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Tender Details
- Country: Czech Republic
- Summary: Laboratory Examination of Blood Donors - Nat Testing of Viral Infections 7/2025 to 6/2026
- CZT Ref No: 118995732
- Deadline: 23 May 2025
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: 2000000
- Notice Type: Tender
- Document Ref. No.:
- Purchaser's Detail :
- Description :
- A/ Provision of services - performing laboratory examinations - NAT testing of blood and blood donor donors (plasma, platelet) from sampling for the production of transfusions and collection for the production of raw materials for further processing pursuant to Section 4 (3) and (4) of Decree No. 143/2008 Coll.Requirements for ensuring the quality and safety of human blood and its components (decree on human blood), as amended, including the collection of samples. The contracting authority shall ensure sampling for laboratory examinations in tubes approved by the supplier (service provider). General Requirements: • Service ProviderIt must be the manufacturer of medicinal products, a transfusion service or a control laboratory in accordance with Section 67 (3) of Act No. 378/2007 Coll. on medicines and on changes of related laws, as amended • the contracting authority must be allowed to perform an audit in the Laboratory of the Provider to assess the fulfillmentRequirements resulting from the principles of correct production practice • In the case of planned changes with the impact on the quality and safety of transfusion products and raw materials for further processing, the contracting authority will be informed in writing by the provider at least 3 months before the change. Technical Requirements: Service ProviderNAT of samples testing in accordance with Decree No. 143/2008 Coll. as amended from 01.and 2 ") by the method of direct detection of viral RNA; b) by hepatitis B virus (hereinafter referred to as" HBV "), by the method of direct detection of viral DNA; (c) hepatitis C virus (hereinafter referred to as "HCV"), by direct viral RNA detection; and paragraph (4) - Examinations are performed • for the production of transfusion products by methods with demonstrableSensitivity by default sample at least 500 IU/ml at the determination of HIV RNA, 35 IU/ml at the determination of HBV DNA and 150 IU/ml at the determination of HCV RNA, examination must be performed o...
- Documents :
Purchaser : ZNOJMO HOSPITAL, ALLOWANCE ORGANIZATION
MUDr. Jan Jansky 11 669 02 Znojmo
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