Hungary – Diagnostic agents – 21-Mikrogyöngyökkel működő HLA tesztek beszerzése

Procurement of HLA diagnostic test kits operating with fluorescently labeled microbeads. Ensuring the right to put into use analysers suitable for analysing microbeads, based on the flow principle, validated for the proposed test kits at the delivery address, as well as performing tasks related to ensuring the continuous operability of the analysers put into use during their usage period. II. Quantity of test kits and analysers 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 transplant and haematopoietic stem cell transplant patients and their potential donors 2. row: 4,500 units of low-resolution, DNA-based HLA-B typing test kit for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 3. row: 2,200 units of low-resolution, DNA-based HLA-C typing test kit for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 4. row: 1,400 units of low-resolution, DNA-based HLA-DP typing test kit for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 5. row: 2,300 units of low-resolution, DNA-based HLA-DQ typing test kit for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 6. row: 3,300 units of low-resolution, DNA-based HLA-DR typing test kit for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 7. row: 10,700 units of test kit suitable for screening HLA antibodies (I.+II. class) for solid organ transplant and haematopoietic stem cell transplant patients and their potential donors 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 transplant and haematopoietic stem cell transplant patients and their potential donors 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 transplant and haematopoietic stem cell transplant patients and their potential donors 10. row: 375 units of supplementary test kit suitable for determining the specificity of complement-binding antibodies against HLA antigens with individual antigens for solid organ transplant patients The Inviting Entity understands a test kit to be the test required for one determination (examination), Taq polymerase, conjugate, control, calibrator, other solution, detecting reagent (fluorescent reporter). The Inviting Entity accepts as a test kit also that in which the tests are not in a factory-packaged kit with Taq polymerase, controls, calibrator, other solution, 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 required for the use of the tests, and the offer price must also include their value. (Hereinafter, the Inviting Entity refers to both the separately packaged and the co-packaged tests, Taq polymerase, controls, calibrator, other solution, and detecting reagent uniformly as test kit.) The correctness of the offered quantity of these separately packaged materials must be justified by a calculation presented in the user manual or manufacturer's declaration. The total quantity must be offered per row (per test kit type) from an identical product. All elements (test, Taq polymerase, conjugate, control, calibrator, other solution, detecting reagent) of a test kit type offered in a given row must originate 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 analysers, and the devices forming part of the analyser must be of the same make and type. An 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 completely identical.