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

Abstract

<b><i>Background:</i></b> 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. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> 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.

Suitability of Different Diagnostic Platforms for Virological Testing of Blood Samples from Cornea Donors

“…Despite the suitability of validated assays for the serological screening of cadaveric samples, in a study by Larscheid et al [ 16 ] the total IgG in post-mortem blood samples of tissue donors was significantly lower when compared to pre-mortem blood samples. This highlights the utility of additional NAT-based screening for the confirmation of negative, equivocal, or weakly positive test results, thus increasing the safety of tissue preparations [ 17 , 18 ]. Regarding the NAT-based assays validated in our study, all examined assays were able to detect all HBV, HCV, and HIV spiked and unspiked pre- and post-mortem samples with no significant deviations of virus concentrations and internal QCs.…”

“…Macroscopically abnormal cadaveric serological samples should be interpreted with care [ 19 ]. In addition, haemodilution and other factors also need to be assessed when screening is performed [ 17 ]. Studies showed that the timeframe of post-mortem taken blood samples may be further extended >24 h with serological and NAT assays still generating valid test results [ 5 , 15 , 20 , 21 ].…”

Epidemiological Survey of the Prevalence of HCV and HBV in the Periphery of Lahore City

“…Both of these are viral infections that can be disseminated via sexual contact, blood or by the use of blood products, and even through methods of intra-familial transmission [20]. As claimed by the World Health Organization (WHO) approximately two billion individuals have been exposed to this virus, out of which 240 million are long lasting carries [24].…”

Epidemiological Survey of the Prevalence of HCV and HBV among the Factory Workers in the Periphery of Lahore

“…Hepatitis C and hepatitis B are major health-related issues all over the globe [1]. Both of these are viral infections that can be disseminated via sexual contact, by blood or the use of blood products, and through methods of intra-familial transmission [2]. According to the World Health Organization (WHO), approximately two billion individuals have been exposed to Hepatitis C virus, out of which 240 million are long lasting carriers [3].…”