Developed for easy and reliable measurement of glycated hemoglobin (HbA1c) used in the detection and management of diabetes, the Quo-Test analyser, which is awaiting FDA clearance with a launch expected early in 2013, will be sold in North, Central and South America by Stanbio Laboratory acquired by EKF Diagnostics in May 2011. Quo-Test enables clinicians to make a rapid determination of diabetes management , thereby improving patients’ experience, thanks to the fast and accurate results obtained from the machine in just four minutes from 4μl of blood from finger prick or venous sample. The user-friendly device has a multi-lingual menu and allows for efficient data handling, with a barcode reader and storage of up to 7,000 results, which can be downloaded to a computer via a USB port. Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT): a simple, fast and accurate method, based on the well-documented boronate affinity for glycated hemoglobin, which is not affected by hemoglobin variants. Although Quo-Test has been developed to be used in a point of care setting, it is a professional product providing laboratory level accuracy, reporting its results in IFCC and DCCT standards (Mono S & JDS reporting are also available). The CE-marked analyser has been approved by China’s SFDA for the monitoring of HbA1c in diabetes patients.
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S100A11 ELISA
, /in Product News /by 3wmediaS100A11 (S100C, Calgizzarin) is a Ca2+-binding protein of the S100 family that has been implicated in the regulation of cytoskeletal function through its Ca2+-dependent interaction with annexin I. S100A11 has been found in many different human tissues, both normal and cancerous. S100A11 appears to play distinct roles depending on the tumour involved. In bladder carcinoma or renal carcinoma, its expression is related to tumour suppression, however in prostate cancer, breast and pancreatic cancer, S100A11 is thought to be a tumour promoter. S100A11 may be a potential biomarker of infective endocarditis. Recently, increased S100A11 concentrations have also been found in patients with pulmonary diseases – COPD, idiopathic pulmonary fibrosis (IPF) and sarcoidosis. The assay has been validated to measure S100A11 in serum, bronchoalveolar lavage fluid and amniotic fluid. The 96 well-microtitre plate format ensures the applicability on standard ELISA equipment or robotic systems.
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4-channel coagulometer
, /in Product News /by 3wmediaProviding an efficient solution for low to medium-volume hemostasis laboratories, the Coag4D instrument is a compact, lightweight, manual 4-channel coagulometer designed to include everything that could be improved in its category: it is extremely user-friendly due to its large-sized and robust touchscreen; it has an easy to follow „traffic light guidance system” for error-free sample and test handling, and barcode reading for samples, reagents and test specific parameters with LIS connection through both USB and serial ports. Coag 4D offers the advantages of photo-optical clot detection by turbodensitometry and combines nephelometry and photometry in one instrument. Moreover, it can be conveniently used for D-Dimer testing. The instrument has excellent analytical performance for clotting and immunological assays with a throughput of up to 50 PT/hour used in quick mode with 4 independent channels. The coagulometer comes with a complete reagent system including PT / aPTT both in liquid and lyophilized formats, TT / Fib tests, bi-level controls and calibrator. Additional tests and special tests can be easily configured and adapted on the instrument, further assisted by an automated internal sensitivity setting. The Coag4D system is available both for distribution and customized OEM cooperation.
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PCR Kit for Dermatophytes and Tricophyton rubrum
, /in Product News /by 3wmediaNail infections are caused by dermatophytes, most commonly by Trichophyton rubrum, followed by Trichophyton mentagrophytes. As onychomycosis requires long-term systemic antifungal treatment, the correct identification of causal fungi is mandatory. The time required for traditional species identification by culture ranges from two to four weeks. With SSI™ Dermatophyte PCR Kit dermatophytes, and T. rubrum specifically, can be detected within five hours. Also, a study has showed that this multiplex PCR method increases the detection of pan-dermatophytes by 4.3% and T.rubrum by 18.6% compared with conventional methods (Brillowska-Dabrowska A, et al. Jour Clin Microbiol 2007; 1200). Hence SSI® Dermatophyte PCR Kit is a time- and cost-effective alternative. SSI® Dermatophyte PCR Kit is CE-marked. It contains all reagents and controls needed to perform a multiplex PCR detection of dermatophytes causing fungal infections in nails. It comes in boxes with material for 100 tests.
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Customized services for IVD industry
, /in Product News /by 3wmediaMedixMAB Services cover recombinant antibody development, contract manufacturing of antibodies, antibody conjugation and coating of microplates. MedixMAB by Design is a customized recombinant antibody production service that off ers a possibility to produce customized next generation antibodies. With MedixMAB recombinant antibodies the affinity is improved and cross reactions with existing monoclonal antibodies are reduced. MedixMAB by Design utilizes phage display libraries and human retinal cell line for flexible monoclonal antibody production. MedixMAB manufacturing is a contract manufacturing service that enables the outsourcing of antibody manufacturing in a more efficient and economical way. It is based on a specially developed streamlined process for the production of monoclonal antibodies in vitro utilizing hollow fibre technology. MedixMAB Coating & Conjugation offers monoclonal antibodies coated with HRP or AP enzymes and microplates coated with desired antibodies.
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Total Bile Acids
, /in Product News /by 3wmediaThe testing of Total Bile Acids is a valuable diagnostic tool for patients with acute hepatitis, chronic hepatitis, hepatic sclerosis and hepatic cancer. In this kind of patients, Total bile acids are increased in serum. When the enterohepatic circulation system is impaired, blood levels of bile acids are increased as a result of diminished hepatic elimination of bile acids from the portal blood, which results from diminished hepatic clearance. Therefore, serum or plasma bile acids levels is a sensitive indicator of liver function in all species, reflecting both hepatic synthesis as well as secretory and re-absorptive functions. Th e Total Bile Acids kit of BioSystems S.A. uses the enzymatic cycling method measured colorimetrically (bireagent fixed time). Although the kit includes an aqueous standard, the use of the company’s Biochemistry Calibrator is recommended.
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HbA1c near patient analyser
, /in Product News /by 3wmediaDeveloped for easy and reliable measurement of glycated hemoglobin (HbA1c) used in the detection and management of diabetes, the Quo-Test analyser, which is awaiting FDA clearance with a launch expected early in 2013, will be sold in North, Central and South America by Stanbio Laboratory acquired by EKF Diagnostics in May 2011. Quo-Test enables clinicians to make a rapid determination of diabetes management , thereby improving patients’ experience, thanks to the fast and accurate results obtained from the machine in just four minutes from 4μl of blood from finger prick or venous sample. The user-friendly device has a multi-lingual menu and allows for efficient data handling, with a barcode reader and storage of up to 7,000 results, which can be downloaded to a computer via a USB port. Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT): a simple, fast and accurate method, based on the well-documented boronate affinity for glycated hemoglobin, which is not affected by hemoglobin variants. Although Quo-Test has been developed to be used in a point of care setting, it is a professional product providing laboratory level accuracy, reporting its results in IFCC and DCCT standards (Mono S & JDS reporting are also available). The CE-marked analyser has been approved by China’s SFDA for the monitoring of HbA1c in diabetes patients.
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Smartphone-based lateral flow reader
, /in Product News /by 3wmediaSkanSmart promises to accelerate uptake of POC in the field testing, as well as hospital, clinic and doctors office settings, since its proprietary soft ware platform enables rapid handheld reading of existing commercially available flow assay formats. Utilizing Skannex patented image analysis and barcode software technology, users read simple yes/no, semi or fully quantitative results. Results can be printed wirelessly, emailed or downloaded to HIS systems. Infectious Disease, STD and Drugs of Abuse testing are immediate potential beneficiaries. Skannex has already introduced a series of well-received desktop readers over the last 3 years, including SkanMulti and SkanFlexi. The company aims to market the device to lateral flow manufacturing companies, providing a portable device for their proprietary assays.
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Coagulation analyser
, /in Product News /by 3wmediaSTA Compact Max®, the new generation Stago analyser, delivers accurate and timely answers to clinicians while helping laboratories to cope with economic and functional challenges by improving efficiency both operationally and environmentally. Its reliability enables this multiparametric system to operate optimally in every situation, including in highly demanding environments in terms of workload and volume testing. Its ergonomic and graphical user interface ensures a seamless integration in the lab. Furthermore, the new additional expert module will provide standardized results with fast turnaround time. Designed for mid-volume throughput laboratories, the instrument is suitable for routine and specialty assays. It offers viscosity-based (mechanical) detection system for clotting assay, chromogenic and immunological testing, extended sample, reagent and disposable loading capacities, true STAT management and high traceability. A wide range of dedicated reagents, quality controls and calibrators is available.
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Vitamin D analysis
, /in Product News /by 3wmediaImmundiagnostik AG offers a comprehensive test panel for the analysis of vitamin D in research and daily routine. ELISA, HPLC and LC-MS/MS tests enable the reliable determination of the analytes 1,25-(OH)2 vitamin D and 25(OH) vitamin D. The ImmunoTube® LC-MS/MS kit features a superior sample preparation that allows the precise analysis of 1,25-(OH)2 vitamin D3 and D2 in serum or plasma with high specificity and sensitivity and without ion suppression by interfering matrix components. This fast, robust and accurate detection method can be used on commercial high-end instruments. The 25(OH) vitamin D Xpress ELISA accomplishes a convenient and precise status determination in less than three hours. This automatable test quantitatively measures 25(OH) vitamin D in serum, even in small sample volumes. The protocol does not require overnight incubation or cooling, making the assay most suitable for vitamin D status analysis in daily clinical routine.
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Fully automated fecal calprotectin test
, /in Product News /by 3wmediaEliA Calprotectin is the first fully automated test for fecal calprotectin helping to differentiate inflammatory bowel diseases (IBD) from irritable bowel syndrome (IBS) and other functional bowel disorders. After stool extraction the test can be processed fully automated on four Phadia® Laboratory Systems (Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000), which meet the needs of laboratories of all sizes. This reduces the workload for the lab personnel, minimizes operational costs and optimizes the workflow. On top of this, EliA Calprotectin shows an excellent performance and provides results of high clinical usefulness. Because of its high sensitivity, the test can be used as a first-line test to rule out IBD, and can help to avoid unnecessary endoscopic procedures, while its high specificity assures a clear identification of IBD patients.
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