1. DEFINING THE SUBJECT OF THE ORDER: 1.1. The subject of the order is the purchase of medical devices for cytometric diagnostics (diagnostic tests) in the quantities specified in the Detailed Description of the Subject of the Order (hereinafter known as SzOPZ or OPZ), necessary for monitoring ARV therapy of patients infected with the HIV virus and suffering from AIDS, along with storage and shipment services to laboratories conducting tests for specialist centers/medical facilities selected through a competition for Implementers, as part of the implementation of the Government Health Policy Program entitled: “Antiretroviral treatment of people living with the HIV virus in Poland for the years 2022-2026” (hereinafter referred to as: Health Policy Program) https://www.gov.pl/web/zdrowie/rzadowy-program-polityki-zdrowotnej-leczenie-antyretrowirusowe-osob-zyjacych-z-wirusem-hiv-w-polsce-na-lata-2022-2026) 1.2. Each of the parts listed in the OPZ constitutes a separate proceeding. 1.3. The order must be carried out in full accordance with the requirements specified in the SWZ, OPZ as well as the principles described in the Draft contract provisions (hereinafter referred to as PPU), which constitute attachments to the SWZ. 1.4. The OPZ containing the requirements and conditions for the implementation of each part of the order constitutes an attachment to the SWZ.

LOT-0001
1
Part 1: Reagent kits for the identification and quantitative assessment of CD3/CD4 and CD3/CD8 lymphocytes by immunofluorescence using flow cytometers: BD FACS Lyric and BD FACS Canto.
1. DEFINING THE SUBJECT OF THE ORDER: 1.1. The subject of the order concerning part number 1 is the delivery - at the cost and risk of the Contractor - of CE IVD reagent kits for the identification and quantitative assessment of helper CD3+/CD4+ and cytotoxic CD3+/CD8+ lymphocytes in human whole blood samples by immunofluorescence using the flow cytometers specified in the above table, to laboratories conducting tests for reference centers treating HIV/AIDS patients, operating based on hospitals/medical facilities that have entered into agreements with the National AIDS Center as part of the implementation of the Government Health Policy Program entitled “Antiretroviral treatment of people living with the HIV virus in Poland for the years 2022-2026”. 2.1. The Ordering Party requires the offer of a reagent kit that includes: a) BD Tritest - a mixture of fluorochrome-labeled monoclonal mouse antibodies: CD4 FITC SK3 / CD8 PE SK1/ CD3 PerCP SK7 intended for the identification, determination of the percentage value, and total number of lymphocytes in whole blood; b) BD Trucount - single-use tubes containing a specified number of fluorescently labeled microparticles, intended by the manufacturer for use with the above-mentioned antibodies to carry out reliable determination along with calibration. 3.1. The number of reagent kits described above must allow for the performance of 6,800 effective results. 4.1. Expiration date - minimum 10 months from the date of delivery to the deposit warehouse of the National AIDS Center. 5.1. The offered reagent kits should meet the requirements listed below: a) ensure compatibility with flow cytometers: FACS Lyric, FACS Calibur, and FACS Canto from Becton Dickinson; b) allow for the conduct of clinical sample tests, hardware, and software controls, using the analyzers indicated in the table along with the accompanying software; c) allow for the automatic determination of the total number of examined lymphocyte cells of each population CD3+, CD3+/CD4+, and CD3+/CD8+ calculated per 1 μl of the analyzed volume of patients' peripheral blood, percentage share, and numerical ratio; d) possess CE IVD marking; e) other requirements in accordance with the evidence requirements specified in the Specifications for Order Conditions. 2. EVIDENCE MEANS: 2.1. Based on Articles 105 and 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics, or criteria specified in the description of the subject of the order or criteria for the evaluation of offers or requirements related to the execution of the order, the Ordering Party requires contractors to present the following documents: 2.1.1. instructions for using the medical product or a description of the measurement methodology; 2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the Regulation of the European Parliament and of the Council (EU) 2017/746 of April 5, 2017, on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU and Good Distribution Practice - e.g., in the form of printed temperature monitoring records for a period corresponding to at least 12 months of the warehouse's activity regarding all temperatures specified by the manufacturer for that medical product and its individual components. 2.1.3. notification or announcement referred to in Article 58 of the Act of May 20, 2010, on medical devices (Journal of Laws of 2021, item 1565), regarding Article 138 of the Act of April 7, 2022, on medical devices (Journal of Laws of 2022, item 974). 2.1.4. manufacturer's declaration of compliance with the essential requirements for in vitro diagnostic medical devices, in accordance with the requirements of Directive 98/79/EC or Regulation of the European Parliament and of the Council (EU) 2017/746 of April 5, 2017, on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 2.1.5. documents certifying the conduct of the conformity assessment procedure with a notified body (notified body certificate) - if applicable. 2.2. According to Article 107(1) of the Pzp Act, the Contractor is obliged to submit the above-mentioned evidence means together with the offer and must exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify their correctness. 2.3. The Ordering Party, in accordance with Article 107(2) of the Pzp Act, provides for the possibility of a single supplement of the above-mentioned evidence means within the period specified by the Ordering Party. 2.4. The evidence means mentioned above are submitted in the manner provided for in the regulations issued under Article 70 of the Pzp Act - i.e., in the Regulation of the Prime Minister of December 30, 2020, on the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in the procedure for awarding public contracts or competitions. 2.5. Documents drawn up in a foreign language are submitted along with a translation into Polish.

LOT-0002
2
Part 2: Reagent kits for the identification and quantitative assessment of CD3/CD4 and CD3/CD8 lymphocytes by immunofluorescence using the automated flow cytometer Aquios Beckman Coulter.
1. DEFINING THE SUBJECT OF THE ORDER: 1.1. The subject of the order concerning part number 2 is the delivery - at the cost and risk of the Contractor - of CE IVD reagent kits intended for the identification and quantitative assessment of helper CD3+/CD4+ and cytotoxic CD3+/CD8+ lymphocytes in human whole blood samples by immunofluorescence using the automated flow cytometer mentioned in the above table, to laboratories conducting tests for reference centers treating HIV/AIDS patients, operating based on hospitals, which have entered into agreements with the National AIDS Center as part of the implementation of the Government Health Policy Program entitled “Antiretroviral treatment of people living with the HIV virus in Poland for the years 2022-2026”. 2.1. The Ordering Party requires the offer of a reagent kit that includes: a) Aquios Tetra-1 Panel Monoclonal Antibody Reagents - a mixture of fluorochrome-labeled monoclonal mouse antibodies: CD45-FITC B3821F4A / CD4-RD1 SFCI12T4D11/ CD8-ECD SFCI21Thy2D3/ CD3-PC5 UCHT1 intended for the identification, determination of percentage value, and total number of lymphocytes in human whole blood; b) Aquios Immuno-trol and Aquios Immuno-trol Low – positive control; c) Aquios Flow-Count Fluorospheres – fluorescently labeled microspheres - quantitative reference. d) Aquios Lysing Reagent Kit – buffer for lysing erythrocytes. 3.1. The number of reagent kits described above must allow for the performance of 750 effective results. 4.1. Expiration date - minimum 10 months from the date of delivery to the deposit warehouse of the National AIDS Center. 5.1. The offered reagent kits should meet the requirements listed below: a) ensure full compatibility with the automated, closed cytometric system AQUIOS from Beckman Coulter; b) allow for the conduct of clinical sample tests, hardware, and software controls, using the analyzer indicated in the table along with the accompanying software; c) allow for the automatic determination of the total number of examined lymphocyte cells of each population CD3+, CD3+/CD4+, and CD3+/CD8+ calculated per 1 μl of the analyzed volume of patients' peripheral blood, percentage share, and numerical ratio. d) possess CE IVD marking; e) other requirements in accordance with the evidence means specified in the Specifications for Order Conditions. 2. EVIDENCE MEANS: 2.1. Based on Articles 105 and 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics, or criteria specified in the description of the subject of the order or criteria for the evaluation of offers or requirements related to the execution of the order, the Ordering Party requires contractors to present the following documents: 2.1.1. instructions for using the medical product or a description of the measurement methodology; 2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the Regulation of the European Parliament and of the Council (EU) 2017/746 of April 5, 2017, on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU and Good Distribution Practice - e.g., in the form of printed temperature monitoring records for a period corresponding to at least 12 months of the warehouse's activity regarding all temperatures specified by the manufacturer for that medical product and its individual components. 2.1.3. notification or announcement referred to in Article 58 of the Act of May 20, 2010, on medical devices (Journal of Laws of 2021, item 1565), regarding Article 138 of the Act of April 7, 2022, on medical devices (Journal of Laws of 2022, item 974). 2.1.4. manufacturer's declaration of compliance with the essential requirements for in vitro diagnostic medical devices, in accordance with the requirements of Directive 98/79/EC or Regulation of the European Parliament and of the Council (EU) 2017/746 of April 5, 2017, on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 2.1.5. documents certifying the conduct of the conformity assessment procedure with a notified body (notified body certificate) - if applicable. 2.2. According to Article 107(1) of the Pzp Act, the Contractor is obliged to submit the above-mentioned evidence means together with the offer and must exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify their correctness. 2.3. The Ordering Party, in accordance with Article 107(2) of the Pzp Act, provides for the possibility of a single supplement of the above-mentioned evidence means within the period specified by the Ordering Party. 2.4. The evidence means mentioned above are submitted in the manner provided for in the regulations issued under Article 70 of the Pzp Act - i.e., in the Regulation of the Prime Minister of December 30, 2020, on the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in the procedure for awarding public contracts or competitions. 2.5. Documents drawn up in a foreign language are submitted along with a translation into Polish.

LOT-0003
3
Part 3: Reagent kits for the identification and quantitative assessment of CD3/CD4 and CD3/CD8 lymphocytes by immunofluorescence using the flow cytometer DX FLEX Beckman Coulter..
1. DEFINING THE SUBJECT OF THE ORDER:
1.1. The subject of the order for part no. 3 is the delivery - at the cost and risk of the Contractor - of CE IVD reagent kits for the identification and quantitative assessment of helper lymphocytes CD3+/CD4+ and cytotoxic CD3+/CD8+ in samples of human whole blood using immunofluorescence method with flow cytometers specified in the table above, to laboratories conducting tests for reference centers treating HIV/AIDS patients, operating based on hospitals that have entered into agreements with the National AIDS Center under the Government Health Policy Program titled "Antiretroviral Treatment of People Living with HIV in Poland for the Years 2022-2026."
2.1. The Ordering Party requires the offered reagent kit to include:
a) Cyto-STAT tetraCHROME - a mixture of mouse monoclonal antibodies labeled with fluorochromes: CD45-FITC B3821F4A / CD4-RD1 SFCI12T4D11/ CD8-ECD SFCI21Thy2D3/ CD3-PC5 UCHT1 designed for the identification, measurement of percentage and total count of lymphocytes in human whole blood;
b) Immuno-TROL and Immuno-TROL Low – positive control to verify the accuracy of analyses;
c) Flow-Count Fluorospheres – fluorescently labeled microspheres - quantitative reference;
d) DxFlex Daily QC Fluorosphere – calibrator for quality control of the system;
e) Lysing Solution VersaLyse – 30% erythrocyte lysis buffer;
f) Fixation Solution - stabilizing buffer;
g) Immunoprep ABC – buffers for preparing samples for cytometric analysis 70%;
h) DX Flex Sheath Fluid - flow buffer;
i) Cleaning Agent - system buffer;
j) Tubes for cytometric measurements.
3.1. The number of reagent kits described above must allow for the execution of 14,100 effective results.
4.1. Expiration date - a minimum of 10 months from the date of delivery to the depot warehouse of the National AIDS Center.
5.1. The offered reagent kits should meet the requirements specified below:
a) ensure compatibility with flow cytometers DX FLEX, Beckman Coulter;
b) allow for the performance of clinical sample tests, equipment and program control, using the indicated analyzers in the table along with the accompanying software;
c) allow automatic designation of the total number of examined lymphocyte cells of individual populations CD3+, CD3+/CD4+ and CD3+/CD8+ calculated per 1 μl of volume of analyzed peripheral blood of patients, percentage share and numerical ratio;
d) have a CE IVD mark;
e) other requirements according to the subject evidence specified in the Terms of Reference.
2. SUBJECTIVE EVIDENCE:
2.1. Based on Articles 105 and 106 of the Public Procurement Law, in order to confirm the compliance of the offered supplies with the requirements, characteristics, or criteria specified in the description of the subject of the order or criteria for bid evaluation or requirements related to the execution of the order, the ordering party demands from contractors the presentation of the following documents:
2.1.1. instructions for the use of the medical product or description of the marking methodology;
2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the Regulation of the European Parliament and the Council (EU) 2017/746 of April 5, 2017, regarding in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU and Good Distribution Practice - e.g., in the form of temperature monitoring records for a period corresponding to no less than 12 months of storage activity regarding all temperatures specified by the manufacturer for the particular medical device and its individual components.
2.1.3. notification or declaration referred to in Article 58 of the Act of May 20, 2010, on medical devices (Journal of Laws 2021 No. 1565), related to Article 138 of the Act of April 7, 2022, on medical devices (Journal of Laws 2022 No. 974).
2.1.4. manufacturer's declaration of conformity with the essential requirements for medical devices for in vitro diagnostics, in accordance with the requirements of Directive 98/79/EC or Regulation of the European Parliament and the Council (EU) 2017/746 of April 5, 2017, regarding in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
2.1.5. documents confirming the compliance assessment procedure with the notified body (certificate from the notified body) - if applicable.
2.2. According to Article 107(1) of the Public Procurement Law, the Contractor is obliged to submit the above-mentioned subjective evidence along with the bid and should take all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify their correctness.
2.3. The Ordering Party, according to Article 107(2) of the Public Procurement Law, provides for the possibility of a one-time supplement of the aforementioned subject evidence within the time specified by the Ordering Party.
2.4. The subjective evidence referred to above is submitted in a manner provided for in the regulations issued under Article 70 of the Public Procurement Law. - i.e., in the Regulation of the Prime Minister of December 30, 2020, regarding the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in the public procurement procedure or competition.
2.5. Documents prepared in a foreign language are submitted along with a translation into Polish.

LOT-0004
4
Part 4: Reagent kits for the identification and quantitative assessment of CD3/CD4 and CD3/CD8 lymphocytes using the immunofluorescence method with the DX FLEX Beckman Coulter flow cytometer..
1. DEFINING THE SUBJECT OF THE ORDER:
1.1. The subject of the order for part no. 4 is the delivery - at the cost and risk of the Contractor - of CE IVD reagent kits for the identification and quantitative assessment of helper lymphocytes CD3+/CD4+ and cytotoxic CD3+/CD8+ in samples of human whole blood using immunofluorescence method with flow cytometers specified in the table above, to laboratories conducting tests on behalf of reference centers treating HIV/AIDS patients, operating based on hospitals/medical facilities that have entered into agreements with the National AIDS Center under the Government Health Policy Program titled "Antiretroviral Treatment of People Living with HIV in Poland for the Years 2022-2026."
2.1. The Ordering Party requires the offered reagent kit to include:
a) Monoclonal antibodies labeled with fluorochromes, respectively: CD4-FITC, CD8-PE, CD3-PC5 (three independent products), designed for the identification, measurement of percentage and total count of lymphocyte populations in human whole blood;
b) Immuno-TROL and Immuno-TROL Low – positive control to verify the accuracy of analyses;
c) Flow-Count Fluorospheres – fluorescently labeled microspheres - quantitative reference;
d) Lysing Solution VersaLyse – erythrocyte lysis buffer.
3.1. The number of reagent kits and controls described above must allow for the execution of 1,700 effective results.
4.1. Expiration date - a minimum of 10 months from the date of delivery to the depot warehouse of the National AIDS Center.
5.1. The offered reagent kits should meet the requirements specified below:
a) ensure compatibility with flow cytometers: DX FLEX, Beckman Coulter;
b) allow for the performance of measurement, equipment, and program control, using the indicated analyzers in the table along with the accompanying software;
c) allow automatic designation of the total number of examined lymphocyte cells of individual populations CD3+, CD3+/CD4+ and CD3+/CD8+ calculated per 1 μl of volume of analyzed peripheral blood of patients, percentage share and numerical ratio.
d) have a CE IVD mark;
e) other requirements according to the subject evidence specified in the Terms of Reference.
2. SUBJECTIVE EVIDENCE:
2.1. Based on Articles 105 and 106 of the Public Procurement Law, in order to confirm the compliance of the offered supplies with the requirements, characteristics, or criteria specified in the description of the subject of the order or criteria for bid evaluation or requirements related to the execution of the order, the ordering party demands from contractors the presentation of the following documents:
2.1.1. instructions for the use of the medical product or description of the marking methodology;
2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the Regulation of the European Parliament and the Council (EU) 2017/746 of April 5, 2017, regarding in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU and Good Distribution Practice - e.g., in the form of temperature monitoring records for a period corresponding to no less than 12 months of storage activity regarding all temperatures specified by the manufacturer for the particular medical device and its individual components.
2.1.3. notification or declaration referred to in Article 58 of the Act of May 20, 2010, on medical devices (Journal of Laws 2021 No. 1565), related to Article 138 of the Act of April 7, 2022, on medical devices (Journal of Laws 2022 No. 974).
2.1.4. manufacturer's declaration of conformity with the essential requirements for medical devices for in vitro diagnostics, in accordance with the requirements of Directive 98/79/EC or Regulation of the European Parliament and the Council (EU) 2017/746 of April 5, 2017, regarding in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
2.1.5. documents confirming the compliance assessment procedure with the notified body (certificate from the notified body) - if applicable.
2.2. According to Article 107(1) of the Public Procurement Law, the Contractor is obliged to submit the above-mentioned subjective evidence along with the bid and should take all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify their correctness.
2.3. The Ordering Party, according to Article 107(2) of the Public Procurement Law, provides for the possibility of a one-time supplement of the aforementioned subject evidence within the time specified by the Ordering Party.
2.4. The subjective evidence referred to above is submitted in a manner provided for in the regulations issued under Article 70 of the Public Procurement Law. - i.e., in the Regulation of the Prime Minister of December 30, 2020, regarding the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in the public procurement procedure or competition.
2.5. Documents prepared in a foreign language are submitted along with a translation into Polish.