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

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.

Figure 1. Suspected False-positive Donor Algorithm

Potential explanations for discordant HIV Ab and NAT testing in a potential donor with no prior history of HIV per the medical record or family history. In cases of a reactive Ab test (left), a Western blot or HIV Ag/Ab combination assay would be the preferred next test. If the Western blot is negative, this confirms result was a false-positive. If the Western blot is positive, the donor could be HIV-infected and taking effective antiretroviral therapy or have an effective immune response (i.e. elite controller). In cases of a nonreactive Ab test and a positive qualitative NAT (right), a quantitative viral PCR would be the preferred next test. If the quantitative PCR is undetectable, this confirms the qualitative NAT was a false-positive. If the quantitative PCR is positive this indicates the donor was recently HIV-infected and has not yet