title: Deceased tissue donor serology and molecular testing for HIV, hepatitis B and hepatitis C viruses: a lack of cadaveric validated tests.
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.
authors.affiliation: Department of Cell Biology, University of Brasília, Brasília, 70919-970, Brazil.
authors.forename: Thayssa Neiva da Fonseca
authors.initials: TN
authors.lastname: Victer
authors.affiliation: Department of Cell Biology, University of Brasília, Brasília, 70919-970, Brazil.
authors.forename: Cris Stéphany Rodrigues
authors.initials: CS
authors.lastname: Dos Santos
authors.affiliation: Department of Cell Biology, University of Brasília, Brasília, 70919-970, Brazil.
authors.forename: Sônia Nair
authors.initials: SN
authors.lastname: Báo
authors.affiliation: Department of Cell Biology, University of Brasília, Brasília, 70919-970, Brazil. thati_sampaio@yahoo.com.br.|Federal Institute of Brasília, Brasília, 73380-900, Brazil. thati_sampaio@yahoo.com.br.
authors.forename: Thatiane Lima
authors.initials: TL
authors.lastname: Sampaio
mesh_terms: D001344:Autopsy; D001938:Brazil; D002102:Cadaver; D006678:HIV / Q000302:isolation & purification*; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis*; D016174:Hepacivirus / Q000302:isolation & purification*; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis*; D006515:Hepatitis B virus / Q000302:isolation & purification*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D012698:Serologic Tests / Q000379:methods; D014019:Tissue Donors; D009927:Tissue and Organ Procurement
keywords: Donors; Infectious disease molecular detection; Infectious disease serology; NAT; Post-mortem blood; Validation