1) Purchase of molecular diagnostic devices and consumables: 1 unit of high-performance real-time PCR automation and consumables for (HCV, HBV quantitative PCR tests) 1 unit of high-performance nucleic acid isolation automation + 2 units of real-time PCR automation + procurement of 1 isolator and related consumables (for Thrombophilia + HEV PCR + HCV genotype tests). The contracting authority draws attention to the possibility that fewer devices than prescribed can be offered by the economic operators, provided that the device fully covers/ensures the measurement requirements set by the contracting authority. 2) Tests: 2.1 Factor II G20210A (Prothrombin) mutation Number of tests: 800/24 months 2.2 Factor V, G1691A (Leiden) mutation Number of tests: 800/24 months 2.3 MTHFR C677T (SNP) Number of tests: 700/24 months 2.4 HEV-RNA quantitative Number of tests: 100/24 months 2.5 HCV-RNA quantitative Number of tests: 1600/24 months 2.6 HBV-DNA quantitative Number of tests: 2200/24 months 2.7 HCV genotype Number of tests: 600/24 months 3) The winning bidder's task: - Delivery of devices to the site of performance and commissioning within 30 working days after the contract comes into effect. - Complete maintenance and servicing of the devices during the contract duration. 4) For servicing, the winning bidder must provide a Hungarian service background with a Hungarian-speaking service engineer. By Hungarian service background, the contracting authority means a service that provides on-site service for devices placed/installed in the institution. In case of breakdown, troubleshooting must therefore begin on site, with dispatch to the installation site. 5) The fulfillment time for individual orders is 2-7 working days according to the commitment of the bidder. 6) The expiry date of the test is a minimum of 6 months from the delivery of the test. Further information can be found in the technical description included in the procurement documents.

LOT-0001
EKR000716262025/1
Molecular Diagnostics.
1) Purchase of molecular diagnostic devices and consumables: 1 unit of high-performance real-time PCR automation and consumables for (HCV, HBV quantitative PCR tests) Minimum requirements: - method: real-time PCR - should have CE-IVD certification - after inserting samples, reagents, and consumables, it performs nucleic acid extraction and the complete PCR reaction without user intervention - even 1 sample can be measured economically - reports results in a printable report format - comes with a built-in touch screen-based control computer - processes a minimum of 120 samples during an 8-hour working cycle - new samples can be loaded even while tests are being performed - in urgent tests, results should be reported within a maximum of 180 minutes - capable of performing 5 or more types of tests simultaneously - maximum weight: 650 kg/sqm - includes solutions based on physical prevention and enzymatic reaction to avoid cross-contamination, the quantity of reagents and consumables should be traceable, and these can be replenished during operation, should have a refrigerated storage compartment for reagents. 1 unit of high-performance nucleic acid isolation automation + 2 units of real-time PCR automation + procurement of 1 isolator and related consumables (for Thrombophilia + HEV PCR + HCV genotype tests) Minimum requirements: 1. Nucleic acid isolation automation - both the automation and isolation reagents should be CE-IVD marked - suitable for simultaneous processing of 1-24 samples without reagent waste - technology: magnetic bead technology - isolation process takes maximum 80 minutes - sample requirement: whole blood anticoagulated with K2EDTA - uses barcoded “ready to use” reagents - should have a built-in UV lamp 2. PCR analyzer - real-time PCR analyzer, CE-IVD certified - suitable for simultaneous analysis of 96 samples, testing time 45 minutes - sample volume: 10-100 µl - the instrument should maintain a homogeneous temperature, allowed temperature fluctuation 0.1 C degrees - excitation wavelength (Xenon lamp) at least 465, 498, 540, 610, 680 nm - detection wavelength at least 510, 580, 610, 645, 670, 700 nm - after the completion of the PCR reaction, results should be available in at least pdf report - maximum weight of the instrument: 150 kg/sqm 3. HCV genotype - for the tests to be performed, analysis of samples must be CE-IVD certified - method: real-time PCR - a nucleic acid isolation automation must be provided for the analysis of samples (manual isolation is not accepted) + a real-time PCR analyzer for detection, which should be controlled by the same software/computer - the detection part for HCV GT and thrombophilia + HEV PCR tests should be the same. 2) Tests: 2.1 Factor II G20210A (Prothrombin) mutation Number of tests: 800/24 months 2.2 Factor V, G1691A (Leiden) mutation Number of tests: 800/24 months 2.3 MTHFR C677T (SNP) Number of tests: 700/24 months 2.4 HEV-RNA quantitative Number of tests: 100/24 months 2.5 HCV-RNA quantitative Number of tests: 1600/24 months 2.6 HBV-DNA quantitative Number of tests: 2200/24 months 2.7 HCV genotype Number of tests: 600/24 months For the announced tests that require preliminary nucleic acid isolation: the device and reagents must also be offered! 3) The winning bidder's task: - Delivery of devices to the site of performance and commissioning within 30 working days after the contract comes into effect. - Complete maintenance and servicing of the devices during the contract duration. 4) In case of breakdown, the bidder provides on-site dispatch within minimum 4 - maximum 48 hours after the fault report during working days. (The speed of dispatch is an evaluation criterion). 5) The fulfillment time for individual orders is 2-7 working days according to the bidder’s commitment. (The fulfillment deadline is an evaluation criterion). Individual orders must be confirmed within 24 hours. 6) The test expiry date is a minimum of 6 months from the delivery of the test. 7) In case of technical equivalence (321/2015. (X.30.) Government decree. § 46 (3)), this is guiding. 8) During the contract period, monthly orders and deliveries of tests will take place. 9) Manufacturer and/or distributor product descriptions must be submitted for all proposed instruments and tests included in the offer. The product description must specify the - type of offered product - country of origin - manufacturer of the offered product - name of the offered product - manufacturer's identification number, article number - for tests, a test description, and - all product characteristics that support the proposed parameters in the specification table(s). If the product description does not contain any of the parameters to be tested, a company statement from the product manufacturer and/or distributor must declare the specifications of that product. The bidder must also submit its company declaration - or in another form suitable for having legal effect - stating that all submitted certificates/equivalent documents/manufacturer’s declarations are valid. 10) The offered products must have valid manufacturer’s declarations for products classified as I risk class at the time of the offer submission; for products classified as higher risk classes: CE certifications, which the bidder must attach to their offer. It is the winning bidder's obligation to supply products with valid Hungarian-language permits and quality certificates during the contract period. 11) The bidder must attach the filled price table, signed properly. The completed price table must be submitted as part of the offer in both .pdf and editable (.xls) format. 12) A specification table filled with data for the proposed devices must also be attached in .pdf format, duly signed. Further information can be found in the technical description included in the procurement documents.