Biological tests carried out on serum/plasma samples from donors of human body material for transplantation: Belgian experience and practical recommendations

Abstract

This paper on the biological tests carried out on serum/plasma samples from donors of human body material (HBM) is the result of a project of the working Group of Superior Health Council of Belgium formed with experts in the field of HBM and infectious serology. Indeed, uncertainty about the interpretation of biological test results currently leads to the sometimes unjustified cancelling of planned donations or the rejection of harvested HBM, whilst more sophisticated diagnostic algorithms would still allow the use of organs or HBM that would otherwise have been rejected. NAT tests will not be discussed in this publication. In the first part some general aspects as the need for a formal agreement between the Tissue Establishment l and the laboratory responsible for the biological testing, but also some specifications regarding testing material, the choice of additional biological tests, and some general aspects concerning interpretation and reporting are discussed. In a second part, detailed information and recommendations concerning the interpretation are presented for each of the mandatory tests (human immunodeficiency virus, hepatitis B virus, hepatitis C virus and syphilis) is presented. A number of not mandatory, but regularly used optional serological tests (e.g. for the detection of antibodies to Toxoplasma gondii, Epstein-Barr virus, human T cell leukemia virus and cytomegalovirus) are also extensively discussed. Although the project was meant to provide clarification and recommendations concerning the Belgian legislation, the majority of recommendations are also applicable to testing of donors of tissues and cells in other (European) countries.

Preanalytical variables influencing the interpretation and reporting of biological tests on blood samples of living and deceased donors for human body materials

“…This agreement must include at least the following elements, but should not necessarily be limited to them: The type of cell or tissue donor (living vs deceased), The fact that it is often not possible to obtain a new sample, The minimal sample volume required, The priority of the tests to be performed, in the event of limited volume, The collection conditions (centrifugation, type of tubes, labelling (incl. anonymisation,…), The transport conditions (interval time, temperature, packaging, time of delivery), Information about the performed tests, their CE marking, their validation, frequency of performance, time to response, …, Performance of tests on individual samples, no pooling, Reporting and documentation (formatting) of the test results (Padalko et al 2018 ; SHC 2016 ; e.g. results of microbiological cultures, etc.…”

“…Reporting and documentation (formatting) of the test results (Padalko et al 2018 ; SHC 2016 ; e.g. results of microbiological cultures, etc.…”