Delivery of tests for virological monitoring of HIV. The public procurement includes 3 separate lots. The technical specifications for the individual sub-lots are detailed in Appendix 1.​​​​​​​

LOT-0001
Tests for whole-genome sequencing of HIV for subtyping and determining drug resistance. The test must contain a set of reagents, consumables for next-generation sequencing (NGS), and analysis of mutations associated with drug resistance in HIV-1 - 144 pieces.
Tests for whole-genome sequencing of HIV for subtyping and determining drug resistance. The test must contain a set of reagents, consumables for next-generation sequencing (NGS), and analysis of mutations associated with drug resistance in HIV-1 - 144 pieces, as detailed in the technical specification - Appendix 1. To the technical proposal for all separate lots - TO DEMONSTRATE the respective characteristics, the following must be attached: catalogs of the producing companies with catalog numbers and/or other documents (manufacturer's manuals, instructions for use, excerpts from the manufacturer's website, and others, with catalog numbers) from which it is clear that the offered product meets the requirements of the Contracting Authority set out in the technical specification. To the technical proposal FOR ALL SEPARATE LOTS, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for in vitro diagnostic medical devices must also be attached. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the amount to which they are paid, the participant must DECLARE that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b“ of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL; they are paid for in at least three Member States of the European Union through their respective public payment systems or their respective health insurance funds. For separate positions marked as complex (with sub-lots), participants must submit an offer for all sub-lots covered by the respective separate position; otherwise, they will be removed from the procedure.​​​​​​​

LOT-0002
Tests for sequencing the integrase (INT) gene of HIV-1 to determine resistant mutations to antiretroviral medications. The test must contain a set of reagents, consumables for next-generation sequencing (NGS), and analysis of mutations associated with drug resistance in HIV-1 - 120 pieces.
Tests for sequencing the integrase (INT) gene of HIV-1 to determine resistant mutations to antiretroviral medications. The test must contain a set of reagents, consumables for next-generation sequencing (NGS), and analysis of mutations associated with drug resistance in HIV-1. Tests for sequencing the integrase (INT) gene of HIV-1 to determine resistant mutations to antiretroviral medications. The test must contain a set of reagents, consumables for next-generation sequencing (NGS), and analysis of mutations associated with drug resistance in HIV-1 - 120 pieces, as detailed in the technical specification - Appendix 1. To the technical proposal for all separate lots - TO DEMONSTRATE the respective characteristics, the following must be attached: catalogs of the producing companies with catalog numbers and/or other documents (manufacturer's manuals, instructions for use, excerpts from the manufacturer's website, etc., with catalog numbers) from which it is clear that the offered product meets the requirements set out in the technical specification. To the technical proposal FOR ALL SEPARATE LOTS, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for in vitro diagnostic medical devices must also be attached. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the amount to which they are paid, the participant must DECLARE that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b“ of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL; they are paid for in at least three Member States of the European Union through their respective public payment systems or their respective health insurance funds. For separate positions marked as complex (with sub-lots), participants must submit an offer for all sub-lots covered by the respective separate position; otherwise, they will be removed from the procedure.

LOT-0003
Tests for sequencing protease (PR) and reverse transcriptase (RT) of HIV-1 to determine resistant mutations to antiretroviral medications - 120 pieces.
Tests for sequencing protease (PR) and reverse transcriptase (RT) of HIV-1 to determine resistant mutations to antiretroviral medications - 120 pieces, as detailed in the technical specification - Appendix 1. To the technical proposal for all separate lots - TO DEMONSTRATE the respective characteristics, the following must be attached: catalogs of the producing companies with catalog numbers and/or other documents (manufacturer's manuals, instructions for use, excerpts from the manufacturer's website, etc., with catalog numbers) from which it is clear that the offered product meets the requirements of the Contracting Authority set forth in the technical specification. To the technical proposal FOR ALL SEPARATE LOTS, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for in vitro diagnostic medical devices must also be attached. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the amount to which they are paid, the participant must DECLARE that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b“ of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL; they are paid for in at least three Member States of the European Union through their respective public payment systems or their respective health insurance funds. For separate positions marked as complex (with sub-lots), participants must submit an offer for all sub-lots covered by the respective separate position; otherwise, they will be removed from the procedure.