote access and network capabilities; bi-directional communication with LIS. 
Vision Hema® Bone Marrow automates the analysis of bone marrow cells. 
For more information please visit our web-site bm.wm-vision.com

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C279 Euroimmun crop

Full automation of ELISA

The new EUROLabWorkstation ELISA provides complete walkaway processing of ELISA, from primary sample to end result. The high-throughput system has a high capacity of up to 15 microplates and more than 700 samples in one run. More than 200 tests can be processed per hour. Samples and reagents are pipetted at high speed using 10 pipetting channels, and the microplates are processed with high efficiency. Soft wareguided loading and barcode/matrixcode scanning of samples, reagents and accessories ensure high result integrity and minimal hands-on time. Moreover, the automated identification of samples, plates, slides and reagents throughout the entire process enables comprehensive traceability. Personnel expenditure is minimized by the handling of plates or slides by the integrated robot. The dynamic working area of the EUROLab- Workstation ELISA allows laboratory workflow to be adapted to individual requirements. The system has a deck capacity of 45 tracks and a variable configuration with a definable number of needles and selectable additional modules. EUROIMMUN offers an extensive portfolio of ELISA which are validated for use on the instrument. The parameter spectrum encompasses over 350 parameters for autoimmune and infection diagnostics. Starting sample materials include serum, plasma and cerebrospinal fluid. All EUROIMMUN ELISA come complete with colour-coded, ready-to-use reagents for added convenience and standardization.
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