Amino Sign is a point of care analyser to measure lysine easily and quickly. Lysine, or L-lysine, is an essential amino acid. That means it is necessary for human health, but the body can’t manufacture it, so the only sources are dietary, including supplements. Amino acids like lysine are the building blocks of protein. Lysine is important for proper growth, and it plays an essential role in the production of carnitine, a nutrient responsible for converting fatty acids into energy and helping to lower cholesterol. Lysine appears to help the body absorb calcium, and it plays an important role in the formation of collagen, a substance important for bones and connective tissues including skin, tendon, and cartilage. Most people get enough lysine in their diet, although athletes, vegans who don’t eat beans, as well as burn patients may need more. Not enough lysine can cause fatigue, nausea, dizziness, loss of appetite, agitation, bloodshot eyes, slow growth, anemia, and reproductive disorders. For vegans, legumes (beans, peas, and lentils) are the best sources of lysine. Amino Sign uses the Lysine Card test strip in a 4-step procedure to measure lysine concentration in whole blood specimens. Sample volume is 5μL and the test is performed in two minutes. The pocket size analyzer’s dimensions are 115x58x20mm.
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Combination cell/microbead autoantibody IFT assay
, /in Product News /by 3wmediaThe novel CytoBead technology offers for the first time the combination of autoantibody analysis by cell-based screening and the confirmation of the corresponding autoantigen reactivities by multiplexing, using the immunofluorescence technique (IFT) in one reaction environment. The CytoBead ANCA for example allows the screening of antineutrophil cytoplamsic antibodies (ANCA) on ethanol-fixed neutrophiles and the confirmation thereof using proteinase 3 (PR3) and myeloperoxidase (MPO) coated microbeads. Furthermore, the detection of Goodpasture antibodies, which can occur in 10% of rapid progressive glomerulonephritis patients, is integrated by adding glomerular basement membrane (GBM) coated microbeads. Additionally, this technology provides an ideal reaction environment for multiplexing antinuclear antibody (ANA) assessment and the detection of celiac disease specific antibodies. This assay format can be interpreted with a standard fluorescence microscope for semi-quantitative analysis and with the automated interpretation system Aklides for quantitative testing. CytoBead technology is an attractive alternative to classical, time-consuming single parameter antibody detection and is applicable for high throughput routine diagnostics.
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Troponin I point-of-care test has obtained CE marking
, /in Product News /by 3wmediaThe ESC, ACCF, AHA and WHF stipulate that Troponin assays should demonstrate a coefficient of variation (CV) of 10% or less at the 99th percentile of the normal population, which no prior POC device could do. The high sensitivity Meritas test achieves a CV of 10% at 36pg/ml which is the 99th percentile. Results are available patient-side within 15 minutes and the Meritas analyser uses only a single drop of whole blood in a one-step process. This test will, for the first time, allow doctors to evaluate potential MI patients quickly and accurately. With CE marking achieved, Trinity Biotech now intends to release the product for sale in Europe and other carefully selected markets through its specialist cardiology distributor network.
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Genetic testing prevents abacavir hypersensitivity in HIV patients
, /in Product News /by 3wmediaThe genetic risk of abacavir hypersensitivity in HIV patients can be established in whole blood samples using a new microarray based on EUROArray Direct technology. The DNA test identifies the presence of the HLAB* 57:01 allele, which is the main genetic factor associated with adverse reactions to abacavir-containing drugs. The EUROArray HLA-B*57:01 analysis is fast and simple and does not require any in-depth molecular biology knowledge. Gene sections are first amplified from the samples by multiplex polymerase chain reaction (PCR). The use of whole blood as starting material significantly reduces the costs and hands-on time required. The PCR products are then incubated with Biochip microarray slides containing immobilized complementary DNA probes. Results are evaluated and interpreted fully automatically by specialized software (EUROArrayScan). Meticulously designed primers, ready-to-use PCR components and integrated controls all contribute to the reliability of the analysis. In studies using precharacterized samples, the microarray demonstrated 100% sensitivity and 100% specificity. Abacavir is an important chemotherapeutic agent for the treatment of HIV patients. Nevertheless hypersensitivity reactions occur in 48-61% of Caucasian, 8-16% of black African and 20-22% of Hispanic carriers of the HLA-B*57:01 allele undergoing treatment, compared to 0-4% of non-carriers. Therefore, all HIV-infected patients, regardless of their ethnicity, should be tested for the presence of the HLA-B*57:01 allele before starting treatment with drugs containing abacavir sulphate (e.g. Ziagen tablets and suspension, Kivexa tablets and Trizavir tablets).
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New stabilizer for urine specimens
, /in Product News /by 3wmediaThe stabilization of urine is most important if the specimen cannot be analysed within two hours. A particular problem is exponential bacterial growth, since certain bacteria divide every 20 minutes. This can lead to an overgrowth of pathogenic bacteria, making detection difficult. Furthermore, the lysis of cells is accelerated in native urine at room temperature, altering the concentration of various analytes constantly. This problem is essential for longer transportation and processing times. It has been shown, that on average 15% of urine samples intended for urine culture are contaminated. Some additives that may have been used up to now for stabilization have proven not to be optimal, as oft en the additive does not dissolve quickly or fully. The new Vacuette Urine CCM tube contains a stabilizer in powder form, which keeps the urine sample stable for up to 48 hours at 20 – 25°C. During this time period, the urine specimen can be stored or transported without refrigeration. All mandatory and facultative uropathogenic bacteria can be stabilized and reliably detected in the Vacuette Urine CCM tube for up to 48 hours. A particular advantage is the high solubility of the stabilizer in powder form. By inverting the tube several times, the urine mixes completely with the stabilizer additive, ensuring quick stabilization of the urine sample. The tube can be used for urine screening (strip test, sediment, clinical chemistry) and/or for microbiology, since sample stability is guaranteed for up to 48 hours. The extensive application in urine diagnostics makes daily routine work easier and more efficient: one urine sample for a broad range of determinations. This is not only an advantage for medical staff but also for the patient. Made from shatter-proof, highly transparent PET plastic, the Vacuette Urine CCM tube with safety cap is user-friendly as it is especially easy to open. This allows for a hygienic operating method, with no risk of splashes or aerosols.
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Point of care lysine analyser
, /in Product News /by 3wmediaAmino Sign is a point of care analyser to measure lysine easily and quickly. Lysine, or L-lysine, is an essential amino acid. That means it is necessary for human health, but the body can’t manufacture it, so the only sources are dietary, including supplements. Amino acids like lysine are the building blocks of protein. Lysine is important for proper growth, and it plays an essential role in the production of carnitine, a nutrient responsible for converting fatty acids into energy and helping to lower cholesterol. Lysine appears to help the body absorb calcium, and it plays an important role in the formation of collagen, a substance important for bones and connective tissues including skin, tendon, and cartilage. Most people get enough lysine in their diet, although athletes, vegans who don’t eat beans, as well as burn patients may need more. Not enough lysine can cause fatigue, nausea, dizziness, loss of appetite, agitation, bloodshot eyes, slow growth, anemia, and reproductive disorders. For vegans, legumes (beans, peas, and lentils) are the best sources of lysine. Amino Sign uses the Lysine Card test strip in a 4-step procedure to measure lysine concentration in whole blood specimens. Sample volume is 5μL and the test is performed in two minutes. The pocket size analyzer’s dimensions are 115x58x20mm.
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Portable blood gas and chemistry analyser
, /in Product News /by 3wmediaThe EDAN i15 portable blood gas and chemistry analyser is specifically designed for quickly measuring various panels of time sensitive tests in critical care settings, e.g. emergency room, intensive care units, anesthesia, respiratory and the operating room. The key features and advantages of the state of the art system include zero maintenance, automatic aspiration of sample, colour graphic display and touch screen intuitive user interface, on-board 2D barcode scanning for patient ID, operator ID, cartridges and QC control information and WIFI network connectivity to HIS/LIS facilities, making it an ideal solution for point of care testing.
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Mass spectrometry analyser for hospitals and diagnostic laboratories
, /in Product News /by 3wmediaThe new AB SCIEX IVD-MS analyser provides a combination of the high sensitivity and selectivity of mass spectrometry (MS) technology and the molecular separation power of liquid chromatography (LC) with a technicianfriendly, intuitive interface. The new SCIEX ClearCore MD Software provides streamlined data processing, reporting and review functionality. This will help make the adoption of LC/MS/MS for routine analysis significantly easier. The ClearCore software enables quantitation and data exploration without the need for additional software packages. It provides simple method development tools with separate LC and MS method editors. It also provides customizable access to modules based on user security levels, including routine users, method developers, data reviewers and administrators, so personnel is only able to access approved modules. This software drives the workflow that utilizes the power of the analyzer. The new IVD-MS analyser joins the company’s growing line of in vitro diagnostic devices for certain European countries, including the AB SCIEX 3200MD CE-IVD series of MS systems. The intended use of this CE marked, regulatory-compliant device is to identify inorganic or organic compounds in human specimens for clinical use, providing routine diagnostic testing laboratories in certain countries in Europe with the ability to quantitate multiple trace level compounds in a single analysis with high confidence in the results.
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Non invasive test for fetal trisomies
, /in Product News /by 3wmediaAs Europe’s first non-invasive molecular diagnostic blood test for the determination of fetal chromosomal aneuploidies from maternal blood, PrenaTest has now successfully been validated for use in multiple pregnancies. It is the only blood test that can be used without any restriction following all methods of fertility treatment, such as IVF or egg donation, after the 9th week of gestation. The number of multiple pregnancies has steadily increased over the last years due to an increased use of fertility treatments especially with women of higher age. For these, PrenaTest is a valuable and risk-free improvement for the determination of fetal chromosomal aneuploidies given the significantly increased risk for miscarriage following an invasive diagnostic procedure like amniocentesis, compared to such risk in case of singleton pregnancies. In addition, conventional non-invasive examinations such as first trimester screening show a two to three fold increase with respect to the false positive rate. In addition, the innovative PrenaTest express is now available in other European countries, too. Th is express version of the PrenaTest provides the test results in one week and thus shortens the stressful waiting period for pregnant women to a minimum. PrenaTest determines the fetal trisomies 21, 18 and 13 from maternal blood reliably, rapidly and safely. It has successfully been validated in a total of 870 samples from singleton and multiple pregnancies in several studies and provides a clear result in 99.8 % of all performed analyses. With its low false positive rate of 0.1% it further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. PrenaTest is for pregnant women who are in the 9th week of gestation (W 9 + D 0) and who have an elevated risk of trisomies in the unborn child. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis. The PrenaTest analysis is exclusively performed in Germany (Constance) in strict compliance with the high quality standards required by the European In Vitro Diagnostic Directive.
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Sample collection tube capping system
, /in Product News /by 3wmediaA post-analytical capping solution has been introduced for sample collection tubes containing blood or urine that require secure storage for several days in case additional tests need to be done. Blood and urine analysis are two of the most important diagnostic tools available to clinicians testing for evidence of infection, disease or abnormalities. Typically blood and urine is collected in vacuum tubes before being sent to a hospital laboratory for testing. After these analytical tests, the vacuum tubes need to be stored for several days in case additional tests need to be performed. Designed in conjunction with healthcare professionals, Novitain TPE Push Caps off er an ideal solution for the secure short-term sealing of 13mm diameter sample collection tubes in a 50-tube format. These caps are manufactured from a chemically resistant medical grade hydrophobic polymer to ensure stored sample integrity. Novitain Capcluster-50 offers a rapid and economical solution for capping 50 individual sample tubes using the Novitain Manual Capper CV750. Th e Novitain Manual Capper CV750 operates as a stand-alone device that is very easy to use. To operate, the Novitain Capcluster- 50 is placed on the racked sample tubes, the rack is placed into the Novitain Manual Capper CV750 rack entrance and with a simple forward / reverse action of the black handle all 50 tubes are evenly capped. After capping 50 sample tubes in two seconds, the Novitain Capcluster-50 retaining foil can be simply removed to leave each tube individually securely capped. Each tube can be easily opened again using the tab attached to each cap without the need for additional tools.
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Total hCG (5th IS) assay
, /in Product News /by 3wmediaHaving recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, the Access Total βhCG (5th IS) assay is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for chorionic gonadotropin, a glycoprotein hormone most commonly measured for pregnancy determination. The assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment which could potentially be harmful to a fetus. The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that cover women over the age of 40 and post-menopausal women. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, the Total βhCG (5th IS) assay has been improved to make it more resilient to pre-analytical factors. Access reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
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