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Deceased tissue donor serology and molecular testing for HIV, hepatitis B and hepatitis C viruses: a lack of cadaveric validated tests

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Abstract

Vital to patient safety is the accurate assessment and minimization of risk for human immunodeficiency virus (HIV), Hepatitis C (HCV), and Hepatitis B (HBV) virus transmission by deceased donor organ and tissue transplantation. The pathogens are tested by serological kits based on enzyme-linked immunosorbent assay (ELISA), chemiluminescence (CLIA) and eletrochemiluminescence (ECLIA) immunoassays. Organ transplantation is a highly successful life-saving treatment in Brazil, but the Brazilian Health Surveillance Agency currently mandates that all deceased organ donors are screened for HIV, HCV and HBV following living donor policies. In this review, six ELISA (Wama®, Bio-Rad®, Biomerieux®, DiaSorin®, Acon Biotech® and Biokit®), three CLIA (Abbott®, Siemens®, Diasorin®) and one ECLIA (Roche®) were utilized for evaluating the effectiveness of those serological tests for deceased donors in Brazil according to manufacturer’s guidelines. NAT for HIV, HCV and HBV can assist with detection of pre-seroconversion for those infections, and only Cobas® TaqScreen MPX® test, the Tigris System® Procleix Ultrio Assay® and the Bio-Manguinhos® HIV/HCV/HBV NAT are commercially available. Between all the tests, only the manufacturer Abbott® and Cobas® TaqScreen MPX® test are currently validated for cadaver samples.

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Abbreviations

Anti-HBc:

Antibody to hepatitis B virus core antigen

Anti-HCV:

Hepatitis C virus antibody

Anti-HIV 1/2:

Human immunodeficiency 1 and 2 virus antibody

ANVISA:

Brazilian Health Surveillance Agency

CLIA:

Chemiluminescent assay

ECLIA:

Eletrochemiluminescent assay

ELISA:

Enzyme linked immuno sorbent assay

HBsAg:

Hepatitis B virus surface antigen

NAT:

Nucleic acid test

PCR:

Polymerase chain reaction

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Acknowledgments

This work was supported by National Agency for Health Surveillance (ANVISA)/National Counsel for Scientific and Technological Development (CNPq) (Grants 403360/2012-9 and 440029/2014-7) and Foundation for Research Support of Distrito Federal (Grant 23098.021477.2015-87). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Language help was supported by Prime Scientífica LTDA-ME.

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Authors and Affiliations

  1. Department of Cell Biology, University of Brasília, Brasília, 70919-970, Brazil

    Thayssa Neiva da Fonseca Victer, Cris Stéphany Rodrigues dos Santos, Sônia Nair Báo & Thatiane Lima Sampaio

  2. Federal Institute of Brasília, Brasília, 73380-900, Brazil

    Thatiane Lima Sampaio

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  1. Thayssa Neiva da Fonseca Victer
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  2. Cris Stéphany Rodrigues dos Santos
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  3. Sônia Nair Báo
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  4. Thatiane Lima Sampaio
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Correspondence to Thatiane Lima Sampaio.

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Victer, T.N.d., dos Santos, C.S.R., Báo, S.N. et al. Deceased tissue donor serology and molecular testing for HIV, hepatitis B and hepatitis C viruses: a lack of cadaveric validated tests. Cell Tissue Bank 17, 543–553 (2016). https://doi.org/10.1007/s10561-016-9564-7

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