Donor Screening Research Articles

Declining trend of HTLV-1 among organ/ tissue donors in Iranian Tissue Bank between 2014–2021

BackgroundHuman T-cell Lymphotropic Virus type-1 (HTLV-1) infection is associated with serious disorders, including Adult T-cell Leukemia/Lymphoma (ATLL) and HTLV-1–associated myelopathy/tropical spastic paraparesis (HAM/TSP). In addition to sexual, vertical, parenteral, and blood transfusion, organ/tissue transplantation is considered as a transmission route of HTLV infection. Given the substantial risk of HTLV-1 transmission and the subsequent development of HAM/TSP (approximately 40%) in kidney transplant recipients, pre-transplant donor screening is crucial. The present study aimed to investigate the prevalence of HTLV-1 in potential organ/tissue donors referred to the Iranian Tissue Bank and Research Center (ITBRC).Materials and methodsThe study population was potential organ and/or tissue donors referred to ITBRC between 2014 and 2021, including two groups of brain death (potential donors of organs and/or tissues) and circulatory death donors (potential tissue donors from Iranian Legal Medicine Organization). Initial screening was performed using enzyme-linked immunosorbent assay (ELISA), and positive cases were confirmed for HTLV-1 infection with polymerase chain reaction (PCR).Results111 out of 3,814 donors were positive for HTLV-1 (3%). The rate of positive tests between 2014 and 2017 was 6%, which was significantly higher than the positive tests percentage between 2017 and 2021 with 0.5% (P-value < 0.001). The rate of test positivity in females was 4% compared to 2% in males (P-value = 0.001). Furthermore, individuals diagnosed with brain death exhibited a significantly lower likelihood of HTLV-1 infection (0.2%) compared to cases with circulatory death (4%) (P-value < 0.001).ConclusionConsidering the contraindication of organ/tissue donation from donors with HTLV-1 positive test, these findings give an insight into the prevalence of HTLV-1 among potential organ/tissue donors in Iran. Moreover, the higher prevalence of HTLV-1 infection in circulatory death donors from Iranian Legal Medicine Organization urges for cautious evaluation in these donors.

From pandemic to participation: A two-year follow-up of blood donors in the Netherlands who registered during the first wave of the COVID-19 pandemic.

During the height of the COVID-19 pandemic (2020-2021), people were urged to minimize movements. Nevertheless, the Netherlands observed a huge increase in new donor registrations in early 2020. It is unclear whether such "pandemic" donors are willing to become repeat donors. The aim of this study was to analyze the donation behavior of these "pandemic" donors during 2 years after registration. All donors registered in weeks 11-20 of 2020 were followed for 2 years and their turnout for the new donor screening (NDS), their first-time donation (FTD), their donation(s) in the follow-up period, and their availability at the end of the follow-up period was compared with donors registered in weeks 11-20 of the previous years, 2017-2019. Totally 26,463 donors registered during week 11-20 in 2020; more than double as in the same period in previous years. Their turnout for the NDS (80%) and FTD (60%) was like donors registered in 2017-2019. On the longer term, we saw lower donor availability with a shift in number of whole blood and plasma donations. During the first phase of the pandemic, more people registered than usual. Their show rates for the NDS and the FTD were comparable with previous years, suggesting that "pandemic" donors show identical behavior as regular donors. On the long term, however, donation behavior differed (lower return rates and shift in donation types). Further research is needed to disentangle impacts of the pandemic especially on the long-term changes as they happened simultaneously with policy and recruitment changes.

Geospatial Distribution of HIV Seroprevalence Among Blood Donors in South Asian Countries: A Systematic Review and Meta-Analysis.

The reliance on replacement blood donors in developing countries has led to an increased prevalence of transfusion-transmitted infections (TTIs), including HIV. This systematic review and meta-analysis aimed to assess the seroprevalence of HIV among blood donors in South Asian countries and disseminate the findings in choropleth maps. In addition, gender-specific prevalence or the yearly trend of HIV prevalence among blood donors was also investigated. Following the PRISMA guidelines, we searched PubMed, Scopus, CAB abstracts, CINAHL, and Google Scholar for articles published between January 2000 and December 2022. The DerSimonian-Laird effect model was used due to the high heterogeneity of the data. Data analysis was performed using R Studio version 4.1.0, ArcGIS, and GraphPad Prism 7.0. The pooled seroprevalence of HIV among blood donors in South Asian countries was found to be 0.13%, with the highest prevalence of 0.19% in India and the lowest prevalence of 0.02% in Bangladesh and Bhutan. Female blood donors had a higher seroprevalence than their male counterparts (0.24%, vs. 0.17%). In contrast to voluntary blood donors with an HIV seroprevalence of 0.13%, replacement blood donors have a higher HIV prevalence of 0.26%. The observed high heterogeneity was attributed to variations in country, gender, type of blood donors, and study year. This study demonstrates a significant burdenof HIV among blood donors in South Asia, emphasizing the need forenhanced donor screening protocols, targeted interventions and educational campaigns to ensure the safety of blood transfusionservices.Future research should explore additional risk factors and focus on expanding screening methods, particularly in resource-limited settings.

Fecal Microbiota Transplantation: Indications, Methods, and Challenges.

Over the past two decades, as the importance of gut microbiota to human health has become widely known, attempts have been made to treat diseases by correcting dysbiosis of gut microbiota through fecal microbiota transplantation (FMT). Apart from current knowledge of gut microbiota, FMT to treat disease has a long history, from the treatment of food poisoning in the fourth century to the treatment of Clostridioides difficile infections in the twentieth century. In 2013, FMT was recognized as a standard treatment for recurrent C. difficile because it consistently showed high efficacy. Though recurrent C. difficile is the only disease internationally recognized for FMT efficacy, FMT has been tested for other diseases and shown some promising preliminary results. Different FMT methods have been developed using various formulations and administration routes. Despite advances in FMT, some issues remain to be resolved, such as donor screening, manufacturing protocols, and unknown components in the fecal microbiota. In this review, we discuss the mechanisms, clinical indications, methods, and challenges of current FMT. We also discuss the development of alternative therapies to overcome the challenges of FMT.

Arbovirus in Solid Organ Transplants: A Narrative Review of the Literature.

The incidence of arbovirus infections has increased in recent decades. Other than dengue, chikungunya, and West Nile viruses, the data on arbovirus in solid organ transplant (SOT) are limited to case reports, and infections in renal transplant recipients account for most of the reported cases. Dengue and West Nile infections seem to be more severe with higher mortality in SOT patients than in the general population. Acute kidney injury is more frequent in patients with dengue and chikungunya although persistent arthralgia with the latter is less frequent. There is no clear relationship between arboviral infection and acute cellular rejection. Pre-transplant screening of donors should be implemented during increased arboviral activity but, despite donor screening and negative donor nucleic acid amplification test (NAT), donor derived infection can occur. NAT may be transiently positive. IgM tests lack specificity, and neutralizing antibody assays are more specific but not readily available. Other tests, such as immunohistochemistry, antigen tests, PCR, metagenomic assays, and viral culture, can also be performed. There are a few vaccines available against some arboviruses, but live vaccines should be avoided. Treatment is largely supportive. More data on arboviral infection in SOT are needed to understand its epidemiology and clinical course.

An Updated Assessment of Safety Strategies for Platelet Blood Concentrates (PCs): A Short Review Article

Background: Platelet concentrates (PCs) are one of the most used blood components in blood banks due to their essential role in treating thrombocytopenia, and while viral transmission has been largely addressed, bacterial contamination of platelet concentrates (PCs) are still regarded as a crucial safety concern. Objective: This short review aimed to consolidate current knowledge on the strategies followed in blood banks to maximize the quality and shelf life of platelet concentrates (PCs). Different methods of each strategy were considered, focusing on outcomes related to approved and effective outcomes. Methods: The current study is based on PubMed, Wiley, and Web of Science databases to assess donor selection, bacterial screening, and pathogen reduction technologies utilized for PCs quality. All articles were collected until April 2024. Studies utilizing approved interventions and relevant hospital outcomes were inclusive. However, repetitive data and unapproved methods were among the exclusive criteria. Collected published manuscripts were reviewed. Results: The studies reviewed and referenced in this article consensus that pathogen reduction technologies (PRTs) utilizing Ultraviolet rays (UV) was found to be effective in eliminating various bacterial contamination. Furthermore, the need for donor and bacterial screening is still essential and could not be overlooked. Pathogen reduction technologies (PRTs) remain important and valid despite studies suggesting the reduced platelet concentrates (PCs) quality and the need for frequent transmission of PCs. Some studies even foresee pathogen reduction technologies (PRTs) as replacing the cultural bacterial detection methods. Conclusion:We conclude that preventing bacterial contamination in platelet concentrates (PCs) requires a multifaceted approach. However, future research should focus on optimizing these strategies while minimizing their potential adverse effects on platelet function and safet

An iridium(III) complex-based luminogenic probe for high-throughput screening of hydrogen sulfide donors in living cells

The scarcity of suitable high-throughput screening technology for hydrogen sulfide (H2S) donors has hampered the discovery of H2S donors. In this study, a long-lived cyclometalated iridium complex was rationally designed as a mitochondria-targeted H2S probe to monitor the real-time dynamic change of H2S. By using the time-resolved emission spectroscopy (TRES) technique, an anti-interference high-throughput screening system was developed to monitor H2S in living cells with decreased false negative results. As a proof-of-concept, three natural products were identified as potential H2S donors from a natural product library using the developed TRES probe. Notably, the discovery of allicin and diallyl trisulfide demonstrated the feasibility of this screening platform, while garlic-derived allyl methyl sulfide was explored as a H2S donor candidate. The results were further validated by a commercial assay. We anticipate this high-throughput platform could facilitate the discovery of H2S donors by discriminating the endogenous interfering fluorescence from biological systems.

Donor-Derived Infections: A Journey From Evidence to Policy.

The prevalence of donor-derived Bartonella quintana infection poses an emerging issue in solid organ transplantation. Further studies are needed to validate criteria for donor screening to prevent transmission without negatively affecting organ utilization.

Prevalence and screening of hemoglobinopathies and glucose-6-phosphate dehydrogenase deficiency in Yemeni blood donors

ABSTRACT Hemoglobinopathies and Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency pose significant health threats in Yemen, which can be alleviated through robust preventive strategies, highlighting the importance of implementing a cost-effective and efficient blood donor screening method to facilitate early diagnosis and management of erythrocyte disorders, ultimately improving both donor safety and patient health outcomes. Objectives This study aimed to determine the prevalence of total blood cell abnormalities, hemoglobinopathies and G6PD deficiency and evaluate the efficacy of red blood cell (RBC) indices, mentzer index (MI) and naked-eye single tube red cell osmotic fragility (NESTROF) test as screening tools for diagnosis of β thalassemia trait among Yemeni blood donors. Methods A cross-sectional study was conducted with 106 volunteer blood donors who met the national standard criterion of blood donation. Various tests were performed, including complete blood count (CBC), serum ferritin, sickling test, G6PD assay, NESTROF test and high-performance liquid chromatography (HPLC). Results The prevalence of hematological abnormalities among blood donors reached 68.9%, with functional RBC abnormalities at 51.9%, leukopenia at 10.4%, thrombocytosis at 1.9%, and thrombocytopenia at 4.7%. Additionally, hemoglobinopathies were found in 21.7% of donors, with β-thalassemia trait at 3.8%, sickle cell trait at 1.9%, and suspected α-thalassemia trait at 16%, while G6PD deficiency and iron deficiency were present in 12.3% and 17.9% of donors, respectively. The NESTROF test, MCV and MCH demonstrated a sensitivity rate of 100%. MI and MCH exhibited the highest specificity followed by NESTROF test in the screening of β-thalassemia trait. Conclusions The prevalence of hemoglobinopathies and G6PD deficiency appear to be common among Yemeni blood donors. These results emphasize the necessity of comprehensive blood donation screening programs to safeguard the blood supply and promote early detection and management of hemoglobinopathies and G6PD deficiency in Yemen.

Laboratory detection of donors implicated in transfusion-transmitted malaria.

Transfusion-transmitted malaria (TTM) is rare in non-endemic areas (non-EAs) but can potentially be fatal. This review analyzes the laboratory results of donors causing TTM in non-EAs, to assess the detectability of their Plasmodium infection by molecular or antibody tests. TTM cases in the United States, Canada, and Europe since 2010 were identified through a literature review. Authors and laboratories were contacted for missing details about sample types and laboratory methods. Results of Plasmodium polymerase chain reaction (PCR) and antibody tests were summarized. Twelve cases of TTM and one bone marrow transplant transmission were identified. Of the 13 source donors, 12 were tested by PCR, 10 were positive on at least one sample; the 2 negative donors were tested only on retained segments of blood refrigerated for several weeks. All donors were PCR positive on a fresh sample except one who was positive on a retained but not a fresh sample. These PCRs targeted Plasmodium DNA with sensitivities in the range of 1000-10,000 parasites/mL. Antibody EIA was positive in only three of seven donors tested. This review found that antibody EIAs failed to detect four of the seven TTM donors tested. DNA-based PCRs were able to detect Plasmodium infection in all donors tested except for two tested only on samples likely to have deteriorated from prolonged storage. Recently developed ribosomal RNA-based molecular donor screening assays are approximately 1000 fold more sensitive than these DNA-based PCRs, holding promise as a potential method to further reduce TTM.

Fecal Microbiota Transplantation: A Systematic Review of Therapeutic Potential, Preparation Techniques, and Delivery Methods Across Medical Conditions

Fecal microbiota transplantation (FMT) is revolutionizing the treatment of gastrointestinal disorders by leveraging the gut microbiome in innovative ways. This systematic review evaluates the clinical effectiveness and safety of FMT across various medical conditions, offering insights into its therapeutic potential and limitations. A comprehensive search of PubMed, Web of Science, Scopus, Embase, and ClinicalTrials.gov from January 2000 to December 2023 identified 97 relevant studies on FMT's efficacy, safety, and microbiome changes after eliminating duplicates. FMT has demonstrated high success rates, particularly in treating recurrent and refractory Clostridium difficile infections (CDI), with up to 90% effectiveness, establishing it as a primary treatment for antibiotic-resistant cases. FMT’s applications are expanding to inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, as well as metabolic disorders and neuropsychiatric conditions. Remission rates for IBD range from 37-45%, with outcomes influenced by donor characteristics, stool preparation, and disease subtype. with mild, self-limiting side effects such as transient diarrhea and abdominal cramping. However, rare serious adverse events underscore the need for rigorous donor screening and standardized preparation protocols to mitigate risks. FMT’s ability to restore healthy gut flora highlights its promise in both gastrointestinal and systemic disease management. However, further research is essential to establish optimized procedures, standardized guidelines, and long-term safety data to facilitate its integration into mainstream medical practice.

Fecal Microbiota Transplantation: Insights into Colon Carcinogenesis and Immune Regulation.

Colorectal cancer (CRC) constitutes a significant global health challenge, with recent studies underscoring the pivotal role of the gut microbiome in its pathogenesis and progression. Fecal microbiota transplantation (FMT) has emerged as a compelling therapeutic approach, offering the potential to modulate microbial composition and optimize treatment outcomes. Research suggests that specific bacterial strains are closely linked to CRC, influencing both its clinical management and therapeutic interventions. Moreover, the gut microbiome's impact on immunotherapy responsiveness heralds new avenues for personalized medicine. Despite the promise of FMT, safety concerns, particularly in immunocompromised individuals, remain a critical issue. Clinical outcomes vary widely, influenced by genetic predispositions and the specific transplantation methodologies employed. Additionally, rigorous donor selection and screening protocols are paramount to minimize risks and maximize therapeutic efficacy. The current body of literature advocates for the establishment of standardized protocols and further clinical trials to substantiate FMT's role in CRC management. As our understanding of the microbiome deepens, FMT is poised to become a cornerstone in CRC treatment, underscoring the imperative for continued research and clinical validation.

Infectivity of Hepatitis B Virus Surface Antigen-Positive Plasma With Undetectable HBV-DNA: Can HBsAg Screening Be Discontinued in Egyptian Blood Donors?

Hepatitis B Virus (HBV) infectivity data were reviewed and the 50% infectious dose (ID50) was reassessed in different HBsAg-positive infection stages enabling modelling of transfusion-transmitted (TT)-HBV infection risk if HBsAg donor screening was replaced by individual donation nucleic acid amplification technology (ID-NAT). Quantitative HBsAg and HBV-DNA assays were performed against international standards to compare the ratio between potential infectious HBV virions and subviral HBsAg particles in Egyptian HBsAg-positive blood donors as well as in Japanese chimpanzee samples of known infectivity. HBV-DNA load below the quantification limit of detection was estimated against a reference standard by replicate NAT testing (n = 25). Infectivity of chimpanzee samples collected during ramp-up and declining viremic phase were tested in a human liver chimeric mice (HLCM) model and compared with published infectivity data from different HBsAg-positive infection stages. Lowest estimates of ID50 in HBsAg-positive plasma were 3-6 HBV virions in chimpanzee studies. Infectivity decreased approximately 10-100-fold in the declining viremic phase using HLCM. In acute phase samples, HBV to HBsAg particle ratios varied between 1:102-104 but in HBsAg-positive blood donors this particle ratio reached 1:106-1012 when viral load was below 100 HBV-DNA copies/mL. Modelled TT-HBV risk of an HBsAg-positive/ID-NAT nonreactive blood transfusion was estimated at 5.5%-27% for components containing 20-200 mL of plasma when assuming an ID50 of 316 (point estimate between 100 and 1000) virions. It cannot be ensured that discontinuation of HBsAg donor screening and reliance on ID-NAT alone is safe.

Genomic characterization of clinically significant blood group variants in Aboriginal Australians.

Hematological disorders are often treated with blood transfusions. Many blood group antigens and variants are population-specific, and for patients with rare blood types, extensive donor screening is required to find suitable matches for transfusion. There is a scarcity of knowledge regarding blood group variants in Aboriginal Australian populations, despite a higher need for transfusion due to the higher prevalence of renal diseases and anemia. In this study, we applied next-generation sequencing and analysis to 245 samples obtained from Aboriginal Australians from South-East Queensland, to predict antigen phenotypes for 36 blood group systems. We report potential weak antigens in blood group systems RH, FY and JR that have potential clinical implications in transfusion and pregnancy settings. These include partial DIII type 4, weak D type 33, and Del RHD (IVS2-2delA). The rare Rh phenotypes D+ C+ E+ c- e+ and D+ C+ E+ c+ e- were also detected. The comprehensive analyses of blood group genetic variant profiles identified in this study will provide insight and an opportunity to improve Aboriginal health by aiding in the identification of appropriate blood products for population-specific transfusion needs.

Prevalence of HIV, Syphilis, and Hepatitis B and C Among Blood Donors in a Tertiary Care Hospital in Mexico

The prevalence of transfusion-transmissible infections (TTIs) among blood donors is critical for ensuring blood safety. Aim: To provide an updated assessment of TTIs at a tertiary care hospital in Mexico over a ten-year period. We conducted a retrospective cross-sectional study. Blood samples were analyzed from potential donors at tertiary care hospital between 2012 and 2022. Donors completed a questionnaire and were screened for HIV, syphilis, hepatitis B, and hepatitis C using nucleic acid testing and serological tests. Prevalence and trends were estimated. Among the 117,756 donors analyzed, 0.48% were positive for syphilis, with a significant annual decrease of −5.9% (p &lt; 0.001), although notable fluctuations occurred, including a peak in 2021. HIV showed a significant annual increase of 9.8% (p = 0.029), with a peak in approximately 2019–2020. Hepatitis C maintained a stable trend, with a slight annual decrease of −5.6% (p = 0.170). Hepatitis B consistently decreased, with an annual decrease of −11.3% (p = 0.06). This study highlights the importance of continuous monitoring and screening of blood donors to ensure blood safety. These findings underscore the need for localized public health interventions, particularly to address the increasing incidence of HIV. Further research should focus on enhancing donor screening practices and public health strategies to reduce the prevalence of TTIs.

Association of regular plasmapheresis donation with serum protein and electrolyte levels: a multicentre cross-sectional study in China

BackgroundChina’s plasmapheresis donation policy differs from that of Western countries. The association between regular plasmapheresis donation and donor health in China is still unknown.ObjectivesTo investigate the association of regular plasmapheresis...

Transfusion reaction patterns by blood component

Abstract Introduction/Objective Blood transfusion is becoming safer by continuous improvement of donor screening, patient identification, blood management, and infectious disease screening. This study was conducted to examine the rate and characteristics of transfusion reactions in the setting of universal leukoreduction of cellular products as well as pathogen reduction and/or irradiation of apheresis platelets. Methods/Case Report Data from the blood bank database for a 5-year period from 1/1/2019 to 12/31/2023 was collected. Transfusion reaction data as reported to National Healthcare Safety Network (NHSN) was analyzed. Results (if a Case Study enter NA) A total of 134,552 transfusions and 491 transfusion reactions were reported over the study period, resulting in the overall transfusion reaction rate of 0.36%. Allergic reaction was the most common reaction (38%), followed by febrile non-hemolytic transfusion reaction (FNHTR, 30%), delayed serologic transfusion reaction (DSTR, 14%), transfusion-associated circulatory overload (TACO, 10%), and transfusion-associated dyspnea (TAD, 4%). Platelets had the highest rate of transfusion reaction at 0.61% (n=167 of 27,180), red blood cells (RBC) at 0.35% (n=289 of 82,963), plasma at 0.13% (n=24 of 19,114), and cryoprecipitate at 0.06% (n=3 of 5295). The most common reaction associated with platelet transfusion was allergic reaction (64%, n=107), while FNHTR was the most common reaction associated with RBC transfusion (37%, n=106). By severity, 9 (2%) reactions were life-threatening, 21 (4%) were severe, 374 (75%) were non-severe, and 87 (18%) were not determined. Of life-threatening reactions, allergic reactions were the most common (5 of 9), while TACO was the most common severe reaction (9 of 21). Platelets were the most commonly implicated component in life- threatening reactions (4 allergic and 2 TACO), and RBCs were more commonly implicated in severe reactions. Conclusion Platelet transfusions were associated with a higher rate of transfusion reactions and life-threatening allergic reactions compared to other blood components.

From Bank Preparation to Clinical Use of Homologous Skin Allografts in Wound Healing: A Sustainable Approach.

Given progressive population ageing and the increase in the number of patients with comorbidities, the management of chronic and/or hard-to-heal wounds (HHWs) nowadays represents a common problem in many clinical settings. In these cases, standard strategies may not be sufficient. Autologous grafting represent the gold standard for permanent wound closure, but is almost never realized when the skin loss is extensive/the patient is young. The grafting of homologous skin/dermal tissue procured from cadaver donors (i.e., allografting) represents the best alternative, especially when the dermal component is lost. This request supports the activities of skin bank establishments (including donor screening, skin procurement, processing, storage, and distribution) that are regulated by specific guidelines and need to continuously meet quality standard requirements. The aim of this work is to both give specific insights of all the procedures implied in allograft preparation as well as an overview of their practical application in the treatment of different HHWs. The particular characteristics of each skin/dermal allograft released by Siena Skin Bank (cryopreserved/glycerol-preserved skin/de-epidermized dermis, acellular lyophilized de-epidermized dermis/reticular dermis) are also discussed. The exemplificative series of HHWs managed in the Dermatology Department of Siena were classified according their etiology into post-traumatic, vascular (arterial/venous/mixed/lymphatic), inflammatory, surgical, and heat/chemical burns. Globally, the clinical advantages obtained include: acceleration of healing process, pain sparing, resistance to bacterial contamination, dermal regeneration (instead of scarring), and better aesthetic-functional outcome.

Risk and benefits of expanded donor screening: A viewpoint from Germany.

This review describes the risks and benefits of expanding screening for transmissible pathogens in deceased organ donors. The focus is on the experience and procedure in Germany to make a decision on how to proceed with a possible donor. Three issues are of interest in how screening policies impact the process with the aim of mitigating unexpected transmission risks: (1) Should we add universal or targeted nucleic acid testing to serological tests for common blood-borne viruses (BBVs; HIV, HBV, and HCV)? (2) Which tests should be added for screening in a geographically restricted region beyond testing for these BBVs? (3) Being faced with changes (e.g., climate and population) in the own geographically restricted region, what strategies are needed before implementing new tests, and which considerations apply for proper indication to do this? Testing may only be effective when during donor characterization the appropriate conclusions are drawn from the existing findings and screening tests are initiated. This statement overlaps the need to implement universal screening for a pathogen or targeted screening based on the risk that the donor has acquired the transmissible pathogen or is not as possible to identify by current methods of clinical judgment and/or specific tests.

B-099 Validation and Clinical Implementation of Organ Procurement Serology Testing: Our Analytical and Regulatory Experience in Implementing a New Donor Testing Program

Abstract Background The Mount Sinai Hospital recently implemented a comprehensive organ donor testing program to service the clinical needs of transplant services in the New York City metro area. Conventional serology testing is not approved by the FDA for donor testing. To support this program, the MSH Chemistry Laboratory implemented and validated a comprehensive donor testing panel on the Abbott Alinity S donor testing platform. We validated donor serology testing for the following assays: HIV-1/2 (HIV), Anti-Hepatitis B Core (Anti-HBc), Hepatitis B Surface Antigen (HBsAg), Human T-lymphotropic virus I and II (HTLV-I/II), Anti-Hepatitis C (Anti-HCV), and Trypanosoma cruzi antibodies (T.Cruzi). The Alinity S System is an automated immunoassay-based analyzer FDA-approved for donor testing. The analyzer consists of two distinct sample ‘paths’ and is effectively two instruments combined in one analyzer. The analyzer is approved for use in living donor serum and plasma and in cadaveric serum. Prior to going live, we found that there was limited guidance on laboratory quality assurance programs related to donor testing. In addition to confirming assay analytical performance, we designed and implemented a comprehensive quality assurance program prior to satisfy compliance with regulatory guidelines, addressing proficiency compliance, sample TAT, and control ranges, amongst other quality indicators. Methods Inter and Intraday precision was assessed through replicate analysis of positive and negative controls, where 10 replicates of both controls were assayed on a single day, and one replicate of each control was assayed daily for 7 distinct days, results were represented as %CV. Result accuracy was assessed through split sample analysis of known serologically positive (n=20) and negative samples (n=40). Each sample was assayed on two distinct lots of reagents, each with its own unique calibration curve. Accuracy was confirmed in both living donor (n=30), and cadaveric samples (n=10). In addition, split sample analysis was performed between the Alinity S and FDA-approved donor testing assays in a reference laboratory (N=7). A carryover study was performed through the analysis of triplicate replicates of low, high, and then low controls. These analyses were performed for all 6 assays. Results Intraday precision using assay general controls afforded the following %CV: HIV: 3.1%, 6.5%; Anti-HBc: 1.3%, 2.6%; Anti-HCV: 3.3%, 11.7%; HTLV-I,II: 2.5%, 5.9%; T.Cruzi: 2.8%, 0%; HBsAg: 3.2%, 11.6%. Interday precision yielded the following in %CV: HIV: 2.9%, 10.0%; Anti-HBc: 3.0%, 5.6%; Anti-HCV: 3.3%, 3.4%; HTLV-I,II: 2.8%, 4.6%; T.Cruzi: 2.4%, 0%; HBsAg: 4.7%, 7.8%. Accuracy studies yielded 100% positive and negative correlation for all 6 assays in both living donor and cadaveric samples. In addition, there was a 100% serological correlation for samples compared to reference laboratories. Carryover studies showed no evidence of sample carryover. Conclusions The Abbott Alinity S shows acceptable assay precision on all 6 validated assays. The assays are serologically accurate in both cadaveric and living donor samples. As such, the assays and platform are acceptable for use in donor screening. We designed a unique quality assurance program including a comprehensive self-proficiency and instrument crosscheck program to ensure analyzer accuracy, as well as adherence to regulatory guidelines.