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"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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]