REQUEST FOR INFORMATION: CE-IVDR compliant test for serum therapeutic drug monitoring by LC-MS/MS

Description du marché

The aim of this request for information: The aim of this request for information is to find out the availability of CE-IVDR compliant LC-MS/MS assays for serum therapeutic drug monitoring (TDM). The procurement unit aims to obtain comprehensive information of reagents, assay kits, supplies and/or instrumentation including eventual service and 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 Uusima 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 Laboratory of Endocrinology and Metabolism of HUS Diagnostic Center is looking for alternatives for TDM in serum samples by liquid chromatography tandem mass spectrometry (LC-MS/MS). We are now especially interested in assays including quantitation of 10-OH-carbazepine, that is used for follow-up of oxcarbazepine treatment. The yearly number of 10-OH-carbazepine tests in our laboratory is approximately 2000. At present, HUS employs an HPLC-assay for 10-OH- carbazepine. The assays are run in HUSLAB-building (Helsinki, Finland) in batches, only daytime on working days, not 24/7. The possible future procurement of LC-MS/MS-based TDM is likely to involve all needed assay-dependent products like reagents, calibrators, the manufacturer’s control samples, the method parameters for the LC-MS/MS instrumentation, product support, training and all other products needed for the assay except ordinary laboratory necessities, e.g. laboratory water, pipettes or glassware. At present, the instumentation available at HUS comprises LC either from Shimadzu (LC-30AD Nexera CL) or Agilent Technologies (1200 Series or 1290 Infinity II) and MS/MS instruments from AB Sciex (5500 Triple Quadrupole or Citrine) or Agilent Technologies (Ultivo). In addition, basic laboratory instrumentation like mixers, incubators, pipetting robots and centrifuges are available. The possible future procurement may include: CE-IVDR compliant reagents including calibrators and controls, LC-columns, LC-eluents, reagents and accessories for sample preparation, assay parameters and possible software for the required instrumentation, user and main user training, and any other training or issue needed for the intended use of the test. 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 60-min Teams-presentation of your suggested solution? The presentation will be recorded for internal use of HUS Diagnostic Center. 3. In addition to 10-OH- carbazepine please provide us with a list of other therapeutic drugs included in the same assay. 4. Please provide us with preliminary pricing. 5. Please describe earlier experiences of providing mentioned 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 to Helsinki, Finland? 8. What is the metrological traceability of your assay for therapeutic drugs? 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 kilpailutus.laboratorio@hus.fi, at the latest on December 19th 2024.

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