Microbiology and Serology Testing

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  "description": "NHSBT requires a direct contractual relationship with either a manufacturer or any other economic operator for a complete end-to-end integrated solution for the Microbiology Serological screening/testing of blood and non-blood donations , which must include all the necessary equipment, installation, maintenance, consumables, reagents, software including an inter-operability provision with NHSBTs existing IT infrastructure and overall ongoing support mechanism that may be required to carry out the necessary testing as stated below. All invitro diagnostic medical devices, for example, instruments, consumables and reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR ( following the government timetable) devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended. The end-to-end solution must be capable of producing test results in a format that can be utilised by NHSBT’s host IT system (PULSE) without the need for changes to PULSE.<br/><br/>The current contract held with NHSBT for the Microbiology Serology Service includes the supply of the mandatory and selective serology assays, consumables, instrumentation, uninterruptable power supply and software required for result management and interface(s) with host systems; including servers to support the IT infrastructure.<br/><br/>Mandatory testing is undertaken on all blood and non-blood donations. The assays required include: Hepatitis B (HBsAg), Human immunodeficiency virus (HIV 1&2 Ab/Ag), Hepatitis C (anti-HCV), syphilis antibodies, and anti-HBc for non-blood donations. These tests are undertaken on high throughput automated equipment. Additional discretionary testing is also undertaken on select donations. These include testing for human T- lymphotropic virus (anti-HTLV), cytomegalovirus (anti-CMV), malarial antibody (anti-malaria), Hepatitis B antibodies (anti-HBc & anti-HBs) and Trypanosome cruzi (anti-T. cruzi). Deceased (non-heart beating) donor screening is performed at Microbiology Services Laboratory (MSL), Colindale and the assays used in MSL Colindale must be suitable for deceased donor screening.<br/><br/><br/>Kit Evaluation Group (KEG) approval of the assays must be obtained prior to the award of the contract.<br/><br/>There is a requirement for automated instrumentation to enable high throughput testing of mandatory and discretionary testing for blood and non-blood donors, archiving and long-term storage of plasma samples as part of this contract. Instrumentation for sample sorting is also for consideration.<br/><br/>All Microbiology Serology testing requirements must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (https://www.transfusionguidelines.org/red-book) and rules and guidance for pharmaceutical manufacturers and distributors.<br/><br/>NHSBT undertakes Microbiology Serology testing on approximately 1,600,000 donations per annum across two principal testing sites, namely Manchester and Filton, and also at the Microbiology Services Laboratory at Colindale.<br/><br/>This procurement contains Lots:<br/>Lot 1 – Contract A Microbiology and Serology Testing for Manchester and Filton<br/>Lot 2 – Contract B Microbiology and Serology Testing for Colindale and accommodates the requirements for Deceased Donor Screening",
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}