{"title":"Establishing India’s first accredited EQA program in transplant immunology and Immunophenotyping: The CHIMERA® EQA experience","authors":"Niharika Singh , Vikash Chandra Mishra , Ashutosh Rawat , Aseem Kumar Tiwari , Anil Handoo , Shubhangi Shukla , Vimarsh Raina","doi":"10.1016/j.humimm.2025.111581","DOIUrl":"10.1016/j.humimm.2025.111581","url":null,"abstract":"<div><div>Quality Assurance (QA) plays a pivotal role in safeguarding the accuracy and reliability of laboratory test results, which are integral to informed clinical decision-making and optimal patient outcomes. External Quality Assessment (EQA), a cornerstone of QA, is mandated by international standards such as ISO/IEC 15189 to ensure laboratory competence and comparability across institutions.</div><div>Despite India’s position as the third-highest organ transplanting nation globally, a significant void persists in the availability of accredited EQA providers specialising in transplant immunology and immunophenotyping (IPT). Recognising this critical gap, the Chimera Translational Research Fraternity (CTRF) undertook a comprehensive gap analysis in 2019. The majority of participating laboratories articulated a strong demand for a locally accessible, cost-effective EQA program tailored to the specific requirements of the transplant immunology domain.</div><div>In response, Chimera EQA initiated a structured implementation strategy that included the recruitment of qualified personnel, the formation of a specialised core committee to develop technical protocols, the establishment of a Quality Management System (QMS), conducting pilot surveys and internal audits. These foundational steps preceded the formal application for ISO/IEC 17043 accreditation through the National Accreditation Board for Testing and Calibration Laboratories (NABL), a division of Quality Council of India (QCI).</div><div>Following the successful closure of nonconformities (NCs) and rigorous assessments, the program obtained ISO/IEC 17043 accreditation (initially ISO/IEC 17043:2010 and now updated to ISO/IEC 17043:2023) covering 25 analytes, officially establishing India’s first accredited EQA program in this niche field.</div><div>Since its inception, Chimera EQA has successfully conducted 82 PT surveys, overcoming formidable challenges such as securing clinical samples, raising awareness, and developing a robust digital infrastructure. This article demonstrates the successful implementation of this program and shows that, even within limited resources, an accredited EQA initiative is feasible. It can contribute to enhancing diagnostic quality, regulatory compliance, and international recognition in transplant immunology and IPT.</div></div>","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 5","pages":"Article 111581"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145018770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Using reverse vaccinology to construct multi-epitope subunit vaccine candidates for Klebsiella pneumoniae","authors":"Tehrim Ballim , Palesa Pamela Seele , Keleabetswe Lerato Mpye , Thandeka Khoza","doi":"10.1016/j.humimm.2025.111568","DOIUrl":"10.1016/j.humimm.2025.111568","url":null,"abstract":"<div><div><em>Klebsiella pneumoniae</em> (<em>K. pneumoniae</em>) is a Gram-negative clinically relevant pathogen responsible for causing nosocomial infections. This bacterium is resistant to a spectrum of antibiotics and has been listed under “critical” priority for research and development of new antibiotics and alternative strategies. Reverse vaccinology was used to construct multiepitope vaccine candidates against six <em>K. pneumoniae</em> outer membrane proteins. Predicted B- and T-cell epitopes were evaluated using various bioinformatic tools to confirm their antigenic and non-allergenic nature. Additionally, the global population coverage of the epitopes was observed to be 75% as per <em>in silico</em> analysis. These epitopes were then used for the design and <em>in silico</em> characterization of seven multiepitope vaccine candidates. Molecular docking and simulation studies demonstrated that 5 out of the 7 vaccine candidates formed strong stable interactions with TLR2 and TLR4. Furthermore, <em>in silico</em> immunization simulations demonstrated the ability of these candidates to elicit effective immune responses. Lastly, high codon adaptation Index (CAI) values ensured that the candidates can be expressed in the <em>Escherichia coli</em> K12 host system following codon optimized multiepitope cloning. Importantly, the high antigenicity and global coverage of the combined construct represents a novel combination not previously reported. Based on our findings, the designed multiepitope vaccine candidates have potential as a vaccination strategy against <em>K. pneumoniae.</em></div></div>","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 5","pages":"Article 111568"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145048853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Human ImmunologyPub Date : 2025-09-01DOI: 10.1016/j.humimm.2025.111426
L.E. Creary , A. Nizio , L.D. Slavich , Y. Li , D.S. Monos
{"title":"A case of severe combined immunodeficiency with sticky myeloid cells","authors":"L.E. Creary , A. Nizio , L.D. Slavich , Y. Li , D.S. Monos","doi":"10.1016/j.humimm.2025.111426","DOIUrl":"10.1016/j.humimm.2025.111426","url":null,"abstract":"","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 ","pages":"Article 111426"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Human ImmunologyPub Date : 2025-09-01DOI: 10.1016/j.humimm.2025.111412
K. Skill , J. Maloy , H.K. Islam , P. Putheti
{"title":"Incorporation of business intelligence into laboratory information system for efficient test performance and workload monitoring","authors":"K. Skill , J. Maloy , H.K. Islam , P. Putheti","doi":"10.1016/j.humimm.2025.111412","DOIUrl":"10.1016/j.humimm.2025.111412","url":null,"abstract":"","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 ","pages":"Article 111412"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Human ImmunologyPub Date : 2025-09-01DOI: 10.1016/j.humimm.2025.111414
T. Hachiya , M. Ishii , Y. Kawai , T. Katayama , B. Matern , S.J. Mack , K. Osoegawa , K. Tokunaga
{"title":"A database system for supporting data management and sharing in the 19th international histocompatibility and immunogenetics workshop","authors":"T. Hachiya , M. Ishii , Y. Kawai , T. Katayama , B. Matern , S.J. Mack , K. Osoegawa , K. Tokunaga","doi":"10.1016/j.humimm.2025.111414","DOIUrl":"10.1016/j.humimm.2025.111414","url":null,"abstract":"","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 ","pages":"Article 111414"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Human ImmunologyPub Date : 2025-09-01DOI: 10.1016/j.humimm.2025.111399
K. Osoegawa , J. Son , K. Yim , M.Fernandez Vina
{"title":"Guidelines reporting allo antibodies using the updated WHO serological HLA nomenclature – Ultra accurate specificity assignment (UASA)","authors":"K. Osoegawa , J. Son , K. Yim , M.Fernandez Vina","doi":"10.1016/j.humimm.2025.111399","DOIUrl":"10.1016/j.humimm.2025.111399","url":null,"abstract":"","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 ","pages":"Article 111399"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Human ImmunologyPub Date : 2025-09-01DOI: 10.1016/j.humimm.2025.111386
D. Guan , J. Wen , L. Dou , X. Li , Z. Wang , D. Wang , H. Xiong , B. Zhang , D. Liu , Y. He , X. Liu
{"title":"Integration of HLA evolutionary divergence with post-transplant biomarkers enhances prediction of non-relapse mortality in pediatric haploidentical hematopoietic stem cell transplantation","authors":"D. Guan , J. Wen , L. Dou , X. Li , Z. Wang , D. Wang , H. Xiong , B. Zhang , D. Liu , Y. He , X. Liu","doi":"10.1016/j.humimm.2025.111386","DOIUrl":"10.1016/j.humimm.2025.111386","url":null,"abstract":"","PeriodicalId":55047,"journal":{"name":"Human Immunology","volume":"86 ","pages":"Article 111386"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}