A new ELISA provides detection of the cytokine CXCL13 in cerebrospinal fluid (CSF) and is the first such assay worldwide to be approved for in vitro diagnostics. CXCL13 represents a novel biomarker for the early diagnosis of acute Lyme neuroborreliosis. It is present at high concentrations in CSF soon after the illness starts, even before intrathecal production of Borrelia antibodies can be detected. CXCL13 measurement thus helps to close the diagnostic gap between infection and a positive antibody test. CXCL13 is also a suitable marker for monitoring the disease course – its concentration decreases rapidly with successful therapy. The ELISA is based on a highly purified anti-CXCL13 monoclonal antibody. Measurements are made quantitatively using six calibrators. In a test panel of CSF samples from twelve neuroborreliosis patients the ELISA yielded strongly positive results in all cases, confirming its reliability and applicability. Acute neuroborreliosis is traditionally diagnosed using the clinical picture (meningitis, meningoradiculitis, neurological deficits), detection of an inflammatory CSF syndrome (e.g. pleocytosis blood-brain barrier dysfunction) and detection of intrathecal synthesis of Borrelia-specific antibodies. The antibody detection, however, unlike CXCL13 does not provide information on the activity of the disease. Furthermore, persistence of Borrelia-specific antibodies despite treatment can hinder reliable differentiation of past and active infections. The chemotactic cytokine CXCL13 is a cellular messenger which is produced by monocytes, macrophages and dendritic cells. It is an important chemoattractant for lymphocytes in the CSF. The detection of CXCL13 in CSF is of greatest relevance in the diagnosis of neuroborreliosis. However, increased levels of CXCL13 are also found in other inflammatory diseases of the CNS such as neurosyphilis, HIV, meningitis, streptococcus infections, toxoplasmosis and multiple sclerosis.
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New assay for the measurement of Glycated Haemoglobin
, /in Product News /by 3wmediaAxis-Shield is excited to announce the launch of our new assay for the measurement of Glycated Haemoglobin (HbA1c) in human whole blood.
Regular monitoring of HbA1c levels is a key component of diabetic blood glucose control and the Axis-Shield assay provides a convenient method for use in routine testing laboratories. The Latex Turbidimetric Immunoassay methodology gives a highly accurate and precise method combined with a number of convenient features for the user and the lab. Operator handling time is reduced as the assay uses only 2 liquid-stable reagents so there is no requirement for pre-analytical mixing of reagents. Reagents are supplied in instrument-specific packaging so they can be directly loaded onto many systems without the need to further decant. The use of only two reagents also means that only one instrument channel is required, freeing space on your instrument.
The Axis-Shield assay removes the need for a simultaneous Total Hb measurement by utilising a monoclonal antibody against HbA1c.
The reagents can be used on any clinical chemistry instrument and programming is simple – applications for many common instruments are available from Axis-Shield. A 2-level control pack and 5-level calibrator pack are also available.
The Axis-Shield assay is certified by the National Glycohemoglobin Standardisation Program (NGSP).
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Lactate reagent
, /in Product News /by 3wmediaBlood lactate concentration is directly related to the availability of oxygen: when the amount of oxygen is inadequate in cells and tissues (hypoxia), the anaerobic carbohydrate metabolism leads to lactic acidosis. So, lactic concentration is increased in any type of tissue hypoxia, such as severe congestive heart failure, shock of any etiology (septic, cardiogenic…), severe anemia or monoxide carbon intoxication. Lactic acidosis can also happen in favourable tissue oxygenation, as in leukemia and solid tumours where the cause may be excessive lactate production by the neoplastic tissue. Other causes include poorly controlled diabetes or severe hepatic insufficiency. Lactate levels may also increase during intense exercise, causing a transitory and benign lactic acidosis. A cerebrospinal fluid (CSF) lactate test may be ordered, along with a blood lactate test, to help distinguish between viral and bacterial meningitis. Increased levels also occur in any clinical condition associated with reduced oxygenation of brain and/or increased intracranial pressure. This new lactate reagent is based on the Lactate Oxidase/Peroxidase method, which is more convenient for random access–type equipment because of its long stability on board and lack of cross contamination when compared with the Lactate Dehydrogenase method.
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Automated electrolyte analyser
, /in Product News /by 3wmediaThis fully automated electrolyte analyser is available in two versions: model EX-D with autosampler and EX-Ds without autosampler. It is equipped with an ion selective electrode for measuring sodium, potassium, and chloride in whole blood, serum and diluted urine. Twenty samples can be processed in one run and results are available within 36 seconds/test. An auto-retest function allows for the automatic retesting of samples with abnormal values. Emergency samples can be tested at any time during routine measurement. Electrodes are highly sensitive and C.V is less than 0.5%. A radiofrequency identification (RFID) reader attached to the analyser and IC (integrated circuit) tags attached to reagents provides reagent identification. The IC tag records the expiry date and the concentration of the reagent at the time of shipment.
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Automated slide stainer for blood smears
, /in Product News /by 3wmediaV-Chromer III is a slide stainer with a pre-programmed standardized May-Grunwald Giemsa staining protocol. Protection of personnel and environment is supported by the utilization of charcoal filter for evaporation control while odours are neutralized. Featuring minimal reagent consumption, the instrument prevents contamination of reagents thanks to a drip system and doesn’t require connection to a water supply and drainage system.
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Celiac disease rapid tests
, /in Product News /by 3wmediaCeliac disease is a permanent intolerance to ingested gluten – a protein of wheat, rye and barley – that results in damage of the small-intestine mucosal surface. This causes malabsorption of critical nutrients and can cause a variety of health problems from gastrointestinal symptoms, anemia and lactose intolerance to dental anomalies and skin problems. The vast majority of patients with celiac disease go undiagnosed; the incidence is estimated to be as high as 1/100 in Europe. Because of the genetic factor involved, there is 1/10 risk of celiac disease if a close relative has the condition. A selection of Biocard celiac disease rapid tests is now available for home and professional use. The tests are based on a patented method of detecting the tissue transglutaminase IgA antibodies associated with celiac disease from fingertip blood samples. The easy and reliable method gives results in less than 10 minutes with high sensitivity and specificity. All accessories for sampling are included. Total IgA detection is included to detect the IgA-defi cient patients.
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CXCL13 ELISA detects early neuroborreliosis
, /in Product News /by 3wmediaA new ELISA provides detection of the cytokine CXCL13 in cerebrospinal fluid (CSF) and is the first such assay worldwide to be approved for in vitro diagnostics. CXCL13 represents a novel biomarker for the early diagnosis of acute Lyme neuroborreliosis. It is present at high concentrations in CSF soon after the illness starts, even before intrathecal production of Borrelia antibodies can be detected. CXCL13 measurement thus helps to close the diagnostic gap between infection and a positive antibody test. CXCL13 is also a suitable marker for monitoring the disease course – its concentration decreases rapidly with successful therapy. The ELISA is based on a highly purified anti-CXCL13 monoclonal antibody. Measurements are made quantitatively using six calibrators. In a test panel of CSF samples from twelve neuroborreliosis patients the ELISA yielded strongly positive results in all cases, confirming its reliability and applicability. Acute neuroborreliosis is traditionally diagnosed using the clinical picture (meningitis, meningoradiculitis, neurological deficits), detection of an inflammatory CSF syndrome (e.g. pleocytosis blood-brain barrier dysfunction) and detection of intrathecal synthesis of Borrelia-specific antibodies. The antibody detection, however, unlike CXCL13 does not provide information on the activity of the disease. Furthermore, persistence of Borrelia-specific antibodies despite treatment can hinder reliable differentiation of past and active infections. The chemotactic cytokine CXCL13 is a cellular messenger which is produced by monocytes, macrophages and dendritic cells. It is an important chemoattractant for lymphocytes in the CSF. The detection of CXCL13 in CSF is of greatest relevance in the diagnosis of neuroborreliosis. However, increased levels of CXCL13 are also found in other inflammatory diseases of the CNS such as neurosyphilis, HIV, meningitis, streptococcus infections, toxoplasmosis and multiple sclerosis.
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Fecal calprotectin assay
, /in Product News /by 3wmediaQUANTA Lite Calprotectin is a new FDA-cleared assay which aids in the diagnosis of Inflammatory Bowel Disease (IBD) and can also help differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory and clinical findings. The accurate detection of calprotectin levels in stool can provide critical information to physicians determining the appropriate care of millions of patients suffering from gastrointestinal disorders. QUANTA Lite Calprotectin is a quantitative enzymelinked immunosorbent assay (ELISA) that detects calprotectin levels. The benefits of fecal calprotectin testing are being recognized by healthcare systems around the world as evidenced by the recent recommendation from the National Institute for Health and Care Excellence (NICE) in the UK.
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Fast and connected lactate testing
, /in Product News /by 3wmediaThe new Sens Point handheld lactate analyser is designed for professional use with built-in connectivity functions to hospital or lab information systems. The measuring time is only 10 seconds using 0.2μl sample volume. The handheld analyser has a lightweight, ergonomic design and is highly accurate, offering excellent correlation to lab analysers. Its intuitive user interface utilizes a large high resolution colour display. The device also features an integrated barcode scanner. Results can be linked to operator ID, patient ID, time, date and LOT number of sensors, allowing traceability of users and eliminating use by untrained staff. Results are printable using a small external Bluetooth-enabled printer.
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Recombinant Prothrombin Time (PT) reagent
, /in Product News /by 3wmediaThe liquid-stable reagent from Analyticon is produced by utilizing the most advanced technology in PT testing as it is based on a recombinant human tissue factor (TF). It is used for the quantitative determination of Prothrombin Time (PT) in human citrated plasma and the evaluation of extrinsic coagulation factor assays II, V, VII and X. The sensitivity of PT tests towards vitamin K-dependent clotting factors strongly depends upon the source and type of the TF. Since the recombinant TF in the PT reagent from Analyticon does not contain any contaminating coagulation factors it is particularly appropriate for extrinsic pathway factor assays and for monitoring oral anticoagulant therapy (OAT). The recombinant PT is a liquid-stable reagent with excellent open and closed vial stability (> 12 months at 2-8°). The instrument-based ISI of approximately 1.0 has been calibrated against an International Reference Preparation for accurate INR results. An ISI values of 1.0 or below demonstrates the sensitivity and responsiveness towards oral anticoagulants.
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Human NGAL monomer-specific ELISA Kit
, /in Product News /by 3wmediaBioPorto’s new ELISA Kit will enable researchers to measure the monomeric form of NGAL with a highly specific assay for monomeric NGAL, which cross-reacts less than 1 % with the homo-dimer form of NGAL. During the past 5 years, researchers around the world have discussed and debated different theories about NGAL molecular forms (monomer, homodimer, heterodimer). The discussions have been about which of the forms are the predominant in different clinical situations, and also if one form is more specific for one clinical diagnosis than the other. BioPorto is now making the unique monomer-specific ELISA kit publicly available. This is the first monomer-specific NGAL assay on the market. The assay has already been used in two communications, at poster level, at the annual meeting of the American Society of Nephrology in both 2012 and 2013 (Bagert et al). The assay is for research use only, not for use in diagnostic procedures.
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