Hepatitis A virus (HAV) RNA & Parvovirus B19 DNA 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. <br/>All in vitro diagnostic medical devices, for example, instruments, consumables, and reagents must be CE/UKCA marked for EDTA plasma drawn from blood donors. Other specific requirements are outlined below. <br/>The solution: <br/>A s Fully integrated high throughput testing solution is required for screening blood and plasma donors for HAV RNA and Parvovirus B19 DNA. Samples will be pooled prior to screening therefore pooling equipment is also required as part of the solution. <br/>The HAV RNA and Parvovirus B19 DNA testing solution must have the ability to test EDTA plasma samples from blood & plasma donors that have been stored frozen for up to 2 years at minus 20 degrees (-20). <br/>In addition, the solution will be required to support NHSBT’s Microbiology Services Laboratory, a small specialist laboratory based in Colindale, solely in a contingency role to support NHSBT business continuity for essential screening services, therefore the testing solution MUST also have the ability to test the following as individual donations ie not pooled ) using the same analyser as for HAV and B19: 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 those from deceased (non-heart beating) donors.<br/>Great Britain (GB) will continue to recognise CE marking under the IVDD or IVDR until 30 June 2024 and from 1 July 2024 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 (PULSE) system. <br/>HAV RNA and Parvovirus B19 DNA testing will be performed at an purpose built NHSBT laboratory based in Manchester with the following approximate number of samples per marker per year for donation screening: <br/>Throughput: Approx: 146,000 samples per month until July 2024; July 2024 onwards 95,000 samples per month<br/>Molecular Screening Throughput Contingency <br/>The HAV & B19 laboratory will act as a contingency laboratory for the Molecular Screening service. As this is a contingency requirement due to a business continuity need, the numbers of tests required will be variable depending on the business continuity response. We anticipate the numbers to be relatively low compared to HAV and B19 and NHSBT will manage the work flow during a business continuity response working in partnership with the supplier to execute.<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). NHSBT will seek to understand the status of assays which would be offered with regards to KEG. Any organisations wishing to participate in the KEG evaluation process must also submit their relating assay IFUs by 17th April 2023 to tennille.madigan@nhsbt.nhs.uk<br/>Further details on KEG and the process will be provided during Supplier Engagement. 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 March/April 2023. Expressions of interest should be e-mailed to tennille.madigan@nhsbt.nhs.uk by 17th April 2023.