RESQUET FOR QUOTATION -Fully Automated Nucleic Acid Testing (NAT) System for Blood Donor Screening.

Dear Sales Team, We are interested in purchasing a Fully Automated Nucleic Acid Testing (NAT) System for Blood Donor Screening for a blood transfusion service in Mozambique. Please provide your technical and commercial quotation for a fully automated platform using real-time PCR, TMA or equivalent validated nucleic acid amplification technology, covering the complete workflow from primary sample loading to final result reporting. 1. Technical Requirements - Fully automated sample preparation, nucleic acid extraction, amplification, detection and result interpretation. - Continuous loading of samples, reagents, consumables and waste without interrupting ongoing tests. - Minimum capacity of 500 reportable results per 24 hours. Specify throughput per 8-hour shift and time to first results (maximum 4 hours). - Automatic 1D and 2D barcode reading, including Code 128 and Data Matrix, with full sample traceability. - Simultaneous processing of different assays or random-access capability. - Donor screening assays covering HIV-1 (groups M and O), HIV-2, HCV and HBV, preferably multiplex. - Identification of reactive viruses in the same run or through a subsequent discriminatory assay. Include its cost. - Individual sample and mini-pool testing, according to manufacturer validation. Specify pool sizes and provide validation documents. - Internal control for every sample and positive/negative external controls in every run. - Automatic reagent integrity monitoring, result validation, reagent/control identification, lot and expiry tracking. - Automatic result interpretation, bidirectional LIS connection (HL7 or equivalent), audit trail, user access levels and exportable reports. - Daily operator maintenance ≤30 minutes, automatic cleaning, remote diagnostics and software updates. - Contamination and carry-over prevention through filtered tips, single-use consumables and physical separation or sealing of the amplification area, or equivalent. 2. Regulatory and General Requirements - Brand-new equipment in original manufacturer packaging. - Power supply: 220–230 V ±10%, 50 Hz, with compatible plug or adapter. - CE-IVD under applicable IVDR requirements and/or FDA approval specifically applicable to blood donor screening, or equivalent IMDRF regulatory approval. - Manufacturer ISO 13485 certified or equivalent. - IEC 61010-1 or equivalent electrical safety compliance, as applicable. - ANARME import authorization or commitment to obtain it before delivery. - User manual and quick-start guide in Portuguese; service manual in Portuguese or English. - Original catalogue and technical datasheets. - Spare parts and consumables availability for at least 5 years, or 7 years where applicable. - Technical support in Mozambique or formal commitment to provide it. - Manufacturer authorization letter if the bidder is not the manufacturer. 3. Required Supply and Services The quotation must include: - Online UPS appropriately sized for the complete platform. - Computer, software and bidirectional LIS interface/integration. - Reagents, controls and consumables for installation, start-up and local validation. - On-site commissioning and validation. - Manufacturer-certified training for at least 2 operators and 1 technical staff member. - Preventive and corrective maintenance throughout the warranty period. - Formal commitment to supply reagents for at least 3 years, with an attached price list. 4. Model Status The proposed model must be the manufacturer's latest generation for this application and currently marketed in the EU or USA, or in its country of origin if that country is an IMDRF member. 5. Documents and Commercial Quotation Please provide: - Original catalogue, technical datasheet, exact model and software version. - Complete NAT workflow description and assay IFUs for HIV-1, HIV-2, HCV and HBV. - Regulatory certificates and evidence of donor-screening intended use. - Assay performance and validation documents. - Throughput per 8-hour shift and 24 hours, and time to first result. - Individual and mini-pool configurations and viral discrimination documentation/pricing. - LIS integration specifications and costs. - ISO 13485 and applicable electrical safety certificates. - Manufacturer declarations and authorization letter, if applicable. - Maintenance schedule and spare parts list with indicative prices. - Reagent and consumable prices, including the 3-year supply commitment. Please identify any partially compliant, optional or unavailable requirements and all additional costs. We look forward to receiving your complete proposal. Best regards,