Enumeration of White Blood Cells in Leucodepleted Blood

Please note this is not the start of a procurement process. A separate contract notice will be published to cover this requirement. The primary purpose of this PIN is to inform the market of prospective requirements, as far as the details are known at this time, for a reagent system for the enumeration of residual white blood cells in leucodepleted blood components.

As a safety measure NHSBT filter blood components to reduce the white blood cell concentration. A proportion of filtered components are sampled and tested by the routine quality monitoring laboratories to ensure compliance with guidelines for the blood transfusion services in the UK and the blood safety and quality regulations for white blood cell count specifications such that 90 % of component have < 1 x 1 000 000 WBC per unit with 95 % confidence.

Prior to commencing a formal procurement process and to help inform our strategy/requirements, NHSBT would like to consult the market to establish the likely level of interest and identify further opportunities and potential issues. The below sets out NHSBT's requirement.

1. A system capable of quantitatively counting WBC concentrations in the range of 1 x 1 000 000 cells per Litre to 100 x 1 000 000 cells per Litre;

2. A system capable of meeting an annual requirement of approximately 100 000 tests;

3. Either:

• (a)a reagent system compatible with existing NHSBT flow cytometers; or

• (b)a reagent system and analyser dependent on an alternative methodology to flow cytometry;

4. The reagent system, and analyser, must be CE marked with certificated evidence of EC conformity where necessary comply with the EU Regulation on In Vitro Diagnostic Medical Devices 2017/746.

Prior to commencing a formal procurement process and to help inform our strategy/requirements, NHSBT would like to consult the market to establish the likely level of interest and identify further opportunities and potential issues. It is our intention to invite those organisations who express an interest in this PIN to a supplier engagement meeting to be held in November/December 2019.

To enable NHSBT to finalise arrangements (e.g. send meeting location details and agree time slots) for the supplier engagement meetings, interested organisations are required to send an email (expressing their interest) to Marta Drozdzowska by no later than 17.00 (GMT) on 27.11.2019, including a list of your potential attendees and a brief of overview (or a website link) of the goods/services which might be offered.

Further information (e.g. the DRAFT technical specifications, award criteria, intended timescales, etc.) may be released - for consultation purposes only - to those organisations who express an interest.

It is the intention of NHSBT to award a framework agreement or contract for this requirement by May/June 2020.

Please note that all details are subject to change.