Norway – Laboratory, optical and precision equipments (excl. glasses) – Intention notice: reagents to qCPR CALR for Helse Bergen HF

Justification for direct procurement: The laboratory would like to change the analysis method to a more efficient and sensitive qPCR based method. The transition to qPCR significantly alters the test flow in the laboratory and increases patient safety by transferring sample numbers and analysis results directly from the instrument to LIMS. Searches have been carried out in the market, but we have not found other suppliers who offer ready kits that are both compatible with our instrument and the CE-IVD brand. Reagents to CALR qPCR from TRUPCR have already been tested and validated in the laboratory. A change to another supplier will require new testing and validation, at the same time that the current method must be maintained during the transition period. This will be very resource demanding, both in the form of personnel resources and increased reagent costs, and it will not give any improvement in either sensitivity or specificity. Consequences of switching to another supplier: A change to another supplier will delay the start-up of the new method and thereby reduce patient safety. This can lead to an increased risk of downtime and reduced tenders, as the laboratory must then maintain two parallel analysis methods for a period of time. Conclusion: Direct procurement of TRUPCR reagents for qPCR CALR is considered necessary to ensure patient safety, continuity of laboratory operation and effective implementation of the new analysis method. The contracts will be signed without a prior tender notice, as according to what the contracting authority knows, there are no other suppliers who can fulfil the requirements in the market. Pursuant to procurements without a competition is the Public Procurement Regulations § 13-4 first section, letter b second point. An intention notice is published in accordance with the provision in § 21-5. Any enquiries on the intention of signing the contract shall be directed to Mathias Høydal Nilsen by 15.09.2025.