Transplant Centers Research Articles

The iPeer2Peer mentorship program for adolescent thoracic transplant recipients: An implementation-effectiveness evaluation

BackgroundAn increase in self-management skills for adolescent thoracic transplant recipients may improve health outcomes and facilitate a successful transition to adulthood. The iPeer2Peer© program is an online peer mentorship program that has been successfully implemented as a self-management intervention in multiple chronic disease populations. This study aimed to determine the implementation and effectiveness outcomes of the iPeer2Peer program for adolescent thoracic transplant recipients. MethodsA type III, hybrid implementation-effectiveness pilot study that comprised a quasi-experimental single-arm pre-post design was used to evaluate the iPeer2Peer program. Participant mentees, ages 12 to 17, were recruited from two large Canadian transplant centres. Peer mentors, ages 18 to 25, were thoracic transplant recipients who had successfully transitioned to adult care and self-manage their condition. A mixed methods approach for data collection was used, including interviews, focus groups, and standardized questionnaires. ResultsTwenty mentees (median 15.0 years, IQR 3.3 years; 65% female) completed the iPeer2Peer program with nine young adult mentors (median 21.0 years, IQR 3.0 years; 78% female). Implementation outcomes indicated that the iPeer2Peer intervention was perceived as feasible, adoptable, acceptable, and appropriate for adolescent thoracic transplant recipients. Significant findings were noted in mentees for increased self-management and a decrease in overall depression and anxiety symptoms. ConclusionsThe successful implementation of the pilot iPeer2Peer program offers support to evaluate the scalability, sustainability, and cost-effectiveness of the program for adolescents with chronic illness, specifically thoracic transplant recipients. Changes to the iPeer2Peer program that facilitate a flexible delivery may help implementation and acceptance.

Enhancing Donor Transport Success: Lessons From the Iranian Experiences.

Organ transplant is a complex process that involves various medical, legal, and social factors. The organ demand continues to outweigh the supply, leading to global challenges in the expansion of transplant programs. Ischemic time is crucial for the viability of organs, and efforts are being made to reduce transport time to improve transplant success rates. The viability and quality of the organ for transplant depends on minimized ischemic time. A new method is presently being implemented in Iran, in which, instead of transfer of organs, leading to reduced organ quality due to ischemic time, the donors themselves are transferred to transplant centers with the help of a trained team after brain death is confirmed and with the consent of the family. During the transfer process, an anesthesiologist or nurse specialized in donor care performs the relevant pretransplant procedures. The successful transportation of donors to centers for organ procurement requires meticulous planning, trained personnel, and adherence to safety protocols. Quality assurance measures, including audits and safety protocols, are in place to ensure the timely and safe delivery of donated organs. Ultimately, improvements in the transportation process for organ donation can enhance transplant success. Successful transportation of donors to organ procurement units is crucial for reducing ischemic time and improving the success rate and quality of organ transplants. Careful planning, communication, and collaboration among health care professionals are necessary for the timely and safe delivery of donated organs.

First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

Postoperative Delirium Screening Characteristics in Pediatric Intestinal, Liver, and Renal Transplant Recipients: Single-Center Retrospective Cohort Study.

To describe and compare the results of delirium screening in the immediate post-transplant PICU admission for pediatric intestinal, liver, and renal transplant recipients. We also examined associations with known and suspected risk factors for pediatric delirium (PD). Retrospective analysis of a single-center cohort, 2016-2022. Twenty-four-bed PICU in a high-volume transplant center. All intestinal, liver, and renal transplant recipients under 23 years old admitted between July 2016 and August 2022. We identified 211 pediatric transplant recipients: intestinal ( n = 36), liver ( n = 78), and renal ( n = 97). Results of the Cornell Assessment for PD during the immediate post-transplant PICU admission were reviewed and patients were categorized into screen positive, screen negative, and unscreened. Corresponding data on known and suspected risk factors for PD were also collected. Data on delirium subtypes were not collected. Screens were available for 156 of 211 patients (74%) who were included in the final analysis. The prevalence of a positive screen by transplant category was: intestine 80% (24/30), liver 75% (47/63), and renal 14% (9/63). A positive screen was associated with younger age, greater duration of mechanical ventilation, and greater PICU length of stay (LOS) in bivariate analysis. In multivariable analysis, age and PICU LOS remained strongly correlated with a positive screen ( p < 0.05). Deep sedation and agitation as categorized by the State Behavioral Scale was associated with a positive screen, as was significant iatrogenic withdrawal symptoms ( p < 0.05). Most patients screened positive by post-transplant days 2 and 3 (58/80 [72%] and 64/80 [80%], respectively). In our 2016 to 2022 experience, we found a high prevalence of positive PD screens in pediatric intestinal and liver transplant recipients in the immediate post-transplant PICU admission. A positive screen was associated with younger age and greater PICU LOS.

Perioperative extracorporeal membrane oxygenation in liver transplantation—bridge to transplantation, intraoperative salvage, and postoperative support: outcomes and predictors for survival in a large-volume liver transplant center

Data on perioperative extracorporeal membrane oxygenation (ECMO) in liver transplantation (LT) are scarce. ECMO has been used preoperatively, intraoperatively, and postoperatively for a variety of indications at our center. This retrospective, single-center study of ECMO use peri-LT aimed to describe predictors for successful outcome in this highly select cohort of patients. Demographics, support method, and indication for LT were compared between survivors and nonsurvivors. Twenty-nine patients received venovenous (V-V; n = 20), venoarterial (V-A; n = 8), and venoarteriovenous (n = 1) ECMO. Twelve (41.4%) patients were bridged to emergency LT for acute liver failure, and emergency redo LT. Four (13.3%) patients required intraoperative V-A ECMO salvage, 2 necessitating extracorporeal cardiopulmonary resuscitation. Thirteen (43.3%) patients required ECMO support after LT: V-V ECMO (n = 9); V-A ECMO (n = 1); and extracorporeal cardiopulmonary resuscitation (n = 3) between postoperative days 2 to 30. Overall, 19 patients (65.5%) were successfully weaned off ECMO; 15 (51.7%) survived to intensive care unit discharge. All patients who underwent intraoperative salvage ECMO and all who were bridged to emergency redo LT died. Peri-LT ECMO is feasible. Post-LT ECMO outcomes are encouraging, in particular for V-V ECMO. Intraoperative ECMO salvage, uncontrolled sepsis, and graft failure are associated with poor outcomes.

245.8: Shiraz Transplant Center; leader of the intestinal transplant in the Middle East; challenges and opportunities.

245.8: Shiraz Transplant Center; leader of the intestinal transplant in the Middle East; challenges and opportunities.

Prognosis of Transplant-Ineligible Patients with Cirrhosis and Acute Kidney Injury Who Initiate Renal Replacement Therapy.

Data to guide dialysis decision-making for transplant-ineligible patients with cirrhosis are lacking. We aimed to describe the processes, predictors, and outcomes of renal replacement therapy (RRT) initiation for transplant-ineligible patients with cirrhosis at a single liver transplantation center. We conducted a mixed-methods study of a retrospective cohort of 372 transplant-ineligible inpatients with cirrhosis with acute kidney injury (AKI) due to hepatorenal syndrome (HRS-AKI) or acute tubular necrosis (ATN) between 2008 and 2015. We performed survival analyses to evaluate 6-month survival and renal recovery and examined end-of-life care outcomes. We used a consensus-driven medical record review to characterize processes leading to RRT initiation. We identified 266 (71.5%) patients who received RRT and 106 (28.5%) who did not receive RRT (non-RRT). Median survival was 12.5days (RRT) vs. 2.0days (non-RRT) (HR 0.36, 95%CI 0.28-0.46); 6-month survival was 15% (RRT) vs. 0% (non-RRT). RRT patients were more likely to die in the intensive care unit (88% vs. 32%, p < 0.001). HRS-AKI patients were more likely to be RRT dependent at 6months than ATN patients (86% vs. 27%, p = 0.007). The most common reasons for RRT initiation were unclear etiology of AKI on presentation (32%) and belief of likely reversibility of ATN (82%). Most transplant-ineligible patients who were initiated on RRT experienced very short-term mortality and received intensive end-of-life care. However, approximately 1 in 6 were alive at 6months. Our findings underscore the critical need for structured clinical processes to support high-quality serious illness communication and RRT decision-making for this population.

Report on post-transplantation cancer in southeast Asia from the Thai kidney transplantation cohort

Post-transplantation cancer is a significant cause of mortality among kidney transplant recipients (KTR). The incidence of post-transplantation cancer varies based on geographic region and ethnicity. However, data on KTR from South East Asia, where characteristics differ from other parts of Asia, is lacking. We conducted a retrospective cohort study at a transplant center in Thailand to investigate the incidence of post-transplantation cancer and mortality rates. Factors associated with post-transplantation cancer and patient outcomes were analyzed using competing-risks regression. The study included 1156 KTR with a post-transplant follow-up duration of 5.1 (2.7–9.4) years. The age- and sex-adjusted incidence rate of post-transplant cancer was highest for urothelial cancer (6.9 per 1000 person-years), which also resulted in the highest standardized incidence ratio (SIR) of 42.5 when compared to the general population. Kidney cancer had the second-highest SIR of 24.4. Increasing age was the factor associated with an increased risk of post-transplant cancer (SHR 1.03; 95% CI 1.01–1.05). Human leukocyte antigen (HLA) DR mismatch was associated with a decreased risk of post-transplant cancer (SHR 0.72; 95% CI 0.52–0.98). Post-transplantation cancer was significantly associated with patient mortality (HR 3.16; 95% CI 2.21–4.52). Cancer significantly contributes to KTR mortality, and the risk profile for cancer development in Thai KTRs differs from that of Western and most Asian counterparts. Further research is essential to explore appropriate screening protocols for countries with high rates of urothelial and kidney cancer, including Thailand.

Determinants of Long Waiting Time to Kidney Transplantation

BackgroundDisparity in waiting time to kidney transplantation led to new policy (KAS250). Our aims were to identify variables associated with long wait time (LWT); assess the impact of KAS250 on WT; and analyze modifiable transplant center behaviors correlated with WT. MethodsSRTR data for adult deceased donor kidney transplants were analyzed. Time-periods from 8/1/2018-7/31/2019 and 5/1/2021-4/30/2022 were chosen for pre- and post-KAS250 analyses. Transplant centers were categorized as LWT or SWT centers depending on whether pre-KAS250 median center waiting times were greater or less than the national pre-KAS250 median waiting time of 57.8 months. ResultsIn multivariate analysis, transplantation with HCV NAT negative kidneys was associated with an additional 21.3 months of WT (CI: 18.5-24.2, P < .0001), and transplantation with KDPI <85% kidneys was associated with an additional 10.8 months (CI: 8.2-13.3, P < .0001). Post-KAS250 national kidney transplant waiting time decreased from 61-58 months (P < .0001) and waiting time at LWT centers decreased from 74-69 months (P < .0001). Cold ischemic times (CIT) increased (20.2 hours vs 18.3 hours, P < .0001) and DGF rates also increased (32.7% vs 31.0%, P < .0001). Centers generally displayed more aggressive transplantation practices post-KAS250 however significant differences in DCD utilization, organ offer acceptance ratios and tolerance for long CIT persist between SWT and LWT centers. ConclusionKAS250 has reduced waiting time disparities between SWT and LWT centers at the cost of increased CIT and DGF and reduced allocation efficiency. Significant differences in transplant practice persist between SWT and LWT centers.

LEGISLATIVE FRAMEWORK AND TRANSPLANTATION SYSTEM IN UKRAINE NOWADAYS

Introduction. In Ukraine, the system of human organ and anatomical material transplantation is still developing. The advancement of this process is partly hindered by complex legal issues related to human organ and tissue transplantation. Moreover, the transplantation mechanism is further complicated by the requirements for reporting, medical examinations, and multiple administrative inspections. The current functioning of the transplantation system necessitates a thorough review and critical analysis to facilitate its improvement. Aim. To study the legal framework and socio-ethical prerequisites for the further development of the transplantation in Ukraine. Materials and methods. The authors use systematic, comparative, and critical methods, as well as analytical generalization, to describe the current state and legislative prerequisites for the development of the transplantation in Ukraine. Conclusions. A review of the legal framework and socio-ethical prerequisites for the operation of the human organ and tissue transplantation system in Ukraine has revealed numerous administrative, legislative, and informational gaps that hinder the development of the Ukrainian transplantation. However, there have been recent indications of positive changes. Consequently, there is an urgent need to establish special funds with such primary goal as the financing, technical, and technological re-equipment of healthcare institutions, specifically for the needs of transplantation centres. Equally important is the implementation of various measures to incorporate foreign experience to improve the qualification of medical professionals.

Access to kidney transplantation from dialysis facilities affiliated with a transplant center versus free-standing dialysis facilities in the US.

Access to kidney transplantation from dialysis facilities affiliated with a transplant center versus free-standing dialysis facilities in the US.

Utilization of allogeneic hematopoietic stem cell transplantation among patients with newly diagnosed acute myeloid leukemia in California: a population-based linked dataset study.

Acute myeloid leukemia (AML) often requires allogeneic hematopoietic cell transplantation (alloHCT) for cure, but historically alloHCT has been strikingly underutilized. Reasons for this remain uncertain at the population level. We examined alloHCT utilization over time and explored associations between demographic/healthcare factors and use of alloHCT by age group (AYA 15-39y, adult 40-64y, older adult 65-79y) using a linked dataset merging the Center for International Blood and Marrow Transplant Research, California Cancer Registry, and California Patient Discharge Database. Eligibility included patients newly diagnosed with AML in California between 2001-2016 who received induction therapy and had no prior HCT. Multivariable Fine-Gray regression analyses were fitted separately across age groups. Among 7,925 patients with AML, alloHCT utilization increased over time across all age groups; however, in the most recent time period studied (2011-2016), utilization within 2 years of diagnosis remained lowest in older adults (13%) relative to adults (41%) and AYAs (49%). Factors statistically significantly associated with lower alloHCT utilization: (1) AYAs: female sex, lower neighborhood socioeconomic status (nSES), uninsured or Indian Health Services (IHS) coverage; (2) adults: older age, male sex, non-Hispanic Black or Asian race and ethnicity, unmarried, lower nSES, uninsured or covered by Medicaid, Medicare, or IHS, higher comorbidity, and living 100+ miles from a transplant center; and (3) older adults: older age, Asian race, and unmarried. In conclusion, using a population-based linked dataset, we demonstrate that utilization of alloHCT among older patients newly diagnosed with AML remains low in California, and factors associated with utilization vary by age group.

Proceedings of the 2024 Transplant AI Symposium.

With recent advancements in deep learning (DL) techniques, the use of artificial intelligence (AI) has become increasingly prevalent in all fields. Currently valued at 9.01 billion USD, it is a rapidly growing market, projected to increase by 40% per annum. There has been great interest in how AI could transform the practice of medicine, with the potential to improve all healthcare spheres from workflow management, accessibility, and cost efficiency to enhanced diagnostics with improved prognostic accuracy, allowing the practice of precision medicine. The applicability of AI is particularly promising for transplant medicine, in which it can help navigate the complex interplay of a myriad of variables and improve patient care. However, caution must be exercised when developing DL models, ensuring they are trained with large, reliable, and diverse datasets to minimize bias and increase generalizability. There must be transparency in the methodology and extensive validation of the model, including randomized controlled trials to demonstrate performance and cultivate trust among physicians and patients. Furthermore, there is a need to regulate this rapidly evolving field, with updated policies for the governance of AI-based technologies. Taking this in consideration, we summarize the latest transplant AI developments from the Ajmera Transplant Center's inaugural symposium.

The Italian experience on liver transplantation for unresectable peri-hilar cholangiocarcinoma: a national survey and future perspectives.

Liver transplantation (LT) was considered an ineffective treatment for perihilar cholangiocarcinoma (pCCA) until the successful experience of the Mayo Clinic, proposing a protocol with strict inclusion criteria and neoadjuvant radio-chemotherapy. Since 2015, pCCA is considered an indication for LT in Italy only in the context of controlled prospective studies. We performed a survey among the 22 Italian Liver Transplant Centers to assess the results of LT for pCCA. Eight centers reported 53 cases from 1986 to 2021 (Bologna 12, Padova 10, Niguarda 10, Milano Tumori 8, Torino 5, Pisa 4, Ancona 2, Modena 2). Patients were divided according to whether they recieved neoadjuvant radio-chemotherapy (Group 1, 25 cases) or not (Group 2, 28 cases). Eleven patients were transplanted without neoadjuvant treatment after 2015. Overall survival at 1, 3 and 5years was 83.8%, 56.6% and 50.6% in Group 1 and 72.4%, 41.4% and 35.5% in Gropu 2 (p = 0.13). Recurrence-free survival at 1, 3, and 5years was 91.2%, 61.1% and 47.2% in Group 1 and 58.2%, 42.2%, and 36.1% in Group 2 (p = 0.16). A competing risk regression analysis showed a 5-year risk of cancer-related death of 19% for patients in Group 1 against 62.3% in Group 2, with a hazard ratio of 0.31 (95%CI [0.10-0.98], p 0.047). This survey promoted a discussion about the limitations of the Mayo protocol and set the basis for the adoption of a new nationwide protocol (LITHALICA-NCT06125769), having the same inclusion criteria but proposing standard of care chemotherapy as neoadjuvant regimen.

A Survey of United States Transplant Center Donation After Circulatory Death Kidney Transplant Practices in the Modern Era

IntroductionThe mismatch between the number of patients awaiting kidney transplantation and the supply of donor organs has in part resulted in a rise in kidney transplantation from donors after circulatory death (DCD). Persistently long waiting times have led the transplant community to continue to explore the use of expanded criteria DCD kidneys. In parallel, advances in organ preservation strategies have contributed to an overall increase in DCD organ transplantation and are altering the transplant landscape. Some of these techniques may improve kidney allograft outcomes and affect how DCD kidneys are utilized. We aimed to better understand practices in accepting DCD kidney offers in the modern era. MethodsDirectors of 196 U.S. kidney transplant centers were emailed a link to an online survey over a 5-week period. Results48 (13%) out of the 364 directors responded with all UNOS regions represented. Definitions of warm ischemia time (WIT) used in DCD kidney evaluation varied widely amongst respondents. The maximum total WIT limit varied with 19 (39.6%) less than 60 minutes responses, followed by 16 (33%) less than 90 minutes responses, and 10 (20.8%) less than 120 minutes responses. ConclusionDespite increasing DCD kidney transplantation volumes in the U.S. there are no standardized procurement biopsy practices, OPO pre-operative protocols, or consensus definition or limits of WIT. Agreement upon terminology may facilitate rapid clinical communication, efficiency of organ allocation and utilization, recording of data, research, and improvements in policy.

Evolving trends in liver transplantation eligibility: A shift toward inclusivity for older adults at a Canadian Transplant Center

Background: The surge of end-stage liver disease among older individuals challenges traditional age-based criteria for liver transplantation (LT), historically capped at 65 years. Our Canadian center shifted away from using chronologic age as an absolute refusal criterion since 2019, enabling those aged 65 years and older to seek LT. This study aimed to investigate temporal trends in the transplant care cascade for patients aged 65 and older at our center, pre- and post-clinical shift. Methods: A retrospective study in a single Canadian transplant center reviewed LT referrals between 2015 and 2023, analyzing proportions of patients aged 65 and above at each stage. Specific intervals, 2015–2018 and 2019–2023, were defined for pre- and post-comparisons. Results: Among the 1,007 LT referrals, 11% (n = 110) were patients aged ≥65 years, with 74% ( n = 81) of them being referred after 2019. From 2015 to 2023, older patient proportions increased at all stages of the transplant care cascade: referrals (7.4% to 12.6%), evaluations (7.6% to 11.4%), waitlisting (5.6% to 15.4%), and transplantations (5.8% to 17.5%). Post-clinical shift, the proportion of older patients referred nearly doubled (7.5% vs 13.7%; p &lt; 0.05), with a similar increase in transplants (5.7% vs. 11.5%; p &lt; 0.05). Conclusions: Removing the age cap increased older patient engagement in the LT care cascade. This emphasizes the crucial role of actively promoting awareness of evolving LT eligibility criteria. Concerted efforts should focus on improving transplantation accessibility in older patients, ensuring age alone does not impede the process.

Myosteatosis and muscle loss impact liver transplant outcomes in male patients with hepatocellular carcinoma.

Sarcopenia is associated with unfavourable long-term survival in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC). However, the impact of myosteatosis and muscle loss on patient prognosis has not been investigated. Seven hundred fifty-six HCC patients who received LT at 3 transplant centres were included. Computed tomography (CT) images of recipients were collected to measure skeletal muscle index (SMI) and skeletal muscle radiodensity (SMRA). The impact of myosteatosis on the prognosis of sarcopenic and non-sarcopenic patients was studied separately. Muscle status was evaluated based on the presence of sarcopenia and myosteatosis. The muscle loss of 342 males was calculated as the relative change of SMI between pre- and post-LT evaluations. Cox regression models were used to identify predictors of overall survival (OS) and recurrence-free survival (RFS). The study comprised 673 males and 83 females. The median follow-up time was 31months (interquartile range, 19-43months). Prior to LT, 267 (39.7%) and 187 (27.8%) males were defined as sarcopenic (low-SMI) and myosteatotic (low-SMRA), respectively. For sarcopenic recipients, the presence of myosteatosis was followed by a 23.6% decrease in 5year OS (P<0.001) and a 15.0% decrease in 5year RFS (P=0.014). Univariate and multivariate analyses revealed that muscle status was an independent predictor of OS [hazard ratio (HR), 1.569; 95% confidence interval (CI), 1.317-1.869; P<0.001] and RFS (HR, 1.369; 95% CI, 1.182-1.586; P<0.001). Postoperatively, a muscle loss >14.2% was an independent risk factor for poor OS (HR, 2.286; 95% CI, 1.358-3.849; P=0.002) and RFS (HR, 2.219; 95% CI, 1.418-3.471; P<0.001) in non-sarcopenic recipients (N=209). Pre-transplant myosteatosis aggravated the adverse impact of sarcopenia on liver transplant outcomes in male HCC patients. Post-transplant muscle loss might assist in prognostic stratification of recipients without pre-existing sarcopenia, intriguing new insights into individualized management.

Determining Predictors of Actual Living Kidney Donation Based on Potential Donor Characteristics.

Living donor kidney transplantation is the optimal treatment for end-stage kidney disease; however, few living donor candidates (LDCs) who begin evaluation actually donate. While some LDCs are deemed medically ineligible, others discontinue for potentially modifiable reasons. At five transplant centers, we conducted a prospective cohort study measuring LDCs' clinical and psychosocial characteristics, educational preparation, readiness to donate, and social determinants of health. We followed LDCs for 12 months after evaluation to determine whether they donated a kidney, opted to discontinue, had modifiable reasons for discontinuing, were medically ineligible, or had other recipient-related reasons for discontinuing. Among 2184 LDCs, 18.6% donated, 38.2% opted to or had modifiable reasons for discontinuing, and 43.2% were deemed ineligible due to medical or recipient-related reasons. Multivariable analyses comparing successful LDCs with those who did not complete donation for modifiable reasons (N=1241) found that LDCs who discussed donation with the recipient before evaluation (OR, 2.31; 95% CI, 1.54-3.46), had completed high school (OR, 2.01; 95% CI, 1.21-3.35), or were a "close relation" to their recipient (OR, 1.89; 95% CI, 1.33-2.69) were more likely to donate. Conversely, LDCs who reported religion as important (OR, 0.55; 95% CI, 0.38-0.80), were Non-White (OR, 0.70; 95% CI, 0.49-1.00), or had overall higher anxiety scores (OR, 0.92; 95% CI, 0.86-0.99) were less likely to donate. With fewer than a fifth of LDCs donating, developing programs to provide greater emotional support and facilitate open discussions between LDCs and recipients earlier may increase living donation rates.

CT-252 First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

CT-252 First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

A novel high-performance rapid screening test for the detection of total HTLV-I and HTLV-II antibodies in HTLV-I/II infected patients

Rapid diagnosis of human T-cell lymphotropic virus (HTLV) type-I and -II infections are essential for timely and cost-effective disease interventions. MP Diagnostics ASSURE HTLV-I/II Rapid Test was developed for the rapid detection of anti-HTLV-I/II antibodies in patients’ serum, plasma, and whole blood specimens. ASSURE HTLV-I/II Rapid Test employed MP Biomedicals’ proprietary HTLV-I/II Trifusion recombinant antigen conjugated with gold nanoparticles and HTLV-I / HTLV-II recombinant antigens immobilized on the nitrocellulose membrane to detect total HTLV-I and HTLV-II antibodies. The overall performance of the ASSURE HTLV-I/II Rapid Test was found to be 99.42% sensitivity (95% Confidence Interval, 98.32–99.88%) and 100% specificity (95% Confidence Interval, 99.58–100.00%) in the tested clinical samples, including a total of 518 HTLV-I/II positive specimens (396 HTLV-I infection, 97 HTLV-II infection and 25 HTLV-I/II dual infection) and 872 HTLV negative clinical specimens consisting of 691 healthy donor samples, 116 potentially cross-reactive samples, and 65 samples with interfering substances. The ASSURE HTLV-I/II Rapid Test can effectively be deployed as a screening tool in any prevalence studies, blood banks or organ transplant centres.