title: Organ donor screening using parallel nucleic acid testing allows assessment of transmission risk and assay results in real time.
abstract: Expansion of the donor pool may lead to utilization of donors with risk factors for viral infections. Donor laboratory screening relies on serological and nucleic acid testing (NAT). The increased sensitivity of NAT in low prevalence populations may result in false-positive results (FPR) and may cause unnecessary discard of organs.We developed a screening algorithm to deal, in real time, with potential FPR. Three NAT assays: COBAS AmpliScreen assay (CAS), AmpliPrep Total Nucleic Acid Isolation/CAS, and AmpliPrep/TaqMan assays, were validated and used in parallel for prospective screening of increased-risk donors (IRD), and the probability of FPR was calculated. The lower limit of detection of this algorithm was 9.79, 21.02, and 4.31 IU/mL for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus, respectively, with an average turn-around-time of 7.67 h from sample receipt to result reporting. The probability that a donor is potentially infectious with two NAT concordant results was >90%. NAT screening of 35 IRD within 18 months resulted in transplantation of 102 additional organs that without screening would either not be used or used with restrictions in Australia. Using a parallel testing algorithm, real-time confirmation of seropositive donors allows use of organs from IRD and safer expansion of the donor pool.
authors.affiliation: Virology, Department of Microbiology, South Eastern Area Laboratory Services (SEALS), Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Baleriola
authors.forename: E
authors.initials: E
authors.lastname: Tu
authors.forename: H
authors.initials: H
authors.lastname: Johal
authors.forename: J
authors.initials: J
authors.lastname: Gillis
authors.forename: M G
authors.initials: MG
authors.lastname: Ison
authors.forename: M
authors.initials: M
authors.lastname: Law
authors.forename: P
authors.initials: P
authors.lastname: Coghlan
authors.forename: W D
authors.initials: WD
authors.lastname: Rawlinson
mesh_terms: D000465:Algorithms; D001315:Australia; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D046148:Donor Selection / Q000379:methods*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D016377:Organ Transplantation / Q000009:adverse effects*; D011446:Prospective Studies; D012307:Risk Factors; D014019:Tissue Donors