Guidance

Chapter 9: laboratory requirement for the microbiological screening of donors

Updated 21 May 2024

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This publication is available at https://www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-organs-tissues-and-cells-used-in-transplantation/chapter-9-laboratory-requirement-for-the-microbiological-screening-of-donors

Microbiology laboratories that test serum or plasma samples from organ donors should:

  • be UK Accreditation Service ISO 15189 accredited
  • have available at all times expert advice for the interpretation of microbiology results and the knowledge to give informed advice to the transplant clinicians about the likelihood and implications of donor transmitted infection. These implications would include the severity of any transmitted infection and possible interventions to prevent, screen for and/or ameliorate these infections in the recipients. The advice would be given by a senior clinician (usually of consultant status) or microbiologist or virologist with FRCPath qualification who has understanding of donor transmitted infections
  • have appropriately trained Health and Care Professions Council (HCPC) registered biomedical scientists on call at all times for testing
  • have full quality assurance procedures in place for all tests in routine use

All blood samples taken for testing must be accurately identified and labelled with records retained to ensure continuing linkage of donor details with the donor samples.

The tests used for testing donors of cells, tissues and organs should be CE (Conformité Européenne) or UKCA (UK Conformity Assessed) marked.

Tests validated for deceased donor blood samples should be used if available. Inhibitors to nucleic acid testing (NAT) tests in deceased donor samples may generate false negative results but may be detected by the incorporation of appropriate internal controls in the assays.

The principles for determining the infection status of donors of organs, tissues and cells are based on the strategies that have been established for screening blood donors. Laboratory screening can take the form of serological testing for antibody, for antigen, and molecular testing for the DNA or RNA sequences of infectious agents. The EU directive currently requires serological testing of donors irrespective of NAT testing. While antibody detection relies on the host response, antigen and molecular assays directly detect components of the infectious agent.

Laboratories undertaking donor testing should archive donor blood or plasma samples for a minimum period of 10 years and should keep testing records, whether as paper or electronic reports, for a period of 30 years.[footnote 1] Maintaining the potential for retesting can also help prevent donated and archived tissue and cells being discarded unnecessarily because novel risks of infection cannot otherwise be assessed.

See a list of all chapters in this guidance

  1. See The retention and storage of pathological records and specimens (PDF, 561 KB), published by the Royal College of Pathologists. ↩

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