1. DEFINITION OF THE SUBJECT OF THE CONTRACT:
1.1. The subject of the order is the purchase of medical products for molecular diagnostics (diagnostic tests) in quantities specified in the Detailed Description of the Subject of the Order (hereinafter: SzOPZ or OPZ), necessary for the monitoring of ARV therapy for patients infected with the HIV virus and those with AIDS, with shipment directly 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 HIV in Poland for the years 2022-2026" (hereinafter referred to as: the 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 mentioned in the OPZ constitutes a separate proceeding.
1.3. The order must be completed in its entirety in accordance with the requirements specified in the SWZ, OPZ, and under the rules described in the Draft Contract Provisions (hereinafter PPU), which constitute attachments to the SWZ.
1.4. The OPZ containing the requirements and conditions for the execution of each part of the order is an attachment to the SWZ.

LOT-0001
1
Part 1: Reagent kits (with direct delivery to specified laboratories) for genotypic HIV-1 drug resistance testing by DNA sequencing.
1. DEFINITION OF THE SUBJECT OF THE CONTRACT:
1.1. The subject of the order in the scope of Part 1 is the delivery - at the expense and risk of the Contractor - of laboratory reagent kits intended for genotypic determination of HIV-1 drug resistance to antiretroviral drugs belonging to the class of inhibitors: reverse transcriptase (NRTI-nucleoside analogues, NNRTI-non-nucleoside analogues), protease (PI), and integrase (INSTI) to laboratories conducting tests for the implementers of the health policy program treating patients infected with HIV/ diagnosed with AIDS, who work based on hospitals/medical facilities that have entered into agreements with the National AIDS Center for the implementation of the Government Health Policy Program entitled “Antiretroviral treatment of people living with HIV in Poland for the years 2022-2026.”
2.1. The Ordering Party requires the offer of a laboratory reagent kit intended for "in vitro" diagnostics along with components necessary to carry out the diagnostic process starting from the reverse transcription step of HIV-1 RNA, through DNA amplification and sequencing by Sanger's dideoxy method, to obtain 940 effective results of determining the drug resistance profile of clinical isolate strains of HIV-1 to NRTI, NNRTI, PI, and INSTI inhibitors.
3.1. Validity period - a minimum of 10 months from the date of delivery to the direct recipient.
4.1. The offered reagent kit should meet the following requirements:
a) it should be based on nucleic acid amplification technology using polymerase chain reaction with a preceding reverse transcription step (reverse transcription polymerase chain reaction, RT-PCR);
b) it should allow amplification of adjacent regions of the HIV-1 genome encoding PR and RT HIV-1 in a common RT-PCR reaction sequence resulting in one PR-RT DNA product;
c) it should utilize standardized thermal profiles of PCR reactions at the various stages of the procedure for the PR-RT and INT HIV-1 encoding fragments, allowing for both amplifications to be carried out under the same conditions, in one thermocycler;
d) it should contain at least four different sequencing primers for each of the obtained types of DNA amplicons;
e) it should allow fluorescent labeling of the DNA products obtained for sequencing using the chain termination method - dideoxy Sanger;
f) it should allow sequencing of the following regions of the HIV-1 genome, covering codons not less than respectively for the enzymes: protease - PR (10-99), reverse transcriptase - RT (5-250), integrase - INT (20-280);
g) it should allow reading of the indicated HIV-1 genome sequences through capillary electrophoresis in polyacrylamide gel of the labeled DNA fragments;
h) it should ensure compatibility with the capillary sequencer;
i) it should ensure the lower sensitivity range of the test for HIV-1 subtype B no greater than 2000 copies/ml;
j) it should allow sequencing of the genomic regions of HIV-1 pol gene covering coding regions for the enzymes: RT, PR and INT in respect of all HIV-1 group M and CFR subtypes;
k) it must have CE IVD marking;
l) other requirements according to the relevant evidence specified in the Specification of Order Conditions.
2. PROOF OF SUBJECT MATTER:
2.1. Based on Article 105 and 106 of the Public Procurement Law, in order to confirm compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the order or offer evaluation criteria or requirements related to the execution of the order, the ordering party demands from contractors to present the following documents:
2.1.1. instruction for use of the medical product or description of the testing methodology;
2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the European Parliament and Council Regulation (EU) 2017/746 of April 5, 2017, concerning medical devices for in vitro diagnostics and repealing Directive 98/79/EC and Commission Decision 2010/227/EU as well as Good Distribution Practice - e.g. in the form of temperature monitoring prints for a period corresponding to at least 12 months of storage activity regarding all temperatures specified by the manufacturer for the specific medical product and its individual components.
2.1.3. notifications or reports referred to in Article 58 of the Act of May 20, 2010 on medical devices (Journal of Laws of 2021, item 1565), in connection with 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 medical devices for in vitro diagnostics, in accordance with the requirements of Directive 98/79/EC or European Parliament and Council Regulation (EU) 2017/746 of April 5, 2017, concerning medical devices for in vitro diagnostics and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
2.1.5. documents certifying the implementation of the conformity assessment procedure with a 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 aforementioned relevant proof of the subject matter along with the offer and he should exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify them for correctness.
2.3. The Ordering Party, in accordance with Article 107(2) of the Public Procurement Law, provides for the possibility of one-time supplementation of the above-mentioned relevant proof within the deadline set by the Ordering Party.
2.4. The relevant proof referred to above is submitted in the manner specified in regulations issued under Article 70 of the Public Procurement Law – 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 public procurement proceedings or competition.

LOT-0002
2
Part 2: Reagent kits (with direct delivery to specified laboratories) for genotypic HIV-1 drug resistance testing by DNA sequencing.
1. DEFINITION OF THE SUBJECT OF THE CONTRACT:
1.1. The subject of the order in the scope of Part 2 is the delivery at the expense and risk of the Contractor of laboratory reagent kits intended for genotypic determination of HIV-1 drug resistance to antiretroviral drugs belonging to the class of inhibitors: reverse transcriptase [NRTI-nucleoside analogues, NNRTI-non-nucleoside analogues], protease [PI] and integrase [INSTI] to laboratories conducting tests for implementers of the health policy program treating patients infected with HIV/ diagnosed with AIDS, working based on hospitals/medical facilities that have entered into agreements with the National AIDS Center for the implementation of the Government Health Policy Program entitled “Antiretroviral treatment of people living with HIV in Poland for the years 2022-2026.”
2.1. The Ordering Party requires the offer of a laboratory reagent kit intended for "in vitro" diagnostics along with components necessary to carry out the full diagnostic process starting from the nucleic acid isolation stage from the tested samples, through reverse transcription of HIV-1 RNA, DNA amplification, and sequencing by the dideoxy Sanger method, to obtain 1400 effective results of determining the drug resistance profile of clinical isolate strains of HIV-1 to NRTI, NNRTI, PI, and INSTI inhibitors.
3.1. Validity period - a minimum of 10 months from the date of delivery to the direct recipient.
4.1. The offered reagent kits should meet the following requirements:
a) it should be based on nucleic acid amplification technology using polymerase chain reaction with a preceding reverse transcription step (reverse transcription polymerase chain reaction, RT-PCR);
b) it should allow amplification of adjacent regions of the HIV-1 genome encoding PR and RT HIV-1 in a common RT-PCR reaction sequence resulting in one PR-RT DNA product;
c) it should utilize standardized thermal profiles of PCR reactions at the various stages of the procedure for the PR-RT and INT HIV-1 encoding fragments, allowing for both amplifications to be carried out under the same conditions, in one thermocycler;
d) it should contain at least four different sequencing primers for each of the obtained types of DNA amplicons;
e) it should allow fluorescent labeling of the DNA products obtained for sequencing using the chain termination method - dideoxy Sanger;
f) it should allow sequencing of the following regions of the HIV-1 genome, covering codons not less than respectively for the enzymes: protease - PR (10-99), reverse transcriptase - RT (5-250), integrase - INT (20-280);
g) it should allow reading of the indicated HIV-1 genome sequences through capillary electrophoresis in polyacrylamide gel of the labeled DNA fragments;
h) it should ensure compatibility with the capillary sequencer;
i) it should ensure the lower sensitivity range of the test for HIV-1 subtype B no greater than 2000 copies/ml;
j) it should allow sequencing of the genomic regions of HIV-1 pol gene covering coding regions for the enzymes: RT, PR, and INT in respect of all HIV-1 group M and CFR subtypes;
k) it must have CE IVD marking;
l) other requirements according to the relevant evidence specified in the Specification of Order Conditions.
2. PROOF OF SUBJECT MATTER:
2.1. Based on Article 105 and 106 of the Public Procurement Law, in order to confirm compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the order or offer evaluation criteria or requirements related to the execution of the order, the ordering party demands from contractors to present the following documents:
2.1.1. instruction for use of the medical product or description of the testing methodology;
2.1.2. documentation confirming compliance with the requirements resulting from Article 13(5) and Article 14(3) of the European Parliament and Council Regulation (EU) 2017/746 of April 5, 2017, concerning medical devices for in vitro diagnostics and repealing Directive 98/79/EC and Commission Decision 2010/227/EU as well as Good Distribution Practice - e.g. in the form of temperature monitoring prints for a period corresponding to at least 12 months of storage activity regarding all temperatures specified by the manufacturer for the specific medical product and its individual components.
2.1.3. notifications or reports referred to in Article 58 of the Act of May 20, 2010 on medical devices (Journal of Laws of 2021, item 1565), in connection with 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 medical devices for in vitro diagnostics, in accordance with the requirements of Directive 98/79/EC or European Parliament and Council Regulation (EU) 2017/746 of April 5, 2017, concerning medical devices for in vitro diagnostics and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
2.1.5. documents certifying the implementation of the conformity assessment procedure with a 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 aforementioned relevant proof of the subject matter along with the offer and he should exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Ordering Party to verify them for correctness.
2.3. The Ordering Party, in accordance with Article 107(2) of the Public Procurement Law, provides for the possibility of one-time supplementation of the above-mentioned relevant proof within the deadline set by the Ordering Party.
2.4. The relevant proof referred to above is submitted in the manner specified in regulations issued under Article 70 of the Public Procurement Law – 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 public procurement proceedings or competition.