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

作者：da Fonseca Victer Thayssa Neiva; Rodrigues dos Santos Cris Stephany; Bao Snia Nair; Sampaio Thatiane Lima

来源：Cell and Tissue Banking, 2016, 17(4): 543-553.

DOI：10.1007/s10561-016-9564-7

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

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(A (R)), Bio-Rad(A (R)), Biomerieux(A (R)), DiaSorin(A (R)), Acon Biotech(A (R)) and Biokit(A (R))), three CLIA (Abbott(A (R)), Siemens(A (R)), Diasorin(A (R))) and one ECLIA (Roche(A (R))) 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(A (R)) TaqScreen MPXA (R) test, the Tigris System(A (R)) Procleix Ultrio Assay(A (R)) and the Bio-Manguinhos(A (R)) HIV/HCV/HBV NAT are commercially available. Between all the tests, only the manufacturer Abbott(A (R)) and Cobas(A (R)) TaqScreen MPXA (R) test are currently validated for cadaver samples.

• 出版日期2016-12