Supply of tests for blood borne virological markers and syphilis by chemiluminescence/ electrochemiluminescence, virological tests: HBsAg with confirmation tests, anti-HCV virological tests, anti-HIV 1+2 virological tests and syphilic tests for detection antibodies to Treponema pallidum and consumable, calibrating, control materials together with the lease of two analyzers necessary to perform the tests for the number: 195,000 donations for a period of 36 months with the connection of the apparatus to the IT system.
Supply of tests for simultaneous detection of molecular virological markers, i.e. HIV RNA, HCV RNA and HBV DNA, and consumable control materials, together with the lease of the apparatus necessary for automatic testing and the necessary archiving necessary to perform the tests for the number of 195,000 donations over a period of 36 months together with the connection of the apparatus to the teleinformatz system.
A detailed description of the item of the contract includes the “Offer Form”, the “Detailed Description of the Object of the Order” and the proposed contract provisions that are annexes to the SWZ. After the conclusion of the contract, the documents will be annexes to the contract. (a) the delivery of tests for blood borne virological markers and syphilis by chemiluminescence/ electrochemiluminescence, i.e. virological tests: HBsAg with confirmation tests, anti-HCV virological tests, anti-HIV virological tests 1+2 and syphilic tests for detection of antibodies to Treponema pallidum and consumable, calibration, control materials together with the lease of two analyzers necessary to perform tests for the number of: 195,000 donations for a period of 36 months with connection apparatus for the IT system.
(b) supply of tests for simultaneous detection of molecular virological markers, i.e. HIV RNA, HCV RNA and HBV DNA, and consumable control materials, together with the lease of the apparatus necessary for automatic testing and the necessary archiving necessary to perform the tests for the number of 195,000 donations over a period of 36 months with the connection of the apparatus to the IT system
(c) supply of a preanalytical system enabling automation of the pre-analytical phase of the review virological tests, i.e. centrifugation of samples according to specific parameters, proper identification of the test sample, evaluation of qualitative parameters (lipemia, hemolysis) and quantitative (volume) and opening, and transporting test tubes meeting the criteria to designated sites for testing, including leasing the necessary apparatus and connecting the apparatus to the IT system
The test material can be both serum and plasma.
2. Under the term 'tests' used later in the specification, all tests listed in points 1a and 1b should be understood.
3. Under the term 'auxiliary materials' used later in the specification shall be understood: flushing fluids, buffers, dosing tips, other consumable, calibration, control materials, sanitizer and any other material necessary for testing by means of the tests offered on the offered cameras as well as all other materials necessary for the correct operation of the apparatus.
4. The term 'donation test' shall be understood to perform the necessary actions on the test apparatus until a final result is obtained for an identifiable donation based on an ISBT 128 compliant number, taking into account the performance of repetition tests in the case of reactive results in the first study.
5. The term 'CITO test' should be understood to allow the delivery of the sample for the test at any time in the test cycle.
1. The Contractor shall provide two fully automatic analyzers to perform serological tests, analyzers necessary for automatic molecular testing and necessary archiving by means of the tests offered and a system of preanalytical devices enabling automation of the pre-analytical phase of review virological studies. Analyzers, apparatus and equipment, hereinafter referred to as' apparatus', must automatically perform the preanalytic phase and the marking procedure for each test, i.e. without the need for operator interference in the individual stages preceding the test, and to perform the test from the time the samples are loaded to receiving the results.
2. Each of the components of the apparatus offered must be factory new or not older than 2014.
3. Each serological analyzer must ensure the performance of a minimum of 200 tests of each type (4 types of tests) within 7 hours.
The molecular test apparatus set must ensure that a minimum of 546 donations can be tested within 7 hours.