Organ donor screening using parallel nucleic acid testing allows assessment of transmission risk and assay results in real time

C. Baleriola, E. Tu, H. Johal, J. Gillis, M. G. Ison, M. Law, P. Coghlan, W. D. Rawlinson*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)278-287
Number of pages10
JournalTransplant Infectious Disease
Volume14
Issue number3
DOIs
StatePublished - Jun 1 2012

Keywords

  • Donor screening
  • Increased-risk donors
  • Parallel nucleic acid testing

ASJC Scopus subject areas

  • Infectious Diseases
  • Transplantation

Fingerprint Dive into the research topics of 'Organ donor screening using parallel nucleic acid testing allows assessment of transmission risk and assay results in real time'. Together they form a unique fingerprint.

Cite this