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

Tender description

Universal screening for human herpes virus type 8 antibodies is to be added to the portfolio of tests required for deceased organ donor characterisation in the UK. Routine testing for all currently required markers will continue to be performed pre-donation, and on an urgent 24/7 basis by a network of 17 UK-wide NHS diagnostic laboratories. Donor samples will be sent by these laboratories by overnight DX delivery to the NHSBT Microbiology Services Laboratory (MSL) in London. MSL will separate samples on arrival, in readiness for transport to the third-party laboratory where HHV-8 testing will be done. <br/><br/>Given the intrinsic requirements of deceased organ donation, this testing is to occur in a centralised laboratory with results required in a clinically relevant and timely manner, as close as possible to the point of donation. Close and seamless liaison between MSL and the third-party laboratory will be essential. Lot 1: 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