LC-MS/MS test kit for antiepileptic drugs

The HUS Diagnostic Center (later referred as "Client" or "Contracting Entity") requests tenders for LC-MS/MS test kit for antiepileptic drugs. The yearly number of these tests in our laboratory is approximately 2000. The test kit should at least contain quantitative assays for serum 10-OH-carbamazepine, levetiracetam, ethosuximide and topiramate. The procurement of LC-MS/MS-based TDM includes all assay-dependent products needed i.e. reagents, calibrators, the manufacturer’s control samples, the method parameters for the LC-MS/MS instrumentation, product support and all other products needed for a CE-IVDD/IVDR compliant assay excluding ordinary laboratory necessities, e.g. laboratory water, pipettes or glassware. At present, the instrumentation available at HUS comprises either from Shimadzu (LC-30AD Nexera CL) or Agilent Technologies (1200 Series or 1290 Infinity II) liquid chromatrography and from AB Sciex (5500 Triple Quadrupole or Citrine) or Agilent Technologies (Ultivo) mass spectrometers. In addition, basic laboratory instrumentation, such as mixers, incubators, pipetting robots, and centrifuges, is available to the Client. These items are not being procured as part of this procurement. One analytical column should apply at least above mentioned analytes, i.e. 10-OH-carbamazepine, levetiracetam, ethosuximide and topiramate. The Agreement is in force for a fixed period of two (2) years, and thereafter until terminated. The Client does not commit to the consumption figures indicated in the invitation to tender. The final order quantities may be higher or lower than stated. The subject matter and requirements of the procurement are described in detail in the invitation to tender and its annexes.

Under the Agreement, The Client may obtain from the Supplier additional accessories categorized as “Other accessories available for the offered assay kit” as specified in Table C of the Price List Annex. The Client also reserves the right to acquire additional products during the contract period that are not listed in the Price List Annex but fall under the product groups defined as “Other Products” in the Agreement. The Client accepts these Other Products separately during the contract period in accordance with its terms. The Client estimates that the volume of such procurements will remain low. However, if such procurements are made, their total value—including both other accessories available for the offered assay kit (as specified in Table C of the Price List Annex) and Other Products—shall remain below EUR 60,000 (excluding VAT) during the contract period.