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Analytical and clinical performance evaluation of enhanced chemiluminescence-based fourth-generation HIV combo assay: Report from tertiary health-care setup in North India. 基于增强化学发光的第四代 HIV 组合检测的分析和临床性能评估:印度北部三级医疗机构的报告。
IF 0.6 Q4 HEMATOLOGY Pub Date : 2023-07-01 Epub Date: 2023-05-11 DOI: 10.4103/ajts.ajts_128_22
Aseem Kumar Tiwari, Geet Aggarwal, Swati Pabbi, Subhasis Mitra, Neeti Yadav, Virendra Verma, K Cheirmaraj

Introduction: HIV fourth-generation assay, designed for the detection of HIV p24 antigen along with anti-HIV antibodies of both immunoglobulin M and immunoglobulin G type against HIV 1 and HIV 2 viral antigens, have helped in the early detection of HIV infection and supports in minimizing the transmission risk in the acute phase of infection. The objective of this study was to evaluate the analytical and clinical performance of HIV fourth-generation assay based on enhanced chemiluminescence technology.

Materials and methods: The analytical performance of the assay was evaluated in terms of accuracy, precision, limit of detection, type of sample (serum vs. plasma), cross-reactivity (with other transfusion transmissible infections markers), and interference (with endogenous substances). Proficiency control material included kit-controls, archived known positive donor samples, third-party controls, and World Health Organization (WHO)/National Institute for Biological Standards and Controls (NIBSC, MHRA, UK) controls. The clinical performance was evaluated using routine donor and patient samples received during the study period.

Results: HIV fourth-generation assay showed reliable and reproducible results measured in terms of coefficient of variation % with kit-controls, archived known positive donor samples, third-party controls, and WHO international standards for anti-HIV 1 and 2 antibodies, HIV1 p24 antigens and HIV2 p26 antigen controls. The analytical sensitivity of the HIV fourth-generation assay was found to be 0.1 IU/mL of HIV1 p24 antigen control and there was no cross-reactivity or interference observed. In the clinical performance of the assay, HIV fourth-generation assay showed reliable performance in both donor and patient samples.

Conclusion: HIV fourth-generation assay meets the requirements for its use as a screening assay for HIV infection based on the analytical and clinical performance of the assay.

导言:第四代 HIV 检测试剂盒设计用于检测 HIV p24 抗原以及针对 HIV 1 和 HIV 2 病毒抗原的免疫球蛋白 M 型和免疫球蛋白 G 型抗 HIV 抗体,有助于早期检测 HIV 感染并在感染急性期将传播风险降至最低。本研究旨在评估基于增强化学发光技术的第四代 HIV 检测方法的分析和临床性能:从准确度、精密度、检测限、样本类型(血清与血浆)、交叉反应(与其他输血传播感染标记物)和干扰(与内源性物质)等方面评估了该检测方法的分析性能。能力对照材料包括试剂盒对照、存档的已知阳性供体样本、第三方对照以及世界卫生组织(WHO)/英国国家生物标准与控制研究所(NIBSC,MHRA,UK)对照。使用研究期间收到的常规捐献者和患者样本对临床性能进行了评估:结果:第四代艾滋病毒检测法与试剂盒对照品、已知阳性捐献者存档样本、第三方对照品以及世界卫生组织抗艾滋病毒 1 和 2 抗体、HIV1 p24 抗原和 HIV2 p26 抗原对照品的变异系数(%)相比,结果可靠且可重复。第四代艾滋病毒检测法的分析灵敏度为 0.1 IU/毫升(HIV1 p24 抗原对照),未发现交叉反应或干扰。在检测的临床表现方面,第四代艾滋病毒检测法在供体和患者样本中均表现出可靠的性能:结论:根据第四代 HIV 检测试剂盒的分析和临床表现,该试剂盒符合用作 HIV 感染筛查试剂盒的要求。
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引用次数: 0
Determination of the Rh/Kell phenotypes in donor as well as patients might be significant to provide phenotype-matched blood to cancer patients: A retrospective analysis from a tertiary care oncology center in North India. 确定献血者和患者的 Rh/Kell 表型对于为癌症患者提供表型匹配的血液具有重要意义:印度北部一家三级肿瘤中心的回顾性分析。
IF 0.6 Q4 HEMATOLOGY Pub Date : 2023-07-01 Epub Date: 2023-11-07 DOI: 10.4103/ajts.ajts_44_23
Amardeep Pathak, Narender Tejwani, Devasis Panda, Anurag Mehta

Background: Multiple reports are available from different parts of the globe indicating the incidences of alloimmunization and blood transfusion-related reactions, which emphasizes the need for phenotyping and providing antigen-matched safe blood.

Aims and objectives: This study aims to determine the frequency of Rh and Kell antigens and phenotype for both donors and patients to propose the importance of providing Rh Kell phenotype cross-matched packed red blood cell (RBC) units to minimize the alloimmunization and transfusion reactions.

Materials and methods: Ten thousand blood donors and four thousand patients were investigated between October 2017 and July 2019. Each donor unit was tested for blood grouping, antibody screening, and Rh Kell antigen Phenotyping, and the blood unit was issued after the patient's blood grouping, antibody screening by 3 cell panels, and Rh Kell antigen phenotyping followed by cross-matching with an Rh Kell-matched phenotype RBC unit.

Results: Nine thousand four hundred and fifty-two donors were D positive (94.5%) while 548 tested D negative (5.5%). Overall Rh and K antigens frequencies in donors were: "e" (98%) >"D" (94.5%) >"C" (86.6%) > "c" (57.5%) >"E" (18.8%) >K (0.98%). Among patients, 3762 tested D positive (94.05%), and 238 tested D negative (5.95%). Overall Rh and K antigens frequencies in patients were: "e" (98.5%) >"D" (94.05%) >"C" (90.2%) >"c" (51%) >"E" (18.2%) >K (1.8%).

Conclusion: Our study has given us more clarity on the prevalence of major Rh and K antigens in our donor as well as patient populations, highlighting the similarities as well as differences. This variance holds a great significance, since such donor units when transfused into patients may lead to alloimmunization and adverse transfusion reactions. Hence, the determination of Rh and Kell phenotypes and providing phenotype-matched blood will help prevent such events.

背景:来自全球不同地区的多份报告显示了同种免疫和输血相关反应的发生率,这强调了进行表型分析和提供抗原相匹配的安全血液的必要性:本研究旨在确定献血者和患者的 Rh 和 Kell 抗原及表型的频率,从而提出提供 Rh Kell 表型交叉匹配的包装红细胞(RBC)的重要性,以最大限度地减少同种免疫和输血反应:在 2017 年 10 月至 2019 年 7 月期间,对一万名献血者和四千名患者进行了调查。每个献血单位都进行了血型检测、抗体筛查和Rh Kell抗原表型检测,在对患者进行血型检测、3个细胞平板的抗体筛查和Rh Kell抗原表型检测后,再与Rh Kell匹配表型的RBC单位进行交叉配血,然后发放血液单位:结果:9452 名献血者的血型为 D 阳性(94.5%),548 名献血者的血型为 D 阴性(5.5%)。捐献者的总体 Rh 和 K 抗原频率为e"(98%)>"D"(94.5%)>"C"(86.6%)>"c"(57.5%)>"E"(18.8%)>K(0.98%)。在患者中,3762 人检测出 D 阳性(94.05%),238 人检测出 D 阴性(5.95%)。患者的 Rh 抗原和 K 抗原总频率为e"(98.5%)>"D"(94.05%)>"C"(90.2%)>"c"(51%)>"E"(18.2%)>K(1.8%):我们的研究让我们更清楚地了解了主要 Rh 抗原和 K 抗原在供体和患者人群中的流行情况,突出了两者的相似性和差异性。这种差异具有重要意义,因为这些供体输给患者时可能会导致同种免疫和不良输血反应。因此,确定 Rh 和 Kell 表型并提供表型匹配的血液将有助于防止此类事件的发生。
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引用次数: 0
Poster Papers 海报论文
Q4 HEMATOLOGY Pub Date : 2023-05-01 DOI: 10.4103/0973-6247.377173
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引用次数: 0
47th Annual National Conference of Indian Society of Blood Transfusion and Immunohaematology (ISBTI) TRANSCON-2022 B 11th-13th November 2022, Jammu 第47届印度输血和免疫血液学学会(ISBTI)全国年会TRANSCON-2022 B 2022年11月11日至13日,查谟
Q4 HEMATOLOGY Pub Date : 2023-05-01 DOI: 10.4103/0973-6247.377171
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引用次数: 0
47th Annual National Conference of Indian Society of Blood Transfusion and Immunohaematology (ISBTI) TRANSCON-2022 B 11th-13th November 2022, Jammu. 第47届印度输血和免疫血液学学会(ISBTI)全国年会TRANSCON-2022 B 2022年11月11日至13日,查谟。
Q4 HEMATOLOGY Pub Date : 2023-05-01
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引用次数: 0
Oral Abstracts TRANSMEDCON 2022 TRANSMEDCON 2022
Q4 HEMATOLOGY Pub Date : 2023-05-01 DOI: 10.4103/0973-6247.377169
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引用次数: 0
E-Poster Abstracts TRANSMEDCON 2022 电子海报摘要TRANSMEDCON 2022
Q4 HEMATOLOGY Pub Date : 2023-05-01 DOI: 10.4103/0973-6247.377170
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引用次数: 0
Write Up. 写了。
Q4 HEMATOLOGY Pub Date : 2023-05-01
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引用次数: 0
Impact of buffy coat reduction on the severity of febrile nonhemolytic transfusion reactions with red cell components. 血沉棕皮减少对具有红细胞成分的发热性非溶血性输血反应严重程度的影响。
Q4 HEMATOLOGY Pub Date : 2023-01-01 Epub Date: 2022-12-12 DOI: 10.4103/ajts.ajts_90_22
Lakhvinder Singh, Nippun Prinja, Ashish Jain, Ratti Ram Sharma, Neelam Marwaha

Background: Febrile nonhemolytic transfusion reactions (FNHTRs) are the most common adverse reaction reported under the Haemovigilance Programme of India, and the use of leukodepleted blood products is recommended. The severity of the reaction may affect the morbidity associated with the reaction. This study aims to calculate the incidence of various transfusion reactions in our blood center and to evaluate the impact of buffy coat reduction on the severity of febrile reaction and other hospital resource-consuming activities.

Materials and methods: It was an observational retrospective study in which all reported FNHTRs were evaluated during the period July 1, 2018-July 31, 2019. Patient demographic details, component transfused, and clinical presentation were analyzed to identify factors affecting the severity of FNHTRs.

Results: The incidence of transfusion reaction in our study period was 0.11%. Out of total 76 reactions reported, 34 (44.7%) were febrile reactions. Other reactions included allergic reactions (36.8%), pulmonary reactions (9.2%), transfusion-associated hypotension (3.9%), and others (2.7%). The incidence of FNHTR in buffy coat-depleted packed red blood cells (PRBCs) and PRBCs is 0.03% and 0.05%, respectively. FNHTRs are seen more in females with prior history of transfusion (87.5%) as compared to males (66.67%) (P = 0.046). We also found that FNHTRs are less severe with buffy coat-depleted PRBC transfusion than PRBC transfusion as mean ± standard deviation temperature rise was less in buffy coat-depleted PRBC (1.3 ± 0.8) than PRBC (1.74 ± 1.129). The febrile response to buffy coat-depleted PRBC transfusion occurred at higher volume (145 ml) transfusion than PRBC transfusion (87.2 ml), and it was statistically significant (P = 0.047).

Conclusion and summary: Leukoreduction remains the main modality to prevent FNHTR, but in developing countries like India, the use of buffy coat-depleted PRBC over PRBC can reduce the incidence and severity of FNHTR.

背景:发热性非溶血性输血反应(FNHTRs)是根据印度血液监测计划报告的最常见的不良反应,建议使用白细胞贫化的血液制品。反应的严重程度可能会影响与反应相关的发病率。本研究旨在计算我们血液中心各种输血反应的发生率,并评估血沉棕皮减少对发热反应严重程度和其他医院资源消耗活动的影响。材料和方法:这是一项观察性回顾性研究,对2018年7月1日至2019年7月31日期间所有报告的FNHTR进行了评估。分析患者的人口统计学细节、输血成分和临床表现,以确定影响FNHTRs严重程度的因素。结果:在我们的研究期间,输血反应的发生率为0.11%。在报告的76例反应中,34例(44.7%)为发热反应。其他反应包括过敏反应(36.8%)、肺部反应(9.2%)、输血相关低血压(3.9%)和其他反应(2.7%)。在血沉棕黄层耗竭的堆积红细胞(PRBCs)和PRBCs中,FNHTR的发生率分别为0.03%和0.05%。与男性(66.67%)相比,有输血史的女性(87.5%)出现的FNHTRs更多(P=0.046)。我们还发现,与输注PRBC相比,输注血沉棕黄层的FNHTR不那么严重,因为输注血黄层的平均±标准差温升(1.3±0.8)小于输注PRBC1.74±1.129)输血量(145ml)高于PRBC(87.2ml),具有统计学意义(P=0.047)。
{"title":"Impact of buffy coat reduction on the severity of febrile nonhemolytic transfusion reactions with red cell components.","authors":"Lakhvinder Singh,&nbsp;Nippun Prinja,&nbsp;Ashish Jain,&nbsp;Ratti Ram Sharma,&nbsp;Neelam Marwaha","doi":"10.4103/ajts.ajts_90_22","DOIUrl":"10.4103/ajts.ajts_90_22","url":null,"abstract":"<p><strong>Background: </strong>Febrile nonhemolytic transfusion reactions (FNHTRs) are the most common adverse reaction reported under the Haemovigilance Programme of India, and the use of leukodepleted blood products is recommended. The severity of the reaction may affect the morbidity associated with the reaction. This study aims to calculate the incidence of various transfusion reactions in our blood center and to evaluate the impact of buffy coat reduction on the severity of febrile reaction and other hospital resource-consuming activities.</p><p><strong>Materials and methods: </strong>It was an observational retrospective study in which all reported FNHTRs were evaluated during the period July 1, 2018-July 31, 2019. Patient demographic details, component transfused, and clinical presentation were analyzed to identify factors affecting the severity of FNHTRs.</p><p><strong>Results: </strong>The incidence of transfusion reaction in our study period was 0.11%. Out of total 76 reactions reported, 34 (44.7%) were febrile reactions. Other reactions included allergic reactions (36.8%), pulmonary reactions (9.2%), transfusion-associated hypotension (3.9%), and others (2.7%). The incidence of FNHTR in buffy coat-depleted packed red blood cells (PRBCs) and PRBCs is 0.03% and 0.05%, respectively. FNHTRs are seen more in females with prior history of transfusion (87.5%) as compared to males (66.67%) (<i>P</i> = 0.046). We also found that FNHTRs are less severe with buffy coat-depleted PRBC transfusion than PRBC transfusion as mean ± standard deviation temperature rise was less in buffy coat-depleted PRBC (1.3 ± 0.8) than PRBC (1.74 ± 1.129). The febrile response to buffy coat-depleted PRBC transfusion occurred at higher volume (145 ml) transfusion than PRBC transfusion (87.2 ml), and it was statistically significant (<i>P</i> = 0.047).</p><p><strong>Conclusion and summary: </strong>Leukoreduction remains the main modality to prevent FNHTR, but in developing countries like India, the use of buffy coat-depleted PRBC over PRBC can reduce the incidence and severity of FNHTR.</p>","PeriodicalId":42296,"journal":{"name":"Asian Journal of Transfusion Science","volume":"17 1","pages":"69-73"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ec/63/AJTS-17-69.PMC10180807.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9475879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Structured feedback: A teaching and learning tool for the postgraduate medical students in transfusion medicine. 结构化反馈:输血医学研究生的教学工具。
Q4 HEMATOLOGY Pub Date : 2023-01-01 Epub Date: 2022-09-28 DOI: 10.4103/ajts.ajts_127_21
Daljit Kaur, Gita Negi, Ashish Jain, Sushant Kumar Meinia, Tanvir Kaur Sidhu, Bharti Bhandari Rathore

Context: Structured Feedback is a learning and assessment tool designed to provide feedback to students and educators to adjust learning and teaching during the training. Lack of provision of structured feedback to postgraduate (PG) medical students prompted us to plan a study to introduce a structured feedback module into the existing monthly assessment schedules in the Department of Transfusion Medicine.

Aim: This study aims to introduce a structured feedback module and evaluate its efficacy after incorporation into the existing monthly assessment schedules for the PG students in the Department of Transfusion Medicine.

Design and setting: A quasi-experimental study was commenced after obtaining clearance from the Institutional Ethics Committee in the Department of Transfusion Medicine for the students pursuing postgraduation in Transfusion Medicine.

Methodology: A peer-validated feedback module was designed and implemented for MD students by the core team faculty. The students underwent the structured feedback sessions after each monthly assessment for of 3 months. One on one, verbal feedback was conducted using Pendleton's method, for monthly online assessment for the learning that happened during study period.

Data collection and statistical analysis: The data were collected from the open-ended and closed-ended questions using Google form-based Student/Faculty perception and students' pre-post self-efficacy questionnaires on 5-point Likert Scale and the quantitative data analysis was done using percentage of Likert scores, median values for each item for pre-and post-responses and comparison using nonparametric test - Wilcoxon signed-rank test. The qualitative data analysis was done using thematic analysis from the open ended questions.

Results: All (n = 9; 100%) the PG students strongly agreed and agreed (median score of 5 and 4) that the feedback they received made them aware of their learning gaps, enabled them in bridging those gaps and provided ample opportunity to interact with faculty. Both students and faculty agreed that the feedback session should be an ongoing and continuous process in the department.

Conclusion: Both the students as well as faculty were satisfied with the implementation of the feedback module in the department. Students reported awareness about the learning gaps, identification of appropriate study resources, and ample opportunity to interact with faculty, after taking the feedback sessions. The faculty felt satisfied on the acquisition of new skill for delivering structured feedback to students.

背景:结构化反馈是一种学习和评估工具,旨在向学生和教育工作者提供反馈,以在培训期间调整学习和教学。由于缺乏向研究生(PG)医学生提供结构化反馈,我们计划进行一项研究,将结构化反馈模块引入输血医学系现有的月度评估计划中。目的:本研究旨在引入结构化反馈模块,并在将其纳入现有的输血医学系的PG学生。设计和设置:在获得输血医学系机构伦理委员会的批准后,为追求输血医学毕业的学生开始了一项准实验研究。方法:核心团队为MD学生设计并实施了一个经同行验证的反馈模块官能在为期3个月的每月评估后,学生们接受了结构化的反馈会议。使用Pendleton的方法进行了一对一的口头反馈,每月对学习期间发生的学习进行在线评估。数据收集和统计分析:数据来自开放式和封闭式问题,使用基于谷歌表格的学生/教师感知和5分Likert量表的学生前后自我效能感问卷,并使用Likert分数百分比进行定量数据分析,每个项目前后反应的中值,并使用非参数检验进行比较——Wilcoxon符号秩检验。定性数据分析采用了对开放式问题的专题分析。结果:所有(n=9;100%)PG学生都强烈同意并同意(中位得分为5和4),他们收到的反馈让他们意识到了自己的学习差距,使他们能够弥合这些差距,并提供了与教师互动的充足机会。学生和教职员工都认为,反馈会议应该是该系持续不断的过程。结论:学生和教职员工都对反馈模块在该系的实施感到满意。学生们报告说,在参加反馈会议后,他们意识到了学习差距,确定了适当的学习资源,并有充足的机会与教师互动。教员们对获得向学生提供结构化反馈的新技能感到满意。
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引用次数: 0
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Asian Journal of Transfusion Science
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