Stago has received approval from the US Food and Drug Administration (FDA) for the STA-Liatest D-Di reagent for the exclusion of pulmonary embolism (PE) in patients with low or moderate risk, presenting at an emergency unit. FDA requirements for D-dimer assays for exclusion are now based on the new and more restrictive standards established and published by the Clinical Laboratory Standards Institute (CLSI, H59-A). Stago’s rapid, automated and highly sensitive D-Dimer is the first test to comply with these new requirements. In order to comply with the new CLSI guidelines, the company performed a 2-years international prospective study similar to clinical studies performed in the pharmaceutical field (9 sites, 5 countries, more than 1100 patients, including evaluation of clinical pretest probability, imaging and 3 months of follow-up), a first in the field of hemostasis diagnostics. As its coordinator Prof. Gilles Pernod (Grenoble University Hospital, France) pointed out: “As well as providing the results required to validate this test for the exclusion of PE, this study brought to light some significant evolutions in clinical practice and shifts in prevalence. In fact, these findings will be presented in some interesting upcoming publications”. This study also confirmed the excellent diagnostic performance of the STA-Liatest D-Di assay, with a very high negative predictive value (NPV) for the exclusion of PE, far exceeding FDA requirements (>99.7% versus 97%), and excellent sensitivity (>97% versus 95%). The second part of this international clinical study, concerning deep vein thrombosis (DVT), is underway and due to be completed in the next few months.
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Allergy in-vitro diagnostics
, /in Product News /by 3wmediaPatients often show a wide range of varying symptoms and sensitization patterns against several allergens. Therefore diagnosing an allergic disease is always based on anamnesis, in-vivo testing and in-vitro diagnostics. In-vitro diagnostics in particular, i.e. the determination of specific IgE against the suspected allergens, are essential whenever an allergic response or severe reaction is suspected but furthermore also as a foundation for possible immunotherapy and its preparation. The preparation for immunotherapy requires the results of a quantitative test system like single allergen systems. These tests are expensive and need expensive laboratory equipment. With the RIDA qLine Allergy test, R-Biopharm AG has developed a sophisticated allergy in-vitro test system that combines both quantitative determination and very economic and easy handling.
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Blood gas sample collection system
, /in Product News /by 3wmediaLiquid electrolyte compensated-heparin secures the optimum quality of the blood gas sample during specimen collection. The basic version of the blood gas sample collection system is treated with ~ 50 I.U. anticoagulant. Further heparin concentrations are available on request. Applicable to and compatible with all common blood gas analyser types, the sample collection syringes are unbreakable for maximum safety and efficient laboratory work. They are available in different volumes of 1ml or 2ml and Luer-Slip connector style as well as in Luer Lock version with 2ml volume and are single packed in sterile blister packaging. Special accessories include the SC-AUTOSTOP-Cap to avoid contamination during sample collection.
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OXA-48 carbapenemase detection kit
, /in Product News /by 3wmediaInfections by carbapenemase-producing Enterobacteriaceae (CPE) are the cause of major public health concern worldwide and their detection is very challenging for diagnostic laboratories. Classical identifications need 48 to 72 hours with cultures and susceptibility testing followed by phenotypic and molecular methods. Development of new rapid diagnostic tests to track antimicrobial resistance patterns is considered as a priority core action. Non-molecular confirmatory testing of Class A (KPC) and B (VIM, IMP, NDM) carbapenemases already exists but not for detection of Class D carbapenemase (OXA-48-like). Phenotypic colorimetric assays are not able to confirm OXA-48 presence, while molecular tests need a dedicated environment, skilled staff and are expensive. Coris BioConcept has developed a new assay for identifying OXA-48 carbapenemase in collaboration with the CPE Belgian National Reference Centre of CHU Dinant-Godinne UCL. This test is performed directly from a single colony and represents the first non-molecular confirmatory assay for OXA-48 detection with results available in minutes.
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D-Dimer test meets new CLSI H59-A standards for exclusion of pulmonary embolism
, /in Product News /by 3wmediaStago has received approval from the US Food and Drug Administration (FDA) for the STA-Liatest D-Di reagent for the exclusion of pulmonary embolism (PE) in patients with low or moderate risk, presenting at an emergency unit. FDA requirements for D-dimer assays for exclusion are now based on the new and more restrictive standards established and published by the Clinical Laboratory Standards Institute (CLSI, H59-A). Stago’s rapid, automated and highly sensitive D-Dimer is the first test to comply with these new requirements. In order to comply with the new CLSI guidelines, the company performed a 2-years international prospective study similar to clinical studies performed in the pharmaceutical field (9 sites, 5 countries, more than 1100 patients, including evaluation of clinical pretest probability, imaging and 3 months of follow-up), a first in the field of hemostasis diagnostics. As its coordinator Prof. Gilles Pernod (Grenoble University Hospital, France) pointed out: “As well as providing the results required to validate this test for the exclusion of PE, this study brought to light some significant evolutions in clinical practice and shifts in prevalence. In fact, these findings will be presented in some interesting upcoming publications”. This study also confirmed the excellent diagnostic performance of the STA-Liatest D-Di assay, with a very high negative predictive value (NPV) for the exclusion of PE, far exceeding FDA requirements (>99.7% versus 97%), and excellent sensitivity (>97% versus 95%). The second part of this international clinical study, concerning deep vein thrombosis (DVT), is underway and due to be completed in the next few months.
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Urine microscopy analyser
, /in Product News /by 3wmediaThe UriSed mini is a professional semi-automated urine microscopy analyser producing whole fields of view microscopic images of urine sediment, and automatically classifying and counting urine sediment particles in the images. UriSed mini utilizes the traditional gold standard method while eliminating the most time-consuming and operator-dependent procedures in laboratories performing manual microscopy. In addition it can also serve as a backup instrument of automated sediment analysers. Main features include automatic identification of urine particles by the Auto Image Evaluation Module (AIEM); total measurement cycle of less than 1 minute; cost-effective operation without liquid reagents or calibrators. Easy to operate and requiring minimal training, the analyser is a highly effective tool in a wide range of medical and clinical settings.
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Dual cooling freezer range
, /in Product News /by 3wmediaA combination of technologies, such as the dual-cooling refrigeration system and VIP PLUS vacuum insulation, ensure that all biological samples are maintained securely in their optimum environment. The VIP Dual Cool models, which include the large capacity, 728 litre MDF-U700VX, are ideal for storing valuable samples for highly regulated applications within the biotech and pharmaceutical industries, stem cell research laboratories, tissue banks and blood transfusion centres. The freezers are able to maintain a reliable and uniform -86ºC ultralow temperature environment through the use of two independent refrigeration systems. Should one cooling system suffer an unexpected failure, the other circuit will keep samples safely in the -70ºC range until service can be arranged. The central door-mounted LCD display panel provides straightforward programming of set points and clear confirmation of freezer status.
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Automated IFA/ELISA/blot analyser
, /in Product News /by 3wmediaThis automated instrument for IFA, ELISA and Blot methods is able to run two ELISA micro-plates with 8 methods on board or 16 IFA slides, from sample pre-dilution, sample and reagent dispensing incubation and washing cycles as well as to the final ELISA reading and data processing. It is also able to carry out the full automated process for Dot/Western Blot. The software provides data recording and patient report.
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Fast and accurate hemoglobin analyser
, /in Product News /by 3wmediaExpanding the EKF range of point-of-care analysers, the DiaSpect Tm hemoglobin analyser is a palm-sized instrument that combines laboratory quality performance with unmatched measurement speed and a 10,000 test battery life. This reliable analyser can be used in any environment.
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Kit for steroid analysis by tandem mass spectrometry
, /in Product News /by 3wmediaChromsystems has introduced a complete solution that enables laboratories to perform steroid analysis efficiently without the need of high-end instrumentation. MassChrom Steroids in serum/plasma allows the determination of 13 steroids by LC-MS/MS with one single column. The sample preparation is the same for both steroid panels, using an optimized and efficient clean up procedure in 96 SPE well plates. The parameters that can be analysed with the kit include the clinically most important steroids. The use of stable isotope-labelled internal standards for every single analyte ensures reproducible and reliable quantification of the steroids. The new steroid kit is available with the analytical column for all parameters together with 6PLUS1 Multilevel Calibrator Sets and MassCheck Controls.
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Cholesterol testing system
, /in Product News /by 3wmediaDesigned for in vitro professional and self-testing, the Mission Cholesterol Monitoring System includes individual test devices and a 3-1 lipid panel test device which tests for Total Cholesterol (CHOL), High Density Lipoprotein (HDL), Triglycerides (TRIG), and also calculates Low Density Lipoprotein (LDL), CHOL/HDL ratio, and Cardiac Risk Assessment. Results are provided in as little as 45 seconds with a required specimen size of 35 µL. Other features include a large LCD display for easy reading and 200 test memory with Date/Time. The system is CE-marked for professional and OTC sales in Europe and other international markets. It is well suited for use in physician offices, homes, community health centres, hospitals, public and private labs, and pharmacies. Patients and home users will be able to better monitor their cholesterol levels in order to reduce the risk of heart disease, strokes, and heart attacks.
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