Subministrament de reactius i sistema integral automatitzat de detecció ràpida per biologia molecular per al Laboratori del CHV

The contract has an initial duration of 4 years, starting from the date of its signing. There is a possibility of extending the contract for a maximum of 12 months, which would bring the total duration up to 5 years. The specific start and end dates will be determined by the signing date of the contract. The contractor is required to adhere to the total execution period and any partial periods that may be established in a work program.

The core scope of work for this tender involves the successive supply of reagents and the cession of an automated integrated platform system for rapid molecular biology detection of microbiology and hematological genetics tests for the Consorci Hospitalari de Vic (CHV) laboratory.

The Statement of Work summary and core deliverables include:

• Supply of Reagents and Equipment: The awarded company must supply all necessary reagents and provide the required machinery and other materials through a cession agreement. This includes the necessary platform and associated materials provided at no cost, with the offering company being responsible for its operation and maintenance.
• Molecular Diagnostic Platform: Provision of a real-time PCR molecular diagnostic platform that integrates and automates extraction, amplification, and detection processes. This tabletop equipment must include all specified tests and have internal controls for all techniques. The platform should have a 10-fluorophore reading capacity across different light spectrum zones, report results directly via software without subjective interpretation, and feature a closed individual cartridge system with QR or bar codes for traceability. It must also be modular and scalable to adapt to the center's needs and sample demand, offering a broad portfolio of techniques.
• Specific Tests/Pathogens to Detect: The contract specifies various tests to be performed annually, including PCR for Covid-VRS-Grip (750 tests), Gen factor II / Factor V Leiden (150 tests), BCR-ABL quantitative (125 tests), Streptococcus agalactiae (50 tests), M. Tuberculosis complex (PCR) (150 tests), Toxina Cl. Difficile (PCR) (50 tests), M. Genitalium (resistencies) (100 tests), Chlamidia - Gonococ (125 tests), and TBC XDR (10 tests). This includes specific detection of *Mycoplasma genitalium* and its azithromycin resistance, differentiation of SARS-CoV-2, Influenza A, Influenza B, and RSV, and quantitative detection of BCR:ABL p210 rearrangement.
• Reagent Certification: All reagents supplied must have CE-IVD marking.
• Maintenance and Support: The awarded company is responsible for all associated maintenance and IT support services to ensure the correct performance of tests. This includes all connection costs, as well as the costs for maintenance, fungible materials, and consumables, ensuring the equipment's perfect working condition through preventive, normative, and corrective maintenance without additional cost.
• Quality Control: The adjudicators must cover the cost of external controls if deemed necessary.
• System Integration: The equipment must connect to the CHV Laboratory's LIS/SIL (Laboratory Information System).
• Contract Duration: The contract duration is four years from the date of signing, with a possible extension of up to 12 months.