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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]

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]

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 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]

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]

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]

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]

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]

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 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]

• 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]

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