The subject of the contract is the supply of qualitative diagnostic tests in plasma / serum samples of blood donors anti-HCV antibodies, anti-HIV 1 + 2 antibodies, HBsAg and syphilis (anti-Treponema pallidum) together with the required consumables and consumables, internal and external inspections and the lease of necessary equipment to automatic methods for releasing 58,000 donations in a period of 24 months and for connecting devices (research apparatus) to the computer system of the ordering party.

A detailed description of the subject of the contract is included in Annex 4 to the ToR.

The subject of the contract is the supply of qualitative diagnostic tests in plasma / serum samples of blood donors anti-HCV antibodies, anti-HIV 1 + 2 antibodies, HBsAg and syphilis (anti-Treponema pallidum) together with the required consumables and consumables, internal and external inspections and the lease of necessary equipment to automatic methods for releasing 58,000 donations in a period of 24 months and for connecting devices (research apparatus) to the computer system of the ordering party.

I. Device requirements:

- the contracting authority requires that the devices and tests offered allow tests to be carried out for at least 170 donations (detection of anti-HCV, anti-HIV 1 + 2, HBsAg and anti-Treponema Pallidum antibodies in each donation) in a total working time of not more than 6 hours,

- the term 'releasing one donation' should be understood as performing the necessary actions with the help of a device (testing apparatus) until the final result for an identifiable donation is obtained on the basis of a number compliant with the ISBT 128 standard (with a flag), including repetitive tests (performing 2 repetitions ) in the case of reactive results in the first test.

II. Test requirements:

- tests must be CE IVD marked and have appropriate quality certificates in accordance with the requirements of European Union Directive No. 93/42 EEC of June 14, 1993 and the Act of 20 May 2010 on medical devices,

- the sensitivity and specificity of the tests offered must be accepted by the testing supervisor at RCKiK. It should be documented in the company leaflet that the sensitivity and specificity is not lower than required:

- anti-HCV antibody detection test - sensitivity and specificity approx. 100%,

- anti-HIV1 + 2 antibody test - sensitivity and specificity approx. 100%,

- HBsAg detection test, sensitivity and specificity approx. 100%,

- syphilis infection test (anti-Treponema pallidum for Ig M and IgG antibodies) - sensitivity and specificity approx. 100%.

Other requirements are set out in Annex 4 to the ToR.