Finland - Laboratory, optical and precision equipments (excl. glasses) - REQUEST FOR INFORMATIONS: Luminex -based assay for HPA antibody detection

The purpose of this request for information (RFI) is to gather details and cost estimates related to: (1) the Luminex based assay, which detects at least IgG antibodies to Human Platelet Antigen (HPA-1, -2, -3, -4, -5, GPIV) and Human Leukocyte Antigen (HLA) Class I in patient serum samples. The analysis is based on detecting patient antibodies against platelet glycoprotein epitopes and differentiating the patient antibodies against different HPA alleles (a and b) in HPA-1, -2, -3, -4 and -5. In the test the binding of the patient IgG class antibodies against different epitopes coated on the beads is detected by fluorophore -conjugated antibody. The sample is analyzed on Luminex instrument with specialized software that interprets the results as negative or positive against specific antigen and/or allele. (2) Luminex instrument, needed accessories and software for detecting the above-described IgG HPA-1, -2, -3, -4 and -5 antibodies in addition to IgG antibodies against GPIV and HLA Class I. The goal is to gather comprehensive information about available assay kits CE-IVDD/CE-IVDR compliant, the accessories needed and Luminex instruments to facilitate a future call for tenders in the most appropriate manner. This request for information is not a call for tenders but aims to gather information and knowledge of the mentioned assays in the market. This notice does not obligate HUS procurement unit for any actions. The suppliers are not paid for responding to this request for information or participating in the possible technical dialogue. Background Information on the Procurement: The Joint Authority of the Helsinki and Uusimaa Hospital District (HUS) is the largest healthcare operator in Finland and HUS Diagnostic Center is responsible for providing diagnostical services, both laboratory and imaging, for 2,2 million inhabitants. The Helsinki University Hospital is also responsible for providing treatment for rare diseases or diseases that require demanding treatment for patients all around the country. The hemostasis and platelet laboratory of HUS Diagnostic Center serves the whole country of Finland for special analytics. The members of HUS are the city of Helsinki and the four well-being services counties of Uusimaa: Western Uusimaa, Central Uusimaa, Eastern Uusimaa, and Vantaa-Kerava, and it employs approximately 27,000 professionals. The annual turnover of HUS is approximately three billion euros. HUS Logistics is part of the Joint Authority of the Helsinki and Uusimaa Hospital District organization. The Department acts as the joint procurement unit of the joint authority. It is responsible for the provision of procurement and logistics services and the availability of medical supplies, also during a crisis. More information about HUS and its operations can be found at www.hus.fi. HUS Diagnostic Center’s Division of Clinical Chemistry is exploring options for performing (1 and 2) Luminex -based assay performed with Luminex instrument for detecting antibodies against platelet glycoproteins and against specific alleles as well as Class I HLA antibodies in patient samples for future procurement. Now, detection and identification of patient serum IgG antibodies against platelet glycoproteins is performed manually by in-house sandwich binding, MAIPA assay (monoclonal antibody-specific immobilization of platelet antigen). In addition, autoantibodies against patient’s own platelet glycoproteins and crossmatch analyses with two patient blood samples are analyzed with MAIPA assay are performed as requested in our laboratory almost weekly. The analyses are used for diagnosing FNAIT/NAIT (fetal and neonatal alloimmune thrombocytopenia), refractoriness to platelet transfusions and ITP (immune thrombocytopenia). Analyses are performed at the HUS Diagnostic Center’s Automation Laboratory in the HUSLAB building in Helsinki. The procurement may include: - CE-marked kit for detecting IgG antibodies to at least Human Platelet Antigen (HPA-1, -2, -3, -4, -5, GPIV) and Human Leukocyte Antigen (HLA) Class I in patient serum samples, reagents including controls and calibrators and device-specific accessories, Luminex instrument with software, periodic maintenance, necessary spare parts and accessories, technical support, possible software updates (maintenance contract if necessary), and product training if needed. - Necessary workstations and software must be available. The yearly number of patient samples for NAIT analysis has been about 20, the number of platelet glycoprotein autoantibody tests has been about 20 and we have analyzed about 6 platelet refractory patient samples per year. In the annex 1 "Questions" the procurement unit has presented questions about the object of this RFI. The procurement unit inquire your views on these matters. Responses to this RFI should include replies to the questions presented in the Annex 1. The answers to this request for information are asked to be sent by e-mail to kilpailutus.diagnostiikka@hus.fi, at the latest on September 19th 2025.