Hongrie – Agents diagnostiques – 21-Mikrogyöngyökkel működő HLA tesztek beszerzése

Acquisition of HLA diagnostic test kits operating with fluorescent-labeled microbeads. Ensuring the right to use analyzers suitable for analyzing microbeads, based on the flow principle, validated for the proposed test kits, at the delivery address, as well as tasks related to ensuring the continuous operability of the analyzers put into use during their usage time. II. Quantity of test kits and analyzers to be procured for the entire contract period, 24 months: a.) Test kits: 1. row: 3,500 units of low-resolution, DNA-based HLA-A typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 2. row: 4,500 units of low-resolution, DNA-based HLA-B typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 3. row: 2,200 units of low-resolution, DNA-based HLA-C typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 4. row: 1,400 units of low-resolution, DNA-based HLA-DP typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 5. row: 2,300 units of low-resolution, DNA-based HLA-DQ typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 6. row: 3,300 units of low-resolution, DNA-based HLA-DR typing test kit for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 7. row: 10,700 units of test kit suitable for screening HLA antibodies (I.+II. class) for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 8. row: 6,700 units of test kit suitable for determining the specificity of antibodies against HLA class I antigens with individual antigens (single antigen) for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 9. row: 6,100 units of test kit suitable for determining the specificity of antibodies against HLA class II antigens with individual antigens (single antigen) for solid organ transplantation and hematopoietic stem cell transplantation for patients waiting for transplantation and their potential relatives 10. row: 375 units of supplementary test kit suitable for determining the specificity of complement-binding antibodies against HLA antigens with individual antigens for patients waiting for solid organ transplantation.

By test kit, the tenderer understands the test, Taq polymerase, conjugate(s), control(s), calibrator, other solution, and detecting reagent (fluorescent reporter) necessary for one determination (examination). The tenderer accepts as a test kit even if the tests are not provided in a factory-packaged set with Taq polymerase, controls, calibrator, other solution, and detecting reagent, but separately. If the Taq polymerase, controls, calibrator, other solution, and detecting reagent are not marketed in the same packaging as the tests, then these materials must also be offered in the quantity necessary for the use of the tests, and the offer price must also include their value. (Hereinafter, the tenderer refers to both separately packaged and co-packaged tests, Taq polymerase, controls, calibrator, other solution, and detecting reagent uniformly as test kit.) Regarding these separately packaged materials, the offered quantity must be justified by the calculation presented in the user manual or manufacturer's declaration. The total quantity must be offered per row (per test kit type) from the same product. All elements (test, Taq polymerase, conjugate, control, calibrator, other solution, detecting reagent) of a given test kit type offered in one row must come from the same legal manufacturer. If this is not the case, then the compatibility with the test kit must be justified! The offer must contain two (2) identical analyzers, and the devices forming part of the analyzer must be of the same make and type. The offer is invalid if it contains devices of different makes and/or types. Those devices are considered to be of the same make and type, the item numbers of which are fully identical.