Molecular Screening Services

Description

This Prior Information Notice (PIN) is a call for competition and is separate to any tender opportunity. Its purpose is to inform the market of an up-and-coming tender opportunity. NHSBT are looking for a fully integrated high throughput testing solution for an automated Nucleic Acid Amplification Testing (NAT) system which can detect HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma from blood and non-blood (e.g. stem cell, tissue) donors including from deceased (non-heart beating) donors. The solution must have the relevant CE/UKCA marking to support this ability. <br/>Organisations who express an interest must declare this by 17th April 2023 including a statement confirming their current participation in a Kit Evaluation Group (KEG) evaluation, or their intention to join the KEG process, or confirmation that their testing solution has previously been KEG approved. Any organisations wishing to participate in the KEG evaluation process must also submit their relevant assay Instructions For Use (IFU) by 17th April 2023 to tennille.madigan@nhsbt.nhs.uk<br/><br/>Organisations who express an interest to participate will be invite to future engagement sessions in March/April 2023. Lot 1: 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 specifically cadaveric 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 system. NHSBT are looking for a fully integrated, high throughput, automated Nucleic Acid Amplification Testing (NAT) screening system which can detect HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma samples from blood and non-blood (e.g. stem cell, tissue) donors including samples from deceased (non-heart beating) donors, as individual donations i.e.: not pooled<br/>Molecular Screening will be performed by NHSBTs Microbiology Services Laboratory in Colindale (London) with the following approximate number of samples (based on historical actual tests) per marker per year for both donation screening and confirmatory testing: <br/>• HBV DNA: 7,381 screening tests as part of a multiplex & 1,082 individual tests for confirmatory testing<br/>• HIV-1/HIV-2 RNA: 7,381 screening tests as part of a multiplex & 652 individual tests for confirmatory testing<br/>• HCV RNA: 7,381 screening tests as part of a multiplex & 640 individual tests for confirmatory testing<br/>• HEV RNA: 7,126 individual tests for either screening or confirmatory testing<br/>• Pooling is not required, all samples will be tested as an individual donation.<br/><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.