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Introduction: Lab-diagnosis of hepatitis C virus (HCV) is based on detecting specific antibodies by enzyme immunoassay (EIA) or chemiluminescence immuno-assay (CIA). Center for Disease Control reported that signal-to-cut-off (s/co) ratios in anti-HCV antibody tests like EIA/CIA can be used to predict the probable result of supplemental test; above a certain s/co value it is most likely to be true-HCV positive result and below that certain s/co it is most likely to be false-positive result. A prospective study was undertaken in patients in tertiary care setting for establishing this “certain” s/co value. Materials and Methods: The study was carried out in consecutive patients requiring HCV testing for screening/diagnosis and medical management. These samples were tested for anti-HCV on CIA (VITROS® Anti-HCV assay, Ortho-Clinical Diagnostics, New Jersey) for calculating s/co value. The supplemental nucleic acid test used was polymerase chain reaction (PCR) (Abbott). PCR test results were used to define true negatives, false negatives, true positives, and false positives. Performance of different putative s/co ratios versus PCR was measured using sensitivity, specificity, positive predictive value and negative predictive value and most appropriate s/co was considered on basis of highest specificity at sensitivity of at least 95%. Results: An s/co ratio of ≥6 worked out to be over 95% sensitive and almost 92% specific in 438 consecutive patient samples tested. Conclusion: The s/co ratio of six can be used for lab-diagnosis of HCV infection; those with s/co higher than six can be diagnosed to have HCV infection without any need for supplemental assays. [ABSTRACT FROM AUTHOR]

Introduction: Renal transplantation is the treatment of choice for patients suffering from end stage renal disease (ESRD). Indian regulations defined under Transplantation of Human Organs and Tissues Act (THOTA), 2014 restricts organ donations to near-related living donors to curb any malpractices like 'paid donors' in living-donor kidney transplantation (LDKT). The aim of our study was to look at real-world data of donor-recipient pairs and to identify relationship of donors (with their respective patients) and the common (or uncommon) DNA profiling methods used for supporting "claimed relationship" in accordance with the regulations. Material and methods: The donors were categorized and grouped into near-related donor, donors other than nearrelated donors, swap donors and deceased donors. Claimed relationship was confirmed, commonly by HLA typing, using SSOP method. In few cases, which were uncommon (and infrequent), autosomal DNA analysis, mitochondrial DNA analysis and Y-STR DNA analysis were performed to support the claimed relationship. Data collected included age, gender, relationship, DNA profiling test method. Results: Among the 514 donor-recipient pairs evaluated, numbers of female donors out-numbered male donors. The decreasing order of relationships in near-related donor group were wlfe->mother>father>sister>son>brother>husband> daughter>grandmother. 11.9% of donors were in the category of donors other than near-related donors. In 97.86% cases, the claimed relationship was supported by HLA typing and in just 2.1% cases autosomal DNA analysis>mitochondrial DNA analysis> Y-STR DNA analysis, in this order, were performed to establish relationship. Conclusion: This study brought out gender disparity with women out-numbering men as donors. Among recipients, access to renal transplant was largely restricted to men. As far as relationship of donors to recipients was concerned, mostly near-related family members, like wife, were donors and claimed relationship was almost always (99%) was corroborated by HLA typing. [ABSTRACT FROM AUTHOR]

Liver transplant procedure acts as a challenge for transfusion services in terms of specialized blood components, serologic problems, and immunologic effects of transfusion. Red cell alloimmunization in patients awaiting a liver transplant complicate the process by undue delay or unavailability of compatible red blood cell units. Compatible blood units can be provided by well-equipped immunohematology laboratory, which has expertise in resolving these serological problems. This report illustrates resolution of a case with multiple alloantibodies using standard techniques, particularly rare antisera. Our case re-emphasizes the need for universal antibody screening in all patients as part of pretransfusion testing, which helps to identify atypical antibodies and plan for appropriate transfusion support well in time. We recommend that the centers, especially the ones that perform complex procedures like solid organ transplants and hematological transplants should have the necessary immunohematological reagents including rare antisera to resolve complex cases of multiple antibodies as illustrated in this case. [ABSTRACT FROM AUTHOR]

Context: Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency. Aims: This study was designed to evaluate the performance of newly introduced VITROS® syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India. Materials and Methods: A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis sero-reactive samples stored at −20°C, were used to evaluate the performance of VITROS® syphilis TPA assay based on enhanced chemiluminescence assay on VITROS® ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies. Results: VITROS® syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of <10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats. Conclusions: Performance of the VITROS® syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency. [ABSTRACT FROM AUTHOR]

Background: A rule called “30-min rule” defines that red cell unit cannot be used if it has been out of blood bank refrigerator for over 30 min. This rule is useful to guide initiation of transfusion, but is inadequate for deciding whether to reuse or discard units received-back at blood transfusion services (BTS). A simple cost-effective temperature-sensitive indicator was evaluated to decide upon reuse (cold chain was uninterrupted) or discard (where cold chain was interrupted) in a simulation exercise. Materials and Methods: Temperature-sensitive indicators TH-F™ that irreversibly changed color from white to red demonstrated that heat excursion has occurred and the cumulative temperature has exceeded 10°C for over 30 min, were used in outdated red cells for simulating units, which are not used and received-back. These units were also tagged with a standard temperature monitoring device, which was a re-usable credit card sized device, which would log the actual time and temperature. In few units percent hemolysis was also calculated. Results: Statistically insignificant elevation in average temperature was noted in 102 simulated units at the time of return to BTS (Δ 0.04°C), despite the fact that these units were in the transport box for over 4 h. The average supernatant hemoglobin in these units was 0.24%, much below the prescribed threshold. Conclusion: Transportation of blood in controlled conditions with temperature-sensitive indicator is a cost-effective model to save blood, a precious human resource. [ABSTRACT FROM AUTHOR]

Background Unexpected allo-antibody identification is difficult serological test requiring in-depth knowledge of antibody behavior, identification rules, knowledge of zygosity of antigens and dosage phenomenon. Software which uses an algorithm based on characteristics of antibodies is now available to interpret specificity of allo-antibody. A study was undertaken to evaluate the effectiveness of one such software (Resolvigen) for antibody identification compared with manual antibody identification method. Materials and Methods The study was a retrospective observational study where 238 allo-antibody results were re-evaluated using Resolvigen software (Ortho Clinical Diagnostics, Johnson and Johnson, Raritan, NJ, USA) and agreement between manual and software approaches was studied. Resolvigen software was also evaluated for usefulness, ease of use and predicted future usage by administering investigators a questionnaire with Likert scale. Results Agreement between the results of manual and automated methods ranged from 98.6% for single antibody to 65% for two antibodies ( p  = 0.000). Resolvigen software came out as very useful, easy to use, and with high predicted future usage. Conclusion This study concludes that Resolvigen can either replace manual method or be used as adjuvant to routine manual method. [ABSTRACT FROM AUTHOR]

Background and Objectives: The study was undertaken with the objective to provide data on the ABO and Rh(D) blood group distribution and gene frequency across India. Materials and Methods: A total of 10,000 healthy blood donors donating in blood banks situated in five different geographical regions of the country (North, South, East and Center) were included in the study. ABO and Rh (D) grouping was performed on all these samples. Data on the frequency of ABO and Rh(D) blood groups was reported in simple numbers and percentages. Results: The study showed that O was the most common blood group (37.12%) in the country closely followed by B at 32.26%, followed by A at 22.88% while AB was the least prevalent group at 7.74%. 94.61% of the donor population was Rh positive and the rest were Rh negative. Regional variations were observed in the distribution. Using the maximum likelihood method, the frequencies of the IA, IB and IOalleles were calculated and tested according to the Hardy Weinberg law of Equilibrium. The calculated gene frequencies are 0.1653 for IA (p), 0.2254 for IB (q) and 0.6093 for IO (r). In Indian Population, O (r) records the highest value followed by B (q) and A (p); O > B > A. Conclusion: The study provides information about the relative distribution of various alleles in the Indian population both on a pan-India basis as well as region-wise. This vital information may be helpful in planning for future health challenges, particularly planning with regards to blood transfusion services. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Since there is scarce data available on incidence and type of irregular antibodies in patients and donors in India, a study was undertaken to find the incidence of irregular antibodies in patients and irregular antibodies and a positive Direct Antiglobulin Test (DAT) in blood donors. Materials and methods: Antibody screening was performed using commercial pooled “O” cells and three-cell panel for donors and patients respectively and an 11-cell panel for identification using Column Agglutination Technology (CAT) with Low-Ionic-Strength Saline–Indirect Antiglobulin Test (LISS–IAT) technique (Ortho Clinical Diagnostics, Johnson & Johnson, USA). The cassettes used were Anti-human Globulin (AHG) type. DAT on donors was also performed using the AHG cassettes. Results: Cumulative incidence of irregular antibodies amongst patients (n =32,560) and donors (n =31,367) were 0.12–0.009%, respectively. In patients, the commonest antibodies were from Rh system with anti-D being the most common antibody type (14/40; 35%) while in donors it was the MNS system with anti M (2/3) being the most common. Incidence of a positive DAT amongst the healthy blood donors was 0.04% (n =13/32,560). Discussion: Incidence of irregular antibodies in patients at 0.12% was slightly lower than published reports and could be because of the fact that the patient population studied comprised largely of surgical patients many of whom have never received blood transfusion. This data could also be more representative since the number of patients studied was much higher as compared to the previous Indian studies (32,560 vs. 531–2026). The report on incidence of irregular antibodies and DAT (0.009–0.04%) in blood donors was first such attempt in India. [Copyright &y& Elsevier]

Random Donor Platelet (RDP) derived from whole blood is the major source of platelets in India. At our centre, we prepare RDPs by buffy coat method after a holding period of 2-hours (THRDP) as per current regulatory guidelines. Overnight hold of buffy coats before RDP preparation (OHRDP) would logistically optimise the manpower usage at our centre. The aim of this study was to compare both in-vitro as well as in-vivo parameters of OHRDPs with THRDPs. Hematological (Platelet, leucocyte counts), physical (pH and Swirling) and biochemical parameters (pO2, pCO2, lactate, bicarbonate and glucose) as well as platelet activation markers were tested in THRDPs and OHRDPs each at Day-1 and Day-5 as in-vitro studies. Separately, in-vivo study was done where Corrected count increment (CCI) and percentage platelet recovery (PPR) were considered. All parameters were expressed as Mean ± Standard deviation and were analysed using paired t -test with level of significance, p < 0.05. OHRDPs had higher platelet counts and lower leucocytes and CD62 P expression than THRDPs. All other markers were well within the quality control range in both groups. No significant differences were seen in the two groups when comparing CCI and PPR. OHRDPs were found to be as good or better as compared to the THRDPs in the in-vitro part of our study. Additionally, there were no significant differences between the two groups when they were compared in vivo. This makes us conclude that overnight hold of buffy coats may be implemented at our center. [ABSTRACT FROM AUTHOR]

Since no single test is always accurate and sensitive, two or more tests are used to increase the precision of evaluation. Different algorithms have been proposed by centers in Leiden, Basel, Vienna and Minnesota, etc. With an intention to develop an optimal algorithm for India, we evaluated pre-transplant compatibility tests for live-donor kidney transplants. Three tests complement dependent cyto-toxicity cross-match (CDCXM), flow-cytometry cross-match (FCXM) and anti-HLA antibody screening (HAS) were performed and confirmed by the anti-HLA antibody identification (HAI) assay in a multi-centric trial (three transplant centers) in India. All prospective recipients (and their potential donors) underwent low-resolution HLA typing as well as CDCXM, FCXM and HAS assays. In addition, HAI {single antigen bead assay; (SAB)} was done for all recipients to identify possible anti-HLA antibodies. In a virtual cross-match (VXM), antibody specificity was mapped to donor HLA type to determine donor-specific antibodies (DSA). Only patients without DSA were cleared for the transplant. Alternatively, patients with DSA were offered an exchange in the kidney paired donation (KPD) program. The screening results (CDCXM, FCXM, and HAS) were analyzed, individually as well as in combination of screening assays (CDCXM+HAS, CDCXM+FCXM, and FCXM+HAS) and the results were compared with those from the HAI test. Out of 100 patients, 69 were males and 31 were females; 85 recipients (85%) underwent a kidney transplant. The sensitivity of CDCXM was only 12.1% and the specificity of CDCXM was 100%; whereas the sensitivity of FCXM was 84.8% and the specificity of FCXM was 89.6%. The sensitivity and specificity of class I HAS was 88.2% and 84.3%, respectively. The sensitivity and specificity class II HAS was 88.0% and 80.0%, respectively. However, when both class I/II HAS were tested together the sensitivity increased to 97.0% and the specificity to 82.1%. Similarly, the sensitivity of combined FCXM+HAS had the sensitivity of 100% and the specificity of 76.1%; CDCXM+FCXM had the sensitivity of 84.8% and the specificity of 89.6% and CDCXM+HAS assays reached 97% with the specificity of 82.1%. Our results showed that the algorithm of FCXM with HAS produced the best sensitivity of 100%. The specificity of 76.1% indicate that the combined FCXM+HAS assays may detect up to 24.9% false positive results. We suggest that these false-positives may be easily resolved by performing the virtual crossmatch based on HAI (SAB) results. In our reflex testing algorithmic approach only 49% patients needed HAI (SAB). Finally, our results suggested that the CDCXM assay may be discontinued in pre-transplant workup owing to its very low sensitivity (12.1%). • Internationally different algorithms have been proposed named after cities of origin, like Leiden, Basel, Vienna and Minnesota, etc. • In living-donor kidney transplant setting, three screening tests (CDCXM, FCXM and HAS) were compared with confirmatory HAI (SAB) test. • Study recommended an algorithm of FCXM+HAS screening tests (Delhi approach) with highest sensitivity (100%) and specificity of 76.1%. [ABSTRACT FROM AUTHOR]

Background: In spite of many improvements that have reduced the blood component requirements, substantial numbers of transfusions are still needed in liver transplantation. Aims: The objective of the present study was to analyze the perioperative usage of allogenic blood components and predict the preoperative factors as predictors of red cell transfusion in live-related donor liver transplant recipients. Materials and Methods: The retrospective data on utilization of allogenic blood components were analyzed for a total of 150 liver transplant procedures. The data on utilization of blood components during surgery and till 48 hours of ICU stay was collected from the blood bank record and hospital information system (HIS). Results: Red cell concentrate was commonest blood component used in liver transplant recipient and most of the transfusion took place during surgery. During intraoperative period 92.7% (N = 139) of the cases utilized red cell components with the median number of five whereas in postoperative period only 38% (N = 57) of patients received blood with the median number of one. This study demonstrates that the preoperative hemoglobin and platelet count are the predictors of utilization of red cell concentrates during surgery. There were a total of 11 (7.3%) recipients who didn't receive allogeneic blood transfusion in any form.Utilization of blood components was negligible among organ donors. Conclusion: Our study demonstrates the pattern and predictors of usage of allogeneic blood components in liver transplant recipients at a tertiary healthcare center in India. [ABSTRACT FROM AUTHOR]

Introduction: Blood transfusions form a crucial and irreplaceable part in the medical management of many diseases. The collection of blood from voluntary, non-remunerated blood donors from low risk populations is an important measure for ensuring the availability and safety of blood transfusion. In a state like Uttarakhand which is visited by lakhs of visitors during pilgrimage season and where natural calamities and accidents are very common, the availability of blood is of utmost importance. Aim: To find out knowledge, attitude and practices of people towards voluntary blood donation to comprehend the situation and find ways to enhance voluntary blood donation in the state of Uttarakhand. Materials and Methods: Multi stage methodology was designed to target population including general population, influencers (doctors) and supporting organizations (camp organizers, State AIDS Control Society Officials) who were subjected to in-depth interview using pre-structured questionnaires to assess knowledge/awareness about voluntary blood donation, factors preventing and source of knowledge about voluntary blood donation. Result: The sample population consisted of mostly men (67%) in the age-group of 26-35 years. Requirement of blood and the measures to promote voluntary blood donation have a direct relationship with the total population and literacy level of the population. Awareness about blood donation, source of knowledge about blood donation, reasons for not donating blood are particularly stressed. With increase in educational level, the awareness level was also found to increase. While among illiterates 81 percent of the respondents knew about blood donation, among the post graduates the same ratio was found to be almost cent-percent. Among various reasons cited for not donating blood, lack of awareness being the most common reason. People gathered information about blood donation from several different sources with electronic media being the most prominent. Conclusion: This study illustrates how increasing awareness and marketing 'Voluntary blood donation' can enhance adequacy of blood needs of a state or for that matter the entire country. This study also underlines how different media, especially electronic media, can be used to propagate altruistic blood donation. [ABSTRACT FROM AUTHOR]

Abstract: Quality assurance of single donor platelets (SDP) is incomplete unless clinical response to platelet transfusion is measured. The primary objective of the study was to evaluate the quality of SDP derived from plateletpheresis procedures and to evaluate the response to platelet transfusion. Procedures were performed on 2287 accepted donors while 271 donors were deferred. Platelet count <1.5lac/μl and hemoglobin <12.5g/dl were the leading cause of deferral. The median platelet yield in a SDP bag was found to be 3.1×1011. The median corrected count increment (CCI) and post-transfusion platelet recovery (PPR) were found to be 10110×m2/μl and 24.5%, respectively. In India, the criteria for the selection of plateletpheresis donors should be revisited. Based on quality parameters, the Fresenius COM.TEC cell separator is comparable to other cell separators. [Copyright &y& Elsevier]

Background: The objective of the study was to find the incidence of hemolysis in samples transported through a pneumatic tube system (PTS) at different speeds. Methods: This prospective observational study was done in three phases: 'short distance and high speed (115 m at 3 m/s)', 'long distance and high speed (225 m at 3 m/s)' and 'short distance and slow speed (115 at 2 m/s)'. Fifty-two, 215 and 45 serum tube pairs, respectively, were evaluated in these three phases. A set of tubes was sent by PTS while the other was hand-carried. Samples were analyzed for supernatant hemoglobin (Hb), potassium (K+) and lactate dehydrogenase (LD). Results: Mean transit time of samples through the PTS was much shorter as compared to human courier in all three phases. LD was elevated in PTS arm in the 'short distance and high speed' phase and in the 'long distance and high speed' phase, all three indices of hemolysis - Hb, K+ and LD - showed elevation in the PTS arm. However, at 'short distance and slow speed' phase, there was no hemolysis in the PTS arm. Conclusions: Hospitals should validate their PTS before use and, by altering speed of sample transportation, hemolysis may be obliterated. [ABSTRACT FROM AUTHOR]

Five years five month old male child diagnosed with aplastic anemia required blood and platelet support regularly. He was advised bone marrow transplant (BMT) and had 6/6 match with a younger sibling (11 months old). He was admitted for planned BMT and was put on preparatory regimen five days prior to BMT. GCSF-primed bone marrow (BM) harvest was done from the donor, but the harvest was insufficient (1.05 × 10^6 /kg) and target dose of 4 million stem cells per kg could not be achieved. The BM harvest was infused into the patient and a repeat BM harvest was contemplated on next day. After careful evaluation of risks and benefits to the patient and the young donor, a decision to do a peripheral blood stem cell (PBSC) harvest was taken. The apheresis kit was blood primed to preclude possible hemodynamic imbalance in the donor considering low weight and young age. The entire harvest procedure (321 minutes) was uneventful with the donor remaining stable throughout. A dose of 2.40 million per kg of CD34+ cells was harvested and infused. Thus, a total dose of 3.45 million (1.05 BM and 2.4 PBSC) per kg was infused into the patient. Neutrophil and platelet engraftments and donor chimerism were achieved successfully with tandem BM-PBSC infusion and the patient continues to be disease free till 180 days follow up. This is possibly first published Indian report on BM-PBSC tandem transplant suggesting safety of PBSC harvests in small-weight young-age donor. [ABSTRACT FROM AUTHOR]

Background: The prevalence of microcytosis in donors and Iron Deficiency Anemia (IDA) and Beta-Thalassemia trait (BTT) in microcytic and non-microcytic donors has not been studied in India. The present study aims at finding the same. Materials and Methods: Initially 925 donor samples were evaluated on cell-counter. Of these, 50 were found to be microcytic. These were subjected to Ferritin and HbA2 determination. Subsequently, an additional 51, age-and-sex matched non-microcytic donor samples were selected to serve as controls. These were subjected to the same tests. Results: The prevalence of microcytosis was 5.4% (50/925). Among the microcytic donors, 52% were IDA, 36% BTT, 8% both, and 4% none. In case of non-microcytic donors 29.4% were IDA, 3.9% BTT, and 66.7% none. Conclusions: The study revealed a high prevalence of IDA and BTT in blood donors and a higher probability of finding these in the microcytic samples. This prompted authors to suggest an algorithm for screening of blood donors for IDA and BTT. The algorithm recommends doing an hemogram on all donor samples, routinely. Ferritin could be done only in microcytic samples. At levels lower than 15 ng/ml, it is diagnosed as IDA, and therefore, HPLC is performed only for non-IDA samples with Ferritin levels higher than 15 ng/ ml. By employing this algorithm, a substantial number of IDA and BTT could be diagnosed while keeping the number of Ferritin tests small and the number of HPLC tests even smaller and thus making it cost efficient. [ABSTRACT FROM AUTHOR]

The article presents a study on the distributed power-generation applications of reciprocating engines or internal combustion engines in the U.S. such as base load, peaking, and standby applications. The study used the Annual Power Generation Order Survey from the periodical "Diesel & Gas Turbine Worldwide." It highlights several sectors which used the biggest number of engines in the non-interconnected standby operations which include telecommunications, hospitals, and public buildings.

The article explores the impact of reciprocating engines on global distributed power-generation market by identifying and comparing the approximate number of these types of internal combustion engines being used for distributed power generation in different regions of the world from 1978 to 2003. The authors also describe reciprocating engines and its uses in the distributed power generation market as well as its two basic categories: spark ignition engines and compression ignition engines. Data analysis suggests that the largest estimated number of reciprocating engines operating in 2003 can be found in North America with 24, 879 engines. Analysis also reveals that most sales of reciprocating engines happened between 2001 to 2002 in all the classified regions of the world.

The article discusses the study which sought to understand the reciprocating engines and the impact of this technology on the distributed power-generation market. It aims to identify the approximate number of operating reciprocating engines in North America in 2003, determine if a sales trend for the engines is evident from performing a multi-year data analysis on engine sales and to obtain market segment information regarding the various types of installations and applications in the continuous, stand-by and peaking-power applications used in reciprocating engines. The total reciprocating engine power output pertaining to several applications is also examined to understand their total contribution to power generation and their compliance with environmental regulations.

Autoantibodies (AAbs) are important biomarkers for the diagnosis of Autoimmune Diseases (ADs). The detection of AAbs performed by current methods (indirect immunofluorescence test (IIFT)/Immunoblot (dot/line)/enzyme-linked immunosorbent assay ELISA) which have limitations in terms of performing multiple assays to arrive at laboratory diagnosis. We validated a novel multiplex bead-based assay (NMBA) that could quantify five common antibodies, simultaneously, on a flow-cytometry platform. A total of five recombinant antigens (SS-A Ro60, CENP B, RNP 70, Scl 70 and Histones) were covalently coupled onto beads and tested using known positive sera (positive for AAbs) and analyzed using flow cytometer. The sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were obtained for each antigen, analyzed by both assays (NMBA and IIFT). It showed comparable or higher values for the NMBA. The Spearman's rank correlation coefficient (Rho) were ≥ 0.97, (P <.05), indicating that multiplexing of the five autoantigens did not alter the results obtained when antigens were tested individually. The mean intra-assay precision measured by coefficient of variation (CV) was7.56 ± 1.6% and the mean inter-assay CV was 10.03 ± 1.34%. The time taken from sample receipt to reporting of results was 90 minutes in NMBA as compared to 150 minutes of IIFT The NMBA could quantitatively measure antibodies against five autoantigens, simultaneously in patient's sera. The assay is faster, objective, reproducible, requires low sample volume, and stable. Moreover, the flow cytometer in diagnostic laboratory settings for hematological and transplant immunology tests, can also be used for testing AAbs. [ABSTRACT FROM AUTHOR]

Abstract: The biggest hurdle in renal transplantation is the ABO blood group system. But recently ABO incompatible renal transplants have been performed using plasmapheresis (PP) as a part of the preconditioning protocol. In the present study, the objective of PP along with immunosuppression was to bring down the antibody titer of the patient to ⩽16 during the transplant and keep it low, around 32, until post-operative 4–14weeks. The patient (O Negative) had his mother (B Positive) as the ABO non-identical donor. The PP was performed with an apheresis equipment Com.Tec (Fresenius Kabi, Germany) to lower the anti-B antibody titer in the recipient. An Antihuman globulin (AHG) titer was performed for anti-B antibody following the departmental standard operating procedure. A total of 11 plasmapheresis procedures was performed preoperatively and four procedures were performed post-operatively to maintain the titer of the anti-B antibody at or below the desired level. The baseline anti-B antibody titer in the recipient was 512. The baseline titer came down to 8 after the end of the 11th procedure. Post-operatively we performed four plasmapheresis procedures to keep the titer at 32. During the post-operative follow up the titer has been maintained at 32 and the serum creatinine level has been maintained at approximately 1.0mg/dl and other parameters relevant to graft function were within normal limits. Our case could be the first reported case from India in which we used a plasmapheresis procedure as a part of preconditioning protocol instead of using an immunoadsorption column. Furthermore, it could be one of the few ABOiRTx cases, which has been performed at an isoagglutinin titer of 512 using plasma exchange as part of a preconditioning regime. [Copyright &y& Elsevier]

ABO subgroups or weaker variants of A or B are group A or B subjects whose erythrocytes give a weak or negative reaction serologically with anti-A or Anti – B antisera respectively. Occurrence of these subgroups may lead to an ABO discrepancy which often puts transfusion services in a quandary. ABO subgroups which present as ABO discrepancies can be missed if reverse grouping is not performed. This study was planned to estimate the prevalence of different subgroups which can present as an ABO discrepancy in Indian population, and provide an insight to transfusion services for identification of subgroups serologically. A cross-sectional, analytical study was performed at a tertiary healthcare based blood bank on whole blood donors and patients from January 2017 to July 2018. All suspected type II and Type IV (with Anti-A1) ABO discrepant samples were projected to an algorithmic testing process, to confirm discrepancy and then narrow down to the probable subgroup. A total of 33 subgroup discrepancies; 26 of A group and 7 of B group were identified out of 73,380 patient and 35,279 donor samples tested for blood grouping. Following the algorithm, the overall prevalence of weak subgroups which can present as an ABO discrepancy was found to be 1 in 3293 or 0.03% in our population by serological testing. Out of the discrepancies caused by subgroups, the prevalence of subgroups of A were 0.0101%, 0.0018%, 0.0009%, 0.0027%, 0.0027% and 0.0018% for A2 with anti-A1, A3, Aend, Ax, Am and Ael respectively while those of B were 0.009%, 0.0009%, 0.0009% and 0.009% for B3, Bx, Bm and Bel respectively. Algorithmic approach for resolution of ABO discrepancies caused by subgroups helps in identifying the subgroup which is important because these individuals may be mistyped as group O individuals. [ABSTRACT FROM AUTHOR]

• ELISA vs. ECLIA for blood donor screening. • ELISA vs. Chemiluminescence for TTD markers. • Sensitivity, Specificity, kappa value for ELISA and ECLIA. Safe blood transfusion being the cornerstone of any Blood Transfusion Services requires meticulous testing for Transfusion Transmitted Disease (TTD) markers in donated blood. We performed head-to-head comparison of ELISA and ECLIA for detection of TTD markers for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) in 10,164 Indian blood donors. All concordant reactive, discordant reactive and concordant non-reactive samples were re-confirmed using Individual Donor-Nucleic Acid Amplification Test (ID-NAT) as the 'gold standard' test. 223 samples were found reactive; out of which 93 (four HIV, 34 HCV and 55 HBV) samples were concordant reactive and tested positive by both methods while 130 discordant reactive samples were reactive either by ELISA or ECLIA. Out of 130 discordant reactive samples ELISA-reactive and ECLIA-non-reactive samples for HIV, HCV and HBV were 15, eight, and 29 respectively while ECLIA-reactive ELISA-non-reactive samples for HIV, HCV and HBV were 39, 36 and three respectively. Sensitivity of ECLIA and ELISA was 100 % for all three TTD markers, while specificity was 99.62 % and 99.85 % for HIV; 99.64 % and 99.84 % for HCV and 99.97 % and 99.70 % for HBV respectively. Strength of agreement and Kappa Statistics for ECLIA and ELISA compared to the gold standard test was poor and fair for HIV (k = 0.169 and 0.347), moderate and good for HCV (k = 0.539 and 0.763), and very good and good for HBV (k = 0.973 and 0.783). According to this study, it can be concluded both the testing techniques; ELISA and ECLIA have 100 % sensitivity for the detection for HBV, HCV and HIV in blood donors and therefore, either can be used for TTD screening in blood banks in India. [ABSTRACT FROM AUTHOR]

• 6678 donor blood samples were phenotyped to look for unusual phenotypes in Indian population. • Indigenous antibody screening panel was created with the help of phenotyped voluntary donor registry. • A rare donor with D - - phenotype was registered with the IRDP, Bristol, UK. A clinically significant red cell alloantibody is capable of accelerated destruction of red cells bearing the corresponding antigen. Knowledge of prevalence of these antigens is necessary for performing day to day work and for research in immunohematology. The primary aim of this study was to find the prevalence of 18 clinically significant blood group antigens in blood donors. Secondary objectives were to motivate and create a database of accessible, volunteer O blood group donors and to register rare donors with existing registries. A cross-sectional observational study was conducted in the department of Transfusion Medicine at a large tertiary care hospital in India from October 2016 to May 2018 with a planned sample size of 4800. Study population included healthy blood donors of either gender coming for blood donation to the blood centre. A total of 6678 samples were included in the study. First time donors were 21.41 % while 78.59 % were repeat donors. Voluntary donors constituted 15.81 % while replacement donors were 84.19 %. Male donors were 89.82 % while female donors were 10.18 %. The antigen, phenotype and gene frequencies were calculated. An extended phenotyped voluntary donor database was created and four rare donors were identified. One of these rare donors was registered with the International Rare Donor Panel (IRDP) and rest were registered in a local registry. This study might help enhance the confidence of blood banks in finding appropriate units for patients with unexpected antibodies or with rare phenotypes. It also paves a way for registering rare donors locally and internationally. [ABSTRACT FROM AUTHOR]

Anti-neutrophil cytoplasmic autoantibodies (ANCA) associated vasculitis (AAV) is a small vessel vasculitis with insufficient epidemiological estimates in India. We aimed to determine demographic, clinical features, and laboratory diagnosis of AAV patients presenting to a large tertiary care centre in India. 1289 patient samples were screened for ANCA by indirect immunofluorescence test (IIFT) and confirmation of ANCA target antigens was done by line immunoassay. Association between IIFT and LIA was determined in AAV. By IIFT, ANCA was detected in 13.0% (168 out of 1289), of which 23.8% (40/168) were positive with P-ANCA pattern, 25.0% (42/168) were positive with C-ANCA and 47.6% (80/168) showed an atypical pattern. On evaluation with a line immunoassay, 6.7% (86/1289) were positive out of which 52.3% (45/86), 41.9% (36/86), 8.8% (6/86) were positive for anti-MPO, anti-PR3, and anti-GBM respectively. In eosinophilic granulomatosis with polyangiitis (EGPA) 87.5% (7/8), and microscopic polyangiitis (MPA/RLV) 91.3% (21/23), anti-MPO was the predominantly observed antibody. In granulomatosis with polyangiitis (GPA) anti-PR3 antibody was predominant in 87.5% (28/32) cases. Out of 168 IIF positive samples 8, 32, and 23 cases of EGPA, GPA, and MPA/RLV were observed respectively. The primary aim of the study was to provide single-centre data to determine the laboratory diagnosis of AAV. A combination of IIFT and LIA was found to be an optimum testing strategy for the laboratory diagnosis of AAV. [ABSTRACT FROM AUTHOR]

• Sequential serological testing strategy increases diagnostic accuracy. • Sequential testing strategy, previously proven for anti-HIV, can also be applied to HBsAg. • PPV of Strategy III (ECLIA + RDT + ELFA) > Strategy IIB(ECLIA + RDT) > Strategy IIA(ECLIA + ELFA) > Strategy I(ECLIA). • Strategy IIB(ECLIA+RDT) was found to be the best strategy owing to diagnostic accuracy and cost effectiveness. The diagnostic accuracy of any serological test for detection of HBsAg is not 100%. We hypothesized that the sequential testing strategy proven for anti-HIV laboratory diagnosis should also apply to other infectious disease markers like HBsAg. Therefore, we evaluated the diagnostic accuracy of these strategies, I (single test), II (two tests in sequence), III (three tests in sequence) for diagnosis in patients and blood donors and compared it to the confirmatory test for HBsAg (Neutralization Test). Samples were initially tested for HBsAg by A1- Enhanced Chemiluminescent Immuno Assay (ECLIA). Initial reactive (aliquoted donor/patient) samples were reflexly tested by A2- Enzyme Linked Fluorescence Assay (ELFA) and A3- Immuno Chromatography Assay (ICA) assays. Confirmatory neutralization assay was performed on all initial reactive samples. Four strategies (I, II A, II B, and III) that were used in this analysis were; I = A1, IIA = A1 + A2, IIB = A1 + A3, and III = A1 + A2 + A3. The results of all four strategies were compared to Gold Standard (Neutralization Test). A total of, 112, 011 blood samples (75,111 patient samples and 36,900 whole blood donor samples) were initially tested for HBsAg by A-1 (CLIA). Amongst the tested samples, 1,296, 1,188, 1,078, 1,074 samples were found to be reactive by strategy I, IIA, IIB, III respectively. We observed that the PPV (Positive Predictive Value) of Strategy III > Strategy IIB > Strategy IIA > Strategy I. Sequential serological testing strategy comprising of initial sensitive test followed by more specific test increases the diagnostic accuracy of test report as compared to a single test. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an article on the importance of quality check on blood collection monitors.

Objective: Acute lymphoid leukemia (ALL) and acute myeloid leukemia (AML) are neoplastic blood disorders in which the cancerous white blood cells accumulate, resulting in a significant morbidity and mortality. Human leukocyte antigen (HLA) association is observed as one of the factors in the development of leukemia. The objective of the present study was to analyze the allele frequency of HLA Class I (HLA-A, HLA-B, and HLA-C) and Class II (HLA-DRB1 and HLA-DQB1) in Indian acute leukemia patients and to compare them with the frequencies in healthy, unrelated Indian individuals. Materials and Methods: We included 500 Indian leukemic patients (AML = 324 and ALL = 176) and 1000 unrelated, healthy, Indian individuals as controls. The HLA typing was performed using polymerase chain reaction with sequence-specific oligonucleotide probes. Results: On univariate analysis, allele frequencies of HLA-A*11 and HLA-DRB1*11 were lower in patients with ALL (P = 0.0181 and P = 0.0025, respectively). Whereas of HLA-A*11, HLA-DRB1*11, and HLA-B*51, these frequencies were relatively lower in patients with acute leukemia (AML + ALL) (P = 0.0382, P = 0.0093 and P = 0.0384, respectively) and HLA-C*01 (P = 0.0304) in AML when compared with control individuals. In contrast, the HLA-B*39 and HLA-C*07 allele frequency was higher in acute leukemia (P = 0.00372 and P = 0.0463, respectively) and in AML (P = 0.0010 and P = 0.0178, respectively) than that in controls. On multivariate analysis, B*39 showed positive associations with acute leukemia (P = 0.006) and AML (P = 0.002). HLA-A*11 and-DRB1*11 showed a negative association with acute leukemia (P = 0.009 and P < 0.0001, respectively) and ALL (P = 0.013 and P < 0.0001, respectively). Conclusions: The HLA-B*39 has a positive association with AML and acute leukemia, whereas HLA-A*11 and HLA-DRB1*11 alleles have negative association with ALL and HLA-B*51 along with these two alleles with acute leukemia. No positive association was observed with ALL. HLA-C*01 frequency was lower in AML patients than that in controls. [ABSTRACT FROM AUTHOR]

Intravenous (IV) drug abuse has been well established to be the source of transfer of infections, such as HIV, hepatitis C virus, and hepatitis B virus. However, often overlooked fact is that IV drug abusers have a potential for developing alloimmunization due to universal practice of flushing/washing out the syringe by own blood to rinse out the drug in the syringe. We present here a case of a 28-year-old man who presented with a rather unique predicament of having developed four different alloantibodies after exposure to allogenic blood through IV drug abuse. This case was detected promptly due to routine usage of type and screen policy for all the patients receiving transfusion. Such screening for atypical antibodies must be instituted to preemptively identify these antibodies and arrange compatible blood, which could have been difficult otherwise, at short notice during routine crossmatch. This is the first of its kind case ever reported from India and has no precedence. [ABSTRACT FROM AUTHOR]

In a developing country like India, with limited resources and access to healthcare facilities, dealing with massive hemorrhage is a major challenge. This challenge gets compounded by pre-existing anemia, hemostatic disorders, and logistic issues of timely transfer of such patients from peripheral hospitals to centers with adequate resources and management expertise. Despite the awareness amongst healthcare providers regarding management modalities of bleeding patients, no uniform Patient Blood Management (PBM) or perioperative bleeding management protocols have been implemented in India, yet. In light of this, an interdisciplinary expert group came together, comprising of experts working in transfusion medicine, hematology, obstetrics, anesthesiology and intensive care, to review current practices in management of bleeding in Indian healthcare institutions and evaluating the feasibility of implementing uniform PBM guidelines. The specific intent was to perform a gap analysis between the ideal and the current status in terms of practices and resources. The expert group identified interdisciplinary education in PBM and bleeding management, bleeding history, viscoelastic and platelet function testing, and the implementation of validated, setting-specific bleeding management protocols (algorithms) as important tools in PBM and perioperative bleeding management. Here, trauma, major surgery, postpartum hemorrhage, cardiac and liver surgery are the most common clinical settings associated with massive blood loss. Accordingly, PBM should be implemented as a multidisciplinary and practically applicable concept in India in a timely manner in order to optimize the use the precious resource blood and to increase patients' safety. [ABSTRACT FROM AUTHOR]

Abstract: Recent literature has endorsed favorable outcomes following ABOi kidney transplantation in pediatric population. Nevertheless, reluctance to pursue an ABOi still remains pervasive. This could be ascribed to various legitimate reasons, namely less extensive pediatric ABOi data, technical difficulties encountered during PP, cost restraints, and concerns regarding higher rates of antibody‐mediated rejection, infectious complications, and post‐transplant lymphoproliferative disorder as compared to adults. However, given the similar excellent outcomes of both ABOi and ABOc kidney transplantation, clinicians should consider this option sooner if a compatible donor or swap is not available. Here, we describe the outcomes of three pediatric ABOi performed at our institute in India (from 2014 till now), wherein distinct apheresis modalities had been employed in each desensitization protocol, and our techniques evolved with advancing science in apheresis. This case series includes India's first published pediatric ABO‐incompatible transplant (Case 2) and the youngest child to undergo ABO‐incompatible renal transplant in SAARC nations (Case 3). [ABSTRACT FROM AUTHOR]

Introduction: Human leukocyte antigen (HLA).matched unrelated donor (MUD) is the source of MUD transplantation (MUDT) for about 70% of patients who do not have matched related donor. To facilitate MUD search globally, there are 75 stem cell registries with more than 28 million donors registered (as of January 2017). Out of these donors, India has an insignificant representation of approximately 0.23 million. Further, Indians express high genetic variations, making it difficult to find MUD for an Indian patient. Aims and Objectives: The aim of this study is to analyze the MUD search for hematological disorder patients requiring transplant. An attempt was made to observe the MUD scenario for Indian patients requiring MUDT from accessible stem cell registries. Methods: A total of 558 patients approached Genebandhu registry and Chimera Transplant Research Foundation for MUD search over a period of 4 years requiring MUDT were included in this study. High resolution of HLA.A, .B, .C, .DRB1, and .DQB1 was used to perform MUD search through proprietary software called Prometheus and Bone Marrow Donors Worldwide (BMDW) search tool. Results: Out of 558 patients, MUD was located only for 135 (24.19%) patients. Out of these 135 patients, 91 (16.30%) patients found an MUD in global database and only 44 (7.88%) patients within India. Conclusion: This study demonstrates that building a large Indian database will not only help in increasing the chances of finding an MUD for maximum number of patients within India but also provide cost.effective treatment, in a society where cost is a vital factor. [ABSTRACT FROM AUTHOR]

• A novel kit for quantification of SARS-CoV-2 antibodies on clinical samples was developed. • Kit was validated with known samples, blind trial, third party validation and WHO referral samples. • Comparison with FDA approved Surrogate virus neutralization kit was also done. • The kit showed sensitive and selective detection of antibody (IgG) against S1-RBD of SARS-CoV-2. Since the pandemic occurred due to the emergence of SARS-CoV-2, there has always been a demand for a simple and sensitive diagnostic kit for detection of SARS-Cov-2 infection. In January 2020, WHO approved the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for detecting the presence of Covid-19 genetic material in individuals. Till date many diagnostic kits have arrived in the market for quantification of SARS-CoV-2 antibodies. In spite of being the gold standard method of Covid-19 detection, there are some drawbacks associated with RT-PCR which leads to false-negative results. Hence, in order to fulfil the need for an antibody testing kit for evaluating seroconversion and immunity acquisition in the population, an efficient, highly specific and sensitive assay, Chimera Soochak, an enzyme-linked immunoassay (ELISA) Kit has been developed. It works on the principle of detecting IgG antibodies developed specifically against the S1-RBD by employing a recombinant strain of S1-RBD produced in the HEK293 cell line. The developed kit was validated using different modes and methods to attain the utmost confidence on the samples collected from patients. The validation methodology included, validation with known samples, blind study, third-party validation, validation using WHO Reference Panel and comparison with FDA approved Surrogate virus neutralization kit. The kit was found successful in detecting IgG against the S1-RBD of SARS-CoV-2. The kit had been validated on multiple parameters. A total of 900 samples had been tested by using this kit and it has exhibited the sensitivity, specificity and accuracy for all the above-mentioned parameters. [ABSTRACT FROM AUTHOR]