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. 2021 Feb;48(1):12-22.
doi: 10.1159/000513179. Epub 2020 Dec 22.

Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus

Axel Pruß  1 , Akila Chandrasekar  2 , Jacinto Sánchez-Ibáñez  3 , Sophie Lucas-Samuel  4 , Ulrich Kalus  1 , Holger F Rabenau  5
Affiliations

Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus

Axel Pruß et al. Transfus Med Hemother. 2021 Feb.

Abstract

Background: Although transmission of pathogenic viruses through human tissue grafts is rare, it is still one of the most serious dreaded risks of transplantation. Therefore, in addition to the detailed medical and social history, a comprehensive serologic and molecular screening of the tissue donors for relevant viral markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is necessary. In the case of reactive results in particular, clear decisions regarding follow-up testing and the criteria for tissue release must be made.

Methods: Based on the clinical relevance of the specific virus markers, the sensitivity of the serological and molecular biological methods used and the application of inactivation methods, algorithms for tissue release are suggested.

Results: Compliance with the preanalytical requirements and assessment of a possible hemodilution are mandatory requirements before testing the blood samples. While HIV testing follows defined algorithms, the procedures for HBV and HCV diagnostics are under discussion. Screening and decisions for HBV are often not as simple, e.g., due to cases of occult HBV infection, false-positive anti-HBc results, or early window period positive HBV NAT results. In the case of HCV diagnostics, modern therapies with direct-acting antivirals, which are often associated with successful treatment of the infection, should be included in the decision.

Conclusion: In HBV and HCV testing, a high-sensitivity virus genome test should play a central role in diagnostics, especially in the case of equivocal serology, and it should be the basis for the decision to release the tissue. The proposed test algorithms and decisions are also based on current European recommendations and standards for safety and quality assurance in tissue and cell banking.

Keywords: Donor screening; Tissue bank; Tissue donation; Virus inactivation; Virus safety.

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Conflict of interest statement

The authors have no conflict of interests to declare.

Figures

Fig. 1
Fig. 1
Hemodilution assessment.
Fig. 2
Fig. 2
Algorithm for HIV testing.
Fig. 3
Fig. 3
Algorithm for HBV testing.
Fig. 4
Fig. 4
Algorithm for HCV testing.
See this image and copyright information in PMC

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