Requirement for third party HHV-8 antibody screening of deceased organ donors

NHSBT will require:<br/><br/>• Testing to be carried out by an UKAS accredited laboratory<br/>• Testing to commence in the second half of September 2022, exact date tbc.<br/>• Business continuity plan for this particular service to be provided by the testing laboratory in order to guarantee the provision of this essential testing <br/>• Weekly sample numbers of between 20 and 40, with an average of 30 samples (subject to agreed change during the term of the contract), depending on organ donation activity.<br/>• Receipt of samples from the Microbiology Laboratory Services Laboratory in Colindale, London every working day morning (Monday to Fridays except Bank Holidays).<br/>• The ability to test plasma or serum<br/>• Minimum of two assays for screening including detection of antibodies to lytic and latent HHV-8 antigens, with rationale for selection<br/>• At least one assay must be CE marked<br/>• Given the complexity of HHV-8 serology and to guarantee continued testing, it is desirable that other validated, alternative assays are available to complete the testing portfolio<br/>• All assays in-use should be fully validated with provision of evaluation and validation reports<br/>• A confirmatory testing pathway should be in place for screen reactive samples, and must include HHV-8 DNA detection<br/>• Results to be returned to NHSBT electronically via a secure SFTP data file / transfer process<br/>• Final reports on screen negative and screen reactive samples to be sent to NHSBT within 24-48 hours and 48-72 hours from receipt of the sample at the testing laboratory, respectively.<br/>• Turnaround times (TAT); 90% of reports must be received within 3 working days of the sample arriving at the testing laboratory<br/>• Contract term award will initially be 24 months with review after 12 months