Nucleic Acid Testing Services

NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated solution, which must include all the necessary equipment, installation, maintenance, consumables, reagents, software, including an inter-operability provision with NHSBT's existing IT infrastructure, and an overall on-going support mechanism that may be required to carry out the necessary testing as stated below. All in vitro diagnostic medical devices, for example, instruments, consumables, and reagents must be CE/UKCA marked. The intended use of the assays must include use on human blood, stem cell, and tissue donors. Great Britain (GB) will continue to recognise CE marking under the IVDD or IVDR until 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. NHSBT are looking for a fully integrated, high throughput, automated Nucleic Acid Testing (NAT) screening system which can detect HCV RNA, HIV-1 RNA, HIV-2 RNA, HBV DNA, HEV RNA, and WNV RNA. NAT Screening will be performed by NHSBTs two testing sites in England at Manchester and Bristol (Filton). Samples from blood donors donations will be pooled prior to screening therefore pooling equipment is also required as part of the solution. Samples from stem cell and living tissue donors will be screened as individual donations and therefore not pooled. Throughput requirements:

HCV RNA, HIV-1 RNA, HIV-2 RNA, HBV DNA, HEV RNA: 1,520,000 samples per year WNV RNA: 48,000 samples per year At a minimum, HCV, HIV, and HBV must be multiplexed

KEG approval is a mandatory requirement for this opportunity, in-line with the requirements of the Guidelines for the Blood Transfusion Services in the United Kingdom (Red Book - https://www.transfusionguidelines.org/red-book).NHSBT will seek to understand the status of assays which would be offered with regards to KEG within the Tender.

Additional information: To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome.

Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:

Phone: 0800 9956035

E-mail: [email protected]