REQUEST FOR INFORMATION: CE-IVDD or CE-IVDR compliant test for automated serum clozapine

The aim of this request for information: The aim of this request for information is to find out the availability of fully automated, CE-IVDD or CE-IVDR compliant assays for serum clozapine. We aim to obtain comprehensive information of assay kits including eventual technical support available. This information may be used in a possible future call for tenders. 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. This notice is not binding on any kind of solutions or actions. The suppliers are not paid for responding to this request for information or participating in a possible technical dialogue. Background information of the request: The Joint Authority of the Helsinki and Uusimaa Hospital District (HUS) is a joint authority consisting of 24 municipalities. It is the largest health care operator in Finland. HUS is responsible for providing specialized care services for member municipalities and their residents. Nearly half a million patients are treated at HUS hospitals and clinics annually. The Helsinki University Hospital (HUH) is part of HUS. It is responsible for providing treatment for rare diseases or diseases that require demanding treatment for patients in the Helsinki University Hospital Specific Catchment Area, and in some cases, patients from all around the country. 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 employes approximately 27,000 professionals. The annual turnover of HUS is approximately three billion euros. More information about HUS and its operations can be found at www.hus.fi. The Automation Laboratory of HUS Diagnostic Center is looking for alternatives for clozapine assay in serum samples by a fully automated process. We currently use Siemens Atellica® Solution CH 930 platform (Siemens Healthineers) connected to Inpeco laboratory automation track. The yearly number of clozapine tests in our laboratory is approximately 15.000. The possible future procurement of automated serum clozapine assay is likely to involve all needed assay-dependent products like reagents, calibrators, the manufacturer’s control samples, the assay parameters, product support, training and all other products needed for the assay except ordinary laboratory necessities. We kindly ask the possible Vendors about the following things: 1. Would you be interested to give an offer of the mentioned entity? We kindly ask for your opinion or view of execution of the above described entity. 2. Are you willing to give a short Teams-presentation of your suggested solution? The presentation will be recorded for internal use of HUS Diagnostic Center. 3. In addition to clozapine please provide us with a list of other therapeutic drug tests available from you. 4. Please provide us with preliminary pricing. 5. Please describe earlier experiences of providing clozapine or other psyciatric drug assays for laboratory diagnostics in a clinical laboratory. How many references do you have of providing similar solutions into diagnostic clinical laboratories? 6. Can you give a reference client within EU/ETA? 7. What kind of guarantee do you give to your products? What would be the delivery times for your products Helsinki, Finland? 8. What is the metrological traceability of your assay for clozapine? 9. In what country are your products manufactured? 10. How is your product support ensured? Response to this request for information should include replies to the above questions. The answers to this request for information are asked to be sent by e-mail to [yhteystieto: katso alkuperäinen ilmoitus], at the latest on May 16th 2025.