Advertisement

Cell and Tissue Banking

, Volume 17, Issue 4, pp 543–553 | Cite as

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

  • Thayssa Neiva da Fonseca Victer
  • Cris Stéphany Rodrigues dos Santos
  • Sônia Nair Báo
  • Thatiane Lima SampaioEmail author
Full Length Review

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.

Keywords

Post-mortem blood Donors Validation Infectious disease serology NAT Infectious disease molecular detection 

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

Notes

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.

Compliance with ethical standards

Conflict of interest

The authors of this manuscript have no conflicts of interest to disclose.

References

  1. Abbott® (2013a) ARCHITECT® Anti-HBc IIGoogle Scholar
  2. Abbott® (2013b) ARCHITECT® HBsAg QualitativeGoogle Scholar
  3. Abbott® (2014a) ARCHITECT® Anti-HCVGoogle Scholar
  4. Abbott® (2014b) ARCHITECT® HIV Ag/Ab ComboGoogle Scholar
  5. ADVIA Centaur®, ADVIA Centaur® XP, ADVIA Centaur® XPT HBc Total (HBcT) (2014) Siemens Healthcare Diagnostics IncGoogle Scholar
  6. ADVIA Centaur® and ADVIA Centaur® XP HBsAg (HBs) (2010) Siemens Healthcare Diagnostics IncGoogle Scholar
  7. ADVIA Centaur®, ADVIA Centaur® XP HIV 1/O/2 Enhanced (EHIV) (2012) Siemens Healthcare Diagnostics IncGoogle Scholar
  8. Anti-HBsAg II: Antibodies to hepatitis B surface antigen (2015) Roche Diagnostics® Google Scholar
  9. Anti-HBc: Antibodies to hepatitis B core antigen (anti-HBc) (2015) Roche Diagnostics® Google Scholar
  10. Anti-HCV: Antibody to hepatitis C virus (anti-HCV) (2015) Roche Diagnostics® Google Scholar
  11. Appierto V, Callari M, Cavadini E, Morelli D, Daidone MG, Tiberio P (2014) A lipemia-independent NanoDrop(R)-based score to identify hemolysis in plasma and serum samples. Bioanalysis 6:1225–1226. doi: 10.4155/bio.13.344 CrossRefGoogle Scholar
  12. Associação Brasileira de Transplante de Órgãos (2014) Dimensionamento dos Transplantes no Brasil e em cada estado (2007-2014), 2014 [Internet]. Registro Brasileiro de Transplantes, São PauloGoogle Scholar
  13. Associação Brasileira de Transplante de Órgãos (2015) Dimensionamento dos Transplantes no Brasil e em cada estado (2008-2015), 2015 [Internet]. Registro Brasileiro de Transplantes, São PauloGoogle Scholar
  14. Associação Brasileira de Transplante de Órgãos (2016) Dados Númericos da doação de órgãos e transplantes realizados por estado e instituição no período: Janeiro / Março - 2016, 2016 [Internet]. Registro Brasileiro de Transplantes, São PauloGoogle Scholar
  15. Bioelisa® anti-HBc (2012) BioKit® Google Scholar
  16. Bioelisa® HBsAg 3.0 (2012) BioKit® Google Scholar
  17. Bioelisa® HCV 4.0 (2012) BioKit® Google Scholar
  18. Bioelisa® HIV 1/2 3.0 (2012) BioKit® Google Scholar
  19. Bio-Manguinhos®FioCruz (2015) Kit NAT HIV/HBV/HCV® Google Scholar
  20. Bio-Rad® (2006) MONOLISA® HCV Ag-Ab ULTRAGoogle Scholar
  21. Brasil (2008) RDC 67, de 30 de setembro de 2008. Dispõe sobre o Regulamento Técnico para o Funcionamento de Bancos de Tecidos Oculares de origem humanaGoogle Scholar
  22. Brasil (2009) Portaria MS Nº 2.600, de 21 de outubro de 2009 Aprova o Regulamento Técnico do Sistema Nacional de TransplantesGoogle Scholar
  23. Brasil (2014) Dispõe sobre as Boas Práticas no Ciclo de Sangue vol RDC 304Google Scholar
  24. Calmarza P, Cordero J (2011) Lipemia interferences in routine clinical biochemical tests. Biochem Med 21:160–166CrossRefGoogle Scholar
  25. Chen D, Kaplan LA (2006) Performance of a new-generation chemiluminescent assay for hepatitis B surface antigen. Clin Chem 52:1592–1598. doi: 10.1373/clinchem.2005.064063 CrossRefPubMedGoogle Scholar
  26. Chigurupati P, Murthy KS (2015a) Automated nucleic acid amplification testing in blood banks: an additional layer of blood safety. Asian J Transfus Sci 9:9–11. doi: 10.4103/0973-6247.150938 CrossRefPubMedPubMedCentralGoogle Scholar
  27. Chigurupati P, Murthy KS (2015b) Automated nucleic acid amplification testing in blood banks: an additional layer of blood safety. Asian J Transfus Sci 9:9–11. doi: 10.4103/0973-6247.150938 CrossRefPubMedPubMedCentralGoogle Scholar
  28. Davidson T, Ekermo B, Gaines H, Åkerlind BLA (2011) The cost-effectiveness of introducing nucleic acid testing to test for hepatitis B, hepatitis C, and human immunodeficiency virus among blood donors in Sweden. Transfusion 51:421–429. doi: 10.1111/j.1537-2995.2010.02877.x CrossRefPubMedGoogle Scholar
  29. Dimeski G, Bird R, Brown N (2012) Measurement of glycated hemoglobin in a patient with homozygous hemoglobin E. Clin Chem Lab Med CCLM/FESCC 50:1479–1482. doi: 10.1515/cclm-2011-0772 Google Scholar
  30. Garcia VD, Abbud-Filho M, Felipe C, Pestana JM (2015) An overview of the current status of organ donation and transplantation in Brazil. Transplantation 99:1535–1537. doi: 10.1097/TP.0000000000000828 CrossRefPubMedGoogle Scholar
  31. Gaum L, Reynolds I, Jones MN, Clarkson AJ, Gillan HL, Kaye SB (2012) Tissue and corneal donation and transplantation in the UK. Br J Anaesth 108(Suppl 1):i43–i47. doi: 10.1093/bja/aer398 CrossRefPubMedGoogle Scholar
  32. GENSCREEN® HIV1/2 version 2 (2006) Bio-Rad® Google Scholar
  33. GENSCREEN™ ULTRA HIV Ag-Ab (2007) Bio-Rad® Google Scholar
  34. Gubbe K et al (2012) Validation of Virus NAT for HIV, HCV, HBV and HAV using post-mortal blood samples. Transfus Med Hemother Offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie 39:381–385. doi: 10.1159/000345319 Google Scholar
  35. Gupta E, Bajpai M, Choudhary A (2014) Hepatitis C virus: screening, diagnosis, and interpretation of laboratory assays. Asian J Transfus Sci 8:19–25. doi: 10.4103/0973-6247.126683 CrossRefPubMedPubMedCentralGoogle Scholar
  36. Hepanostika® HBsAg Ultra (2012) BioMérieux® Google Scholar
  37. HIV combi PT: HIV-1 antigen and total antibodies to HIV-1 and HIV-2 (2015) Roche Diagnostics® Google Scholar
  38. Hologic® (2012) Procleix® Ultrio® AssayGoogle Scholar
  39. Howard RJ, Schold JD, Cornell DL (2005) A 10-year analysis of organ donation after cardiac death in the United States. Transplantation 80:564–568CrossRefPubMedGoogle Scholar
  40. Imuno-ELISA HCV (2012) Wama Diagnóstica® Google Scholar
  41. Imuno-ELISA Anti-HBsAg (2012) Wama Diagnóstica® Google Scholar
  42. Imuno-ELISA HIV 1 + 2 (2012) Wama Diagnóstica® Google Scholar
  43. Imuno-ELISA HIV 1 + 2 (Ag/Ac) (2012) Wama Diagnóstica® Google Scholar
  44. Interkit Anti-HBc: Anti HBc IgG, Anti Core do HBV-Enzimaimunoensaio (2014) Acon Biotech® Google Scholar
  45. Interkit Anti-HCV: Hepatite C-Enzimaimunoensaio (2014) Acon Biotech® Google Scholar
  46. Interkit HBsAg: Hepatite B-Enzimaimunoensaio (2014) Acon Biotech® Google Scholar
  47. Interkit HIV: 4ª Geração Enzimaimunoensaio (2014) Acon Biotech® Google Scholar
  48. Ison MG et al (2011) Transmission of human immunodeficiency virus and hepatitis C virus from an organ donor to four transplant recipients. Am J Transpl Off J Am Soc Transpl Am Soc Transpl Surg 11:1218–1225. doi: 10.1111/j.1600-6143.2011.03597.x CrossRefGoogle Scholar
  49. Kalus U, Wilkemeyer I, Caspari G, Schroeter J, Pruss A (2011) Validation of the serological testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from post-mortem blood on the siemens-BEP-III automatic system. Transfus Med Hemother Offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie 38:365–372. doi: 10.1159/000334481 Google Scholar
  50. Kumar R, Gupta S, Kaur A, Gupta M (2015) Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety. Asian J Transfus Sci 9:199–202. doi: 10.4103/0973-6247.154250 CrossRefPubMedPubMedCentralGoogle Scholar
  51. Lai JC, Kahn JG, Tavakol M, Peters MG, Roberts JP (2013) Reducing infection transmission in solid organ transplantation through donor nucleic acid testing: a cost-effectiveness analysis. Am J Transpl Off J Am Soc Transpl Am Soc Transpl Surg 13:2611–2618. doi: 10.1111/ajt.12429 CrossRefGoogle Scholar
  52. Len O, Ramos A, Pahissa A (2012) Evaluating the risk of transmission of infection from donor to recipient of a solid organ transplantation. Enferm Infecc Microbiol Clin 30(Suppl 2):19–26. doi: 10.1016/S0213-005X(12)70078-2 CrossRefPubMedGoogle Scholar
  53. LIAISON® XL HIV Ag/Ab (2012) DiaSorin® Google Scholar
  54. LIAISON® XL Murex® HCV Ab (2014) DiaSorin® Google Scholar
  55. LIAISON® Anti-HBc (2014) DiaSorin® Google Scholar
  56. LIAISON® HBc IgM (2014) DiaSorin® Google Scholar
  57. LIAISON® HBsAg (2014) DiaSorin® Google Scholar
  58. LIAISON® XL Murex® HBsAg Quant (2014) DiaSorin® Google Scholar
  59. Linke SJ et al (2013) Thirty years of cornea cultivation: long-term experience in a single eye bank. Acta Ophthalmol 91:571–578. doi: 10.1111/j.1755-3768.2012.02471.x CrossRefPubMedGoogle Scholar
  60. Lippi G et al (2008) Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med CCLM/FESCC 46:764–772. doi: 10.1515/CCLM.2008.170 Google Scholar
  61. Michelon VG, Michelon T, Garcia VD, Marcon AS (2009) Avaliação das atividades do Banco de Olhos da Santa Casa de Porto Alegre 2003–2007. J Brasil Transpl 12:5Google Scholar
  62. MONOLISA® anti-HBc PLUS (2006) Bio-Rad Laboratories® Google Scholar
  63. MONOLISA® HBsAg: ULTRA (2007) Bio-Rad Laboratories® Google Scholar
  64. Morgner F, Lecointre A, Charbonniere LJ, Lohmannsroben HG (2015) Detecting free hemoglobin in blood plasma and serum with luminescent terbium complexes. Phys Chem Chem Phys 17:1740–1745. doi: 10.1039/c4cp04206a CrossRefPubMedGoogle Scholar
  65. Murex® HIV Ag/Ab Combination (2014) DiaSorin® Google Scholar
  66. Murex® anti-HBc (total) (2014) DiaSorin® Google Scholar
  67. Murex® anti-HCV (version 4.0) (2014) DiaSorin® Google Scholar
  68. Murex® HBsAg Version 3 (2014) DiaSorin® Google Scholar
  69. Organ procurement and transplantation network. Final rule (2013) vol 78, 2013/07/10 ednGoogle Scholar
  70. PRISM® Hepatitis B Virus Core Antigen (2002) Abbott Laboratories® Google Scholar
  71. PRISM® HBsAg: Antibody to Hepatitis B Surface Antigen (2005) Abbott Laboratories® Google Scholar
  72. PRISM® HCV: Hepatitis C Virus Encoded Antigens (2008) Abbott Laboratories® Google Scholar
  73. PRISM® HIV Ag/Ab Combo: human immunodeficiency Virus Type 1 and 2 (2008) Abbott Laboratories® Google Scholar
  74. Pruss A, Caspari G, Kruger DH, Blumel J, Nubling CM, Gurtler L, Gerlich WH (2010) Tissue donation and virus safety: more nucleic acid amplification testing is needed. Transpl Infect Dis Off J Transpl Soc 12:375–386. doi: 10.1111/j.1399-3062.2010.00505.x CrossRefGoogle Scholar
  75. Roche® (2015a) Cobas® TaqScreen MPX. Roche Diagnostics® Google Scholar
  76. Roche® (2015b) Cobas® TaqScreen MPX® Google Scholar
  77. Saibaba KS, Bhaskar MV, Rao PV, Ramana GV, Dakshinamurty KV (1998) Interferences in clinical chemistry analysis. Indian J Clin Biochem IJCB 13:55–62. doi: 10.1007/BF02867865 CrossRefPubMedGoogle Scholar
  78. Sampaio TL, Rodrigues IP, Pontes DF, Ribeiro TK, Yamagushi CK, de Araujo WN, Bao SN (2015) Suitability of corneal tissue for transplantation derived from violent death: a 10-year analysis. Transpl Proc 47:2973–2977. doi: 10.1016/j.transproceed.2015.07.034 CrossRefGoogle Scholar
  79. Santos CGd, Pacini KM, Adán CBD, Sato EH (2010) Motivos do descarte de córneas captadas pelo banco de olhos do Hospital São Paulo em dois anos. Revista Brasileira de Oftalmologia 69:4Google Scholar
  80. Shin DH et al (2014) Development of an integrated reporting system for verifying hemolysis, icterus, and lipemia in clinical chemistry results. Ann Lab Med 34:307–312. doi: 10.3343/alm.2014.34.4.307 CrossRefPubMedPubMedCentralGoogle Scholar
  81. Shiratori CN, Hirai FE, Sato EH (2011) Características dos doadores de córneas do Banco de Olhos de Cascavel: impacto do exame anti-HBc para hepatite B. Arquivos Brasileiros de Oftalmologia 74:3Google Scholar
  82. Siemens® (2013) ADVIA Centaur® e ADVIA Centaur® XP HCV (aHCV)Google Scholar
  83. Sommese L et al (2014) Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: evaluation of two chemiluminescent immunoassay systems. Scand J Infect Dis 46:660–664. doi: 10.3109/00365548.2014.926564 CrossRefPubMedGoogle Scholar
  84. Sonntag O (1986) Haemolysis as an interference factor in clinical chemistry. J Clin Chem Clin Biochem Zeitschrift fur klinische Chemie und klinische Biochemie 24:127–139PubMedGoogle Scholar
  85. Theodoropoulos N, Jaramillo A, Ladner DP, Ison MG (2013) Deceased organ donor screening for HIV, hepatitis B, and hepatitis C viruses: a survey of organ procurement organization practices. Am J Transpl Off J Am Soc Transpl Am Soc Transpl Surg 13:2186–2190. doi: 10.1111/ajt.12260 CrossRefGoogle Scholar
  86. Vironostika® HIV Ag/Ab (2010) BioMérieux® Google Scholar
  87. Wang J, Wang MR (2013) [Comparative analysis of electro-chemiluminescence immunoassay and chemiluminescent microparticle immunoassay abilities to quantitatively assess hepatitis B surface antigen]. Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese J Hepatol 21:192–195Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2016

Authors and Affiliations

  • Thayssa Neiva da Fonseca Victer
    • 1
  • Cris Stéphany Rodrigues dos Santos
    • 1
  • Sônia Nair Báo
    • 1
  • Thatiane Lima Sampaio
    • 1
    • 2
    Email author
  1. 1.Department of Cell BiologyUniversity of BrasíliaBrasíliaBrazil
  2. 2.Federal Institute of BrasíliaBrasíliaBrazil

Personalised recommendations