Molecular Screening

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. Great Britain (GB) will continue to recognise CE marking under the IVDD or IVDR until 30 June 2023 and from 1 July 2023 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.<br/><br/>NHSBT are looking for a fully integrated, high throughput, automated Nucleic Acid Testing (NAT) screening system which can detect HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma samples from non-blood (e.g. stem cell, tissue) donors including deceased (non-heart beating) donors.<br/><br/>Molecular Screening will be performed by NHSBTs Microbiology Services Laboratory in Colindale (London) with the following approximate number of samples per marker per year for both donation screening and confirmatory testing:<br/> ~ HBV DNA: 7,381 screening tests (see note) & 1,082 discriminatory/ID tests per year.<br/> ~HIV-1 RNA/ HIV-2 RNA: 7,381* screening tests & 652 discriminatory/ID tests per year.<br/> ~HCV RNA: 7,381 screening tests (se note) & 640 discriminatory/ID tests per year.<br/> ~HEV RNA: 7,126 tests per year.<br/> NOTE:HBV/HIV1&2/HCV tested as a multiplex screen.<br/><br/>It is important that interested parties respond to this PIN, as prior KEG approval will be a mandatory requirement for any associated future tender 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).<br/><br/>NHSBT will seek to understand the status of assays which would be offered with regards to NHSBT’s Kit Evaluation Group (KEG).<br/>Further details on KEG and the process will be provided during Supplier Engagement.<br/><br/>The format of Supplier Engagement will be communicated to those organisations that respond to this PIN; however, this is likely to be virtual meetings conducted via Microsoft Teams during the second half of September 2022.<br/><br/>Expressions of interest should be e-mailed to daniel.kirkbride@nhsbt.nhs.uk by 1200hrs on 12 September 2022.