The subject of the order is the supply of reagents, consumable and consumable materials for immunohematological tests in the microcard system (task number 1) and microplate system (task number 2) for a period of 3 years together with the lease of fully automatic analyzers.

I. Requirements for delivery of reagents and consumable materials for immunohematological tests performed at the Consultative Research Laboratory by a columnar micromethod.

1. Reagents for transfusiological immunology research to the DiaMed/Bio-Rad ID-System method.

2. Reagents derived from one manufacturer for full validation of the method.

3. DiaMed/Bio-Rad, ID-Centrifuge, ID-Incubator, ID-Incubator, ID-Pipetor, ID-Pipetor. The manufacturer's declaration of compatibility of the reagents offered with the equipment held by the Contracting Authority and compliance with the essential requirements of the In vitro diagnostics Directive 98/79/EC the Contractor shall deliver with the first delivery of the goods to the Contracting Authority.

4. Microcards filled with factory suitable reagents, ready for use.

5. Standard blood cells dedicated to the ID-System method in 0.8% suspension, ready for use.

6. Reagents provided for by the instructions for use of ID-system devices which are medical devices within the meaning of the Medical Devices Act in accordance with Article 90 (1) (Journal of Laws of 2021, item 1565).

7. Term of validity of reagents: item 1-6 and 18 of the tender form - min. 9 months from the date of delivery to the Ordering Party; item 14-17 of the tender form — min. 4 months from the date of delivery to the Ordering Party.

8. Standard blood cell expiry date: item 7-13 of the tender form — min. 5 weeks from the date of delivery.

9. CE marked reagents and having relevant certificates and notifications to the President of URPLWMiPB shall be delivered with delivery to the Ordering Party.

10. Reagents supplied with the quality certificate for each series - must be delivered with delivery to the Ordering Party.

11. Reagents supplied with instructions for use in Polish - must be delivered with delivery to the Ordering Party.

II. Requirements for delivery of reagents and consumable materials for immunohematological tests performed in hematomas by columnar micromethod.

1. Reagents for studies in transfusion immunology by columnar micromethod ready for use and derived from one manufacturer for full validation of the method (not applicable to system fluids).

2. AbO blood groups can be determined using anti-A, anti-B monoclonal reagents derived from different cell clones or different series.

3. ABO/RhD blood group reagents for the determination of D antigen with two different clones, including one non-detecting DVI category.

4. Standard blood cells for test performance in 0.8% suspension, dedicated to the method and ready for use.

5. Validity of reference blood cells: min. 5 weeks from the date of delivery to the Ordering Party.

6. Validity of reagents for the ABO/RhD blood group test, Rh-system phenotype and antibody review study: min. 9 months from the date of delivery to the Ordering Party, other group systems — 4 months from the date of delivery to the Ordering Party.

7. Reagents and reference blood cells offered for marketing on the Polish market having notification/notification to the President of URPLWMiPB.

8. Each unit packaging of the reagent must have a name, series and expiry date.

9. Reagents supplied with the manufacturer's instructions in Polish confirming the composition of the reagents supplied and the clones used - must be delivered with delivery to the Ordering Party.

10. Reagents supplied with the quality certificate for each type and series of reagents - must be delivered with delivery to the Ordering Party.

11. Test methodology in Polish for each type of test.

12. Test methodology eliminating red blood cell rinsing at any stage of the study.

13. The Contractor shall provide a validation and start package of reagents to carry out validation of the system in quantity in accordance with the regulations.

I. Requirements for delivery of reagents and consumable materials for immunohematological tests performed in bloodlenders by microplatelet method.

1. Reagents for research in transfusiological immunology by microplatelet method ready for use.

2. Possibility of marking:

- blood group of the ABO system using anti-A monoclonal reagents,

- anti-B, anti-DVI (-), anti-DVI (+),

- isoagglutinins A1, B

- review for immune antibodies in the intermediate antiglobulin test (PTA-LISS) using pulsed blood cells and 3 reference blood cells

- confirmation of blood group in anti-A, anti-B, anti-D category DVI (+) for donors

- Rh + Cw + K phenotype determination

- determination of phenotypes from systems: Kidd, Duffy, MNS

- determination of the antigen D weak

3. Reagents supplied with the quality certificate for each type and series of reagents - must be delivered with delivery to the Ordering Party.

4. Reagents supplied with the manufacturer's instructions in Polish confirming the composition of the reagents supplied as well as the clones used - must be delivered with delivery to the Ordering Party.

5. Each unit packaging of the reagent must have a name, series and expiry date.

6. Reagents and reference blood cells offered authorised on the Polish market, having notification/notification to the President of URPLWMiPB.

7. Validity of reference blood cells: min. 5 weeks from the date of delivery to the Ordering Party.

8. All reagents supplied shall be required to have at least a 6-month shelf life from delivery to the ordering person (not applicable to blood cells and flushing fluids)

9. Contractor provides validation and start package of reagents to carry out validation of the system in quantity in accordance with regulations

II. Requirements for leased analyzer for microplate testing

1. Automatic transfusion immunology test analyzer based on microplate technology, performing the entire test procedure from taking the material from the test sample, making the mark to the transmission of the result to the information system.

2. Analyzer not older than 4 years, equipped with an external voltage support system — UPS, barcode scanner, barcode printer, laser printer, computer set (PC, monitor, keyboard, mouse).

3. A free-standing or intake analyzer with a table delivered to it allowed to work in a medical laboratory.

4. Size (before installation) length up to 200 cm, width up to 90 cm, height up to 200 cm, total weight after installation up to 200 kg/m2

5. Analyzer with loading capacity of not less than 200 13 mm x 75 mm real dimension tubes (vacuum system) allowing free insertion and removal of tubes glued with labels with identifying bar codes, possibility of working with different types of tubes

6. Efficiency of the analyzer: above 60 ABO and antigen D blood group indications (ABO antibodies determined with at least A1 and B blood cells and D antigen determination with 2 anti-RhD reagents)

7. Replenishment of test samples, microplates and reagents and access results without interrupting the operation of the analyzer

8. Perform multiple (at least 3-ech) different markings from one sample at the same time

9. Microplate storage on board analyzer not less than 15

10. Independent programme of daily quality control of reagents

11. Identification of test samples and reagents through barcodes or registration numbers entered manually

12. Automated documentation and control of the series and expiry date of all reagents

13. Automatic system to inform the insufficient amount of reagents on board necessary to perform programmed tests

14. Identification of the operator and recording of its activities, registration of test samples used and tests performed, time and date of test

15. Clot detection system