Comments

Colleen O'Donnell Flores | 10/01/2025

I am not opposed to the proposal to seasonally test living donors for West Nile Virus, but I am also concerned about the turnaround time in the proposal. Although we are a large academic medical center, the turnaround time (TAT) at our center would pose some challenges. Please conduct a further review of the variation in TAT.

In addition to analyzing the turnaround time of these tests, I encourage the Committee to review the experience of the potential living donor, before surgery, with this new proposal in mind.

The analysis should include the requirement to conduct serology testing... pre-surgical testing...and now the shorter timeframe for the proposed WNV test.

While I believe the WNV testing is very important, it seems difficult to require the living donor to conduct various tests at different time points. Thank you for working on this important issue.

Infinite Legacy | 10/01/2025

Infinite Legacy appreciates the need for patient safety initiatives and this proposal’s furtherance of that goal but requests additional flexibility and potential revisions to the current proposal to reduce operational burden and the risk of false positives resulting in significant organ loss. We suggest further consideration into the potential impact that delays in testing could cause and the constraints presented by the seven-day testing timeframe. If the policy is adopted, we urge OPTN to monitor and publish data regarding positivity rates, resulting organ discard rates, and outcomes to identify the effectiveness and impact of the policy.

Region 2 | 10/01/2025

Sentiment: 4 strongly support, 5 support, 1 neutral/abstain, 3 oppose, 0 strongly oppose

Comments: Several attendees supported extending the turnaround window for WNV NAT testing in living donors to 10 days, noting that many NAT labs are send-outs and that a shorter timeframe is not practical. Others suggested requiring that living donor results be valid within 28 days of surgery, emphasizing that a 7-day requirement would be unrealistic, especially for emergent cases such as pediatric or acutely ill liver patients. There was disagreement on whether testing should be tied to the donor’s date of hospital admission after July 1 versus applying to donors as of July 1. Some supported seasonal testing during periods of higher incidence, arguing that this would improve accuracy by reducing false positives. Others expressed concern that limiting testing to certain months does not reflect shifting weather patterns or travel-related risks, particularly in regions like New Jersey where patients often move between climates. These attendees advocated for year-round testing to ensure broader safety. Operational challenges were highlighted, particularly for deceased donors, where results would often not be available before the transplant occurred. This raised concerns about the practical application of the policy in urgent allocation scenarios.

Region 1 | 10/01/2025

Sentiment: 1 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: A member shared two concerns: the cost associated with testing and the uniform national recommendation, suggesting that adjusting testing periods based on regional seasonal risk would be more cost-effective. An attendee noted that the seven-day window allows time for NAT results from outside labs, with their center experiencing a four-day turnaround. A member emphasized the need to understand both the outcomes and financial impact of additional testing and asked for details on the regions where the 11 transmissions occurred, as well as consideration of other mosquito-borne illnesses. An attendee expressed support but raised concerns about turnaround time, especially in expedited organ recovery cases, and suggested flexibility due to the low prevalence of the disease. A member questioned whether the policy could be adjusted to avoid forcing centers to choose between compliance and timely transplants, and raised concerns about unnecessary testing in non-endemic regions and the potential for false positives in rare diseases. An attendee noted that their OPO performs West Nile virus testing in-house with a 5–6 hour turnaround, but expressed concern for OPOs without that capability and suggested exceptions for urgent cases.

Luis Mayen | 10/01/2025

Waiting for a transplant is stressful and emotionally taxing. Transplant patients and their families deserve to know the organs they receive are safe. This proposal ensures that all donors are tested for West Nile Virus during the high-risk season, giving recipients confidence that these organs are being screened to prevent even rare infections.

Testing donors during the season provides reassurance without compromising timely access to life-saving organs. It also demonstrates that the transplant community is proactive in protecting patients, while allowing transplants to proceed efficiently.

Recipients deserve transparency and confidence that the system is designed with their safety as the top priority. Policies like this help ensure peace of mind while supporting the life-saving work of transplantation.

Region 4 | 10/01/2025

Sentiment: 1 strongly support, 10 support, 9 neutral/abstain, 3 oppose, 0 strongly oppose

Comments: During the discussion, several attendees raised concerns about how testing requirements would affect living donors, noting that additional testing could create different workflows and costs for transplant centers. They emphasized the importance of understanding whether living donor transmission has ever been documented and called for more clarity on this issue. Attendees discussed the need for additional data on test sensitivity and the rate of false positives, since these factors would impact the potential for unnecessary organ discards. They noted that while NAT assays are highly specific, false positive, though rare, remain possible, and the full impact of such results on discard rates was not fully addressed in the meeting. Data on transmission risk by organ type and overall prevalence of West Nile Virus were also identified as important to better assess the proposal.

Some attendees highlighted that the proposed approach, which involves testing blood samples, may not be the most accurate method for detecting West Nile Virus, since CNS fluid or tissues are more reliable sample sources. Given the complexity of collecting those types of samples, it was suggested that further consideration be given before moving forward with the current proposal. There were also comments about ensuring testing timelines are practical for both deceased and living donors. Specifically, the seven-day turnaround for living donor testing was seen as potentially challenging for donors who travel from a distance, and the impact on access to rapid DCD organs. One attendee noted that their OPO currently tests all donors and has not encountered false positives, with positive results being very rare.

Association of Organ Procurement Organizations (AOPO) | 10/01/2025

AOPO and its members are committed to ensuring recipient safety and support the Require West Nile Virus Seasonal Testing for all Donors proposal with the modifications suggested below.

The Proposal requires OPOs to screen deceased donors for West Nile Virus and for results to be available pre-implantation. AOPO is concerned the strict pre-implantation requirement could unintentionally create barriers to transplantation and increase the risk of suitable organs going unused. This could occur in expedited cases where family time constraints or donor stability limit available time, or in situations involving deceased donors in remote locations where transporting samples requires additional time.

To address these concerns, AOPO recommends that the OPTN revise the proposal to allow accepting transplant surgeons to use discretion in their medical judgment when deciding to accept and transplant an organ prior to receiving results. This flexibility is important when a donor is at low risk of a positive result or when a recipient faces an imminent risk of death without transplant.

OPTN Membership & Professional Standards Committee | 10/01/2025

The Membership and Professional Standards Committee (MPSC) appreciates the work of the Disease Transmission Advisory Committee (DTAC) in developing and presenting this proposal. Overall, the MPSC supports the proposal and offers the following comments and suggestions for consideration.

In reviewing the proposed West Nile Virus (WNV) testing timeframe for organ recoveries conducted between July 1 and October 31 each year, an MPSC member raised a question regarding whether the DTAC had considered using the hospital admission date instead of the organ recovery date to determine the testing window. This alternative approach could enhance safety at the end of the timeframe, particularly for donors admitted prior to October 31 but recovered afterward. It was also noted that this method may facilitate implementation for Organ Procurement Organization (OPO) members.

MPSC members further discussed the operational logistics of performing WNV testing on donors, specifically the turnaround time and its impact on the donation process. The DTAC Chair clarified that commercial nucleic acid testing typically has a turnaround time of approximately four to five hours, which is not expected to cause significant delays. Additionally, another MPSC member noted that the assay used for WNV is the same as that used for HIV, HBV, and HCV, allowing it to be incorporated into the same testing panel and timeframe.

The MPSC is grateful for the DTAC’s efforts in developing this proposal and appreciates their consideration of the committee’s feedback.

Donor Network West | 09/30/2025

Donor Network West, serving Northern California and Nevada, supports the proposal to require seasonal West Nile Virus (WNV) testing for all donors. Ensuring that organs are screened for WNV is critical to patient safety and maintaining public trust in the organ transplantation system.

We commend the Committee for prioritizing risk mitigation and encourage collaboration with OPOs and transplant centers to implement testing protocols that are timely, reliable, and minimally burdensome.

NATCO | 09/30/2025

NATCO supports DTAC efforts to enhance patient safety and reduce the risk of donor-derived infectious disease transmission. However, the proposed required timeframe for living donors is too close to organ recovery date for living donors. There is a great deal of variability in laboratory turnaround times, which will create significant logistical challenges. We recommend that OPTN change the timeline to 28 days prior to organ recovery to align with existing infectious disease policy (OPTN Policy 14.4).

For deceased donor testing, we note that the proposed policy requires the test to be resulted prior to organ implantation, which we do not support. We believe that this would lead to increased cold ischemic time (CIT) and increased non-use of organs.
It would be helpful to know the prevalence and risk of transmission in the transplant population prior to making final comments of support. It appears that turnaround time for test results is highly variable and unreliable.

HonorBridge | 09/30/2025

While we fully support initiatives aimed at reducing donor-derived infectious disease transmission, we respectfully oppose the proposed requirement for universal WNV testing. At this time, the data presented does not appear to support a policy mandating seasonally-based testing for donors, regardless of geographic location.

WNV transmission through transplantation is exceedingly rare. If we are interpreting the data in the proposal correctly, three donors have died due to a donor-derived WNV transmission between 2002-2023. Implementing broad, seasonal testing for all donors may not be proportional to the actual level of risk and could result in unintended consequences. Specifically, the requirement could:

-Significantly increase operational costs at approximately $250 per authorized case;

-Introduce delays in organ allocation, particularly for deceased donors where time is critical;

-Add unnecessary complexity to an already time-sensitive process;

-Increase cold ischemia times (CIT), potentially leading to higher non-utilization rates;

Lead to false positive results, which would unnecessarily exclude viable donors and transplanted organs and further reduce the donor pool. If confirmatory testing is required this would lead to further delays and non-use.

Rather than a universal seasonal mandate, we encourage consideration of a risk-based testing approach, guided by public health surveillance and targeted to regions and time periods with documented WNV activity. This strategy would continue to support transplant recipient safety while minimizing disruption to the organ recovery and allocation process.

American Society of Transplantation | 09/30/2025

The American Society of Transplantation (AST) supports the concept behind the proposal, “Require West Nile Virus Seasonal Testing for all Donors,” but is concerned with the proposed policy changes. Specifically, the AST is concerned with the practical considerations of adhering to these requirements, anticipated unintended consequences, and unclear goals and metrics to evaluate the success of these policy changes.

The proposal does not thoroughly address practical considerations regarding the time necessary to obtain deceased donor West Nile Virus (WNV) nucleic acid test (NAT) results. Although the proposed policy states that these results must be available prior to implantation of the organ, the AST is concerned that this requirement will lead to delays that yield increased costs, increased cold ischemic time, and increased non-utilization rates. Obtaining timely WNV NAT test results will be particularly challenging for organ procurement organizations (OPOs) and living donor recovery hospitals that outsource this testing. Regardless of where donor testing is performed, these proposed changes are anticipated to present OPOs challenges during rapid deceased donor cases where waiting for test results is not an option. Additionally, WNV NAT results may not be possible for live donor workups in the setting of critically ill intended recipients. In consideration of these rapid donor scenarios and to allow donation to proceed without delay, the AST recommends the addition of policy language to accommodate scenarios when urgency and an inability to secure WNV NAT results prior to donor recovery can be documented.

The AST also recommends that the OPTN develop supporting resources to address the possibility of false positive results and instances where retesting is advisable or may be necessary; e.g., if a result is presumed to be a false positive. Considering the prevalence of WNV in the donor population, the AST is concerned that increased testing will result in more false-positives than true-positives results, and that this will lead to a net detrimental impact on organ utilization.

To fully evaluate the impact of these proposed changes, the post-implementation policy evaluation stands to be more clearly defined. The AST requests more detail on the anticipated impact of the policy and what findings would indicate a successful policy. The AST recommends modifying the monitoring plan to address the concerns outlined in this response- possible organ non-use and waitlist death because of delayed, equivocal, or false positive WNV NAT testing results.

Region 9 | 09/30/2025

Sentiment: 2 strongly support, 1 support, 1 neutral/abstain, 4 oppose, 0 strongly oppose

Comments: A member stated that bringing a living donor back for testing so close to donation is not ideal and proposed aligning it with existing serology testing guidelines. An attendee noted that many labs send out testing to reference labs, which delays results by 3–4 days, and expressed concern that requiring OPOs to have results prior to organ implantation could delay recovery, reduce authorizations, and hinder rapid cases involving donor instability. A member noted that while 7 days for living donors can seem burdensome, five days might be more appropriate since mosquito bites could happen at any time, while also acknowledging concerns about the emotional impact on recipients and the difficulty of ensuring test completion. An attendee encouraged all living donor programs to assess their turnaround time for West Nile virus NAT testing to ensure their ability to comply with the seven-day window. A member raised concern about false negatives from donor blood samples and asked DTAC to confirm the clinical utility of requiring NAT on blood, noting WNV’s stronger tropism toward the central nervous system, organs, and tissues. An attendee stated that seven days is too short, as most labs only run the test on certain days and results take 2–4 days. Two additional members agreed that 7 days is too short of a turnaround time. An attendee commented that the testing infrastructure is not robust enough to support efficient donor placement and that the 7 day timeframe is too short, suggesting that perhaps a middle ground could be 14 days. A member stated that the requirement for testing within 7 days of living donation is onerous for living donors, who are purely voluntary participants, and emphasized that the process should not be made more burdensome while maintaining safety. The member noted that infection via mosquito bite can occur at any time up to donation and recommended aligning any new proposal with the current policy, which requires serologies to be drawn within 28 days of donation.

American Society of Transplant Surgeons | 09/30/2025

Please see attachment.

View attachment from American Society of Transplant Surgeons

Lorrinda Gray-Davis | 09/29/2025

Support

Rebecca Baranoff | 09/29/2025

Neutral/Abstain

OPTN Organ Procurement Organization Committee | 09/29/2025

The OPTN Organ Procurement Organization Committee appreciates the opportunity to provide input on the OPTN Ad Hoc Disease Transmission Advisory Committee’s request for feedback and provides the following comments for consideration:

• The Committee discussed with the presenter that a potential donor with a positive test result for West Nile Virus should be ruled out from donating due to the high morbidity and mortality related to these transmissions and the absence of an approved treatment for West Nile Virus.

• Some members observed that they routinely obtain West Nile Virus testing for deceased donors within the timelines specified in the proposal but noted that some OPOs may have a challenge accessing West Nile Virus testing with a quick turnaround time.

• The Committee supports clear policy language explicitly stating whether OPOs are required to have the test results back prior to transplant.

The Committee appreciates the opportunity to provide their feedback on this project and looks forward to further collaboration on the topic with the DTAC Committee.

UNC Health | 09/26/2025

We are not opposed to the proposal to seasonally test living donors for West Nile Virus but are concerned about the turnaround time in the proposal. Although we are a large academic medical center, our lab does not conduct West Nile Virus testing. We currently do West Nile Virus antibody testing seasonally on living donors. We have to send the sample to a lab halfway across the country and the turnaround time is at least 8 days from draw date to results.

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/26/2025

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) abstains from supporting or opposing this proposal. However, as highly specialized laboratory professionals, ASHI urges DTAC to evaluate the anticipated effectiveness of preventing West Nile Virus (WNV) transmission by requiring testing on donor blood samples as opposed to other sample types, recognizing that WNV has a much stronger tropism towards CNS, organs, and tissues, and not the circulatory system. DTAC should provide more data, specifically concerning the financial and administrative impact to the transplant community, including transplant laboratories and OPOs. Additionally, consideration should be given to any potential delays for organ recovery as a result of this proposal.

VA Pittsburgh Healthcare System | 09/26/2025

Strongly Support

Anonymous | 09/26/2025

Since there has not been a transmission in Living Donors, the testing should be in line with other required testing (28 days of donation) unless it is determined that the needs to be closer timing of testing. Within 7 days of donation may not be possible with turn around times of labs. Easier compliance if in line with all other required pre-donation testing.

International Society for Heart and Lung Transplantation | 09/26/2025

Please reference attachment.

View attachment from International Society for Heart and Lung Transplantation

Family Lifestyle Solutions LLC | 09/26/2025

I would agree that everyone should get tested for the West Nile virus for all donors. The only exception may be a new born baby.

Vanderbilt University Medical Center | 09/25/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. In general, we do not support this proposal as written. The rationale for this change remains unclear, given the limited data on case volume and the proportion of West Nile cases that are donor-derived. The proposed required timeframe is too close to organ recovery date for living donors and does not account for the variability in outside laboratory turnaround times, creating significant logistical challenges. We recommend that the required timeframe align with the existing infectious disease testing requirement of 28 days prior to organ recovery (OPTN Policy 14.4). Additionally, the proposal lacks guidance on handling pending lab results, raising concerns about potential organ discard and donation surgery cancellations.

UCLA Kidney Transplant | 09/24/2025

While we appreciate the serious complications associated with donor transmission of infectious disease, West Nile virus infection is not common and we recommend adding the testing to the same timeline as other virus infections including HIV and hepatitis. The one week time frame will not allow sufficient time to confirm test results and will likely lead to an increased cancellation rate.

American Nephrology Nurses Association (ANNA) | 09/24/2025

ANNA agrees; however, the potential for delays exists for allocation of deceased donor organs or delay living donor surgeries due to the turnaround time for West Nile Virus testing results. It would also be helpful to know the prevalence of positive tests in organ donors thus far, this would help determine the practicality of performing this test.

Region 5 | 09/24/2025

Sentiment: 4 strongly support, 15 support, 6 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: During the discussion, several attendees recommended changing the timing for the West Nile Virus (WNV) testing in living donors to 28 days to align with other living donor testing requirements. Another attendee commented that there should be consideration of geographic requirements given prevalence and incidence of disease. Several attendees had concerns about the turn-around time for the test results for both OPOs and transplant centers, noting that it is variable depending on where the test is sent. One attendee commented that there seem to be a lot of unanswered questions about the timeframe for this test-so it's hard to provide any sentiment. They support the concept but feel like timing and feasibility require additional consideration prior to finalizing. Another attendee noted that the incubation period for WNF can be as early as 2-6 days.

Region 10 | 09/24/2025

Sentiment: 3 strongly support, 10 support, 2 neutral/abstain, 3 oppose, 1 strongly oppose

Comments: An attendee expressed concern at the risk of false positives. Even a single false positive could result in two or more organs not being utilized, which might outweigh the benefit given the very low incidence of mortality from WNV transmission. While some in attendance reported extensive experience testing for WNV since 2016 without false positives, participants pointed out that other infectious disease tests have shown false positive rates of 4–5%. The question of how many false positives might realistically occur in a year was seen as critical. Accessibility and availability of WNV testing was also a concern. An attendee asked how many labs currently offer the test, whether labs are able to meet OPO demand in a timely manner, and whether this would be feasible across wide geographic regions such as the Pacific Northwest. The logic of testing donors rather than recipients was also questioned. Living donor testing was a particular focus of concern. Mandating WNV NAT for living donors was seen as potentially burdensome and could discourage donation. It was noted that many living donors travel significant distances for donation, sometimes from out of state, and often schedule donation surgery close to their travel. This makes it difficult to complete testing within a short time frame, particularly when some hospitals rely on “send-out” labs with long turnaround times. Additionally, living donors often plan vacations or other travel shortly before surgery, further complicating logistics. As such, attendees urged that the required testing window for living donors be extended from 10 days to at least 14 days, or that testing be reserved for symptomatic donors only. Without such flexibility, there was concern that living donor kidney and liver programs would be unduly burdened. Operational considerations included whether the OPTN computer system would be updated to show WNV testing as a required field, and how the costs of this testing would be funded or prioritized among OPTN projects. Attendees also highlighted that while WNV infection carries high morbidity, widespread mandatory testing without sufficient lab access and turnaround capability could paradoxically reduce organ utilization by delaying allocation or leading to organ discard.

University of Arkansas for Medical Sciences | 09/23/2025

We appreciate the opportunity to provide feedback on the OPTN proposal to require seasonal West Nile Virus (WNV) testing for all donors, including both deceased and living donors. As a transplant center performing both living and deceased donor transplants, we fully support OPTN’s efforts to enhance patient safety and reduce the risk of donor-derived infectious disease transmission. Our center currently tests all living donors for WNV during their evaluation process, regardless of the time of year. However, we have concerns regarding the proposed requirement that living donor WNV testing be completed within seven days of organ recovery, as this may create logistical challenges without significantly improving safety outcomes. Additionally, we have concerns about mandating WNV testing for all deceased donors if it results in delays to organ allocation, potentially increasing cold ischemic time and the risk of organ non-use. We recommend that, in cases where WNV test results are pending, OPOs disclose this information to transplant centers and allow the centers to determine whether to proceed with organ acceptance based on the clinical context.

Heather Swonger | 09/22/2025

The 7-day window is too short and may result in multiple pre-op blood draws for donors. The window should align with the 28-day window for the rest of the required pre-op serologies. Region 6 has a unique geography with many donors needing to travel much further distances than other regions, or needing to mail blood for final crossmatches/final serologies, so aligning the WNV NAT with the other required NAT testing will alleviate potential issues with multiple blood draws.

Anonymous | 09/22/2025

If WNV testing is going to be required for living donors during the seasonal period (July 1 to October 31), please consider aligning it with the NAT requirements for HIV, HCV, and HBV, which is 28 days. If the proposal moves forward with a 7-day pre-op requirement, it will be inconvenient for living kidney donors because their other testing can typically be completed earlier.

Gift of Life Michigan | 09/22/2025

We appreciate the Ad Hoc Disease Transmission Advisory Committee’s work on this important topic. We strongly support the Committee’s recommendation to mandate testing for West Nile Virus (WNV) seasonally. The WNV can be serious or fatal to anyone, and its effects are multiplied in organ transplant recipients. We suggest the Committee refine the requirements to fit risk, such as seasonal testing in affected areas.

We are concerned that obtaining WNV results prior to recovery of donated organs increases the risk of losing organs to time. We hope the Committee considers the impact to all recipients and make the requirement useful without risking the loss of organs for transplant.

Region 6 | 09/19/2025

Sentiment: 1 strongly support, 5 support, 1 neutral/abstain, 2 oppose, 0 strongly oppose

Comments: One attendee commented that the policy language requiring living donor testing “within seven days of the planned organ recovery or as close to that date as possible” is difficult to monitor for compliance. They went on to comment that Region 6 covers a large geographic area, with patients often traveling from distant places such as Montana and Alaska. They expressed concern that requiring living donors to be present not only for the operation and recovery but also a week beforehand for testing would place a significant burden on these patients. They also asked if any Organ Procurement Organizations (OPOs) currently performing routine screening have identified any positive results. Another attendee also raised geographic concerns, stating that Region 6’s large area can cause delays in testing. They cautioned that requiring test results prior to transplant could delay the process and impact OPOs’ ability to proceed quickly with deceased donor recoveries, which often operate under strict time constraints. One attendee recommended changing the timeline for living donor testing to align with the timeline for serologies, which requires testing as close as possible but within 28 days prior to organ recovery. They noted that having consistent timelines would reduce confusion and help with planning. Another attendee commented that adding this testing requirement could complicate the coordination of living donor surgeries without providing much benefit. They also noted that for deceased donors, the results would likely arrive post-transplant and the test has a high rate of false positives, reducing its usefulness. Another attendee raised concerns that requiring living donor testing within seven days prior to organ recovery and having results available before implantation could be problematic given the turnaround times for West Nile virus (WNV) NAT testing. They noted that this requirement could force living donors to travel and arrive earlier than necessary, adding hardship. They recommended that WNV testing for living donors be a recommendation rather than a requirement.

Anonymous | 09/12/2025

While I recognize that a donor-derived WNV transmission can be a devastating event for recipients, it is important to keep in mind that the ultimate goal of any policy should be the prevention of deaths overall. Screening may help reduce transmission risk, but it will not eliminate it. PCR testing won't capture all donors who will transmit, and in practice, its performance is limited—one large NEJM study in blood donors found a positive predictive value of only about 50%.

The risk of WNV itself is not uniform; it fluctuates from year to year and differs markedly by geography. Certain regions, such as Texas, consistently report higher case numbers, while others—including the coasts and much of Florida—have very low incidence, even during peak transmission months. In these low-prevalence settings, the likelihood of false-positive results increases, which in turn could lead to unnecessary discard of viable organs. On average, that could mean the loss of roughly three organs for every donor flagged as positive.

For context, the policy cites 11 transmitting donors identified between 2002 and 2023—roughly one every two years. The concern is that the cumulative number of organs not used because of false-positive results could outstrip the number of transmissions prevented, potentially leading to more deaths from lack of transplants than from donor-derived WNV itself.

If this policy is approved, it is essential to build in a strong monitoring component to this policy. That should include tracking the number of positive test results, distinguishing true positives from false positives, and estimating the balance between lives saved from avoided transmissions and lives lost from reduced organ availability. This type of analysis—using historical WNV data, encephalitis and mortality rates (70% and 40%, respectively), and national median organ recovery rates—would help clarify the net impact of the policy and ensure it achieves its intended purpose.

OPTN Living Donor Committee | 09/12/2025

The OPTN Living Donor Committee thanks the Ad Hoc Disease Transmission Advisory Committee for its work on this proposal and the opportunity to provide input. The Committee supports the rationale for seasonal testing for West Nile Virus (WNV), as all known transmission cases have occurred within the proposed seasonal window. Several logistical and operational concerns were raised regarding the implementation of the proposed 7-day testing window.

Nucleic acid testing (NAT) for WNV is not universally available and often requires send-out testing, which can delay results. This presents challenges for living donors, whose pre-operative labs are typically drawn 10–14 days before surgery. Additionally, many donors travel long distances, and requiring additional lab visits would impose a significant burden if additional testing is required within a 7-day pre-donation window.

The cost of NAT was also discussed, with estimates suggesting it is comparable to other polymerase chain reaction (PCR) tests, depending on the laboratory and insurance coverage. To streamline logistics and reduce burden on both donors and transplant centers, it was suggested that the testing window be aligned with existing protocols, such as final human leukocyte antigen (HLA) testing, which is often conducted 10 days prior to surgery.

In light of these concerns, the committee recommends extending the testing window to 10 days. This adjustment would better accommodate smaller centers and improve feasibility without compromising safety.

Region 7 | 09/12/2025

Sentiment: 3 strongly support, 8 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

Comments: Attendees raised concerns and differing views regarding West Nile Virus (WNV) NAT testing for donors. Some centers test seasonally and report very few positive cases, questioning the need for universal testing. Others perform year-round testing and support the proposal, citing safety and consistency benefits. Concerns were expressed about the feasibility of completing testing within a 7-day window for living donors, citing donor inconvenience, test availability, and turnaround times. Questions were raised about compliance if testing is only required seasonally, the potential for false positives leading to unnecessary organ discards, and the impact on allocation timelines. Attendees also highlighted that WNV primarily affects the central nervous system, raising questions about the clinical utility of blood-based NAT testing. The financial impact of implementing testing nationwide was noted, with cost estimates ranging from $2–3 million annually for OPOs and $700K–1.2M for living donor programs. Some requested more data on test performance, the number of confirmed transmissions, and whether previous positive donor cases had been detected through NAT.

Region 8 | 09/12/2025

Sentiment: 1 strongly support, 12 support, 2 neutral/abstain, 4 oppose, 0 strongly oppose

Comments: Attendees raised concerns that the seven-day testing window for living donors is too short and may result in donors undergoing multiple lab draws. It was recommended aligning this requirement with the existing 28-day serology testing window to reduce burden and ensure consistency across required testing. Questions were raised about whether the shortened timeframe is necessary nationwide or only in certain regions, and how international travel might affect applicability. Concerns were also expressed about the turnaround time for test results and the additional costs that may be incurred, with suggestions to coordinate all living donor testing to minimize duplication. Participants noted that there is currently no specific treatment or prophylaxis for West Nile Virus, making prevention difficult. This led to questions about whether NAT testing is the most appropriate method given its 28-day turnaround time and what steps can be taken to reduce the risk of transplant recipients acquiring West Nile Virus in endemic areas after surgery.

Region 11 | 09/11/2025

Sentiment: 2 strongly support, 10 support, 10 neutral/abstain, 3 oppose, 0 strongly oppose

Comments: A member requested the committee consider any potential risks of non-use of an organ for which West Nile Virus (WNV) testing has not come back in time, particularly when it comes to DCD cases. An attendee stated that the turnaround time from LabCorp makes it not feasible at most transplant programs, and another member agreed. An attendee suggested that symptom review with living donors could replace another required NAT test, noting rising transplant costs without reimbursement changes. A member felt there was not enough data or information presented to answer questions about the need and noted insufficient discussion of the OPO burden. An attendee recommended excluding very small pediatric donors or those hospitalized over 21 days from the requirement, or adjusting the timeframe, citing concerns about blood volume loss in neonates due to multiple mandated tests. A member expressed that too many unanswered questions remained after the regional meeting and felt the proposal was not fully thought out. An attendee commented that the timelines for the requirement seem unrealistic for both living and deceased donors, especially at smaller centers/OPOs, and questioned the effectiveness of screening based on past WNV cluster data. A member supported West Nile virus testing for donors but not as currently proposed, citing concerns about turnaround times and potential loss of donor organs. An attendee stated that WNV serology is reasonable for expedited placement and should not prevent OPOs from utilizing kidneys. A member emphasized the need for feasible and quick turnaround and questioned the impact of delayed results on donor organ availability. An attendee opposed the proposal based on the presentation and unanswered questions, requesting more comprehensive data and clarity on timelines and actions for positive results.

Region 3 | 09/10/2025

Sentiment: 1 strongly support, 6 support, 0 neutral/abstain, 3 oppose, 0 strongly oppose

Comments: Some attendees recommended the OPTN provide additional guidance and resources for Organ Procurement Organizations (OPOs) and transplant centers to support extending the testing time frame beyond the proposed policy when local epidemiological conditions warrant it. Several attendees raised concerns about the requirement that living donor testing be completed within 7 days before organ recovery. They commented that this time frame may not be enough because of lab turnaround times and the need to have results before recovery. They recommended extending the testing window to 14 days to allow more flexibility and improve operations. Other attendees recommended aligning the testing window for living donors with the current testing policy, which is within 28 days before donation. Some attendees noted that the 7-day window could be a problem for domino donor transplants due to their unpredictable timing. Attendees commented that extending the testing window would support accurate testing and reduce strain on operations.

Glenna Frey | 09/10/2025

Support

LifeSource | 09/09/2025

We strongly oppose this testing based on the limited data and low frequency of occurrence vs. the low risk of losing out on opportunities for recipients to receive a gift from the donor. This requires extra work/cost with low transmission with no real data to prove poor outcomes.

OPTN Operations and Safety Committee | 09/05/2025

The Committee thanks the Disease Transmission Advisory Committee (DTAC) for their efforts on the Require West Nile Virus (WNV) Seasonal Testing for All Donors proposal and the opportunity to comment. The Committee provides the following feedback:

• False Positives: The Committee voices concern of the policy not addressing instances where re-testing may be needed if a result is presumed to be a false positive. For low-prevalence disease states, even very low false-positive rates can produce more false-positives than true-positives.
• Potential barriers: The Committee notes that the policy requires the test to be resulted prior to organ implantation and implantation and commented that this could be a potential barrier that could result in increased costs, increased cold ischemic time (CIT), and increased non-use/non-utilization rates.
• Time constraints: The Committee voices concern about the turnaround time of the test and the potential burden this may present for OPOs who may need to outsource their testing. The Committee inquires if this proposal considered rapid donor cases as this also poses challenges related to time constraints from the donor family as well as OPOs getting test results back in time. The Committee suggest for those cases that OPOs are required to disclose if WNV testing has not yet resulted.
• Deceased donor transmission: The Committee notes the importance of knowing the instance of deceased donor transmission of West Nile Virus. The prevalence and risk of transmission are requisite to informed decisions about testing.

Overall, the Committee cautions the result of this proposal potentially imposing significant additional costs on the system, burden on OPOs and transplant hospitals, and impair patient access to life-saving organs.

Nevia Greenwell | 09/04/2025

Before implementation, there needs to be data on how many DDT of WNV occurred. If there are very few, then it does not seem reasonable for the additional costs for testing. These costs will be passed on to transplant programs through higher costs for organs. Seems like a solution in search of a problem.

Anonymous | 09/03/2025

Strongly Support

Jullie Hoggan | 08/28/2025

Considering the loss of life, very much support this preventive measure.

Anonymous | 08/28/2025

With the current information provided here I do not feel that there is enough information presented to make this testing mandatory for all living donors and deceased donors. First, the CDC information provided here doesn't indicate how many, if any transmissions were from living donors. Second, it is not clear what the definition of a "confirmed cluster" is therefore I am unsure of the denominator and so the percentages provide minimal impact without the supporting data. If a cluster does mean that each donor saved 8 lives then the total would be 88 recipients. 87% of 88 people then showed signs of MNV which would be about 76 people. 77 percent of 76 people developed encephalitis would equate to 58 people and 40% of those 58 people died is estimated at about 23 people. This total number is also not presented against the total number of transplanted patients between 2002 to 2023 to understand the overall impact. Does every single life matter? ABSOLUTELY? Could those deaths been preventable, yes- if those deaths were solely due to WNV.

Before being in support of this mandate, I would recommend additional assessment regarding living donors vs deceased donor transmission. Locations of these occurrences to see if we can still limit this mandate to only endemic areas and last- what impact will this requirement have on delays in donation? According to my research the turn around times for a WNV NAT test is 1-4 days. Is the plan to prevent these donors from donating if they have WNV or is the plan to treat the WNV earlier in the recipients after results are available.

Terri Milton | 08/27/2025

In areas where mosquitoes carry the virus, yes. However, are all areas of the country affected? I could not find standard guidelines information.

Anonymous | 08/27/2025

Strongly Support

University of Tennessee Medical Center | 08/27/2025

NAT testing for WNV to be completed within 7 days of living donor organ recovery is too short. The usual time frame is 28 days and is something that we are able to accomplish much easier than a 7 day window.

Anonymous | 08/27/2025

Support