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Currently, stem cell donor registries include more than 35 million potential donors worldwide to provide HLA‐matched stem cell products for patients in need of an unrelated donor transplant. DKMS is a leading stem cell donor registry with more than 9 million donors from Germany, Poland, the United States, the United Kingdom, India and Chile. DKMS donors have donated hematopoietic stem cells more than 80,000 times. Many aspects of donor registry work are closely related to topics from immunogenetics or population genetics. In this two‐part review article, we describe, analyse and discuss these areas of donor registry work by using the example of DKMS. Part 1 of the review gives a general overview on DKMS and includes typical donor registry activities with special focus on the HLA system: high‐throughput HLA typing of potential stem cell donors, HLA haplotype frequencies and resulting matching probabilities, and donor file optimization with regard to HLA diversity.

A catalog of common, intermediate and well-documented (CIWD) HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5, -DQB1 and -DPB1 alleles has been compiled from over 8 million individuals using data from 20 unrelated hematopoietic stem cell volunteer donor registries. Individuals are divided into seven geographic/ancestral/ethnic groups and data are summarized for each group and for the total population. P (two-field) and G group assignments are divided into one of four frequency categories: common (>= 1 in 10 000), intermediate (>= 1 in 100 000), well-documented (>= 5 occurrences) or not-CIWD. Overall 26% of alleles in IPD-IMGT/HLA version 3.31.0 at P group resolution fall into the three CIWD categories. The two-field catalog includes 18% (n = 545) common, 17% (n = 513) intermediate, and 65% (n = 1997) well-documented alleles. Full-field allele frequency data are provided but are limited in value by the variations in resolution used by the registries. A recommended CIWD list is based on the most frequent category in the total or any of the seven geographic/ancestral/ethnic groups. Data are also provided so users can compile a catalog specific to the population groups that they serve. Comparisons are made to three previous CWD reports representing more limited population groups. This catalog, CIWD version 3.0.0, is a step closer to the collection of global HLA frequencies and to a clearer view of HLA diversity in the human population as a whole.

Introduction: Although CDC has been the gold standard for many years, this assay is certainly not perfect and its use is associated with several problems. The Luminex anti-HLA antibody detection assay is reportedly more sensitive and specific. One of the test is Luminex DSA cross match which is more sensitive than CDC cross match. It is also considered cost effective tool to evaluate pre and post renal transplant cases. Material and Methods: We started Luminex based Donor specific antibody Cross Match tests (DSA Xm) with lysate by the end of 2009 along with CDC after standardization. This study is planned to evaluate the results of DSA Xm of last three years & also to observe antibody medicated rejections after renal transplant. Results: Total 3137 Luminex DSA Cross Match tests were done & 515 tests were positive cross match with negative CDC xm result. Out of 515 positive results 164 were positive for class I, 223 were positive for class II and 128 were positive for both class I & II. In the three years total 1129 renal transplants were done at various centers and total 42 cases of Antibody medicated rejections were reported. Out of 42 patients, 36 patients had pre transplant history of CDC negative & Luminex DSA xm positive. Conclusion: We evaluated our three year results of DSA Xm test and found a cost effective, sensitive and useful supplementary test to evaluate pre and post renal transplant cases.

Background: Platelet additive solutions (PAS) are crystalloid nutrient media used in place of plasma for platelet storage. They replace 60%–70% of plasma in platelet components, so the amount of storage plasma can be decreased. Platelets in PAS have lower risk for allergic transfusion reactions with equivalent clinical efficacy for controlling bleeding. Aim: The aim of this study is to evaluate the clinical and laboratory efficacy of PAS-platelets. Materials and Methods: A total of 1674 single donor platelet (SDP) were collected in PAS in the month of June to September 2016 by different apheresis systems. The quality control tests were done on 356 units in 4 months. Total number of SDP were processed with Amicus device (n = 232), Trima Accel (n = 84), and MCS+ (n = 40). The parameters analyzed were antibody titer of anti-A and anti-B, volume, platelet count, pH, bacterial contamination, and reporting of adverse transfusion reaction. Antibody titers were checked by tube technique, and platelet counts were checked by hematology analyzer Sysmex poch 100i. The swirling was checked manually, and pH was checked with pH strips. Results: Out of 356, 164 units were O group, 113 units were B group, 68 units were of A group, and the remaining 11 units were of AB Group. Anti-A and anti-B titer was significantly reduced in PAS-SDP and found 1:32 or less for all the units. All the units found negative for bacterial contamination. No transfusion reaction was reported of the units transfused. All other quality parameters for platelets also found satisfactory after implementing the additive solution. Conclusion: The ABO antibody titers were significantly reduced after addition of PAS. This facilitates the ABO incompatible SDP transfusion and helps in inventory management. The risk of allergic transfusion reaction decreases after reducing the amount of plasma from SDP units. Using PAS-SDP certainly improve the inventory management for platelets with no compromise on clinical and laboratory efficacy.

Background: It is well-known that alloimmunization to red blood cell antigens resulting from the genetic disparities between donor and recipient is one of the risks of blood transfusion. The antibody screening cells are used to detect unexpected antibodies. The risk of alloimmunization is higher in patients who have received multiple blood transfusions such as thalassemia, other hematological disorders, renal failure patients on dialysis who receive blood transfusions, and females with bad obstetric history. Antibody screening test using 2–3 cells panel is not a mandatory pretransfusion testing in India and is performed routinely in limited blood centers. Materials and Methods: This bicentric study has been carried out to look at prevalence of antibodies in multi-transfused patients who have higher risks of alloimmunization such as patients who have received multiple blood transfusions such as thalassemia, other hematological disorders, renal failure patients on dialysis who receive blood transfusions, and females with bad obstetric history in the North as well as South India. The study was conducted at two blood centers, one regional blood transfusion of North India and one at South India. Totally, 4569 cases were analyzed and 258 patients were selected for antibody screening and identification. Results: Of total 4569 patients, 258 multi-transfused patients were studied. Among these, seven patients (2.71%) were found alloimmunized. The risk of alloimmunization was 2.90% in thalassemia, 0% in chronic renal failure patients, 3.77% in pregnant females with bad obstetric history, and 2.78% in other multi-transfused patients like cancer. Discussion: Regular monitoring through antibody screening and transfusion of blood matched for minor erythrocyte antigens are recommended in these patients.

Human Leukocyte Antigen (HLA) encoding genes are part of the major histocompatibility complex (MHC) on human chromosome 6. This region is one of the most polymorphic regions in the human genome. Prior knowledge of HLA allelic polymorphisms is clinically important for matching donor and recipient during organ/tissue transplantation. HLA allelic information is also useful in predicting immune responses to various infectious diseases, genetic disorders and autoimmune conditions. India harbors over a billion people and its population is untapped for HLA allelic diversity. In this study, we explored and compared three HLA typing methods for South Indian population, using Sequence-Specific Primers (SSP), NGS (Roche/454) and single- molecule sequencing (PacBio RS II) platforms. Over 1020 DNA samples were typed at low resolution using SSP method to determine the major HLA alleles within the South Indian population. These studies were followed up with medium resolution HLA typing of 80 samples based on exonic sequences on the Roche/454 sequencing system and high-resolution (6-8 digit) typing of 8 samples for HLA alleles of class I genes (HLA-A, B and C) and class II genes (HLA-DRB1 and DQB1) using PacBio RS II platform. The long reads delivered by SMRT technology, covered the full-length class I and class II genes/alleles in contiguous reads including untranslated regions, exons and introns, which provided phased SNP information. We have identified three novel alleles from PacBio data that were verified by Roche 454 sequencing. This is the first case study of HLA typing using second and third generation NGS technologies for an Indian population. The PacBio platform is a promising platform for large-scale HLA typing for establishing an HLA database for the untapped ethnic populations of India.

SUMMARY Informing blood donors about their reactive test results of viral transfusion transmissible infections (TTI) is an important aspect of donor care. Rotary Bangalore TTK Blood Bank offers counseling and referrals to donors to enable them to avail of timely treatment options. Recognizing that donor disclosure is an important public health issue that especially impacts blood safety, we started a program for donor disclosure, counseling and referrals. The number of enzyme-linked immunosorbent assay reactive units in our blood bank in 2007 and 2008 were 0.78% [hepatitis B virus (HBV)], 0.12% [human immunodeficiency virus (HIV)], 0.18% [hepatitis C virus (HCV)], and 0.73% (HBV), 0.16% (HIV) and 0.18% (HCV), respectively. The reactive donors were informed of their test results and called for counseling. Overall, 41.18% and 48.17% of HBV reactive donors attended counseling in 2007 and 2008, respectively. Only 11.11% and 16.22% of HIV reactive donors attending counseling in 2007 and 2008, respectively. The HCV reactive donors who attended counseling were 14.63% for both years. All reactive donors who attended counseling were referred to gastroenterologist or physician for confirmatory testing and further management. This study describes our experiences in counseling donors who were enzyme-linked immunosorbent assay reactive for viral TTI, and challenges faced in implementing the donor disclosure program in a resource-limited environment.

Routinely, Immunohematology Reference Testing Center receives samples with blood group discrepancy, presence of allo/autoantibodies, positive direct antiglobulin test (DAT), etc. We are presenting a case in which we not only resolved blood group discrepancy but also identified multiple alloantibodies reacting at different phases. A tricenarian female patient was diagnosed with chronic anemia with hemoglobin level below 7 g/dl. The patient had a history of blood transfusion and pregnancy as well. On blood grouping, the patient's forward grouping was “AB” and reverse was “O.” Indirect antiglobulin test was found to be positive while DAT and autocontrol were negative. After complete investigation, patient blood group was confirmed to be subgroup of AB along with anti-A1 antibody. Furthermore, a cold-reacting alloantibody with high thermal amplitude was detected along with one warm-reacting alloantibody.

Introduction: Karnataka state has a total of 176 blood banks, with a total collection of around 650,000 units annually. From January 2014, all units under the Department of Health and Family Welfare services are tested at NAT Lab established at the Central facility and from September 2014, standalone Regional Blood Transfusion Centre was included in the State Government project. Aim and Objective: The aim of the study is to analyze the nucleic acid testing (NAT) for our donor population and demonstrate consolidation of blood transfusion service through a centralized testing center for NAT and also to assess safety benefits of implementing individual donor NAT (IDNAT). Materials and Methods: We collect nearly 40,000 units annually from voluntary donors with 30% repeat donations. The donors undergo strict predonation counseling, donor questionnaire, and medical examination. The units collected are tested for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) by ECI using VItros 3600. All the units are tested by NAT at Central NAT Lab, screened by Procleix® Panther System by Grifols. Results: From September 2014 to March 2016, total 50,903 samples tested for NAT. Of 50,903 samples, 588 samples (1.15%) were reactive by Chemiluminescence including 265 for HBV, 188 for HCV, and 135 for HIV. Total NAT reactive samples were 254, out of this 11 reactive for HIV-1 (0.02%), 2 reactive for HCV (0.003%), 235 (0.46%) reactive for HBV. There was one HIV and 10 HBV infection cases that were not detected by serology but reactive by NAT. The yield detected is 0.021% or one in 5000. Conclusion: The IDNAT project has helped in preventing window period infections thus reducing the treatment cost and burden on healthcare. It has added benefits in blood safety and should be considered along with the basic quality assured blood transfusion system such as volunteer base for blood donation, provision of donor self-deferral, donor notification, and quality assured sensitive serological methods.

We performed a study of hepatitis B virus (HBV) risk factors among blood donors in Bangalore, India.HBV infection is prevalent in India and poses a potential risk of transmission by blood transfusion, but studies of risk factors for hepatitis B surface antigen (HBsAg) carriage among Indian blood donors are lacking.Using a case-cohort design, we enrolled 71 cases with repeatedly reactive HBsAg results and a cohort of 212 contemporaneous blood donors with unknown HBsAg status. Questionnaire data were analysed using multivariable logistic regression.In our multivariate analysis controlling for age, HBsAg positivity was associated with repeat donor status (OR = 0·34, 95% CI 0·17-0·71 vs first-time donor status), residence outside Bangalore and Hosur (rural areas) (OR = 15·66, 95% CI 3·60-68·07vs Bangalore residence), having been a customer at a local barber shop (OR = 4·07, 95% CI 2·06-8·03), close contact with a person who had jaundice (OR = 13·64, 95% CI 3·71-50·24) and cigarette smoking (OR = 3·25, 95% CI 1·39-7·60).In addition to recognised demographic risk factors, associations with patronage of local barbers and contact with jaundiced individuals suggest behavioural risk factors that could be adopted as exclusionary criteria for blood donation in India.

Objectives: To estimate HIV and sexually transmitted infection (STI) prevalence within the general population of Mysore district, and to examine differences in the distribution of risk factors associated with HIV prevalence stratified by sex. Methods: A community-based study was conducted in Mysore, Karnataka state, southern India, between October 2005 and November 2006; final sample size 4653. A face-to-face interview was conducted, and blood and urine specimens collected to measure HIV and STI prevalences. Risk factors for HIV among men and women were examined using weighted and clustered logistic regression. Results: Weighted HIV prevalence was 0.8% [95% confidence interval (CI) 0.52‐1.09] overall and 0.7% (0.35‐1.08) and 0.9% (0.51‐1.37) in rural and urban populations, respectively. The prevalence of syphilis, gonorrhoea and chlamydial infection was 2.8% for menand 1.8% for women. In multivariateanalysis, higher HIV prevalencewas associated with ever having used a condom [odds ratio (OR) 2.75, 95% CI 1.01‐7.47] and number of lifetime partners for men (OR 6.9, 95% CI 2.18‐21.91).For women, HIV infection was associated with condom use at last sexual intercourse (OR 10.51, 95% CI 2.05‐53.79), number of lifetime partners and reporting ‘don’t know’ for whether ever had anal sex (OR 9.10, 95% CI 1.14‐72.34). Conclusions: HIV prevalence in the general population of Mysore was found to be comparable to recent prevalence estimates for Karnataka state, and also similar to recent prevalence estimates from antenatal clinic attenders for the district. Few modifiable risk factors for HIV infection were identified. There is evidence from this study that high-risk behaviour may have been underreported, but the prevalence of STI was generally low.

Aim Comparison of new Luminex cross match method with classical method of leukocyte cross match i.e. complement dependent cytotoxicity. Material & method Total 60 living related renal transplant cases were included in the study. All samples were tested for CDC as well as Luminex DSA cross match using donor lysate. The kits used were Gen Probe (Gen Probe transplantation diagnostics, Inc., 550 West Avenue, Stamford, CT 06902). In CDC cross match less than 20% cell lysis was considered negative & Luminex cross match mean fluorescence values (MFI) 1000 was considered negative for class I & II each. All the patients were followed up after 3 months. Result Out of 60 cases, 45 were negative for CDC as well as for Luminex DSA cross match class I & II. One case was found positive (MFI value was 16,165 & 13,219 for class I & II) for both & transplant not done. In 14 cases CDC was negative but Luminex crossmatch was positive. Out of 14, nine patients transplanted, no acute rejection reported. One patient died due to cardiac arrest. All 8 patients followed up after 3 months. In three patients creatinine was found abnormal between 3 and 4. When these patient’s pre transplant test records were checked, two of the patients were class II positive DSA with MFI of 7372 & 4317 and one patient was class I positive with MFI value 6322. Rest other cases found clinical good with normal serum creatinine value less than one. Conclusion CDC cross match found less sensitive than Luminex cross match. It came positive when Luminex MFI values were more than 10,000. Three out of 8 cases which were positive for either class I or II by Luminex cross match but negative CDC cross match have high creatinine value but no clinical sign of rejection within 3 months of transplant. Luminex DSA cross match using donor lysate more sensitive than CDC cross match, therefore could be a better & cost effective pre transplant testing in India where pre transplant tests are very limited and donor specific antibodies are not identified because of cost & resource constrain.

To better plan recruitment of volunteer adult unrelated donors for a registry and umbilical cord blood donations for cord banks to supply grafts for hematopoietic cell transplantation to serve Indian transplant candidate patients, we analyzed existing HLA typing data to estimate Indian national and regional populations’ HLA haplotype frequencies. Indian BMT centers, renal transplant centers, adult donor registries and cord blood banks collaborated to collect HLA typing and demographic data. We have produced a catalogue of the frequency, and regional diversity, of HLA haplotypes in the Indian population. Haplotype frequency analysis was performed on the registry datasets (N=26,239) using a maximum-likelihood method capable of providing high-resolution estimates from typing data with ambiguities. These frequencies were generated for 20 regional subgroups into cohorts defined by either geographic state or by native language; and the 14 largest groups were used to develop a computational model of match rates. Patient family typing data was used to set phase for a group of N=485 patients that was used to run searches against the NMDP registry. The match rates for Indian patients searching the NMDP USA database (over 11 million donors including DKMS) were 39.7% at the 8/8 allele level (A, B, C, DRB1 high-resolution) and 92.2% at the 7/8 level. Matching models for patients (averaged across the 14 regional subgroups) showed a match rate within India at the current registry sizes of 13.7% at the 8/8 level and 38.2% at the 7/8 level. Increasing the registry to 1,000,000 would raise this to 55.0% for 8/8 and 84.1% for 7/8. A cord blood inventory of 50,000 units would provide a match rate of 22.2% at the 6/6 level and 78.9% at the 5/6 level. Increasing to a cord blood inventory of 250,000 units would increase these match rates to 42.5% at the 6/6 level and 90.3% at the 5/6 level. These data will define the needs and serve as critical planning data to define and direct donor recruitment goals to establish an effective Donor Registry and cord blood banking facilities able to serve the needs of Indian patients who could benefit from the curative potential of transplantation. Developed data will be shared with the broader scientific community to facilitate future studies of HLA in areas such as disease association, anthropology and transplantation. Disclosures: Joshi: Manipal Hospital, Bangalore: Employment. Damodar:NARAYAN HRUDAYALAYA: Employment. Cereb:Histogenetics: Employment. Young Yang:Histogenetics: Employment. Dedhia:Marrow Donor Registry (India): Employment.