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Require West Nile Virus Seasonal Testing for All Donors

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Background

West Nile Virus (WNV) is a disease found across the United States, as well as many places around the world. It is transmitted by mosquito bites, organ transplantation, and blood transfusions. WNV poses a significant risk to transplant recipients, as it is associated with high morbidity and mortality rates in solid organ transplants. Although the OPTN has guidance for when donors should be tested for WNV, it is not mandatory and is currently done voluntarily by organ procurement organizations (OPO) and living donor hospitals. This proposal seeks to reduce the risk of donor-derived WNV transmission, standardize testing practices, and enhance the safety and outcomes of transplant recipients.

Supporting presentation

View presentation

Proposed changes

  • Require all OPOs and living donor hospitals to conduct seasonal WNV nucleic acid testing (NAT) for all living and deceased donors
    • Testing would be required from July 1 until October 31 of each year

Anticipated impact

  • What it's expected to do
    • Reduce the risk of donor-derived WNV transmission
    • Provide more consistency in practices across OPOs and living donor hospitals
    • Improve transplant recipient safety and outcomes
  • What it won't do
    • Will not require year-round WNV testing
    • Will not prohibit OPOs or living donor hospitals from year-round WNV testing

Terms to know

  • West Nile Virus (WNV): Virus that spreads primarily through mosquito bites. Most people infected do not have symptoms, but about 1 in 5 have symptoms such as a fever, rash, or muscle aches. In rare cases, WNV can cause serious brain and spinal cord inflammation.
  • Nucleic Acid Test (NAT): type of diagnostic test that identifies the genetic material of a virus or other pathogen sample.
  • Organ Procurement Organization (OPO): An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation. OPOs serve as the vital link between the donor and recipient and are responsible for the identification of donors, and the retrieval, preservation and transportation of organs for transplantation. They are also involved in data follow-up regarding deceased organ donors.

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eye iconComments

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, 7 support, 0 neutral/abstain, 4 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