The target of the procurement is immunofluorescence automation equipment for autoimmune serology (IF) studies. The purpose of the procurement is to automate the staining, imaging and analysis of autoantibody assays from patient serums using the immunofluorescence method. The equipment to be purchased shall comply with Regulation (EU) 2017/746 of the European Parliament and of the Council (‘IVDR’). The device must bear the CE marking required by the IVDR, which is suitable for the intended purpose of the purchase. The apparatus shall be capable of analysing at least the following tests in accordance with the IVDR: ANA, ANCA (EtOH and formalin), EMA IgA and IgG, rat LKS (liver-kidney-stomach), and Crithidia luciliae. The apparatus shall be capable of analysing at least three different tests at the same time, i.e. a series of combinations. In combination series where several tests have been run at the same time, it must be possible to analyse the results on a case-by-case basis so that the results can be sent to the laboratory information system one sample at a time. For example, in a situation where ANCA and ANA samples have been run in the same series, ANCA samples should be able to be analysed as a separate entity without the need to analyse ANA samples or ANA controls at the same time. This is essential for the operation, as the combination series may include urgent samples, the results of which must be able to be reported as soon as the series is completed. A Finnish-language user training and maintenance organisation must be available for the equipment to be purchased. The system of the device shall automatically identify the patient sera to be examined based on the barcode, and the device shall be compatible with the My+ laboratory information system that uses the HL7 communication connection. The system shall perform the dilution and application steps of the samples for commercial substrate glasses, such as cellular and tissue substrates. In addition, the system must perform the incubation of samples with sample glasses, the application of secondary antibody samples, all washing steps and the pipetting of mounting medium. The automation system should cover the key steps of autoantibody assays according to the IF protocol, from dilution of patient serums and staining of microscope glasses to imaging and computer-based analysis of results. In the analysis software, the patient's data and the patient's previous IF results must be visible on the same screen in the results analysis view. Based on the market survey conducted by the contracting entity, only Reagena Oy's UNIQO 160 device fulfils all the absolute requirements set for the procurement. The basis for direct award is Section 40(2)(2) of the Procurement Act. According to that provision, direct procurement is possible if, for technical reasons or reasons connected with the protection of exclusive rights, the procurement can be carried out only by a particular supplier. It is also required that there are no reasonable alternatives or substitutes and that the absence of competition is not the result of an artificial narrowing down of the terms of the contract. The contract is valid for a fixed term from 1.9.2026 to 31.8.2030, after which the contract will continue for an indefinite period.
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