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Background and Objectives: Malaria continues to be a significant public health concern in India, with several regions experiencing endemicity and sporadic outbreaks. The prevalence of malaria in blood donors, in India, varies between 0.02% and 0.07%. Common techniques to screen for malaria, in blood donors and patients, include microscopic smear examination and rapid diagnostic tests (RDTs) based on antigen detection. The aim of this study was to evaluate a new fully automated analyser, XN‐31, for malaria detection, as compared with current practice of using RDT. Materials and Methods: Cross‐sectional analytical study was conducted to evaluate clinical sensitivity and specificity of new automated analyser XN‐31 among blood donors' samples and clinical samples (patients with suspicion of malaria) from outpatient clinic collected over between July 2021 and October 2022. No additional sample was drawn from blood donor or patient. All blood donors and patients' samples were processed by malaria rapid diagnostic test, thick‐smear microscopy (MIC) and the haematology analyser XN‐31. Any donor blood unit incriminated for malaria was discarded. Laboratory diagnosis using MIC was considered the 'gold standard' in the present study. Clinical sensitivity and specificity of XN‐31 were compared with the gold standard. Results: Fife thousand and five donor samples and 82 diagnostic samples were evaluated. While the clinical sensitivity and specificity for donor samples were 100%, they were 72.7% and 100% for diagnostic samples. Conclusion: Automated haematology analysers represent a promising solution, as they can deliver speedy and sensitive donor malaria screening assessments. This method also has the potential to be used for pre‐transfusion malaria screening along with haemoglobin estimation. [ABSTRACT FROM AUTHOR]

"In solid organ transplantation, the compatibility between recipient and donor relies on testing prior to transplantation as a major determinant for the successful transplant outcomes. This compatibility testing depends on the detection of donor-specific antibodies (DSAs) present in the recipient. Indeed, sensitized transplant candidates are at higher risk of allograft rejection and graft loss compared to non-sensitized individuals. Most of the laboratories in India have adopted test algorithms for the appropriate risk stratification of transplants, namely: 1) donor cell-based flow-cytometric cross-match (FCXM) assay with patient's serum to detect DSAs; 2) HLA-coated beads to detect anti-HLA antibodies; and 3) complement-dependent cytotoxicity crossmatch (CDCXM) with donor cells to detect cytotoxic antibodies. In the risk stratification strategy, laboratories generally accept a DSA median fluorescence index (MFI) of 1000 MFI or lower MFI (low-MFl) as a negative value and clear the patient for the transplant. We present two cases of live-related donor kidney transplants (LDKTs) with low-MFI pretransplant DSA values who experienced an early acute antibody-mediated rejection (ABMR) as a result of an anamnestic antibody response by DSA against HLA class II antibodies. These results were confirmed by retesting of both pre-transplant and post-transplant archived sera from patients and freshly obtained donor cells. Our examples indicate a possible ABMR in patients with low MFI pre-transplant DSA. Reclassification of low vs. highrisk may be appropriate for sensitized patients with low-MFI DSA.". [ABSTRACT FROM AUTHOR]

Background and Objectives: Blood transfusions are frequently prescribed for acute and chronic conditions. When transfused judiciously, blood can save life and improve the health of the patient(s). However, transfusion of blood and blood components is never risk-free. Despite this, transfusion consent may not be obtained satisfactorily. We assessed the knowledge of patients about their blood transfusion and consenting process and the impact of structured information on their knowledge. Methods: A cross-sectional qualitative study design was employed. The study included all consenting adult patients who were intended recipients of red blood cell transfusion. Patient information sheet (PIS) along with pre- and postquestionnaire was administered to study patients. Results: Our study examined patients "knowledge and their attitude" about blood transfusion and recalling of their decision on consenting to transfusion. For the reason of being transfused, 58.5% were not aware, while 73% were unaware about the benefits of blood transfusion. Similarly, 85.5% were unaware about the risk of blood transfusion. There was a lack of knowledge about the "alternative option" of blood transfusion. Our findings also suggest that a standardized informed consent process was not being carried out. Conclusion: There is a need for strengthening IEC in the blood transfusion process. The present study has highlighted the role of printed/written information (PIS) in the native language and in imparting knowledge in the context of blood transfusion. [ABSTRACT FROM AUTHOR]

The International Society of Blood Transfusion (ISBT) 128 is an internationally endorsed, electronically readable labeling standard that provides a convenient and accurate means of identification, traceability, publication, and storage of information for blood and blood products. The authors' center recently registered with the International Council for Commonality in Blood Banking Automation (ICCBBA) and progressed to ISBT 128 labeling standard. This manuscript was written with the objective of sharing the authors' experience with respect to the implementation of ISBT 128 standards for whole blood donations and integration of ISBT 128 standards with Indian licensing regulations. The authors explore the process of implementation of ISBT 128 standards through a step-by-step journey that included facility registration with International Council for Commonality in Blood Banking Automation (ICCBBA), allotment of facility identification number, development of four-quadrant label for blood components, and integration of local regulatory requirements in the final "composite" label. Acknowledging the lack of any published report from India on ISBT 128 standards implementation, the authors wish to attempt help their peers in understanding and implementation of this global standard at their respective facilities. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES: Enumeration of hematopoietic progenitor cell (HPC) is vital to decide the time to initiate harvest (TTIH) and adequacy of harvest dose (AOHD). Standard of care used for HPC enumeration is flowcytometric CD34+ enumeration, but it is expensive, time-consuming and requires skilled staff to perform the test. Alternatively, HPC-count by advanced automated cell analyzer is cheaper, quicker, and easy-to-perform test. Our objective was to find a correlation of HPC count with CD34+ enumeration in leukapheresis. MATERIALS AND METHODS: An observational, prospective study was conducted in the year 2018-2019. A total of 126 samples were included in the study, the peripheral blood (PB) group comprised of 42samples and apheresis group of 84 samples. The samples were simultaneously tested for CD34+ expression and complete blood count which included the HPC count, white blood cells (WBC) count and multinational corporation (MNC) count and correlation analysis was performed with CD34+ flowcytometric count. The cut-off of PB HPC count for the target dose of 5 x 106 CD34+ cells/kg was established using Receiver Operator Curve. RESULTS: The correlation coefficient (r) of HPC with CD34+ count was 0.617 and 0.699 for PB group and apheresis group sample respectively, which was statistically significant. The correlation with MNC and WBC count was not very significant. A cut-off value of PB HPC was established to be 66 HPC/µl with a positive predictive value of 94.12%. The cost of CD34 + flow cytometric enumeration was six times that of HPC enumeration by analyzer. CONCLUSION: The HPC count is a cheaper, rapid and easy test and can be clinically applied to predict TTIH and AOHD but requires more studies to validate its efficacy in clinical use. [ABSTRACT FROM AUTHOR]

INTRODUCTION: HIV fourth-generation assay, designed for the detection of HIV p24 antigen along with anti-HIV antibodies of both immunoglobulin M and immunoglobulin G type against HIV 1 and HIV 2 viral antigens, have helped in the early detection of HIV infection and supports in minimizing the transmission risk in the acute phase of infection. The objective of this study was to evaluate the analytical and clinical performance of HIV fourth-generation assay based on enhanced chemiluminescence technology. MATERIALS AND METHODS: The analytical performance of the assay was evaluated in terms of accuracy, precision, limit of detection, type of sample (serum vs. plasma), cross-reactivity (with other transfusion transmissible infections markers), and interference (with endogenous substances). Proficiency control material included kit-controls, archived known positive donor samples, third-party controls, and World Health Organization (WHO)/National Institute for Biological Standards and Controls (NIBSC, MHRA, UK) controls. The clinical performance was evaluated using routine donor and patient samples received during the study period. RESULTS: HIV fourth-generation assay showed reliable and reproducible results measured in terms of coefficient of variation % with kit-controls, archived known positive donor samples, third-party controls, and WHO international standards for anti-HIV 1 and 2 antibodies, HIV1 p24 antigens and HIV2 p26 antigen controls. The analytical sensitivity of the HIV fourth-generation assay was found to be 0.1 IU/mL of HIV1 p24 antigen control and there was no cross-reactivity or interference observed. In the clinical performance of the assay, HIV fourth-generation assay showed reliable performance in both donor and patient samples. CONCLUSION: HIV fourth-generation assay meets the requirements for its use as a screening assay for HIV infection based on the analytical and clinical performance of the assay. [ABSTRACT FROM AUTHOR]

Background: The requirement for the mutation analysis for Kirsten rat sarcoma viral oncogene (KRAS) in colorectal cancer (CRC) is rapidly increasing as it is a predictive biomarker and also, its absence signifies response to anti-epidermal growth factor receptor (anti-EGFR) antibody treatment. The aim of our study was to investigate the pathological diagnosis and distribution of KRAS mutations in colorectal cancer with the use of next generation sequencing platform (Ion Torrent).Methods: A total of 56 CRC samples were tested to identify the genetic mutations, especially KRAS using the primers which included ~2800 COSMIC mutations of 50 oncogenes. Ion Torrent personal genome machine (semiconductor-based sequencing) was used for the sequencing and analysis. Along with KRAS, other 49 genes were also studied for COSMIC mutations.Results: KRAS mutation 25 (44.6%) had the highest frequency, followed by TP53 10 (17.9%) and PIK3CA mutation 4 (7.1%). Of all the KRAS mutations identified, mutations in codon 12 were most frequent followed by mutations in codon 13 and 61. The most frequent substitution was glycine to aspartate mutation in codon 12 (p.Gly12Asp) followed by glycine to valine (p.Gly12Val). Combinations of mutations were also studied. Our study revealed that seven cases (12.5%) had both KRAS and TP53 mutations (highest of all the combinations).Conclusion: The analysis of KRAS mutation frequency and its mutational subtype analysis in human CRCs by using semiconductor-based platform in routine clinical practices have been performed in Indian population. The findings were similar to earlier published reports from the Western literature. [ABSTRACT FROM AUTHOR]

BACKGROUND: Therapeutic plasma exchange (TPE) has been advocated as an adjunct to steroids and cytotoxic drugs in treating patients suffering from vasculitis and presenting with active disease, but we still have insufficient evidence on its effectiveness in improving the clinical response, especially in India. This study was planned to study the clinical outcome in severe vasculitic presentations treated with TPE as an adjunctive therapy. MATERIALS AND METHODS: A retrospective analysis of TPE procedures performed from July 2013 to July 2017 in the department of transfusion medicine at a large tertiary care hospital was done. All consecutive patients admitted with new diagnosis of systemic vasculitis presenting with active disease and severe presentations such as advanced renal failure or severe respiratory abnormalities or life-threatening vasculitis affecting the gastrointestinal tract, neurological and musculoskeletal system; who needed TPE for removal of preformed antibodies, were included in the study. RESULTS: There were a total of 31 patients in whom TPE was performed for severe systemic vasculitis; 26 adults and five pediatric. Six patients tested positive for perinuclear fluorescence, 13 for cytoplasmic fluorescence (cANCA), two for atypical antineutrophil cytoplasmic autoantibody, seven for anti-glomerular basement membrane antibodies, two for antinuclear antibodies (ANA), and one patient tested positive for ANA as well as cANCA before the augmentation of TPE. Out of 31, seven patients showed no clinical improvement and succumbed to the disease. At the end of desired number of procedures, 19 tested negative and five tested weak positive for their respective antibodies. CONCLUSION: Favorable clinical outcomes were observed with TPE in patients with antibody-positive systemic vasculitis. [ABSTRACT FROM AUTHOR]

Background and Objectives: COVID-19 has infected and caused the deaths of millions of people globally with India being the second most affected country in the world. The primary objective of the study was to determine the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) antibodies in healthy blood donors in North India. The secondary objective of the study was to find the association of vaccination and infection with seropositivity in the blood donors. Methods: All blood donor samples were screened for the presence of IgG antibodies against SARS CoV2 spike (S1) protein. Anti-SARS CoV2 IgG antibody status, demographic data, history of past COVID infection, and vaccination of all eligible donors in the study period were collected. Seroprevalence was calculated as the percentage of total number of donors positive for anti-SARS CoV2 IgG antibodies. Month-wise seroprevalence was also calculated and analyzed. Results: Out of 1456 donors, 874 were found to be seropositive, resulting in a seroprevalence of 60%. Seroprevalence was found to be 38.3% and 77%, respectively, in the months of April and May 21. Seropositivity was 100%, 92%, 79%, and 54% in those with a history of both COVID infection and vaccination, vaccination only, infection only, and no history of vaccination or infection, respectively. Conclusion: Blood donors represent an easy access to seroprevalence studies and need to be tapped at the national level to obtain a temporal picture of the COVID-19 situation to guide healthcare policies, mark regions where vaccination drives need to be intensified. [ABSTRACT FROM AUTHOR]

BACKGROUND: In clinical practice, laboratory results are of great importance for the diagnosis and treatment. Reference intervals of different parameters aid health-care professionals in the interpretation of results. There are very few studies on reference intervals from India. This prospective study was conducted to determine the reference intervals for platelet count (PLT) and PLT indices; mean PLT volume (MPV), PLT distribution width (PDW), and PLT large cell ratio (P-LCR). These values can be obtained as a part of a routine complete blood count (CBC) and have diagnostic and prognostic significance in certain diseases. PLT count is an important criterion for the selection of donors for repeat plateletpheresis donation. MATERIALS AND METHODS: Sixteen hundred and thirty-four first-time healthy volunteer plateletpheresis donors were enrolled for the study. CBC was done, values of PLT, MPV, PDW, and P-LCR were noted, and the results were analyzed. The 95% of the reference distribution was estimated using the 2.5th and 97.5th percentiles following Clinical and Laboratory Standards Institute guidelines. Adverse donor reactions, if any and quality parameters of single donor PLTs (SDP) were also studied. RESULTS: Reference range values of PLT, MPV, PDW, and P-LCR were 137,825–355,175/μl, 8.1–13.9/fl, 9.1–22.5/fl, and 11.7%–52.9%, respectively, and compared well with other published studies from India. It was observed that reference values of PLT count obtained in the study were lower than reference values that are currently used in most laboratories (150,000–450,000/μl) in India. CONCLUSION: Based on our results, we are of the opinion that the PLT count cutoffs for repeat plateletpheresis donation may need to be revised downwards for our country which would also mitigate the scarcity of apheresis donors. [ABSTRACT FROM AUTHOR]

BACKGROUND: Human leukocyte antigen (HLA) is a major determinant in deciding upon solid organ histocompatibility. Donor-specific anti-HLA antibodies (Donor-specific anti-HLA antibodies (DSAs)) are always a contraindication for solid organ transplantation, and identification of DSA becomes very crucial before transplantation to provide long-term graft survival. For identification of DSA, usually, either cell-based or HLA bead-based assay is being used in laboratories. However, both cell-based and bead-based assays have certain limitations. One such common limitation is "prozone effect," which can give false-negative results. Here, we would like to present a small pilot study to analyze the effect of the prozone phenomenon in the cell-based and HLA bead-based assays and its utility in histocompatibility testing. MATERIALS AND METHODS: In a series of four experiments, cell-based assay, flow cytometric cross-match (FCXM), and HLA bead-based flow cytometric panel reactive antibodies (PRAs) were performed. Single-antigen bead (SAB) testing was conducted as a first experiment on four known positives samples for anti-HLA antibody-antibodies. In the second experiment, these four samples were pooled together (called pooled sera in the text) and tested for FCXM and PRA. In the third experiment, known commercially available positive control sera were mixed with pooled positive sera (positive control sera + pooled sera) to prepare, what we have called "positive concoction" in the text. In the fourth experiment, the positive concoction was diluted serially (1:2, 1:4, 1:8, and 1:16) and FCXM and PRA were performed again to analyze and compare the prozone effect. RESULTS: Pooled sera did not have the expected median fluorescence intensity (MFI) values in FCXM assay, whereas the PRA was showing >90% positivity. In positive concoction, the MFI of FCXM assay was observed to be declining; however, PRA values remained almost constant. Dilutions of the pooled sera showed that MFI values of FCXM assays were increased suddenly after dilution. The highest MFI values were observed in 1:4 dilution of the sera, and then, it declined gradually, but the PRA values remained almost constant even after serial dilutions. CONCLUSION: In our experimental findings, it was clear that cell-based assay (FCXM) was more severely affected by the prozone, whereas solid-phase (flow PRA) assay remained resistant to prozone. [ABSTRACT FROM AUTHOR]

For assessment of COVID-19 vaccine efficacy, neutralization activity of anti-SARS-CoV-2 antibody is measured. This study was undertaken to determine optimum levels of binding antibody units (BAU/ml) in new quantitative chemiluminescent assay (CLIA) that corresponded to neutralizing potential (30% inhibition) of sVNT assay. Methods: Ninety-one blood samples were analyzed by CLIA and sVNT assays. Test samples (n = 75) were collected from blood donors post-2nd vaccination dose, while control samples (n = 16) were archived pre-COVID donor samples. Correlation between CLIA and sVNT was calculated and receiver operating characteristic (ROC) curve was drawn and analyzed. Results: Results indicated excellent correlation between 57.5 BAU/ml on CLIA and 30%inhibition on sVNT assay. ROC curve analysis revealed that the area under the curve (AUC) was 0.971. Discussion: The present study determined that 57.5 BAU/ml on CLIA corresponded to 30% inhibition on sVNT assay. Periodic quantitative analysis [ABSTRACT FROM AUTHOR]

Background and Objectives: ICMR conducted a multicentric trial "PLACID" that allowed COVID convalescent plasma (CCP) as an experimental drug for the management of moderate COVID-19 disease and the authors' institute was one of the participating centers. The efficacy of CCP in COVID-19 is still debatable. However, unlike therapeutic efficacy, there is not enough literature on issues and challenges faced by health-care institutions in donor recruitment, and the entire vein-to-vein process and approach of CCP transfusion. The authors would like to share their experiences, challenges faced, and their mitigation during the course of donor recruitment, screening, testing, apheresis donation, storage, inventory management, and issue and transfusion of CCP including the regulatory provisions, as their evolution. Methods: This retrospective study was conducted over a period of 7 months at a large tertiary care hospital in north India. Based on ICMR guidelines, the study analyzed the screening process and donation from all consecutive potential CCP donors. The study also identified various issues and challenges faced by the institute and how they were resolved. Results: Prospective donors registered at the blood center were 843. Majority were males (96.6%), first-time CCP donors (93%), age interval 31-45 years (52.2%), who had a history of mild COVID-19 symptoms (86.9%), and were home-quarantined (83.8%). The most common blood group was B positive (50.6%). Only 6.3% of donors were deferred due to the absence of anti-COVID-19 antibodies. Of 843, 705 selected CCP donors donated 1488 CCP units and six donors (0.8%) experienced mild adverse reactions. Challenges faced by authors included donor recruitment, lack of regulatory approval for plasmapheresis, revisions of COVID-specific selection criteria, no "anti-COVID-19 antibody" kit, and CCP inventory management. Conclusion: This study provides real-world comprehensive data on process management of CCP donors and their donations. This understanding of the process, its challenges, and their mitigation could be a template for any possible future pandemic. [ABSTRACT FROM AUTHOR]

Background and Objectives: Indian studies on evaluation of storage lesions in red blood cells (RBCs) are either limited to 21 or 28 days or have evaluated limited parameters for 42 days. Moreover, issue of transfusion of "fresh" versus "old" RBC is far from settled. The study serially assesses, up to 42 days, in vitro and in vivo RBC storage lesion parameters, including di-(2-ethylhexyl) phthalate (DEHP) leaching and its comparison with published literature. Methods: The study serially assessed in vitro RBC storage lesion parameters including potassium, lactate, glucose, pH, supernatant hemoglobin, percentage-hemolysis, and DEHP leaching of RBC unit during storage till 42 days. The study also evaluated in vivo recovery of potassium after transfusion of "older" RBC. Results: Serial monitoring of in vitro biochemical parameters showed increase in potassium, lactate, supernatant Hb, and hemolysis% and reduction in glucose and pH. DEHP content of the RBC bag was within no-observed adverse effect limit on days 42. Measurement of serum potassium after transfusion of "older" RBC unit revealed that levels of potassium were within normal limit in all four patients. Sterility testing done on days 42 was negative for all 24 bags. Conclusion: Development of storage lesions is inevitable. Appropriate storage limits the RBC lesions to within normal limits. The increase in potassium, lactate, or hemolysis consequent to aging of blood has little clinical significance in routine transfusion practice. [ABSTRACT FROM AUTHOR]

OBJECTIVES: The study objective was evaluation of amotosalen and ultraviolet A (UVA) illumination-based inactivation of dengue virus (DENV) in blood platelets. MATERIALS AND METHODS: Whole blood was collected from healthy donors and platelet concentrates were prepared at a tertiary care hospital in Gurugram, India. Platelet units collected from five blood group matched individuals were pooled and spiked with DENV. The spiked platelet units were subjected to amotosalen treatment followed by UVA illumination, to evaluate the efficiency of this method for viral inactivation. The treated platelet units were evaluated for the presence of infectious DENV. Amotosalen levels were quantified in the treated samples using high-performance liquid chromatography. RESULTS: The presence of replicating DENV was not observed in spiked platelet units treated with amotosalen and UVA illumination, whereas untreated units contained actively replicating DENV. Amotosalen levels were found to be in the permissible range after photochemical inactivation. CONCLUSIONS: Amotosalen/UVA pathogen inactivation treatment showed efficient inactivation of DENV in platelet components. Therefore, it seems to be a promising method for mitigating the risk of dengue transmission through transfusion of potentially contaminated platelet components in dengue-endemic countries such as India. [ABSTRACT FROM AUTHOR]

ABO-incompatible transplantations allow patients to receive timely transplants. Isoagglutinin titration to ascertain levels of incompatible antibodies in the recipient is important in determining patient selection and transplant survivability. To find out the prevalent trends in India, the largest, first of its kind survey was carried out among the transplant centers regarding their practices in isoagglutinin titration. The survey was drafted by a working group of Transfusion and Transplant Immunology specialists from six different centers. Data was obtained via the use of an online questionnaire. Results were categorized into four categories, Hospital information, Titration methodology, Role of transfusion specialists and cut-off titers. Most centers had a well-established solid-organ transplant program with considerable number of ABO-incompatible transplantations. Most centers performed isoagglutinin titration in Transfusion Medicine department. Column Agglutination Technique (CAT) was the most common method, using EDTA blood samples and freshly-prepared in-house pooled cells. Most centers had a turn-around time of less than 12 h. While the policy for ascertaining baseline and threshold titers is well-defined in ABO-incompatible renal transplants, variations from center to center still exist for ABO-incompatible liver transplants. Most centers required a Transfusion Medicine consultation for the patients before such transplants. With increasing ABO-incompatible kidney and liver transplants across the country, the role of Transfusion medicine specialists has become vital in pre-conditioning regimes enabling the viability and success of such transplants. This was a unique survey that provided a snapshot of current trends and practices of isoagglutinin titration for ABO-incompatible transplants in India. • This was a survey undertaken among the Transplant centers across the country performing ABO incompatible transplants • Such transplants are being performed not only at larger tertiary centers in metro cities, but also in smaller hospitals across the country • The protocols for kidney transplants in regards to baseline and threshold titers appear better defined as compared to those for liver transplants • Underscores the growing importance of Transfusion Medicine as an integral part of such complex procedures [ABSTRACT FROM AUTHOR]

Background and Objectives: There are limited published data on association of results from commercial serological anti‐SARS‐CoV‐2 IgG antibody CLIA (chemiluminescent immunoassay) assays with neutralizing antibodies. This study was undertaken with an objective to correlate sample‐to‐cut‐off (S/Co) ratio of CLIA antibody tests with inhibition activity, which may then serve as a valuable guide for labelling plasma as COVID convalescent plasma (CCP) for therapy and assessing vaccine efficacy. Materials and Methods: A total of 139 donor serum samples who were previously RT‐PCR positive and had recovered completely from COVID‐19 at least 28 days prior to collection of samples were recruited at three sites. The samples were analysed for S/Co ratio and per cent inhibition activity with VITROS SARS‐CoV‐2 IgG chemiluminescent assay and GenScript cPass SARS‐CoV‐2 Surrogate Virus Neutralization Test (sVNT) kit, respectively. Linear regression equation and receiver operating characteristic (ROC) curve were used to check the proposed model of comparing S/Co with per cent inhibition. Results: The results indicate very good correlation between the S/Co ratio of the chemiluminescent IgG assay and the neutralization activity depicted by per cent inhibition on sVNT assay. S/Co ratio of 4·04 (low‐titre) and 8·19 (high‐titre) correlated with 30% and 68% inhibition, respectively. Conclusion: Chemiluminescent SARS‐CoV‐2 IgG assay can be used as a semi‐quantitative test, with a cut‐off of >8·19S/Co ratio for selecting donors for convalescent plasma therapy and assessing efficacy of vaccination. [ABSTRACT FROM AUTHOR]

Introduction: Solid organ transplantation is the preferred therapeutic modality of treatment in patients affected by terminal organ failures. Human leukocyte antigens (HLAs) plays an important role in graft survival. In many of the cases of rejection, antibodies are directed against HLA antigens expressed on the cells of the transplanted organ. Pre-transplant compatibility testing involves the use of different methodologies for the determination of anti-HLA antibodies. Luminex single-antigen bead (SAB) assay demonstrates higher sensitivity and specificity in detecting anti-HLA antibodies. The aim of this study was to determine the prevalence of anti-HLA antibodies in pre-transplant work up recipients, planned for renal transplant at a tertiary care center in India. Methods: 1640 patients visiting tertiary care hospital for pre-transplant compatibility testing were screened with complement-dependent micro-lymphocytotoxicity crossmatch (CDC-XM) and flow cytometric crossmatch (FC-XM). The patients positive for either or both screening tests were assayed with the Luminex SAB tests in order to establish defined antigen specificity of the alloantibodies and determining donor-specific antibody (DSA). Results: The two most frequent antibodies identified in each A, B, C locus of HLA class I were -A*24:03 (43.9%), A*25:01 (36.6%), B*57:01 (40.3%), B*15:12 (37.1%), C*17:01 (61.9%), C*07:01 (52.4%) and in DR, DQ DP locus in HLA class II were DRB1*09:01(40.0%), DRB1*14:04(37.6%), DQA1*04:01/DQB1*03:03 (58.4%), DQA1*05:01/DQB1*03:01 (55.1%), DPA1*02:01/DPB1*17:01 (55.0%), DPA1*02:01/DPB1*05:01 (45.0%). Conclusion: This study has found the prevalence and specificity of anti-HLA antibodies in north India. [ABSTRACT FROM AUTHOR]

Introduction Methodology Results Conclusion Anti‐D detection and titration plays a major role in RhD negative antenatal cases both, for monitoring maternal as well as fetal status as well as initiation of early therapeutic interventions, such as intra‐uterine transfusions (IUT) to improve maternal as well as fetal morbidity and mortality and reduce the adverse effects of haemolytic disease of fetus and newborn (HDFN). We conducted a survey focusing on the policies and procedures of anti‐D detection and titration among major tertiary care centres across India.The survey was drafted by a working group of transfusion medicine and immunohematology specialists from six different centres in India. Data were obtained via the use of an online questionnaire.Results were categorised into four categories, Hospital information, immuno‐haematological testing methodology, clinical significance of anti‐D testing and the role of transfusion medicine specialists. The survey highlighted the modalities as well as the methodologies of anti‐D detection and titration in antenatal women across different major tertiary care centres in India.This survey provided a unique snapshot of the prevalent methodologies being employed by major tertiary care centres across the country for detection and titration of anti‐D levels as well as the important role it plays in the therapy of affected antenatal women to minimise adverse effects on the fetus. [ABSTRACT FROM AUTHOR]

Background and Objectives: In addition, the role of human leukocyte antigen (HLA) in transplantation, importance of HLA in disease susceptibility, and protection has been widely studied. The aim of the present study was to find out the HLA allelic frequency (HLA-A,-B,-DRB1) and its association with liver diseases. Methods: The present study was done for the duration of 4 years from 2013 to 2017 in a tertiary care center which primarily caters to north Indian patient population. A total of 429 patients were studied. The HLA genotyping was performed by molecular method using commercial available low resolution ABDR sequence-specific oligonucleotide probe-based method (Luminex platform). Results: There was an increased association of HLA-A*01 (n = 9, 18.6%), HLA-B*15, B*35, B*40, B*44 (n = 5, 11.6%), and HLA-DRB1*15 (n = 9, 20.9%) in 43 patients with hepatitis B virus (HBV)-related disease. There was an increased association of HLA-A*24 (n = 9, 20.7%), HLA-B*35, B*40 (n = 14, 15.2%), and HLA-DRB1*15 (n = 17, 18.5%) in 92 patients with alcohol-related disease. An increased association of HLA-A*11 (n = 30, 19.6%), HLA-B*35 (n = 24, 16.8%) and HLA-DRB1*15 (n = 28, 19.6%) in 143 patients with hepatitis C virus (HCV) related disease. Conclusion: This is possibly the first study in the north Indian patients having liver diseases related to HBV, HCV, and alcohol related with respect to A, B, and DR loci previous studies from India were conducted to see disease association of HLA class I and class II with respect to HCV only. [ABSTRACT FROM AUTHOR]

Background: As a part of continuous quality initiatives, while moving from triple bags to quadruple bags, we undertook a study to compare platelet-rich plasma (PRP) and buffy-coat (BC) methods with respect to all blood components (red blood cells [RBCs], random donor platelet concentrate [RDPC], and fresh frozen plasma [FFP]) prepared by PRP and BC methods. Materials and Methods: It was a prospective analysis of different physical and quality parameters of RDPC, RBC, and FFP prepared out of 100 whole blood (WB) donations. Of these, 50 WB units were processed by PRP method using Triple bags and 50 WB units by BC method, using quadruple (top and bottom) bags, with an attached integral filter. Results: RBC prepared by BC method had higher hematocrit (61.3 ± 1.91% vs. 56.03 ± 3.37%; P < 0.05) and lower white blood cell (WBC) contamination (6.3 × 104 ± 6.1 vs. 5.41 × 105 ± 2.5; P < 0.05) in comparison to prepared by PRP method. Higher PLT yield (7.67 × 1010 ± 1.8 vs. 6.47 × 1010 ± 1.5; P < 0.05) and lower WBC count (8.24 × 103 ± 1.1 vs. 1.5 × 104 ± 2.1; P < 0.05) was observed in RDPC prepared by BC method than PRP derived. CD62P expression was lower in RDPC prepared by BC method (31.46 ± 9.7%; P < 0.05) as compared to PRP method (43.35 ± 12.5%; P < 0.05). The BC method also resulted in increased plasma yield (210.56 ± 18.54 ml vs. 187.92 ± 12.93 ml; P < 0.05) in FFP in comparison to PRP method. Conclusion: The blood components produced from WB by the BC method have laboratory variables suggestive of superior quality than those produced by the PRP method. [ABSTRACT FROM AUTHOR]

Anti-G antibody mimics the reactivity pattern of coexistent anti-D and anti-C. Differentiating between the two is significant in antenatal females where the decision to administer RhD prophylaxis is based on the presence or absence of anti-D antibody. The aim of reporting this serological challenge is to emphasize the need for phenotyping red cells for sourcing appropriate in house red cell reagents and to help transfusion services sharpen problem-solving skills. A 26-year-old pregnant female with a complicated obstetric history and a positive indirect antiglobulin test presented to the hospital for antenatal assessment at 24 weeks. A positive antibody screen warranted identification of the implicating antibodies. Since identification was suggestive of multiple alloantibodies whose specificities could not be confirmed, step-wise sequential adsorption and elution was required. Anti-D, anti-C, and anti-E antibodies were identified in patient plasma with titers of 1024, 4, and 32, respectively. The absence of anti-G was also confirmed. Multiple alloantibodies can pose a challenge to transfusion services. However, with the help of select cells, phenotyping, adsorption elution studies, and phenotyped donor units; solving complex serological cases can be accomplished. [ABSTRACT FROM AUTHOR]

Background & objectives: The number of blood components required during a liver-transplant surgery is significant. It is challenging for blood transfusion services to provide the required RhD-negative red blood cells (RBCs) for recipients during the peri-operative period. This retrospective study presents safety data of transfusing RhD-positive RBCs in RhD-negative living donor liver-transplant (LDLT) recipients during the peri-operative period with six-month follow up for risk of developing alloantibodies. Methods: All RhD-negative patients who underwent LDLT and were transfused ABO-compatible but RhD-positive RBC units between January 2012 and May 2018 were included in the study. Twenty one RhD-negative patients who received a total of 167 RhD-positive RBCs peri-operatively were chosen for alloantibody screening. All the patients were started on triple immunosuppression drugs as per the standard hospital protocol. Blood grouping, cross-match and antibody screening were done by column agglutination technique. Results: Post-transplant antibody screen (weekly for 12 wk) was negative, and none of the patients developed anti-D alloantibodies till their last follow up (mean 21 months). Interpretation & conclusions: Our observations suggest that it may be safe to use RhD-positive RBCs peri-operatively in RhD-negative LDLT recipients with low risk of alloimmunization. [ABSTRACT FROM AUTHOR]

End-stage liver disease (ESLD) patients undergoing liver transplant (LT) surgery are often multiply alloimmunized and pose significant challenges to the transfusion services in terms of red cell cross-match incompatibility, unpredictable blood requirements, and often lead to significant delays in availing compatible red cell units. We report a case of a 64-year-old female from Bahrain, a known case of hepatitis C-related ESLD referred for LT surgery. She had a history of multiple uneventful transfusions in the preceding year. Her blood group was A-positive, direct antiglobulin test, and cold antibodies were negative. Indirect antiglobulin test was positive, and antibody identification confirmed the presence of anti-C, anti-e, and anti-K. Her red cell phenotype was R2R2and Kell negative (C-c+E+e-K-). The patient was started on erythropoietin. Requests for R2R2and Kell negative units were sent to various blood banks across the country. After >800 A/O group units phenotyping and a waiting period of 6 weeks, two compatible R2R2phenotypes and Kell negative could be arranged in-house and three units were received from Gurgaon, North India. Intraoperative management included blood preservation techniques including cell salvage, antifibrinolytic drug, and monitoring using thromboelastography. The estimated blood loss was 350 ml with pre- and postoperative Hb 10.4 gm% and 9.2 gm%, respectively. She received intraoperatively two units of single-donor platelet and four units of fresh frozen plasma and postoperatively one unit of leukocyte-depleted-packed red cells and doing well at 12-month follow-up. This case highlights the importance of advance immunohematology for timely detection of alloimmunization and providing antigen-negative compatible units, proper communication between the transfusion specialists, and the clinical team for proper patient blood management as well as the need for central rare donor registry program to avoid delays in providing compatible blood in such inevitable cases. [ABSTRACT FROM AUTHOR]

There are several reports in medical literature about Red Cell Exchange (RCE) being routinely performed pre-operatively in sickle cell disease patients to provide immediate decrease in HbS concentration and prevent post-operative complications. We would like to present one such case of SCD who also had multiple allo-antibodies and had to undergo hemi-arthroplasty for avascular necrosis of head femur. Grouping and antibody screening was performed using column agglutination technique. 3-cell and 11- cell panel were used for antibody screening and identification, respectively. Automated RBC exchange was performed on apheresis machine Com.Tec using the standard PL1 kit (Fresenius Kabi, Germany). Multiple (anti-c, E) allo-antibodies were identified and successful pre-operative RCE was done with corresponding antigen-negative AHG compatible RBC units. Single RCE procedure reduced HbS concentration from 65% to 25%. The patient underwent uneventful hemi-arthroplasty and was discharged on post-operative day-7. Patient is on regular follow-up and continues to do well two months after the day of surgery. This is possibly the first case report from India, which illustrates successful automated RCE in a SCD patient with alloimmunization. [ABSTRACT FROM AUTHOR]

Background: Administration of anticoagulant citrate and dextrose (ACD-A) chelates ionized calcium in blood and causes hypocalcemia in plateletpheresis donors. The aim of the study was to observe the effects of oral calcium (Ca) supplementation during plateletpheresis on various parameters related to calcium metabolism. Materials and Methods: This study was performed between January 2014 and December 2014 on 200 plateletpheresis donors.They were divided into two groups. In group A donors (n=100), no prophylactic oral calcium supplementation was given. In group B (n=100) donors, 2000 mg of calcium was given one hour before the start of the procedure, 500 mg was given at the start of the procedure and 500 mg calcium was given just before the end of procedure. Biochemical parameters like serum total calcium (T Ca), serum total magnesium (T Mg) and ionized calcium level (iCa) were measured before and after the procedure. Relative risk of citrate toxicity was measured between the two groups. Results: There was a significant fall in total calcium (pre 9.02 mg/dl, post 8.23 mg/dl,), ionized calcium level (pre 1.14 mmol/L, post 0.91 mmol/L) and total magnesium (pre 1.92 mg/dl, post 1.79 mg/dl) amongst the donors who did not receive prophylactic calcium supplementation. Despite calcium intake, in prophylactic calcium intake group, we did observe a significant drop in total magnesium (pre 2.04 mg/dl, post 1.94 mg/dl) and ionized calcium level (pre 1.25 mmol/L, post 1.12 mmol/L, p<0.01). We did observe a drop in total calcium level, however, this observation was not statistically significant. The risk (RR=5.44) of citrate toxicity was higher among group A donors. Conclusion: Prophylactic oral calcium carbonate supplementation would help in to reduce the risk of citrate toxicity. Therefore, we suggest for prophylactic oral administration of 3000 mg elemental calcium carbonate in three divided doses to make PP procedures uneventful. [ABSTRACT FROM AUTHOR]

Background: There are no published reports on desensitization protocol for ABO-incompatible kidney transplants using Immuno-Adsorption (IA) plasmapheresis from India. IA offers certain advantages including processing of larger plasma volumes, quicker reduction of isoagglutinin titers and no requirement of replacement fluids. Aims and Objectives: Authors' center evaluated success of desensitization protocol, and graft/patient outcomes when IA procedures were performed for desensitization in adult and pediatric ABO-incompatible kidney transplant patients. Methods: Patients undergoing ABO-incompatible kidney transplant with use of IA were evaluated at tertiary care center in north India. Patient records for 2-years were collated from hospital information system (HIS) and procedure forms. Results: Sixteen IA procedures were performed in five patients who underwent successful ABO-incompatible kidney transplant. Initial isoagglutinin IgG titer ranged from 32-512. Mean number of IA procedures performed to achieve the desired pre-transplant IgG titer ≤8 was 3.2. New IA column was used for each patient (and re-used for the same patient, if needed, after sterilization with Low temperature steam of formaldehyde). Mean plasma volume processed during each IA procedure was 4.5 times. No adverse events were observed during any IA procedure. All patients achieved successful desensitization. All patients continue to do well clinically with mean follow-up period of 8.8 months. Although IA was expensive, it offered advantages like specificity, larger plasma volume processing with desired reduction in titer, no 'replacement fluid' requirements and no adverse events in present case series. Conclusion: IA plasmapheresis was universally successful in decreasing the ABO-isoagglutinin titers to desired level in all prospective ABO incompatible kidney transplant patients. [ABSTRACT FROM AUTHOR]

Background Though seropositivity for anti-HBc is high in India, neither anti-HBc nor single-unit NAT (ID-NAT) is mandatory. Approximately 10% of blood transfusion services in India employ anti-HBc (Total) testing, and approximately 50% of these also do NAT testing routinely. Adding anti-HBc test to transfusion-transmissible disease testing for screening donated blood remains controversial, especially after introduction of ID-NAT testing in several centres. Materials and methods Prospective study was undertaken where anti-HBc positive, HBsAg negative and ID-NAT negative donor samples were investigated for HBeAg, anti-HBe and anti-HBs. Isolated anti-HBc (anti-HBc positive, HBeAg negative, anti-HBe negative and anti-HBs negative) samples were analysed by a sensitive polymerase chain reaction (RT-PCR). Results 955/14296 (7·6%) samples were anti-HBc repeat reactive. While none of these were reactive for HBeAg, 696 samples were in possible convalescent phase (anti-HBe positive) or resolution phase (anti-HBs positive). A total of 259 were isolated anti-HBc positive, and there were two low copy numbers (20 and 17 IU/ml) RT-PCR positive amongst these. This finding is in agreement with several other studies with HBV DNA positivity in isolated anti-HBc cases (0-0·91%). Conclusion About 0·77% DNA positivity (2/259 isolated anti-HBc positive) by alternate PCR missed by ID-NAT underlies the fact that anti-HBc (Total) testing continues to be relevant in context of enhancing blood safety, especially in medium endemicity region like India. It is also possible to adopt screening algorithm of Japan Red Cross where units are considered transfusable if the anti-HBs titre is over 100 mIU/ml, and we could have used 35·3% of repeat reactive anti-HBc units using this approach. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Semi-automated equipment using Column agglutination technology (CAT) is widely used where centrifugation and incubation are automated but substantial amount of the work is still executed manually. Larger laboratories are moving towards automation to eliminate errors, reducing exposure to bio-hazardous samples, assuring traceability, reliability, turnaround time (TAT) and throughput. Moving towards automation and greater reliability, we therefore, decided to install an automated immunohematological (IH) analyzer "Vision". In this study we evaluated reliability and performance before clearing "Vision" for routine use. MATERIALS AND METHODS: Study was conducted in the Department of Transfusion-Medicine. The primary objective was to assess the reliability of results and compare with routine use semi-automated BIOVUE system (Reference system). Secondary objective was to evaluate the performance (TAT and throughput) of the Vision to handle routine and emergency workload. RESULTS: Total of 1276 known samples were used to assess 2640 pre-transfusion tests (1229 ABO/Rh D typing; 1229 antibody screening; 54 antibody identification; 86 crossmatch and 42 DAT). All 1229 ABO Rh typing results were concordant between the two systems. Overall agreement between the Vision IH analyzer and reference system for ABO Rh typing was 99.95%. All antibody screening, crossmatch and DAT results were concordant between the two systems. TAT of Vision was substantially shorter than the reference system for all test profiles. CONCLUSION: Based on study results, Vision was approved for routine use in laboratory. It was found to be reliable with considerably shorter TAT and capable of handling high throughput of immunohematological tests. [ABSTRACT FROM AUTHOR]

Sezary syndrome (SS) is more aggressive leukemic variant of cutaneous T-cell lymphoma in which a significant number of circulating malignant (Sezary) cells are observed in peripheral blood. Although single-agent or combination chemotherapy regimens have produced moderately high response rates in patients with advanced-stage SS, these responses are invariably not durable. Extracorporeal photopheresis (ECP) is recommended as an immunomodulator treatment, offering better life quality for patient. We would like to present the first SS case treated successfully with low-dose methotrexate and ECP in India. A 50-year-old male presented with rash and severe pruritus all over the body for 2 years. He had received various treatment regimens but without any symptomatic improvement. He underwent detailed examination and diagnosis of SS was established. Peripheral smear revealed total leukocyte count of 14900/μ l with 55% cells reported as Sezary cells. Contrast-enhanced computerized tomography revealed few insignificant (<1.5 cm) bilateral nodes in the axillary and inguinal region. The patient's disease stage was determined IVA1, and grade was T4N0M0B2. He received six cycles of CHOP, which led to a short-term remission of <3 months, and he was started on single-agent methotrexate along with skin supportive treatment. He did not respond to low-dose methotrexate alone, and therefore, ECP was added to treatment regimen. This was possibly the first such treatment for SS patient in India. The patient had very good response after six cycles of ECP with pruritus and itching diminishing and scaly lesions down to <10% of body surface area. There was regrowth of hair all over affected area. Sezary cell counts also came down to 35%. The patient continues to do well post-ECP, with single-agent gemcitabine. ECP either as monotherapy or in combination with other immunotherapies offers a good treatment option to otherwise resistant cases of SS. [ABSTRACT FROM AUTHOR]

Background: Hematopoietic progenitor cell transplantation (HPCT) is used as a definitive treatment in hematological malignancies. For a successful HPCT, the donor and recipient should have matching human leukocyte antigens (HLAs). About 25% of patients have a chance of finding matching HLA within family, while rests 75% are dependent on voluntary stem cell donor. Globally, there are 75 stem cell registries with more than 30 million donors registered among which India represents 0.36 million. Therefore, finding a stem cell donor for Indian patient is quite difficult. The aim of the present study is to discuss the significance of voluntary stem cell donor recruitment drive and also to guide the drive organizers and their team for effectively organizing the drive to increase the database of such donors. Materials and Methods: Voluntary stem cell donor recruitment drives are conducted to spread awareness among the people and motivate them to register as a donor. Once the donors have given their consent, the sample is taken and sent to laboratory for HLA typing and the result is uploaded in World Marrow Donor Association, an international association of member to find the best possible matches for patients with hematological disorders. Results: Genebandhu has organized over 127 recruitment camps since 2012 and recruited 13,000 voluntary stem cell donors. HLA typing of 7446 donors has been completed. Out of this small number of typed donors, 11 lifesaving HPCTs have been successfully facilitated. Conclusions: Here, we have demonstrated guidelines along with steps to organize voluntary stem cell donors recruitment drive that is needed to increase number of donors, thus increasing significantly the chances of saving many vital lives. [ABSTRACT FROM AUTHOR]

Background: It is important to detect Latent Iron Deficiency (LID) to prevent development of an overt iron deficiency anemia. Early detection is difficult by using conventional hematological and biochemical parameters. Soluble transferrin receptor (sTfR) is presently the gold standard for diagnosing LID. We evaluated the utility of Reticulocyte Hemoglobin Equivalent (Ret‐He), a newer hematological parameter, to predict LID in blood donors as compared to sTfR. Methods: This was a randomized prospective study performed on 501 donor samples over a period of three‐months. All donors were included after administering medical history questionnaire and a brief physical examination in accordance with national guidelines (Hb ≥12.5). Additional samples were collected during donation according to the institutional standard operating procedure (SOP). All hemograms were performed on the Sysmex XE‐2100 analyzer which included Ret‐He. sTfR was measured in batch assays by ELISA (Biovendor, Czech Republic). Ret He <28 pg and sTfR≥3μg/ml were used to diagnose LID. Serum Iron, Total Iron Binding Capacity (TIBC) and Serum Ferritin were also measured simultaneously. Results: Of the 501 blood donors, sTfR and Ret‐He detected LID in 148 and 135 donors respectively. In comparison to sTfR, Ret‐He had sensitivity of 92.7%, a specificity of 97.16%, PPV of 93.1% and NPV of 96.3%. Serum Ferritin, TIBC and serum Iron had comparatively lower sensitivity of 87.16%, 79.7% and 77.7% respectively. Conclusion: Ret‐He can be used as a routine screening test to detect LID in blood donors. This could provide an opportunity to make appropriate and timely interventions like dietary changes or drug supplementation. [ABSTRACT FROM AUTHOR]

61-year old male patient was admitted to the hospital with clinical picture of hemolytic anemia with hemoglobinuria. Patient was suspected to have Infectious Mononucleosis (IM) with Auto Immune Hemolytic Anemia (AIHA). DAT was positive with anti-C3d specificity. Donath Landsteiner (DL) test was positive; confirming Paroxysmal Cold Hemoglobinuria (PCH). The final diagnosis was IM with PCH. Patient was managed conservatively and discharged after seven days. DL test specifically detects a biphasic autoantibody (IgG type) that binds to RBCs at cold temperatures, and fixes complement on the RBC membrane. However RBCs are only lysed upon warming to 37C when complement cascade proceeds to completion. [ABSTRACT FROM AUTHOR]

Introduction Post-donation counselling informs donors of unusual test results. Timely notification and counselling regarding their Transfusion Transmitted Infection (TTI) status is necessary for early clinical intervention in the donor and reducing risk of transmission. We share our experience with respect to Hepatitis B (HBV) and Hepatitis C (HCV) positive donors who were counselled and followed-up for clinical outcome. Materials and methods It was prospective 2-year study in TTI positive blood donors. Confirmed positive HBV/ HCV donors were notified to attend the donor-clinic or to visit local hepatologist for further management. At donor clinic, donor’s immediate emotional response was observed; donors were offered contact-testing, associated risk factors were noted, counselled, referred to hepatologist, treated and followed-up for clinical outcome. Results Of 481 donors (0.91%) confirmed positives, 351 were contacted telephonically; 280 promised to attend donor clinic and 71 were referred to their local hepatologist. 145 donors attended the donor clinic, eventually. Most common immediate emotional response noted were ‘feeling of fear’ (55.2%) and ‘disbelief’ (35.2%). Most common associated risk factor was history of medical treatment/ injections without knowledge of sterilisation. Five donors availed contact testing and four (spouses in all four cases) came out positive. Of 98 donors contacted post-counselling; 89 went to hepatologist. No medication was advised to seven donors (low viral load), 59 donors completed treatment course and 23 donors were undergoing treatment at time of follow-up. Nine donors opted for alternative treatment or “no treatment”. Conclusion Donor-clinic proved beneficial to substantial number of donors and their families. [ABSTRACT FROM AUTHOR]

BACKGROUND: Erycard 2.0 is a "point-of-care" device that is primarily being used for patient blood grouping before transfusion. MATERIALS AND METHODS: Erycard 2.0 was compared with conventional slide technology for accuracy and time taken for ABO and Rh forward grouping result with column agglutination technology (CAT) being the gold standard. Erycard 2.0 as a device was also evaluated for its stability under different storage conditions and stability of result till 48 h. In addition, grouping of hemolyzed samples was also tested with Erycard 2.0. Ease of use of Erycard 2.0 was evaluated with a survey among paramedical staff. RESULTS: Erycard 2.0 demonstrated 100% concordance with CAT as compared with slide technique (98.9%). Mean time taken per test by Erycard 2.0 and slide technique was 5.13 min and 1.7 min, respectively. After pretesting storage under different temperature and humidity conditions, Erycard 2.0 did not show any deviation from the result. The result did not change even after 48 h of testing and storage under room temperature. 100% concordance was recorded between pre- and post-hemolyzed blood grouping. Ease of use survey revealed that Erycard 2.0 was more acceptable to paramedical staff for its simplicity, objectivity, and performance than conventional slide technique. CONCLUSION: Erycard 2.0 can be used as "point-of-care" device for blood donor screening for ABO and Rh blood group and can possibly replace conventional slide technique. [ABSTRACT FROM AUTHOR]

INTRODUCTION: The authors' center recently changed their pretransfusion testing protocol from "conventional" type and screen (TS) with anti-human globulin (AHG) crossmatch (Policy A) to TS with immediate-spin (IS) crossmatch (Policy B). Red blood cell (RBC) units were issued after compatible IS crossmatch as and when required instead of AHG crossmatch. This study was conducted to compare the effects of change of policy from A to B over 1-year period on crossmatch-to-transfusion (C/T) ratio, RBC issue turnaround time (TAT), outdating of RBC, man-hours consumption, and monetary savings. MATERIALS AND METHODS: This was a comparative, prospective study conducted by the Department of Transfusion Medicine of a tertiary hospital-based blood bank in Northern India. The Policy B was implemented in the department from January 2014. Relevant retrospective data for comparison of the previous 1 year, when Policy A was practiced, were derived from hospital information system. RESULTS: 23909 and 24724 RBC units transfused to patients admitted to the hospital during respective 1-year period of practice for Policy A and B. There was significant reduction in C/T ratio (1.94 vs. 1.01) and RBC issue TAT (79 vs. 65 min) with Policy B. Expiry due to outdating reduced (37 vs. zero) along with man-hours (16% reduction) and monetary (33% reduction) savings. CONCLUSION: Use of 'TS with IS crossmatch' policy provides multiple advantages to all the stakeholders; blood banker, clinician, patient, and the hospital management. [ABSTRACT FROM AUTHOR]

Background: Blood centers in India have published individual donor nucleic acid testing (ID-NAT) data based on an algorithm (Algorithm A) where serologically negative, NAT reactive sample was subsequently tested with discriminatory NAT (d-NAT), and on the basis of d-NAT, initial reactive samples were classified as “NAT yield” or inconclusive. We followed Algorithm B based on replicate testing and Ultrio Plus assay and compared the results with Algorithm A with Ultrio assay. Materials and Methods: Results of ID-NAT using two algorithms were analyzed. Results: A total of 88,583 (31,844 with Algorithm A and 56,739 with Algorithm B) samples were tested. Among serology nonreactive donations, NAT inconclusive results came down from 95.2% in Algorithm A to 73.1% in Algorithm B (P = 0.0001). Discriminated yield (DY) rate went up from 4.7% in Algorithm A to 21.9% in Algorithm B (P = 0.001). Conclusion: The study data suggest that replicate testing strategy and Ultrio Plus reduce the number of “inconclusive results” seen with earlier commonly used algorithm. We recommend a replicate testing strategy in ID-NAT testing since it will increase the DY and will eliminate the unnecessary discriminatory tests. [ABSTRACT FROM AUTHOR]

Background There are several studies on prevalence of individual infectious disease markers (mono-infection) in donors but none on prevalence of coinfection. Co-infection is significant as it leads to accelerated disease progression. We, therefore, evaluated the prevalence of co-infection among blood donors. Materials and methods The cross-sectional analysis was conducted in blood donors. All donors were tested for anti-HIV I and II, HBsAg, anti-HBC IgM, anti-HCV, Malaria and syphilis by chemiluminescence and ID-NAT assay. All reactive donor samples were confirmed by using confirmatory assays. Donors were grouped as mono-infected and co-infected. The student t -test was used for comparison. Results During the study period, a total of 106,238 blood donors were tested. Mean age of donors was 34.2 years and 94.2% of blood donors were males. 1776 (1.67%) donor samples were confirmed serologically reactive. 1714 (1.61%) samples were reactive for single marker (mono-infected) while 62 (0.05%) donors’ samples exhibited co-infection. 18 donors were positive for HBV+HCV followed by HIV +syphilis (14). Conclusion We report for the first time the prevalence of different co-infection patterns in blood donors. Co-infection influence the disease progression; it would be important to investigate the co-infection prevalence in larger sample size. [ABSTRACT FROM AUTHOR]

Background Blood donor experiences both immediate adverse reactions (IAR) and delayed adverse reactions (DAR). With limited published data available on the incidence of DAR, a study was conducted to estimate incidence and profile of DAR through telephonic interview. Materials and methods Study was conducted over a 45-day period for consecutive volunteer whole blood donations at tertiary care hospital. Donors were divided into first-time, repeat and regular and were monitored for IAR. They were given written copy of post-donation advice. Donors were contacted telephonically three weeks post-donation and enquired about general wellbeing and specific DAR in accordance with a standard n international (International Society of Blood Transfusion) standard format. Results Donors participated in the study of which 1.6% donors experienced an IAR. Much larger number reported DAR (10.3% vs.1.6% p < 0.0001). Further, DAR was presented as a variegated profile with bruise, painful arms and fatigue being the commonest. DARs were more common in females than males (25% vs. 10.3%, p < 0.02). Localized DAR like bruise and painful arms were more common in younger donors (age <50 years) whereas systemic DAR like fatigue was common in older donors (>50 years). First time (12.3%) and repeat donors (13.5%) had similar frequency of DAR but were lower among regular donors (6.7%). Conclusion DARs are more common than IAR and are of different profile. Post-donation interview has provided an insight into donor experiences and can be used as a valuable tool in donor hemovigilance. [ABSTRACT FROM AUTHOR]

Patients of β-thalassemia major are dependent on regular blood transfusions for their entire lifetime. Development of antibodies against red blood cell (RBC) antigen which may be alloantibody or autoantibody, several times as a result of frequent red cell component transfusions, further complicates the subsequent transfusion therapy. Among the autoantibodies, warm-reactive autoantibodies are commoner and interfere in the pretransfusion testing. These RBC autoantibodies present in patient's serum potentially react with all the cells of antibody identification panel giving “pan-reactive” picture and making alloantibody identification complex. In this report, we present our approach in a thalassemia patient who presented with warm-type autoimmune hemolytic anemia, low hemoglobin of 5.8 g/dl, and three significant alloantibodies (anti-D, anti-S, and anti-Jk b) which were masked by pan-reactive warm autoantibody(s). Differential adsorption was used to unmask underlying alloantibodies. We suggest that differential adsorption procedure is an effective and efficient method for autoantibody adsorption, detection, and identification of masked alloantibody(s), especially in patients with low hemoglobin and history of recent blood transfusion. [ABSTRACT FROM AUTHOR]

Background and Objectives: The US Food and Drug Administration and American Association of Blood Banks approved the type and screen approach in 1980s, long after antibody screen (AS) was introduced in 1950s. The present study omits conventional anti-human globulin (AHG) crossmatch and replaces it with immediate-spin (IS) crossmatch as part of pretransfusion testing in AS-negative patients to study the safety and effectiveness of IS crossmatch in recipients. Materials and Methods: This prospective longitudinal study was conducted on over 5000 red cell units transfused to AS-negative patients admitted to the hospital. Pretransfusion testing comprised blood grouping and AS followed by IS crossmatch, at the time of issue of red cell unit. The patients were transfused IS compatible red cell units. AHG crossmatch was performed posttransfusion for all red cell units. Any incompatible AHG crossmatch was followed up as suspected transfusion reaction. Results: A total of 5023 red cell units were transfused to 2402 patients with negative AS. 99.7% IS compatible red cell units were also compatible on posttransfusion AHG crossmatch. Anti-P1 alloantibody was identified in one patient who was transfused two IS crossmatch compatible units but later both units were incompatible on AHG crossmatch. There was no clinical or serological sign of hemolysis in the patient. Conclusion: In AS-negative patients, IS crossmatch is as safe as conventional AHG crossmatch and can, therefore, replace conventional AHG crossmatch protocol. [ABSTRACT FROM AUTHOR]

Background: Hematopoietic progenitor stem cell transplantation (HPSCT) is used as a standard treatment option to improve outcome in hematological and nonhematological disorders. It is important for new HPSCT program to look at its patient outcome data and compare it with the published data to evaluate the efficacy of program. Aims: The aim was to compile and collate the patient outcome data of HPSCT and compare with published reports. Materials and Methods: Patient demographics, indications, stem cell harvest by apheresis, dose collected, infusion, engraftment, and follow-up data were collected from hospital information system from 2010 to 2013 in a tertiary care hospital. HPSCs were mobilized with granulocyte colony-stimulating factor, and harvests were done on the 5th day. Engraftment was decided for neutrophil when counts were 0.5 x 109/L and for platelets when counts were 20 x 109/L on two consecutive days without any transfusion support. Results: There were 133 harvests for 95 patients with various disorders; multiple myeloma was most common in autologous and acute lymphoblastic leukemia in allogeneic group. One hundred harvests were done for autologous and 33 for allogeneic HPSCT. In autologous group, of 66 patients, 60 (90.9%) received stem cell infusion at median dose of 4.63 x 106 CD34+ cells/kg. Similarly, in allogeneic group, of 29 patients, 27 (93.10%) received infusion at median dose of 5.8 x 106 CD34+ cells/kg. 58 (96.9%) patients and 25 (92.6%) engrafted in autologous and allogeneic group, respectively. The median time for neutrophils engraftment was 11 days in autologous group and 12 days in allogeneic group. The median time for platelet engraftment was 11.5 days in autologous group and 13 days in allogeneic group. The 100-day survival rate was 95% (n = 57) in autologous group and 77.8% (n = 21) in allogeneic group. Conclusion: This data analysis shows reasonably good results of HPSCTs with majority of patients surviving at 100-day follow-up. [ABSTRACT FROM AUTHOR]

Background In India variable rate of “NAT yield” has been demonstrated in several published reports. This study was performed with the objective to know the rate of “true NAT yield” in blood donors by confirmation with supplementary tests and follow up of initial “NAT yield” donors. Materials and Methods A total of 48,441 blood donors were tested for HIV, HBV and HCV with enhanced chemiluminescence and ID-NAT. To know the true NAT yield status confirmation of NAT yield donors was done as with an array of serological tests, repeat ID-NAT and alternate NAT. Results The cumulative initial “NAT yield” rate was 1:4404 (11/48,441). Seven of 11 initial “NAT yields” were for hepatitis B whereas two each were in HIV and HCV. Among the 11 “NAT-yield” donors, eight donors were followed-up for confirmation. Out of these eight donors only 4 were found to be true HBV NAT yields. Out of four true NAT yields two were window period donations while the other two were occult hepatitis B infection with anti-HBcore total positive. Conclusion Our findings suggest that all “initial NAT yields” may not be “true NAT yields”. We would also like to suggest that to demonstrate the true “NAT yield” status supplementary tests and donor follow up are important to differentiate true NAT yields. [ABSTRACT FROM AUTHOR]

Background: Removal of anti-ABO is an important component of the preconditioning regimen for ABO-incompatible (ABOi) renal transplant. Cascade plasmapheresis (CP) is one of the extracorporeal methods of antibody removal, others being conventional plasma exchange (PE) and immunoadsorption. There is no previous published experience with CP in this context. The purpose of this study was to present an early experience with this approach.Study Design and Methods: Consecutive ABOi renal transplant recipients in whom CP was used for pre- and posttransplant anti-ABO removal were included. All the patients received intravenous rituximab 2 weeks before transplant. After 1 week, CP was started along with oral tacrolimus and mycophenolate sodium. Alternate-day CP was done to attain immediate pretransplant antibody titer of not more than 8.Results: Fifteen ABOi renal transplant recipients had baseline (pretreatment) antibody titers ranging from 16 to 512. Desensitization rate was 100%. The mean number of procedures before transplant to achieve titer of not more than 8 was 3.27 ± 1.39. Patient survival was 93% and death-censored graft survival was 87%. Biopsy-proven acute rejection was seen in three patients (20%), one (6.67%) being acute antibody mediated rejection. The complication rate during CP was 4% and two patients had bleeding complication after surgery. Posttransplant infection rate was 13%.Conclusion: Based on limited number of patients, we conclude that CP is a safe and effective extracorporeal method for pretransplant ABO antibody removal in patients undergoing ABOi transplant. Patients undergoing CP met target preoperative antibody titers and the clinical outcomes were acceptable. [ABSTRACT FROM AUTHOR]

Background: Harvest of hematopoietic progenitor cells via leukapheresis is being used increasingly for transplants in India. Adequate yield of cells per kilogram body weight of recipient is required for successful engraftment. Collection efficiency (CE) is an objective quality parameter used to assess the quality of leukapheresis program. In this study, we calculated the CE of the ComTec cell separator (Fresenius Kabi, Germany) using two different formulae (CE1 and CE2) and analyzed various patient and procedural factors, which may affect it. Materials and Methods: One hundred and one consecutive procedures in 77 autologous donors carried out over 3 years period were retrospectively reviewed. Various characteristics like gender, age, weight, disease status, hematocrit, preprocedure total leukocyte count, preprocedure CD34 positive (CD34+) cells count, preprocedure absolute CD34+ cell count and processed apheresis volume effect on CE were compared. CE for each procedure was calculated using two different formulae, and results were compared using statistical correlation and regression analysis. Results: The mean CE1 and CE2 was 41.2 and 49.1, respectively. CE2 appeared to be more accurate indicator of overall CE as it considered the impact of continued mobilization of stem cells during apheresis procedure, itself. Of all the factors affecting CE, preprocedure absolute CD34+ was the only independent factor affecting CE. Conclusion: The only factor affecting CE was preprocedure absolute CD34+ cells. Though the mean CE2 was higher than CE1, it was not statistically significant. [ABSTRACT FROM AUTHOR]

Background: The present study addressed the interesting findings of supplemental evaluation of hepatitis B “seroyield” donors. Materials and Methods: Each blood donor sample was tested for anti-human immunodeficiency virus type I (HIV-I)/HIV type II (HIV-II), HBsAg, and anti-hepatitis C virus (HCV) antibody by enhanced chemiluminescence method and subjected to individual donor-nucleic acid testing (NAT) for HIV-I, hepatitis B virus (HBV), and HCV. NAT test was performed using the eSAS system, Procleix Ultrio Assay, Novartis Diagnostics, CA, US. Confirmation of HBsAg was done using HBsAg Confirmatory Kit (Ortho Clinical Diagnostics, Johnson & Johnson, USA) and viral load assessment was done using Cobas TaqMan real time-polymerase chain reaction (RT-PCR) assay (Roche Molecular Systems, Branchburg, NJ, USA). To provide information on the stage of infection, specimens were tested for anti-HBc total (IgG + IgM), anti-HBc IgM and HBeAg. HBeAg-negative samples were tested for anti-HBe antibody. Results: A total of 60 hepatitis B seroyield donors which showed mean initial sample/cutoff of 1.6 with enhanced chemiluminescence assay were investigated further for confirmation of disease status. All 60 cases were confirmed positive with neutralization assay (VITROS HBsAg Confirmatory Kit) while no target was detected on viral load assessment with RT-PCR. Sixteen donors were HBeAg positive (4 IgM anti-HBc positive and 12 IgM anti-HBc negative) and 44 were IgM anti-HBc negative, anti-HBc total positive, and anti-HBe positive. Conclusion: About 7.7% of HBsAg positive and NAT nonreactive donors (nondetectable HBV DNA) could be potentially infectious (HBeAg positive), whereas rest of the donors were consistent with chronic HBV infection. [ABSTRACT FROM AUTHOR]