IF Automation System for Autoimmune Serology

Immunofluorescence automation system for autoimmune serology IF examinations: Automation of staining, imaging, and analysis of autoantibody determinations from patient sera using immunofluorescence. The system must comply with Regulation (EU) 2017/746 (IVDR), be CE-marked, and capable of analyzing at least the following IVDR-compliant tests: ANA, ANCA (EtOH and formalin), EMA IgA and IgG, rat LKS (liver-kidney-stomach), and Crithidia luciliae. It must analyze at least three different tests simultaneously in combination series, with results analyzable per test and individually transferable to the laboratory information system. Finnish-language user training and a service organization are required. The system must automatically recognize patient sera via barcode and be compatible with the HL7-based My+ laboratory information system. It performs sample dilution and application to commercial substrate slides (cell and tissue substrates), sample incubations on slides, secondary antibody application, all washing steps, and mounting medium pipetting. The automation system covers the essential work steps of autoantibody determinations according to the IF protocol, from patient serum dilutions and microscopy slide staining to imaging and computer-based result analysis. The analysis software must display patient data and previous IF results on the same screen in the analysis view. The direct award is made according to § 40 para. 2 no. 2 of the Finnish Procurement Act, as only Reagena Oy's UNIQO 160 meets all requirements and no alternative solutions are available. The contract duration is fixed from September 1, 2026, to August 31, 2030, and then extends indefinitely.

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