Microbiology Serology Testing Managed Service

NHSBT undertakes Microbiology Serology testing across three testing sites, the largest being Manchester and Filton testing laboratories. These test approximately 1.7 million donations per annum, which includes tests on blood, tissue and stem cell donations.<br/><br/>The third site, Microbiology Services Laboratory (MSL) in Colindale, tests approximately 5k donations per annum. MSL tests non-blood donations (tissue and stem cell), including those from deceased (not heart beating) tissue donors as well as undertaking confirmatory testing of screen reactive blood donations<br/><br/>Donation testing laboratories in Manchester and Filton perform the following tests:<br/>· Hepatitis B (HBsAg) *<br/>· Hepatitis B core (anti-HBc) **<br/>· Hepatitis B antibody (anti-HBs) ***<br/>· Human immunodeficiency virus (HIV 1&2 Ab/Ag) *<br/>· Hepatitis C (anti-HCV) *<br/>· Syphilis antibodies *<br/>· Human T-lymphotropic virus I/II (anti-HTLV) *<br/>· Cytomegalovirus (CMV) IgG or Total antibody **<br/>· Malarial antibody (anti-malaria) **<br/>· Trypanosome cruzi (anti-T. cruzi) **<br/><br/>The Microbiology Services Laboratory (MSL) in Colindale performs the following tests:<br/>· Hepatitis B (HBsAg) *<br/>· Hepatitis B antibodies (anti-HBc) ** <br/>· Human immunodeficiency virus (HIV 1&2 Ab/Ag) *<br/>· Hepatitis C (anti-HCV) *<br/>· Syphilis antibodies *<br/>· Human T-lymphotropic virus I/II (anti-HTLV) *<br/>· Cytomegalovirus (CMV) IgG or Total antibody **<br/>· Malarial antibody (anti-malaria) ** <br/>· Trypanosome cruzi (anti-T. cruzi) **<br/>· Cytomegalovirus (CMV) IgM ***<br/>· Hepatitis B antibodies (anti-HBs) ***<br/>* Mandatory requirement<br/>** On selected donations<br/>*** Where required<br/><br/>Deceased (non-heart beating) donor screening is performed at Microbiology Services Laboratory (MSL), Colindale and therefore the assays used in MSL must be suitable for deceased donor screening.<br/><br/>Automated instrumentation is required to enable high throughput testing of mandatory and additional testing for blood and non-blood donors. Archiving and long-term storage of plasma samples is also required. Consideration will be given to all efficiency and innovation opportunities, including, but not limited to, middleware and sample presentation technology.<br/><br/>The end-to-end solution must be capable of producing test results in a format that can be utilised by NHSBT’s host IT systems without the need for development to NHSBT host IT systems.<br/><br/>All Microbiology Serology testing requirements must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (www.transfusionguidelines.org/red-book ↗). <br/><br/>In accordance with the Guidelines for the Blood Transfusion service in the United Kingdom, Kit Evaluation Group (KEG) approval of the assays must be obtained prior to the award of contract. The submission of your assay Instructions for Use will allow a desktop review of high-level mandatory requirements. If the high-level mandatory requirements are met during the desktop review, organisations will be invited to participate in the KEG process and be asked to formally submit FRM51 “Application for NHSBT Evaluation of Microbiology Test Kit”, a copy of which will supplied by NHSBT following a successful desktop review.<br/><br/>All in-vitro diagnostic medical devices, for example: instruments, consumables and reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR until 30 June 2024 and from 01 July 2024 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended.