Clarification of OPO and Living Donor Recovery Hospital Requirements for Organ Donors with HIV Positive Test Results
At a glance
The HIV Organ Policy Equity (HOPE) Act was passed by Congress in 2013, and since then donors with human immunodeficiency virus (HIV) positive test results have been able to donate organs to recipients with positive HIV test results. There have been instances where donors test positive for HIV but are not actually infected with the virus. OPTN policy requires donors that test positive for HIV only be transplanted into recipients with HIV infection.
There have been instances when an OPO considers a donor with a positive HIV test result to be HIV uninfected due to additional testing, and proceeds with HIV negative allocation. The OPTN Membership and Professional Standards Committee has asked the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) to provide clinical guidance or policy that is consistent with all applicable laws and regulations to answer the following questions:
- What (if any) test results could be used to classify a deceased donor as not infected with HIV although the donor has at least one positive HIV test result?
- What (if any) test results could be used to classify a living donor as not infected with HIV although the donor has at least one positive HIV test result?
- What (if any) clinical judgment or individual protocols would be appropriate and consistent with requirements to assess situations where the donor is not thought to be infected although there is a positive HIV result?
- What it's expected to do
- Feedback received may help DTAC develop a protocol for all OPOs to assess whether OPOs and living donor recovery hospitals need an algorithm to classify a donor as not infected with HIV although the donor has at least one positive HIV test result
- What it won't do
- This concept paper is not a proposed policy change, but it will help DTAC as they consider a potential policy proposal in the future.
Considerations for the community
- How often do OPOs or laboratories encounter donors who have at least one test that is positive for HIV but are not thought to be infected? Please be as specific as possible.
- Do OPOs need a testing algorithm to address donors who have at least one test that is positive for HIV but are not thought to be infected?
- Due to risk of transmission, does it make sense to create this algorithm only for pediatric donors?
- What percent of organs from donors with a positive HIV test are not utilized? Please be as specific as possible.
- How often are living donor recovery hospitals encountering living donors who have at least one test that is positive for HIV but are found not to be infected through confirmatory testing? Please be as specific as possible.
- How often are OPOs and living donor recovery hospitals receiving positive fourth generation HIV test results for a SARS-CoV-2 positive donor? Please be as specific as possible.
Terms to know
- Human Immunodeficiency Virus (HIV): a virus that attacks the body’s immune system. If HIV is not treated, it can lead to acquired immunodeficiency syndrome (AIDS)
- HIV Organ Policy Equity (HOPE) Act: enacted on November 21, 2013, the HOPE Act called for the development and publication of research criteria relating to transplantation of HIV positive organs into HIV positive candidates
Region 8 | 09/19/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee suggested the committee encourage availability to determine a false positive test through additional testing and ultimately a negative result and explained that currently organs are relegated to HIV patients only, which is an extremely small list. A member inquired about what defines the "false positive" initial HIV and what supporting evidence would be allowed to determine that it is actually negative. The member suggested the committee use a standardized algorithm to ensure consistency and safety. Another member supported the idea to test an algorithm to clarify discrepancy in lab results.
Association of Organ Procurements Organizations | 09/19/2023
AOPO strongly supports the OPTN’s proposed clarification of OPO and living donor hospital requirements for organ donors with HIV positive test results because this proposal addresses a gap in the current OPTN policies that provide no process for OPOs and hospitals to clarify test results when a false-positive is suspected. While all tests have limits of accuracy and detection, OPO laboratories identified an increase in the frequency of suspected false-positive HIV test results during the COVID-19 pandemic and continuing after. OPO laboratories have observed an increase of donors who were exposed to the COVID-19 virus testing positive on HIV antibody assays due to a shared homology between the viruses.1 The Centers for Disease Control and Prevention (CDC) advises the use of additional assay testing when an HIV screening test is positive to rule out the possibility of a false-positive.1 However, currently, OPTN policy does not account for results clinically deemed to be false positive; therefore, if a single test result is HIV positive, the donor must be allocated under the HIV Organ Policy Equity Act (HOPE) Act variance.1 This allocation limitation reduces the pool of possible organ recipients to HIV positive candidates.
Several OPOs have reported instances in which a donor tested positive for HIV but was not considered to be HIV positive and the donor organ was used in regular allocation. These cases were reported to the OPTN’s Membership and Professional Standards Committee; however, none of the donors were later determined to be HIV positive. This OPTN policy proposal appropriately seeks to capture more data on these cases and similar cases to evaluate the possible creation of an algorithm that may assist OPOs and transplant hospitals to evaluate donors who have a positive HIV test result, which after additional testing, is believed to be a false-positive.
The proposed algorithm, if implemented, could increase the number of transplants by ensuring organs from donors with a false positive HIV result can be allocated broadly rather than limited to HIV positive candidates. Further, AOPO supports the OPTN’s annual review of assays for changes in reactivity due to emerging viruses or new, preventative treatments, like pre-exposure prophylaxis, which may cause assay interference and disrupt allocation.
OPTN policy does not account for results clinically deemed to be false positive.
1 Salih, R. Q., Salih, G. A., Abdulla, B. A., Ahmed, A. D., Mohammed, H. R., Kakamad, F. H., & Salih, A. M. (2021). False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Annals of medicine and surgery (2012), 71, 103027. https://doi.org/10.1016/j.amsu.2021.103027
1 CDC. False-Positive HIV Test Results. cdc.org (May 2018) https://www.cdc.gov/hiv/pdf/testing/cdc-hiv-factsheet-false- positive-test-results.pdf
1 (42 C.F.R. §121.6(b)(1))
OPTN Living Donor Committee | 09/19/2023
The OPTN Living Donor Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their efforts in developing this concept paper, Clarification of OPO and Living Donor Recovery Hospital Requirements for Organ Donors with HIV Positive Test Results. The Committee supports the development of guidance for both OPOs and transplant programs on how to address discrepant test results. The Committee notes that discrepant test results are more manageable with living donation due to the ability of having more time built into the processes, and the feasibility to delay these transplants in most cases. The Committee suggests that it is important to consider whether discrepant test results for HIV impact non-use of organs.
Region 10 | 09/19/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee noted that further clarification would be helpful to programs. Another member added that clinical guidance would be imperative in trying to increase the recipient pool for these situations with a positive donor HIV result. Lastly, another attendee stated that it is difficult to understand the scope of the issue. It would be helpful to see data on the incidence of positive HIV results and organs not used due to the positive HIV result.
Infinite Legacy | 09/19/2023
Infinite Legacy is pleased provide the following comments. A standardized algorithm for donors that have one positive HIV test, and a repeat confirmatory testing is negative can meet criteria as a false positive. The clinical trial results are favorable that for a subset of HIV positive donors, an algorithm that allows for non-HOPE Act placement would increase the amount of organs available for transplant, and decrease the non-utilization of organs that are not actually HIV positive. Of the 56 donors whose organs were transplanted as part of the HOPE Act that met the algorithm for false positive, 46% were indicative of false positive. The kidney non-utilization rate for HOPE Act donors was 27% in this data set. Developing an algorithm so that OPOs can provide transplant centers with clinical information, including confirmatory testing for transplant centers to make decisions on transplanting as a HOPE Act case or standard donor, can increase opportunities for transplant. In the event of time constraints for confirmatory testing, the algorithm should include HOPE Act placement (which is the current practice). Infinite Legacy recognizes the groundwork and changes to the Public Health Service Act and OPTN policy that would be needed to implement any of these suggested revisions safely.
UC San Diego Health | 09/19/2023
The UC San Diego Health Center for Transplantation recognizes the importance of this clarification and appreciates the Disease Transmission and Advisory Committee's approach to exploration and data-gathering to determine the breath of this potential patient safety risk. We would support the development of an evidence-based, reliable algorithm to distinguish HIV-positive donor organs from those with a false positive result as a resource or guidance document. The Committee may also consider developing recommendations on the disclosure of such conflicting results to centers and respectively, to potential candidates in support of the informed consent process.
OPTN Membership & Professional Standards Committee | 09/18/2023
The Membership and Professional Standards Committee (MPSC) thanks the DTAC for their time and effort in developing and presenting this concept paper. The MPSC referred this topic to the DTAC and is very supportive of this work progressing. The MPSC hopes this public comment cycle can provide the information needed to justify future work.
Region 7 | 09/18/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee noted that proving an HIV test was a false positive takes multiple confirmatory tests that not all OPOs have the ability to get in a timely fashion. The attendee does not support allowing match runs to be generated as HIV negative when there is no certainty that the test was a false positive. Another attendee added they would be in favor of clarifying how to classify donors as being false positive for HIV. They currently use a test that screens in bulk for HBV, HCV, and HIV. There are instances when that bulk test comes back positive, so they then perform individual test for each infectious disease and all three come back negative. To err on the side of caution they will proceed with the donor as positive for all three infectious diseases, which decreases utilization.
Gift of Life Michigan | 09/15/2023
We appreciate the Committee's work on this important topic.
We strongly support the development of an evidence-based, reliable algorithm to distinguish HIV-positive donor organs from a false positive HIV result. As technology advances and tests become more reliable it should help lessen the occurrence of false positives; however, it is obviously essential that recipients are protected from infection and that an algorithm to determine false positivity is accurate.
Region 6 | 09/15/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that they supported this proposal.
OPTN Organ Procurement Organization Committee | 09/15/2023
The OPTN Organ Procurement Organization Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their work and for the opportunity to comment on this proposal.
Committee members expressed support for this proposal, stating that this is a real issue, and they are glad to see it being addressed. A member shared that their OPO had five false positive HIV tests and was willing to share data with the DTAC. The member also stated that false positive HIV tests can limit the OPO’s ability to recover other organs, therefore this proposal is huge for the community. Other Committee members also agreed to provide data to the DTAC.
American Society of Transplantation | 09/15/2023
The American Society of Transplantation (AST) is generally supportive of what is outlined in the concept paper, “Clarification of OPO and Living Donor Recovery Hospital Requirements for Donors with Positive HIV Test Results,” and offers the following comments for consideration:
• The AST applauds this effort, which must begin with detailed data-gathering. What is the absolute number and proportion of potential donors with any positive test for HIV that are ultimately confirmed to be a false positive, or cannot be confirmed to be a true positive? If this, the broadest example, is very rare, then it may not be efficient to establish a complex protocol and associated safety features for further interrogating this issue.
• The above findings can be considered separately for pediatric and adult donors because of differences in HIV prevalence, pre-test probability of HIV infection, and false-positive rates. There would be a low threshold to expand a protocol and associated safety features created for pediatric donors to also include the adult donors- if the OPTN creates an algorithm to address this issue, it should be put to maximal use.
• An additional study on those donors that test positive for HIV, and whether there are any distinguishing factors for those believed to be false positives, would be welcomed.
• Regarding utilization, the OPTN should also account for hearts and lungs from these donors, i.e., if abdominal organs were used for HOPE transplants but HIV results are ultimately thought to be false positive, could the heart and lungs from these donors also have been transplanted?
• This effort should include the OPTN Ethics Committee and input from other bioethicists to address the ethical implications of having or not having a zero-tolerance policy.
American Society for Histocompatibility and Immunogenetics | 09/14/2023
This proposal is not pertinent to ASHI or its members.
Region 5 | 09/13/2023
This was not discussed at the meeting, but attendees were able to submit comments with their sentiment. Attendees commented that they were in favor of the requirements, agreed with the proposal’s intent, and agreed there is a need for more guidance.
Region 11 | 09/12/2023
A member commented that this is an important topic and these organs will go unnecessarily underutilized if clear guidelines are not established to confirm when a test is thought to be a false positive that it was indeed wrong and the patient is negative and/ or given that there are effective medications, we need to remove the stigma and accept that HIV is a treatable infection and that in this day and age it is probably inappropriate to make HIV transmission a "never event". Another member agreed with more clarification of results to avoid false positives.
American Nephrology Nurses Association (ANNA) | 09/11/2023
ANNA supports the development of a standardized protocol and algorithm for defining and addressing these situations when a potential false positive HIV test may occur.
Iowa Donor Network | 09/01/2023
Region 2 | 09/01/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. It was noted that false positive HIV donors should be more generally allocated. Another member added that having precise protocols and definitions for ensuring a donor is truly negative is key. Additionally, ensuring there is precise follow up of recipients to demonstrate no transmission is also necessary.
Region 4 | 08/29/2023
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that the testing should not delay placement since this is such a rare occurrence.
OPTN Transplant Coordinators Committee | 08/28/2023
The OPTN Transplant Coordinators Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their work and for the opportunity to comment on this proposal.
A member stated that having a standardized algorithm would be helpful to address donors who have at least one HIV positive test but are not thought to be infected, as this would allow for a uniform process as long as it was done in a timely fashion. The member said if time was a concern, then the organ could be reallocated to a candidate who is on the HIV Organ Policy Equity (HOPE) Act match run. The member suggested that the Final Rule stating “infected with HIV” and the OPTN policy that says “HIV positive” needs to be more consistent and clearer, as these are two different things. A member said that pediatric surgeons would be cautious to take an HIV-positive organ, but if there was an algorithm in place to get repeat testing done in a cost-effective and timely manner to prevent significant delays in going to the operating room, there would be no downsides in repeat testing. A member agreed that an algorithm is a great idea, as this would create a standardized process. There have been a handful of donors that come back with an unexpected HIV-positive test but were suspected to be false positive. An algorithm would be extremely helpful and consulting with an infectious disease transplant physician was incredibly helpful and should be included when developing an algorithm.
Ricardo La Hoz | 08/22/2023
This is a relevant topic. No test has perfect diagnostic performance; HIV Ag/Ab and HIV NAT are no exceptions. Between March 2016 and March 2018, the HOPE in Action study group described ten donors with false positive HIV tests. Eight Ab+/NAT and 2 Ag/Ab -/NAT+. The number of donors with a false positive HIV test in this study is likely an underestimate as not all donors that have a false positive HIV test will proceed to donation. Furthermore, there was enough data to adjudicate the test as a false positive before recovery in about half of these donors.
The exact number of potential donors who undergoes screening annually is unknown. Assuming an annual number of eligible or imminent deaths of 25,000 per year and a false positive rate of 0.1% and 0.3% for Ag/Ab and NAT HIV testing, we can assume that there will be 100 potential donors with false positive HIV testing.
I have been involved in at least two situations where an OPO allocated organs from donors with a single HIV-positive test result followed by numerous negative results via the "regular match run." The single-positive HIV test result was most a false positive result based on current diagnostic standards. This is challenging for transplant centers and OPOs, as performing an HIV+ to an HIV- transplant is prohibited in the US. Furthermore, it places recipients at risk if OPOs and or transplant centers adjudicate HIV false positivity independently without guidance. Conversely, if the organs are allocated via the HOPE variance, the organs will also be underutilized as few recipients are listed in the variance.
Establishing a clear definition and distinguishing between an HIV-infected donor and a donor with a false positive HIV test result will allow us to establish an adequate balance between maximizing organ donor utilization and minimizing the risk of HIV transmission. A clear regulatory framework is the only way to safely allocate organs from false positive HIV donors via the "regular match run".