Mainz, Germany – ORGENTEC offers efficient tools for routine quality control of Alegria® assays in autoimmune disease diagnostics.
The regulatory requirements for quality control in the laboratory are constantly increasing. ORGENTEC now offers a selection of control reagents for monitoring the performance of the Alegria® system that help the laboratory to meet these requirements. ORGENTEC has established a cooperation with the French IVD company Theradiag to produce these reagents for daily quality control in the autoimmunity lab.
Autoimmune Controls for Alegria® are multi-parameter-specific, each control reagent contains a selection of specific biomarkers for diagnosis in special clinical indication areas of autoimmune diseases: rheumatology, thrombosis, vasculitis or celiac disease. Seven sets are available, covering 15 of the most important autoimmune parameters.
The controls are validated on the Alegria® system and adjusted to show a clearly positive reaction with the matching autoantibody test kit. The user determines their own laboratory-specific target values for the measurement process and the permitted range of deviation in accordance with current applicable guidelines.
The controls are ready-to-use and can be applied directly in the Alegria® device, to validate the diagnostic performance and to monitor the function of the Alegria® system in everyday laboratory work. Each kit contains two vials á 500 µl of the ready-to-use reagents – each individual measurement requires only 10 µl of the control serum. The control reagents are stable for up to 24 months (IgG sera) or up to 12 months (IgM sera).For more information click on the picture below to download the product brochure:
About ORGENTEC
Headquartered in Mainz, Germany, ORGENTEC Diagnostika offers one of the industry’s most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease and organ function testing. Alegria®, the automated instrument for autoimmune and infectious disease serology enables labs to complete multiple assays and deliver faster results at minimum cost. With subsidiaries in Austria, Hungary, France, U.S. and China, as well as an established global network of distribution partners, ORGENTEC’s products are benefitting patients in over 100 countries around the world.
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