REQUEST FOR INFORMATION: Equipment and reagents for the analysis of biological drug assays

The aim of this request for information is to find out the availability of equipment and reagents for the analysis of biological drug assays. The procurement unit aims to obtain comprehensive information of equipment, reagents, supplies and/or instrumentation including maintenance service and technical support available. This information may be used in a possible future call for tenders. The equipment that fulfills the need should meet the following requirements: - Random access analyzer - Analyzer and reagents have a CE-IVD mark. If not, are these under the CE-IVDR process, and what is the estimated time for the CE-IVDR approval? - Quantitative analyses Mandatory analytes (to be analyzed with same analyzer): - Infliximab, concentration from serum (approximately 2500 samples per year) - Adalimumab, concentration from serum (approximately 1100 samples per year) - Vedolizumab, concentration from serum (approximately 500 samples per year) - Ustekinumab, concentration from serum (approximately 300 samples per year) Optional analytes (must be analyzed with same analyzer as mandatory analytes listed above): - Golimumab, concentration from serum (approximately 150 samples per year) - Golimumab anti-drug antibodies from serum (approximately maximum 50 per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. - Infliximab anti-drug antibodies from serum (approximately 200 samples per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. - Adalimumab anti-drug antibodies from serum (approximately 200 samples per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. - Vedolizumab anti-drug antibodies from serum (approximately maximum 50 per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. - Ustekinumab anti-drug antibodies from serum (approximately maximum 50 per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. - Etanercept, concentration from serum (approximately maximum 50 per year) - Tocilizumab, concentration from serum (approximately maximum 50 per year) - Tocilizumab anti-drug antibodies from serum (approximately maximum 50 per year). Specify, is this test measuring free anti-drug antibodies, total anti-drug antibodies, or are both assay types (free and total) available. In addition to the questions already asked above, market participants are asked to provide the following additional information about available solutions: 1) Primary measuring range for each analyte 2) Duration of the measurement (minutes) for each analyte 3) If the result is over the measuring range, describe the dilution protocol: a) Is it possible to set automated dilutions in the instrument? b) Is it possible to set dilution factors in the instrument (in case of manually diluted sample)? 4) Is it possible to set automated reflex rules in the instrument (reflexing another test)? 5) Describe the traceability of the calibrators for each analyte 6) LIS connection: Is there one-way or two-way LIS connection available? 7) Is there a possibility to export patient and QC results to a USB memory stick in a readable format? 8) Sample loading: a) Does the instrument aspirate samples from the primary sample tube (e.g. 5 ml serum separation tube)? b) Is sample preparation required before sample loading (e.g. predilution or transferring to a specific cup/tube)? 9) Sample volume for each analyte: a) Normal required volume b) Minimum required volume (e.g. microtubes / pediatric tubes) 10) Calibration frequency for each analyte 11) Describe the recommended quality control frequency for each analyte 12) Does the instrument allow using third-part QC-products for quality control? 13) Is it possible to modify target values / limits for QC material on the instrument? 14) Describe reagent stability (opened and unopened) for each analyte. 15) Does the instrument require user maintenance? If yes, describe the required maintenance and its frequency (daily, weekly etc.). 16) What is the recommended frequency for periodic maintenance? 17) Is service available in Finland? If yes, specify how many certified service engineers are available in Finland and describe the service organization. 18) Is each assay validated for different biosimilars (relating to mandatory and optional analytes)? a) If yes, list the tested biosimilars and describe the observed bias (%). b) If yes, attach any available testing data. 19) Attach the assay menu of the instrument. 20) Estimated price for two instruments (annual sample amounts should be considered in instrument selection). 21) Purchase options – are instruments rented or price per test? Describe different purchasing options. 22) Mention the name and model of the instrument and country of manufacture. 23) Attach a brochure of the instrument Answers to this request for information are asked to be sent by e-mail to [yhteystieto: katso alkuperäinen ilmoitus], at the latest on March 10th 2025. The procurement unit also reserves the opportunity to organize market dialogues with the market participants who responds to this request for information. 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 prior information notice does not obligate the procurement unit for any actions. All information presented in this prior information notice is preliminary and indicative. The suppliers are not paid for responding to this request for information or participating in a possible technical dialogue.