Yin Wang , Peilei Hu , Shuorun Tang , Zhuo Zhang , Qian Li
{"title":"Establishment and evaluation of a diagnostic model for severe pulmonary tuberculosis","authors":"Yin Wang , Peilei Hu , Shuorun Tang , Zhuo Zhang , Qian Li","doi":"10.1016/j.diagmicrobio.2025.116946","DOIUrl":"10.1016/j.diagmicrobio.2025.116946","url":null,"abstract":"<div><h3>Background</h3><div>Diagnosing severe pulmonary tuberculosis (PTB) remains challenging because of the absence of reliable biomarkers, delaying management and risk prediction. This study aimed to identify key risk factors for severe PTB and develop a predictive model for early assessment and intervention.</div></div><div><h3>Methods</h3><div>Between January 2022 and December 2023, 182 patients with PTB were included and categorized as having non-severe PTB (<em>n</em> = 112) or severe PTB (<em>n</em> = 70), defined as active PTB involving three or more lung fields on chest radiography. Demographic data, hematological parameters, vascular endothelial growth factor (VEGF), and inflammatory markers were analyzed and compared. Risk factors for severe PTB were identified using regression models. Significant variables were used to construct a diagnostic nomogram, with predictive performance evaluated <em>via</em> receiver operating characteristic (ROC) curve analysis.</div></div><div><h3>Results</h3><div>The analysis identified a history of diabetes (odds ratio [OR] = 3.258), a higher systemic inflammation response index (SIRI; OR = 2.742), and higher VEGF (OR = 1.011) and IL-6 levels (OR = 1.069) as independent risk factors for severe PTB. A diagnostic nomogram was subsequently developed using these factors. ROC analysis demonstrated that the model achieved an area under the ROC curve of 0.866 (<em>P</em> < 0.001), sensitivity of 80 %, specificity of 83.04 %, and Youden index of 0.630, significantly outperforming the individual factors (<em>P</em> < 0.05). An independent validation confirmed its robustness.</div></div><div><h3>Conclusions</h3><div>A predictive model incorporating diabetes, SIRI, VEGF, and IL-6 enables reliable early risk assessment of severe PTB, facilitating targeted interventions and improving clinical outcomes.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116946"},"PeriodicalIF":2.1,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144262893","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":"Diagnostic challenges and misdiagnosis of ameboma as colorectal cancer: A global systematic review","authors":"Mahsa Ayoubi , Reza Ghasemikhah","doi":"10.1016/j.diagmicrobio.2025.116938","DOIUrl":"10.1016/j.diagmicrobio.2025.116938","url":null,"abstract":"<div><div>One diagnostic challenge in the field of gastroenterology is distinguishing between various types of polyps, including amebomas. In this study, we aimed to develop a stronger perspective for professionals to differentiate amebomas from colon cancer based on the clinical and paraclinical findings of patients who were initially diagnosed with cancer but were later found to have amebomas. The international scientific databases consulted for this article on January 6, 2023, 2023, comprised PubMed, Scopus, ScienceDirect, and Web of Science. Moreover, Google Scholar was employed to collect pertinent information. The study included 12 articles about 12 patients with ameboma, mostly reported in Asian countries like India. The patients were aged 27-77 years, with most in their fifties. Common symptoms included abdominal pain (reported almost in all cases), fever (42 % of cases), constipation (33 %), diarrhea (16 %), vomiting and nausea (25 %), abdominal distention (25 %), weight loss (16 %), and hematochezia (16 %) other symptoms such as abdominal mass, anorexia and stiffness were reported in some cases with lower prevalences (8 % or lesss). Diagnosis was mostly through histopathological examination, but Polymerase Chain Reaction, serological tests, and stool exams were also used. The study highlights the significance of accurately diagnosing ameboma, which is frequently misidentified as colon cancer. It underscores the necessity for improved diagnostic methods, including histopathological and microscopic evaluations, particularly in patients aged 50 and older, to identify ameboma as a possible cause of intestinal symptoms.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116938"},"PeriodicalIF":2.1,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240125","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":"Dinga dinga fever: a new emerging disease or a modern-day dancing plague?","authors":"Mitesh Patel , Malvi Surti","doi":"10.1016/j.diagmicrobio.2025.116941","DOIUrl":"10.1016/j.diagmicrobio.2025.116941","url":null,"abstract":"<div><div>Dinga Dinga fever, a novel illness in Bundibugyo district of Uganda, causes uncontrollable tremors, fever and fatigue, primarily in women and girls. Though non-fatal, it disrupts communities. The present article explores its symptoms, epidemiology and ongoing investigations, emphasizing interdisciplinary approaches and public health interventions while drawing comparisons to historical Dancing Plagues.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116941"},"PeriodicalIF":2.1,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271163","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}
Kristine Lindell, Sarah Sheldon, Luke Kingry, Paul S. Mead, Claudia Molins, Alison F. Hinckley
{"title":"Epidemiologic and clinical characteristics and outcomes of patients diagnosed with Southern Tick Associated Rash Illness (STARI) – 2018-2019","authors":"Kristine Lindell, Sarah Sheldon, Luke Kingry, Paul S. Mead, Claudia Molins, Alison F. Hinckley","doi":"10.1016/j.diagmicrobio.2025.116928","DOIUrl":"10.1016/j.diagmicrobio.2025.116928","url":null,"abstract":"<div><div>In this study, we describe the clinical course and outcomes for 58 patients presenting with Southern tick-associated rash illness (STARI). Using 16S sequencing, no known bacterial pathogen was detected. Although an etiologic agent remains unknown, these results do provide updated information on rash color, shape, duration, and treatment outcomes.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116928"},"PeriodicalIF":2.1,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144288894","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}
Serap Süzük Yıldız , Esra Tavukcu , Mert Emre Ölmez , Sevgi Şahin , Habibe Kurtaran Tek , Can Hüseyin Hekimoğlu , Ayşe Semra Güreser , İpek Mumcuoğlu , Tuba Dal
{"title":"Evaluation of EUCAST rapid antibiotic susceptibility testing for positive blood cultures in the Autobio BC60 blood culture system","authors":"Serap Süzük Yıldız , Esra Tavukcu , Mert Emre Ölmez , Sevgi Şahin , Habibe Kurtaran Tek , Can Hüseyin Hekimoğlu , Ayşe Semra Güreser , İpek Mumcuoğlu , Tuba Dal","doi":"10.1016/j.diagmicrobio.2025.116937","DOIUrl":"10.1016/j.diagmicrobio.2025.116937","url":null,"abstract":"<div><div>Early diagnosis and effective treatment of bloodstream infections significantly improve prognosis. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) has developed rapid antimicrobial susceptibility testing(RAST) based on the disk diffusion method. In the present study, we compared the data from the RAST study from positive blood cultures in the Autobio BC (Autobio-diagnostics, Zhengzhou, Chinese) blood culture system with those obtained using the standard disk diffusion method.</div><div>A total of 234 spiked blood culture samples (<em>Klebsiella penumoniae</em> [<em>n</em>= 50], <em>Escherichia coli</em> [<em>n</em>= 50], <em>Acinetobacter baumannii</em> [<em>n</em>= 20], <em>Pseudomonas aeruginosa</em> [<em>n</em>= 13], <em>Staphylococcus aureus</em> [<em>n</em>= 51], and <em>Enterococcus</em> spp. [<em>n</em>= 50]) were collected. The RAST test was performed on positive bottles, and the results were measured at 4, 8, and 20 h. Standard disk diffusion (sDD) was performed, and zone diameters were measured from subculture samples obtained from blood culture bottles. The RAST zone diameters were compared with the sDD zone diameters.</div><div>The categorical agreement based on the readable zone diameters for the 4th, 8th, and 20th h was <em>K.pneumoniae</em> (99.7 %,99.7 %,99.7 %), <em>E.coli</em> (99.4 %,99.6 %,99.7 %), <em>A.baumannii</em> (98.7 %,98.7 %,98.7 %), <em>P.aeruginosa</em> (100 %,99.3 %,100 %), <em>S. aureus</em> (100 %,100 %,100 %), and <em>Enterococcus</em> spp. (100 %,100 %,100 %). The minor error(mE), major error(ME), and very major error(VME) results obtained in the whole study were determined as 0.9, 0, and 1.3 for 4 h; 1.4, 0, and 1.3 for 8 h; 0.6, 0, and 1.3 for 20 h.</div><div>The EUCAST RAST study can be performed from positive bottles in the Autobio BC blood culture system, resulting in reliable outcomes. To report earlier antibiotic susceptibility test results, laboratories using Autobio BC can combine RAST with quality control studies.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116937"},"PeriodicalIF":2.1,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271162","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}
Mahmoud A. Boualam , Erwan Le Provost , Michel Drancourt , Hamadou Oumarou Hama
{"title":"Diagnosing past infections: A review","authors":"Mahmoud A. Boualam , Erwan Le Provost , Michel Drancourt , Hamadou Oumarou Hama","doi":"10.1016/j.diagmicrobio.2025.116933","DOIUrl":"10.1016/j.diagmicrobio.2025.116933","url":null,"abstract":"<div><div>Diagnosis of ancient infectious diseases has seen remarkable advances, contributing significantly to understanding historical health challenges and shaping medical research. This review explores the evolution of diagnostic methods and features emerging diagnostic techniques. The early detection of ancient infectious diseases primarily relied on observational evidence, skeletal remains, and historical records. Notable outbreaks such as the Black Death in the 14th century and smallpox epidemics, have left historical imprints. Pioneering diagnostic methods included the paleopathological analysis of the remains of bones and tissue lesions. Later, microbiology methods were adapted to ancient materials, including molecular and serological techniques such as PCR, serology and immunodetection, which were employed to detect DNA or antibodies from ancient pathogens under the name of the paleomicrobiology approach. This emerged as a distinct field, making it possible to isolate and identify ancient pathogens from preserved samples. Advances in next generation sequencing are now revolutionising the diagnosis of ancient diseases, enabling the retrieval of ancient pathogen genomes from well-preserved samples such as dental pulp, tartar, bone and mummified tissues, helping understand disease evolution and transmission patterns. Ongoing improvements in DNA sequencing and metagenomics will enhance the accuracy and scope of the diagnosis of ancient diseases. Collaboration between archaeologists, historians, paleomicrobiologists, geneticists and epidemiologists will drive further breakthroughs. Advances in paleocytology, metagenomic analysis, including non-invasive techniques, such as mass spectrometry, may offer new avenues for identifying ancient pathogens. Current technologies and interdisciplinary collaboration hold promise for uncovering even more insights from the past and potentially informing future disease prevention strategies.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116933"},"PeriodicalIF":2.1,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271148","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}
Xujie Zhu , Rui Li , Xiaoxin Zhang , Dian Wang , Yijie Wang , Wenxin Lin , Shengkun Zhang , Ming Chu , Lanlan Wei
{"title":"Clinical indicators associated with tuberculous meningitis using multiple correspondence analysis","authors":"Xujie Zhu , Rui Li , Xiaoxin Zhang , Dian Wang , Yijie Wang , Wenxin Lin , Shengkun Zhang , Ming Chu , Lanlan Wei","doi":"10.1016/j.diagmicrobio.2025.116932","DOIUrl":"10.1016/j.diagmicrobio.2025.116932","url":null,"abstract":"<div><h3>Objectives</h3><div>Tuberculous meningitis (TBM), the most severe extrapulmonary manifestation of <em>Mycobacterium tuberculosis</em> (Mtb) infection, contributes to 5–10 % of global tuberculosis-related mortality. This study aimed to delineate clinical indicators predictive of microbiologically confirmed TBM to facilitate early diagnosis in resource-limited settings.</div></div><div><h3>Methods</h3><div>A retrospective cohort analysis was conducted on 146 TBM cases admitted to Shenzhen Third People's Hospital (2018-2020), undergoing cerebrospinal fluid (CSF) culture and Xpert. Epidemiologic profiles and clinical outcomes were systematically characterized. Multiple correspondence analysis (MCA) adjusted for potential confounders was employed to identify clinical indicators associated with microbiologically confirmed TBM.</div></div><div><h3>Results</h3><div>Among 146 patients with defined or probable TBM, 80 cases were detected for Mtb in CSF, with undetected in 66 cases. The increase in CSF white cell count was more significant than that in blood. Serum sodium, serum chloride (Cl), CSF glucose, CSF Cl, and CSF to blood glucose ratio in microbiologically confirmed TBM were significantly lower than those in unconfirmed TBM, in addition to having worse nutrition and lower blood lymphocytes. MCA identified diagnostic indicators related to microbiologically confirmed TBM included neck stiffness, decreased blood lymphocyte counts and serum sodium, elevated CSF white cell count, decreased CSF glucose and Cl levels, HIV positivity, severe pulmonary infection, and malnutrition. However, Hypertension and pulmonary tuberculosis were associated with microbiologically unconfirmed TBM.</div></div><div><h3>Conclusions</h3><div>The clinical indicators identified in this study may assist clinicians in high-tuberculosis-incidence-areas, particularly in regions with limited capacity for CSF microbial culture, to empirically diagnose TBM. When these indicators are abnormal, they may increase the likelihood of detecting microbial evidence in CSF.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 3","pages":"Article 116932"},"PeriodicalIF":2.1,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144366303","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}
Itamar Poran , Bar Basharim , Yaara Leibovici-Weisman , Michal Michaelis , Nassem Ghantous , Noa Eliakim-Raz
{"title":"Characteristics and clinical outcomes of the West Nile virus outbreak in Israel 2024: A retrospective cohort study","authors":"Itamar Poran , Bar Basharim , Yaara Leibovici-Weisman , Michal Michaelis , Nassem Ghantous , Noa Eliakim-Raz","doi":"10.1016/j.diagmicrobio.2025.116936","DOIUrl":"10.1016/j.diagmicrobio.2025.116936","url":null,"abstract":"<div><h3>Background</h3><div>In 2024, Israel experienced its largest West Nile virus (WNV) outbreak in two decades, with over 930 cases and 72 deaths, revealing unique epidemiological patterns.</div></div><div><h3>Aim</h3><div>To describe the clinical features, outcomes, and risk factors for poor hospitalization outcomes in patients with WNV infection during this outbreak.</div></div><div><h3>Methods</h3><div>A retrospective cohort study of WNV-infected patients admitted to Rabin Medical Center (RMC) during the year 2024. Data from electronic medical records were analyzed. A regression model was employed to identify risk factors associated with poor outcomes.</div></div><div><h3>Results</h3><div>We included 177 patients. Their median age was 77 years, and 72 (41 %) were female. Fever (82 %), altered mentation (62 %), malaise (62 %), thrombocytopenia (44 %), acute renal failure (38 %), and lymphopenia (36 %) were common. West Nile neuroinvasive disease (WNND), primarily encephalitis (41 %), was diagnosed in 89 (50 %) patients. The median hospital stay was 7 days, with 22 (12 %) in-hospital deaths. Risk factors for mortality included a history of stroke, WNND, acute renal failure, and lymphopenia. Among survivors, 45 (29 %) were discharged for rehabilitation or long-term care facilities.</div></div><div><h3>Conclusions</h3><div>These findings highlight the clinical severity of WNV infections during the outbreak and underscore the importance of identifying high-risk patients to guide management and public health strategies.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116936"},"PeriodicalIF":2.1,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144230875","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}
Carolina Gracia Poitevin , Carla Adriane Royer , Ana Claudia Bonatto , Cristina de Oliveira Rodrigues , Gabrielle Caroline Peiter , Ana Paula Carneiro Brandalize , Alexia Cristine Oliveira Rocha , Carolina Langaro Brockmann , Gabriela Bravim de Araujo , Giovanna Lourenço Cavagnoli , Ingrid Vitória Simardo , Valentina Miotto Gasparim , Regiane Stafim da Cunha , Vanessa Crocetti Pereira , Edneia Amancio de Souza Ramos , Pedro Henrique Cardoso , Monica Barcellos Arruda , Patrícia Alvarez da Silva Baptista , Emanuel Maltempi de Souza , Daniela Fiori Gradia , Jaqueline Carvalho de Oliveira
{"title":"Non-Invasive molecular dengue virus 1 diagnosis in saliva is possible","authors":"Carolina Gracia Poitevin , Carla Adriane Royer , Ana Claudia Bonatto , Cristina de Oliveira Rodrigues , Gabrielle Caroline Peiter , Ana Paula Carneiro Brandalize , Alexia Cristine Oliveira Rocha , Carolina Langaro Brockmann , Gabriela Bravim de Araujo , Giovanna Lourenço Cavagnoli , Ingrid Vitória Simardo , Valentina Miotto Gasparim , Regiane Stafim da Cunha , Vanessa Crocetti Pereira , Edneia Amancio de Souza Ramos , Pedro Henrique Cardoso , Monica Barcellos Arruda , Patrícia Alvarez da Silva Baptista , Emanuel Maltempi de Souza , Daniela Fiori Gradia , Jaqueline Carvalho de Oliveira","doi":"10.1016/j.diagmicrobio.2025.116935","DOIUrl":"10.1016/j.diagmicrobio.2025.116935","url":null,"abstract":"<div><h3>Objectives</h3><div>Dengue is a systemic virus infection, endemic in tropical/subtropical regions and of increasing global importance. The diagnostic gold standard for acute infection is the detection of viral RNA through reverse transcription quantitative polymerase chain reaction (RT-qPCR) in blood. Regrettably, venous collection requires specialized professionals, and dengue tests may be avoided by those who afraid of needles. Therefore, the aim of the present study is to evaluate the feasibility of using saliva in DENV-1 detection.</div></div><div><h3>Methods</h3><div>RT-qPCR was performed to detect DENV-1 in 201 paired saliva and plasma samples, from individuals with up to five days from the onset of symptoms.</div></div><div><h3>Results</h3><div>140 (69.65 %) patients had DENV-1 positive detection in plasma and 115 (57.21 %) positive in saliva samples. Those values rendered a sensitivity of 82.14 % and 100 % of specificity (agreement kappa index 0.736 [0.69 - 0.77].</div></div><div><h3>Conclusions</h3><div>Despite reduced sensitivity, we demonstrated the feasibility of DENV-1 diagnosis in saliva samples, presenting a valuable alternative, particularly in outbreak scenario.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116935"},"PeriodicalIF":2.1,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240128","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}
Jakob Loschko , Paul Liberator , Jamie Findlow , Jason Yip , Charles Tan , Karen Garcia , MaryAnn Murillo , Yamini Gorantla , Kimberly M. Moss , Panagiotis Maniatis , Stephen A. Clark , Ray Borrow
{"title":"Interlaboratory study to assess precision and reproducibility of the meningococcal antigen surface expression (MEASURE) assay to quantify factor H binding protein expression at the surface of meningococcal serogroup B strains","authors":"Jakob Loschko , Paul Liberator , Jamie Findlow , Jason Yip , Charles Tan , Karen Garcia , MaryAnn Murillo , Yamini Gorantla , Kimberly M. Moss , Panagiotis Maniatis , Stephen A. Clark , Ray Borrow","doi":"10.1016/j.diagmicrobio.2025.116920","DOIUrl":"10.1016/j.diagmicrobio.2025.116920","url":null,"abstract":"<div><h3>Background</h3><div>The serum bactericidal antibody using human complement (hSBA) assay, the accepted surrogate measure of meningococcal vaccine efficacy, is limited by human sera and complement requirements. Pfizer developed and validated the flow-cytometry−based Meningococcal Antigen Surface Expression (MEASURE) assay to quantify surface-expressed factor H binding protein (fHbp) levels on intact meningococci. Surface expression of fHbp is correlated with hSBA assay killing by MenB-fHbp (Trumenba<sup>Ⓡ</sup>)–induced antibody, meaning the MEASURE assay can be used to predict meningococcal serogroup B (MenB) strain susceptibility to antibodies elicited by MenB-fHbp. This study aimed to evaluate interlaboratory precision and reproducibility of the MEASURE assay.</div></div><div><h3>Methods</h3><div>The MEASURE assay was transferred to UK Health Security Agency (UKHSA) and US Centers for Disease Control and Prevention (CDC) laboratories. MEASURE assay results from 42 MenB strains encoding sequence-diverse fHbp variants that express fHbp at different levels were compared between the UKHSA, CDC, and Pfizer laboratories. Intermediate precision within each laboratory was determined.</div></div><div><h3>Results</h3><div>Pairwise comparisons of fHbp expression levels for all 42 MenB test strains showed >97 % agreement across the 3 laboratories when strains were grouped above or below a mean fluorescence intensity level of 1000, the threshold previously established as indicative of susceptibility to MenB-fHbp–induced antibodies in the hSBA assay. Each laboratory met assay precision criteria of ≤30 % total relative standard deviation.</div></div><div><h3>Conclusions</h3><div>Quantification of fHbp surface expression using the MEASURE assay is robust and reproducible across different laboratories. Previously determined cutoffs corresponding to predicted susceptibility to vaccine-induced antibodies can be applied to MEASURE data generated across laboratories.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116920"},"PeriodicalIF":2.1,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279514","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}