The Genspeed C.diff OneStep test identifies toxigenic C. difficile by combining detection of Glutamate Dehydrogenase (GDH), Toxin A, Toxin B and binary toxin in a single, molecular diagnostic test. The complete analysis including the detection on the Genspeed R2 analyser takes under 100 min. The new test addresses one of the most serious threats to healthcare systems worldwide, Clostridium difficile infection (CDI), which is believed to be the most common healthcareassociated infection. The disease is causing antibiotic-associated diarrhea (AAD) that may lead to pseudomembranous colitis and even to death. In a 2013 pub-lished report, the Center for Disease Control (CDC) in the USA categorized C. difficile infections as “Threat Level Urgent”, the highest level available. The Genspeed C.diff OneStep test features a simple, one-step molecular diagnostic test, avoiding the currently used sequential 2-step diagnostic test procedures which combine different test systems and assay principles for GDH and the C. difficile toxins. The rapid test provides conclusive results without the need for confirmatory re-testing and enables inter-laboratory comparisons of test results. Ready-touse reagents and automated dispensing minimize the number of manual process steps within the workflow. The Genspeed R2 analyser represents a reliable solution for customers interested in fast and accurate results. The virtually service-free system is simple to operate and is available at an attractive cost-benefit ratio. Genspeed products are currently available for sale in the EU and EFTA countries only. Availability in other countries outside the US is on request.
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The new PlasmaPrep-12 centrifuge is suitable for use in both the hospital and laboratory. It is designed for STAT serum/plasma separation and is perfect for coagulation studies. Enabling fast blood separation and easy to use, it is controlled by a microprocessor with four pre-programmed spin times. These include the Platelet Poor Plasma mode providing serum or plasma separations in three minutes and the Platelet Rich Plasma mode providing platelet rich plasma in just 30 seconds.

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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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Designed for high volume laboratories, the STA R Max is an innovative and scalable analyser that can be adapted to any lab organization, whether or not it is connected to an automation track system. It brings productivity and reliability to laboratories for their routine and specialized hemostasis assays. The analyser offers the highest loading capacities to enhance walkaway capabilities: 215 samples, 70 reagent positions, 1000 cuvettes on board. True STAT management ensures fast turnaround time (TAT). Autoverification capabilities are built-in and a TAT report helps monitor performances. Ready to operate 24/7, the analyser does not require time to restart. A new hardware design enhances ergonomics while the intuitive user interface ensures seamless integration for laboratory staff . The extended traceability function meets quality requirements. Innovative services include accreditation support and remote diagnosis. The viscosity-based (mechanical) detection system enables immediate delivery of accurate and precise results. Advantages include insensitivity to any type of coloured plasma, maximum precision for weak clot detection and standardization between Stago systems. The environmentally friendly design provides savings because of the use of a limited and contained fluidic waste system and the reduction of disposable waste (1 cuvette = 1 test). All common tube sizes are accepted with automatic positioning of barcode. A wide range of dedicated reagents, quality controls and calibrators is available, offering maximum sensitivity and reproducibility for all tests.
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