P55 The Management of Blood Samples to be Used in Assessing Tests for vCJD in Donor Blood.

Abstract

There are presently 161 reported cases of vCJD in the UK, with three cases associated with the receipt of blood components. However, there is currently no routine large‐scale screening test for vCJD in humans. The NHSBT considers that it is essential to be in a position to validate emerging tests for vCJD as quickly as possible, to ensure that suitable tests can be implemented in a timely manner, if required by the DoH. NHSBT is proactively preparing a panel of samples that will be used in assessing tests, to determine if they are operationally fit for purpose. This work is being undertaken in a specifically designed Test Assessment Facility (TAF) at Manchester Blood Centre, which went live in November 2005. To manage the panel, the Thermo Nautilus Laboratory Information Management System (LIMS) has been installed. Nautilus is a highly configurable LIMS, capable of handling large amounts of data. Irreversible anonymisation, integration with robotic equipment, and the ability to interrogate other data systems and retrieve information, are key features. Whole blood donations are received into the TAF and are logged into the LIMS, which retrieves basic donor demographic information, then irreversibly anonymises it. Red cell, buffy coat and plasma components are then prepared, and robot sample handlers sub‐aliquot them. The LIMS then references a data output file, and processes the sub‐aliquot information, creating a detailed inventory. Wireless technology is used for plate storage. The LIMS underwent extensive validation, including the use of designated test scripts to challenge and validate all aspects of the system, plus verification of compliance with GMP and GAMP regulations. The panel builds at a rate of around 125 donations per week, equating to 18,000 individual sub‐aliquots, all managed by the LIMS. The panel will take 2 years to complete, when it will consist of samples from 10,000 donations(5000 from UK donors and 5000 from US donors), producing a panel size of 1,440,000 sub‐aliquots. The use of Nautilus LIMS in the TAF has proved invaluable to the project, and has contributed to its successful implementation. Furthermore, it will continue to manage the panel, and all associated activities.