Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus: Discordant serology and nucleic acid testing results

Nicole Theodoropoulos*, Marek J. Nowicki, Claudia Chinchilla-Reyes, Sara Dionne, Andrés Jaramillo, Tom Mone, Richard Hasz, Martin D. Jendrisak, Daniela P Ladner, Michael G Ison

*Corresponding author for this work

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Before the 2014 policy change pertaining to infectious disease screening, many organ procurement organizations (OPOs) were supplementing serologic screening of deceased organ donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). The number of seronegative, NAT-positive donors has not been directly measured. Methods: HIV, HBV, and HCV screening results of 11 229 donor referrals evaluated from 2010 to 2013 were obtained from 3 OPO-affiliated laboratories, capturing 35% of all donors in the United States. Laboratories used either polymerase chain reaction assay or transcription-mediated amplification assay to test 9643 deceased donors by NAT. Results: The NAT results were positive in 21 (0.2%), 1 (0.02%), and 11 (0.1%) donors who were seronegative for HIV, HBV, and HCV, respectively. All discordant HIV-1 results were from one laboratory using a polymrease chain reaction assay. Thirteen of the reactive HIV NAT results in seronegative referrals were repeated and were non-reproducibly positive (NRP). Ten (0.1%), 452 (7.8%), and 197 (2.2%) of HIV-, HBV-, and HCV-seropositive donors, respectively, were negative by NAT. Conclusions: This study highlights the importance of robust quality assurance to minimize NRP NAT results. NAT may allow for increased utilization of organs from HBV- and HCV-seropositive, NAT-negative donors.

Original languageEnglish (US)
Article numbere12821
JournalTransplant Infectious Disease
Volume20
Issue number1
DOIs
StatePublished - Feb 1 2018

Fingerprint

Donor Selection
Serology
Hepatitis B virus
Hepacivirus
Nucleic Acids
Tissue Donors
HIV
HIV-1
Tissue and Organ Procurement
Referral and Consultation
Organizations
Communicable Diseases
Polymerase Chain Reaction

Keywords

  • HIV
  • donor screening
  • hepatitis B
  • hepatitis C
  • nucleic acid testing
  • serology

ASJC Scopus subject areas

  • Transplantation
  • Infectious Diseases

Cite this

Theodoropoulos, Nicole ; Nowicki, Marek J. ; Chinchilla-Reyes, Claudia ; Dionne, Sara ; Jaramillo, Andrés ; Mone, Tom ; Hasz, Richard ; Jendrisak, Martin D. ; Ladner, Daniela P ; Ison, Michael G. / Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus : Discordant serology and nucleic acid testing results. In: Transplant Infectious Disease. 2018 ; Vol. 20, No. 1.
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title = "Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus: Discordant serology and nucleic acid testing results",
abstract = "Background: Before the 2014 policy change pertaining to infectious disease screening, many organ procurement organizations (OPOs) were supplementing serologic screening of deceased organ donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). The number of seronegative, NAT-positive donors has not been directly measured. Methods: HIV, HBV, and HCV screening results of 11 229 donor referrals evaluated from 2010 to 2013 were obtained from 3 OPO-affiliated laboratories, capturing 35{\%} of all donors in the United States. Laboratories used either polymerase chain reaction assay or transcription-mediated amplification assay to test 9643 deceased donors by NAT. Results: The NAT results were positive in 21 (0.2{\%}), 1 (0.02{\%}), and 11 (0.1{\%}) donors who were seronegative for HIV, HBV, and HCV, respectively. All discordant HIV-1 results were from one laboratory using a polymrease chain reaction assay. Thirteen of the reactive HIV NAT results in seronegative referrals were repeated and were non-reproducibly positive (NRP). Ten (0.1{\%}), 452 (7.8{\%}), and 197 (2.2{\%}) of HIV-, HBV-, and HCV-seropositive donors, respectively, were negative by NAT. Conclusions: This study highlights the importance of robust quality assurance to minimize NRP NAT results. NAT may allow for increased utilization of organs from HBV- and HCV-seropositive, NAT-negative donors.",
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Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus : Discordant serology and nucleic acid testing results. / Theodoropoulos, Nicole; Nowicki, Marek J.; Chinchilla-Reyes, Claudia; Dionne, Sara; Jaramillo, Andrés; Mone, Tom; Hasz, Richard; Jendrisak, Martin D.; Ladner, Daniela P; Ison, Michael G.

In: Transplant Infectious Disease, Vol. 20, No. 1, e12821, 01.02.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus

T2 - Discordant serology and nucleic acid testing results

AU - Theodoropoulos, Nicole

AU - Nowicki, Marek J.

AU - Chinchilla-Reyes, Claudia

AU - Dionne, Sara

AU - Jaramillo, Andrés

AU - Mone, Tom

AU - Hasz, Richard

AU - Jendrisak, Martin D.

AU - Ladner, Daniela P

AU - Ison, Michael G

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Background: Before the 2014 policy change pertaining to infectious disease screening, many organ procurement organizations (OPOs) were supplementing serologic screening of deceased organ donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). The number of seronegative, NAT-positive donors has not been directly measured. Methods: HIV, HBV, and HCV screening results of 11 229 donor referrals evaluated from 2010 to 2013 were obtained from 3 OPO-affiliated laboratories, capturing 35% of all donors in the United States. Laboratories used either polymerase chain reaction assay or transcription-mediated amplification assay to test 9643 deceased donors by NAT. Results: The NAT results were positive in 21 (0.2%), 1 (0.02%), and 11 (0.1%) donors who were seronegative for HIV, HBV, and HCV, respectively. All discordant HIV-1 results were from one laboratory using a polymrease chain reaction assay. Thirteen of the reactive HIV NAT results in seronegative referrals were repeated and were non-reproducibly positive (NRP). Ten (0.1%), 452 (7.8%), and 197 (2.2%) of HIV-, HBV-, and HCV-seropositive donors, respectively, were negative by NAT. Conclusions: This study highlights the importance of robust quality assurance to minimize NRP NAT results. NAT may allow for increased utilization of organs from HBV- and HCV-seropositive, NAT-negative donors.

AB - Background: Before the 2014 policy change pertaining to infectious disease screening, many organ procurement organizations (OPOs) were supplementing serologic screening of deceased organ donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). The number of seronegative, NAT-positive donors has not been directly measured. Methods: HIV, HBV, and HCV screening results of 11 229 donor referrals evaluated from 2010 to 2013 were obtained from 3 OPO-affiliated laboratories, capturing 35% of all donors in the United States. Laboratories used either polymerase chain reaction assay or transcription-mediated amplification assay to test 9643 deceased donors by NAT. Results: The NAT results were positive in 21 (0.2%), 1 (0.02%), and 11 (0.1%) donors who were seronegative for HIV, HBV, and HCV, respectively. All discordant HIV-1 results were from one laboratory using a polymrease chain reaction assay. Thirteen of the reactive HIV NAT results in seronegative referrals were repeated and were non-reproducibly positive (NRP). Ten (0.1%), 452 (7.8%), and 197 (2.2%) of HIV-, HBV-, and HCV-seropositive donors, respectively, were negative by NAT. Conclusions: This study highlights the importance of robust quality assurance to minimize NRP NAT results. NAT may allow for increased utilization of organs from HBV- and HCV-seropositive, NAT-negative donors.

KW - HIV

KW - donor screening

KW - hepatitis B

KW - hepatitis C

KW - nucleic acid testing

KW - serology

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