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Organs from deceased donors with false-positive HIV screening tests: An unexpected benefit of the HOPE act

https://doi.org/10.1111/ajt.14993Get rights and content
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Abstract

Organs from deceased donors with suspected false-positive HIV screening tests were generally discarded due to the chance that the test was truly positive. However, the HIV Organ Policy Equity (HOPE) Act now facilitates use of such organs for transplantation to HIV-infected (HIV+) individuals. In the HOPE in Action trial, donors without a known HIV infection who unexpectedly tested positive for anti-HIV antibody (Ab) or HIV nucleic acid test (NAT) were classified as suspected false-positive donors. Between March 2016 and March 2018, 10 suspected false-positive donors had organs recovered for transplant for 21 HIV + recipients (14 single-kidney, 1 double-kidney, 5 liver, 1 simultaneous liver-kidney). Median donor age was 24 years; cause of death was trauma (n = 5), stroke (n = 4), and anoxia (n = 1); three donors were labeled Public Health Service increased infectious risk. Median kidney donor profile index was 30.5 (IQR 22-58). Eight donors were HIV Ab+/NAT-; two were HIV Ab-/NAT+. All 10 suspected false-positive donors were confirmed to be HIV-noninfected. Given the false-positive rates of approved assays used to screen > 20 000 deceased donors annually, we estimate 50-100 HIV false-positive donors per year. Organ transplantation from suspected HIV false-positive donors is an unexpected benefit of the HOPE Act that provides another novel organ source.

KEYWORDS

acquired immunodeficiency syndrome (AIDS)
clinical research
clinical trial
donors and donation: donor evaluation
infection and infectious agents—viral: human immunodeficiency virus (HIV)
infectious disease
law
legislation
organ allocation
organ procurement organization
organ transplantation in general
practice

Abbreviations

Ab
antibody
BMI
body mass index
DRAI
Donor Risk Assessment Interview
FDA
US Food and Drug Administration
HBV
hepatitis B
HCV
hepatitis C
HOPE
HIV Organ Policy Equity
IRD
infectious risk donor
NAT
nucleic acid test
OPO
organ procurement organization
OPTN
Organ Procurement and Transplantation Network
qPCR
quantitative polymerase chain reaction
TMA
transcription-mediated amplification

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Andrew D. Redd and Dorry L. Segev contributed equally to the manuscript.