Belgium – Laboratory reagents – framework agreement for the replacement of LC-MS reagents

Opportunity description

LC‑MS analyses within the clinical biology laboratory are currently performed mainly using LDTs, which no longer comply with the IVDR Regulation (EU 2017/746). A transition to CE‑marked commercial reagents is therefore necessary. This transition coincides with the renewal of the LC‑MS instruments and the associated validation, which prompted the launch of a procurement procedure. A term of 5 years has been chosen to spread the significant switching costs (validation, implementation, training and documentation) and ensure operational stability. The additional cost is necessary for regulatory compliance and delivers quality gains (traceability, reproducibility, robustness and validated documentation). Supply of a validated and IVDR-compliant LC-MS/MS solution for the quantitative and semi-quantitative determination of amino acids in plasma, urine and cerebrospinal fluid, including reagents, quality control materials and consumables, compatible with the laboratory's existing LC-MS/MS infrastructure. Supply of an IVDR-compliant kit for amino acid and acylcarnitine determination on DBS via LC-MS/MS or FIA-MS/MS, including reagents, controls and consumables, compatible with the existing laboratory infrastructure. Includes the supply of a validated and IVDR-compliant LC-MS/MS solution for the quantitative determination of antimyotics in plasma, including reagents, quality control materials and consumables. The solution must be compatible with the laboratory's existing Waters and Sciex LC-MS/MS platforms. Includes the supply of a validated and IVDR-compliant LC-MS/MS solution for the quantitative determination of catecholamines, free metanephrines and serotonin in urine, including reagents, quality control materials and consumables. The solution must be compatible with the laboratory's existing Waters and Sciex LC-MS/MS platforms. Supply of a validated and IVDR-compliant LC-MS/MS kit for the determination of homocysteine in plasma and serum, including reagents, quality control materials and consumables, compatible with the existing laboratory infrastructure. Includes the supply of a validated and IVDR-compliant LC-MS/MS solution for therapeutic drug monitoring (TDM) of immunosuppressants in whole blood, with the option to expand to total and free concentrations in plasma. The solution includes reagents, quality control materials and consumables and is compatible with the laboratory's existing Waters and Sciex LC-MS/MS platforms. Includes the supply of a validated and IVDR-compliant LC-MS/MS solution for the quantitative determination of free cortisol and cortisone in urine, including reagents, quality control materials and consumables. The solution must be compatible with the laboratory's existing Waters and Sciex LC-MS/MS platforms. Includes the supply of a validated and IVDR-compliant LC-MS/MS solution for the quantitative determination of vanillylmandelic acid (VMA), homovanillic acid (HVA) and 5-hydroxyindoleacetic acid (5-HIAA) in urine, including reagents, quality control materials and consumables. The solution must be compatible with the laboratory's existing Waters and Sciex LC-MS/MS platforms. Procedure: neg-w-call. Review the original TED notice for the complete requirement, lots, amendments and attachments.