Non-tuberculous mycobacterial (NTM) skin infections present diagnostic and therapeutic challenges in resource-limited primary care settings. This retrospective study evaluated the diagnosis and treatment of NTM skin infections at a primary care hospital in Shouguang City, a coastal region of China with high-risk occupational exposure to aquatic environments, from 2021 to 2022. We analyzed 144 patients, using real-time PCR on formalin-fixed paraffin-embedded (FFPE) tissue samples to validate empirical diagnoses based on clinical symptoms, exposure history, and histopathology. Our results demonstrated a high concordance (79.17%) between empirical and molecular diagnoses, confirming the reliability of the primary care hospital's diagnostic approach. Real-time PCR successfully identified specific NTM species in a subset of cases, with Mycobacterium marinum and Mycobacteroides abscessus being the most prevalent. Empirical treatment with combination antibiotics (primarily clarithromycin and rifampicin) was highly effective, achieving a cure rate of 90.97%. This study highlights the effectiveness of integrated clinical-histopathological assessment for managing NTM infections in resource-limited settings and underscores the value of molecular techniques such as PCR in enhancing diagnostic precision and facilitating retrospective research using archived FFPE samples.
Importance: This study addresses a critical gap in managing non-tuberculous mycobacterial (NTM) skin infections in resource-limited primary care settings, with particular relevance to coastal regions like Shouguang, where occupational exposure to marine environments elevates infection risk. By validating empirical diagnosis through molecular testing, we demonstrate that integrated clinical-histopathological assessment is a reliable method for identifying NTM infections where advanced diagnostics are unavailable. Our adaptation of real-time PCR to archived FFPE tissues provides a feasible model for retrospective species identification and research, overcoming key resource constraints. The high documented cure rate with clarithromycin-rifampicin regimens provides practical treatment benchmarks for regions with similar epidemiological profiles. These findings offer immediate clinical value by: (i) reinforcing the reliability of empirical diagnosis in resource-limited contexts, (ii) establishing a practical pathway for molecular confirmation using stored samples, and (iii) validating effective treatment protocols for high-risk occupational groups. As NTM incidence increases globally, this work equips primary care systems with evidence-based strategies to improve diagnostic accuracy and patient outcomes in settings with high marine exposure while simultaneously enabling future research through the utilization of existing biospecimen repositories.
{"title":"Retrospective analysis of non-tuberculous mycobacterial skin infections: diagnostic accuracy, treatment efficacy, and PCR-based species detection in a Chinese primary care hospital.","authors":"Tianyi Xu, Yingjie Zheng, Ruoning Xue, Ruoyu Li, Wen Zhang, Zaihong Sun, Yinggai Song","doi":"10.1128/jcm.01065-25","DOIUrl":"10.1128/jcm.01065-25","url":null,"abstract":"<p><p>Non-tuberculous mycobacterial (NTM) skin infections present diagnostic and therapeutic challenges in resource-limited primary care settings. This retrospective study evaluated the diagnosis and treatment of NTM skin infections at a primary care hospital in Shouguang City, a coastal region of China with high-risk occupational exposure to aquatic environments, from 2021 to 2022. We analyzed 144 patients, using real-time PCR on formalin-fixed paraffin-embedded (FFPE) tissue samples to validate empirical diagnoses based on clinical symptoms, exposure history, and histopathology. Our results demonstrated a high concordance (79.17%) between empirical and molecular diagnoses, confirming the reliability of the primary care hospital's diagnostic approach. Real-time PCR successfully identified specific NTM species in a subset of cases, with <i>Mycobacterium marinum</i> and <i>Mycobacteroides abscessus</i> being the most prevalent. Empirical treatment with combination antibiotics (primarily clarithromycin and rifampicin) was highly effective, achieving a cure rate of 90.97%. This study highlights the effectiveness of integrated clinical-histopathological assessment for managing NTM infections in resource-limited settings and underscores the value of molecular techniques such as PCR in enhancing diagnostic precision and facilitating retrospective research using archived FFPE samples.</p><p><strong>Importance: </strong>This study addresses a critical gap in managing non-tuberculous mycobacterial (NTM) skin infections in resource-limited primary care settings, with particular relevance to coastal regions like Shouguang, where occupational exposure to marine environments elevates infection risk. By validating empirical diagnosis through molecular testing, we demonstrate that integrated clinical-histopathological assessment is a reliable method for identifying NTM infections where advanced diagnostics are unavailable. Our adaptation of real-time PCR to archived FFPE tissues provides a feasible model for retrospective species identification and research, overcoming key resource constraints. The high documented cure rate with clarithromycin-rifampicin regimens provides practical treatment benchmarks for regions with similar epidemiological profiles. These findings offer immediate clinical value by: (i) reinforcing the reliability of empirical diagnosis in resource-limited contexts, (ii) establishing a practical pathway for molecular confirmation using stored samples, and (iii) validating effective treatment protocols for high-risk occupational groups. As NTM incidence increases globally, this work equips primary care systems with evidence-based strategies to improve diagnostic accuracy and patient outcomes in settings with high marine exposure while simultaneously enabling future research through the utilization of existing biospecimen repositories.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0106525"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710309/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145504140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-12-04DOI: 10.1128/jcm.01452-25
Lisa R McTaggart, Alexandra Scione, Kelty Hillier, Elizabeth Brown, Sarah E Wilson, Julianne V Kus
<p><p>Diphtheria remains a major public health threat in areas of the world where diphtheria toxoid-containing vaccine programs are not successfully implemented or maintained. In countries with high vaccine coverage, diphtheria is well-controlled with occasional travel-related cases eliciting a robust public health response to limit transmission. While classic diphtheria is caused by toxigenic <i>Corynebacterium diphtheriae</i> and rarely by other species, such as <i>Corynebacterium ulcerans</i>, infections due to nontoxigenic <i>C. diphtheriae</i> (not covered by the vaccine) are increasingly being reported. We describe the genomic epidemiology of toxigenic and nontoxigenic <i>C. diphtheriae</i> in Ontario, Canada, based on isolates submitted to the Public Health Ontario Laboratory. Of 146 cases, four cases (2.7%) involved toxigenic <i>C. diphtheriae</i>, three of which were associated with travel from endemic countries. Most isolates were nontoxigenic (97.2%) and from cutaneous sources (84.9%), with an increase in submission of nontoxigenic <i>C. diphtheriae</i> isolates from one in 2016 to 65 in 2023. Based on whole-genome sequencing and BIGSdb-Pasteur core genome multi-locus strain typing, most nontoxigenic isolates were categorized into three highly related genetic clusters from sublineages 32 and 76, suggesting epidemiologically linked cases indicative of local transmission. Apart from intermediate susceptibility to penicillin in 98.0% of isolates, antimicrobial resistance was rarely detected. Because infections with nontoxigenic <i>C. diphtheriae</i> are not prevented by vaccination and do not cause classic diphtheria, healthcare professionals should be aware of these trends, given the clinical, public health, and infection control implications when <i>C. diphtheriae</i> is identified in the microbiology laboratory prior to knowledge of toxigenicity.IMPORTANCEInfections by toxigenic and nontoxigenic <i>Corynebacterium diphtheriae</i> cause vastly different diseases requiring different treatment and public health responses. Healthcare practitioners should be aware of the complexities of diphtheria from a global perspective. Toxigenic <i>C. diphtheriae</i> remains prevalent in regions that do not have well-established vaccination programs, while vaccine hesitancy and compliance issues challenge countries that do require childhood vaccination. These factors, coupled with the propensity for human travel and migration, heighten the risk of cases and outbreaks in non-endemic countries and designate diphtheria as a relevant re-emerging threat. Further complicating public health decisions is the increasing incidence of nontoxigenic <i>C. diphtheriae</i> infections identified among highly vaccinated populations. An excessive public health response in these cases would be burdensome and expensive. Our findings will aid public health departments and hospitals with local risk assessments of the likelihood that a laboratory identification of <i>C. diph
{"title":"Toxigenic diphtheria rarely detected amid rising cases of nontoxigenic <i>Corynebacterium diphtheriae</i> infections in Ontario, Canada, 2011-2023.","authors":"Lisa R McTaggart, Alexandra Scione, Kelty Hillier, Elizabeth Brown, Sarah E Wilson, Julianne V Kus","doi":"10.1128/jcm.01452-25","DOIUrl":"10.1128/jcm.01452-25","url":null,"abstract":"<p><p>Diphtheria remains a major public health threat in areas of the world where diphtheria toxoid-containing vaccine programs are not successfully implemented or maintained. In countries with high vaccine coverage, diphtheria is well-controlled with occasional travel-related cases eliciting a robust public health response to limit transmission. While classic diphtheria is caused by toxigenic <i>Corynebacterium diphtheriae</i> and rarely by other species, such as <i>Corynebacterium ulcerans</i>, infections due to nontoxigenic <i>C. diphtheriae</i> (not covered by the vaccine) are increasingly being reported. We describe the genomic epidemiology of toxigenic and nontoxigenic <i>C. diphtheriae</i> in Ontario, Canada, based on isolates submitted to the Public Health Ontario Laboratory. Of 146 cases, four cases (2.7%) involved toxigenic <i>C. diphtheriae</i>, three of which were associated with travel from endemic countries. Most isolates were nontoxigenic (97.2%) and from cutaneous sources (84.9%), with an increase in submission of nontoxigenic <i>C. diphtheriae</i> isolates from one in 2016 to 65 in 2023. Based on whole-genome sequencing and BIGSdb-Pasteur core genome multi-locus strain typing, most nontoxigenic isolates were categorized into three highly related genetic clusters from sublineages 32 and 76, suggesting epidemiologically linked cases indicative of local transmission. Apart from intermediate susceptibility to penicillin in 98.0% of isolates, antimicrobial resistance was rarely detected. Because infections with nontoxigenic <i>C. diphtheriae</i> are not prevented by vaccination and do not cause classic diphtheria, healthcare professionals should be aware of these trends, given the clinical, public health, and infection control implications when <i>C. diphtheriae</i> is identified in the microbiology laboratory prior to knowledge of toxigenicity.IMPORTANCEInfections by toxigenic and nontoxigenic <i>Corynebacterium diphtheriae</i> cause vastly different diseases requiring different treatment and public health responses. Healthcare practitioners should be aware of the complexities of diphtheria from a global perspective. Toxigenic <i>C. diphtheriae</i> remains prevalent in regions that do not have well-established vaccination programs, while vaccine hesitancy and compliance issues challenge countries that do require childhood vaccination. These factors, coupled with the propensity for human travel and migration, heighten the risk of cases and outbreaks in non-endemic countries and designate diphtheria as a relevant re-emerging threat. Further complicating public health decisions is the increasing incidence of nontoxigenic <i>C. diphtheriae</i> infections identified among highly vaccinated populations. An excessive public health response in these cases would be burdensome and expensive. Our findings will aid public health departments and hospitals with local risk assessments of the likelihood that a laboratory identification of <i>C. diph","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0145225"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145668526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-10-30DOI: 10.1128/jcm.01173-25
Hetal K Patel, Yen T Duong, Sehin Birhanu, Melissa Metz, Jared Garfinkel, Kathryn Lupoli, Daniel Yavo, Herbert Longwe, Faith Ussery, Kristin Brown, Stephen McCraken, Clement B Ndongmo, Jessica Justman, Andrew C Voetsch, Bharat S Parekh
Population-based HIV Impact Assessment surveys were conducted in 14 countries to measure HIV prevalence, incidence, and viral load suppression in children aged 0-14 years and adults aged ≥15 years. We examined the performance of rapid HIV testing algorithms in multiple countries. Survey participants received an HIV diagnosis based on two serial tests in Cameroon, Côte d'Ivoire, Eswatini, Haiti, Kenya, Lesotho, Malawi, Mozambique, Tanzania, and Zambia. Whereas in Ethiopia, Kenya, Namibia, Uganda, and Zimbabwe, diagnosis was based on a tie-breaker algorithm. Testers received intensive training on specimen collection, testing, and results reporting. HIV-positive and indeterminate results were confirmed by Geenius HIV-1/2 test (Bio-Rad). Pooled test 1 and 2 positive concordance, test 2 and 3 negative concordance, and the positive predictive value (PPV) of the algorithm were calculated. A total of 312,069 participants aged ≥18 months (except for Eswatini, Mozambique, and Uganda, where only adults aged 15+ years were included) were tested by either the two-test (n = 243,311) or tie-breaker (n = 98,757) algorithm for diagnosis. The combined test 1 and 2 positive concordance and PPV were 93.8% and 99.4%, respectively, for countries with a two-test algorithm. Similarly, test 1 and 2 positive concordance, test 2 and 3 negative concordance, and PPV were 87.5%, 84.4%, and 98.8%, respectively, for the tie-breaker algorithm. The PPV ranged from 94.2% to 99.9%, with higher PPV in high burden countries. The HIV testing algorithms performed with high accuracy, with PPV reaching 99% or higher. Adoption of continuous quality improvement is essential to ensure accuracy of HIV diagnosis in service delivery settings.
Importance: HIV diagnostic testing in most African countries follows national algorithms that typically use two tests, with or without a tie-breaker. We assessed the accuracy of these algorithms using data from population-based surveys in 14 sub-Saharan African countries, where all HIV-positive results were further confirmed with the Geenius HIV-1/2 supplemental assay. Our findings show that inter-test concordance and positive predictive values (PPVs) varied by HIV prevalence, with higher PPVs observed in higher-prevalence settings. Overall, the PPV of HIV diagnosis was close to 99%, indicating that two-test algorithms can provide highly accurate results when testing is performed with strict adherence to quality standards and tester competency. These results underscore the importance of quality assurance (QA) and suggest that countries with lower HIV prevalence may benefit from adopting a three-test algorithm. However, such changes should be accompanied by careful attention to logistics, procurement, training, record keeping, and other QA measures.
{"title":"Performance of national HIV testing algorithms in 14 Population-based HIV Impact Assessment surveys: accuracy of HIV diagnosis using a two-test strategy, with or without a tie-breaker test, in different prevalence settings, 2015-2022.","authors":"Hetal K Patel, Yen T Duong, Sehin Birhanu, Melissa Metz, Jared Garfinkel, Kathryn Lupoli, Daniel Yavo, Herbert Longwe, Faith Ussery, Kristin Brown, Stephen McCraken, Clement B Ndongmo, Jessica Justman, Andrew C Voetsch, Bharat S Parekh","doi":"10.1128/jcm.01173-25","DOIUrl":"10.1128/jcm.01173-25","url":null,"abstract":"<p><p>Population-based HIV Impact Assessment surveys were conducted in 14 countries to measure HIV prevalence, incidence, and viral load suppression in children aged 0-14 years and adults aged ≥15 years. We examined the performance of rapid HIV testing algorithms in multiple countries. Survey participants received an HIV diagnosis based on two serial tests in Cameroon, Côte d'Ivoire, Eswatini, Haiti, Kenya, Lesotho, Malawi, Mozambique, Tanzania, and Zambia. Whereas in Ethiopia, Kenya, Namibia, Uganda, and Zimbabwe, diagnosis was based on a tie-breaker algorithm. Testers received intensive training on specimen collection, testing, and results reporting. HIV-positive and indeterminate results were confirmed by Geenius HIV-1/2 test (Bio-Rad). Pooled test 1 and 2 positive concordance, test 2 and 3 negative concordance, and the positive predictive value (PPV) of the algorithm were calculated. A total of 312,069 participants aged ≥18 months (except for Eswatini, Mozambique, and Uganda, where only adults aged 15+ years were included) were tested by either the two-test (<i>n</i> = 243,311) or tie-breaker (<i>n</i> = 98,757) algorithm for diagnosis. The combined test 1 and 2 positive concordance and PPV were 93.8% and 99.4%, respectively, for countries with a two-test algorithm. Similarly, test 1 and 2 positive concordance, test 2 and 3 negative concordance, and PPV were 87.5%, 84.4%, and 98.8%, respectively, for the tie-breaker algorithm. The PPV ranged from 94.2% to 99.9%, with higher PPV in high burden countries. The HIV testing algorithms performed with high accuracy, with PPV reaching 99% or higher. Adoption of continuous quality improvement is essential to ensure accuracy of HIV diagnosis in service delivery settings.</p><p><strong>Importance: </strong>HIV diagnostic testing in most African countries follows national algorithms that typically use two tests, with or without a tie-breaker. We assessed the accuracy of these algorithms using data from population-based surveys in 14 sub-Saharan African countries, where all HIV-positive results were further confirmed with the Geenius HIV-1/2 supplemental assay. Our findings show that inter-test concordance and positive predictive values (PPVs) varied by HIV prevalence, with higher PPVs observed in higher-prevalence settings. Overall, the PPV of HIV diagnosis was close to 99%, indicating that two-test algorithms can provide highly accurate results when testing is performed with strict adherence to quality standards and tester competency. These results underscore the importance of quality assurance (QA) and suggest that countries with lower HIV prevalence may benefit from adopting a three-test algorithm. However, such changes should be accompanied by careful attention to logistics, procurement, training, record keeping, and other QA measures.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0117325"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710320/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145401005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-10-21DOI: 10.1128/jcm.00982-25
Ayel Luis R Batac, Michael Marks, Joseph D Tucker, Rosanna Ŵ Peeling
The incidence of syphilis has risen dramatically in many regions despite the availability of affordable facility-based testing and curative treatment. The recent approval of over-the-counter syphilis self-tests (SSTs) represents an important advance for expanding diagnostic access and disease control and prevention. Evidence demonstrates that SSTs are accurate, usable, and acceptable. However, as with HIV and COVID-19 self-testing, implementation challenges remain, including ensuring equitable access, supporting vulnerable groups, securing linkage to care, and maintaining quality assurance.
{"title":"Syphilis self-testing and implications for syphilis control and prevention.","authors":"Ayel Luis R Batac, Michael Marks, Joseph D Tucker, Rosanna Ŵ Peeling","doi":"10.1128/jcm.00982-25","DOIUrl":"10.1128/jcm.00982-25","url":null,"abstract":"<p><p>The incidence of syphilis has risen dramatically in many regions despite the availability of affordable facility-based testing and curative treatment. The recent approval of over-the-counter syphilis self-tests (SSTs) represents an important advance for expanding diagnostic access and disease control and prevention. Evidence demonstrates that SSTs are accurate, usable, and acceptable. However, as with HIV and COVID-19 self-testing, implementation challenges remain, including ensuring equitable access, supporting vulnerable groups, securing linkage to care, and maintaining quality assurance.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0098225"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-10-17DOI: 10.1128/jcm.01068-25
Arianna Carella, Karen C Carroll, Erik Munson
Knowledge of novel and revised bacterial taxonomy facilitates routine operations in the medical microbiology laboratory and communication with important stakeholders. Notable new gram-positive taxa accepted in 2024 include the clinically significant Staphylococcus brunensis sp. nov., as well as Streptococcus suis subsp. hashimotonensis subsp. nov., which can be delineated from other Streptococcus suis subsp. by possession of the Lancefield group A antigen. Four novel Enterobacterales species are discussed, plus a novel eighth family Gallaecimonadaceae. One of these, Providencia huashanensis sp. nov. is clinically significant and harbors multiple genetic determinants that encode antimicrobial resistance mechanisms. Stenotrophomonas forensis sp. nov., derived from specimen transport medium, was determined to be a distinct component within the Stenotrophomonas maltophilia complex. Bartonella tamiae sp. nov. has become officially recognized as the agent of the first culture-confirmed bartonelloses in Thailand. Significant taxonomic revisions include the return of Chlamydophila caviae to the Chlamydia genus, creation of the novel Metaclostridioides genus for Clostridioides mangenotii, and reclassification of two Kocuria spp. into two subspecies of Kocuria rosea. Clinical updates are provided for 13 past Journal of Clinical Microbiology taxonomic compendium entries for which extensive clinical data were not previously available. These include potential clinical significance for non-vaginalis species of the Gardnerella genus and for Pandoraea commovens in a non-cystic fibrosis setting.
{"title":"An update on novel taxa and revised taxonomic status of bacteria isolated from human clinical specimens described in 2024.","authors":"Arianna Carella, Karen C Carroll, Erik Munson","doi":"10.1128/jcm.01068-25","DOIUrl":"10.1128/jcm.01068-25","url":null,"abstract":"<p><p>Knowledge of novel and revised bacterial taxonomy facilitates routine operations in the medical microbiology laboratory and communication with important stakeholders. Notable new gram-positive taxa accepted in 2024 include the clinically significant <i>Staphylococcus brunensis</i> sp. nov., as well as <i>Streptococcus suis</i> subsp. <i>hashimotonensis</i> subsp. nov., which can be delineated from other <i>Streptococcus suis</i> subsp. by possession of the Lancefield group A antigen. Four novel <i>Enterobacterales</i> species are discussed, plus a novel eighth family <i>Gallaecimonadaceae</i>. One of these, <i>Providencia huashanensis</i> sp. nov. is clinically significant and harbors multiple genetic determinants that encode antimicrobial resistance mechanisms. <i>Stenotrophomonas forensis</i> sp. nov., derived from specimen transport medium, was determined to be a distinct component within the <i>Stenotrophomonas maltophilia</i> complex. <i>Bartonella tamiae</i> sp. nov. has become officially recognized as the agent of the first culture-confirmed bartonelloses in Thailand. Significant taxonomic revisions include the return of <i>Chlamydophila caviae</i> to the <i>Chlamydia</i> genus, creation of the novel <i>Metaclostridioides</i> genus for <i>Clostridioides mangenotii</i>, and reclassification of two <i>Kocuria</i> spp. into two subspecies of <i>Kocuria rosea</i>. Clinical updates are provided for 13 past <i>Journal of Clinical Microbiology</i> taxonomic compendium entries for which extensive clinical data were not previously available. These include potential clinical significance for non-<i>vaginalis</i> species of the <i>Gardnerella</i> genus and for <i>Pandoraea commovens</i> in a non-cystic fibrosis setting.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0106825"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-10-31DOI: 10.1128/jcm.01030-25
Kevin Li, Sonia Lacouture, Lucy A Weinert, Tsutomu Sekizaki, Daisuke Takamatsu, Antony T Vincent, Ján Matiašovic, Han Zheng, Hubert Gantelet, Marcelo Gottschalk, Nahuel Fittipaldi
<p><p>Accurate species-level identification among <i>Streptococcus suis</i> and its close relatives remains challenging due to limited resolution of existing diagnostic tools and incomplete taxonomic frameworks. We investigated 61 isolates from diseased swine and three from cows identified as <i>S. suis</i> by MALDI-TOF MS, but which tested negative by a <i>recN</i> gene-based PCR assay commonly used for species confirmation. Whole-genome sequencing revealed that only four isolates were <i>S. suis</i> sensu stricto, while most others belonged to <i>Streptococcus parasuis</i>, <i>Streptococcus ruminantium</i>, <i>Streptococcus iners</i>, <i>Streptococcus suivaginalis</i>, <i>Streptococcus hepaticus</i>, and several other newly proposed <i>Streptococcus</i> species. Core genome phylogenies consistently resolved these novel taxa as monophyletic and taxonomically coherent. However, phylogenies based on the <i>recN</i> gene did not reliably track species boundaries due to limited resolution and recombination, which also affects diagnostic assays. As a proof of concept, we identified 38 genes conserved in ≥95% of <i>S. suis</i> sensu stricto genomes that may support future marker-based diagnostics. Our results confirm extensive taxonomic diversity among <i>S. suis</i>-like organisms, support the recognition of a broader <i>S. suis</i> complex, demonstrate the need for genome-based methods to distinguish its members, and provide evidence supporting the potential clinical significance of several newly recognized and recently proposed species within this complex.</p><p><strong>Importance: </strong>Several new species closely related genetically to <i>Streptococcus suis</i> have recently been formally recognized or proposed, raising the possibility that they form a broader, previously unrecognized <i>S. suis</i> complex. Yet most clinical laboratories still report such isolates simply as <i>S. suis</i>, due to the limited resolution of current diagnostic tools. Here, we show that two widely used methods, MALDI-TOF MS and a <i>recN</i>-based PCR used for molecular confirmation of MALDI-TOF MS results, can misidentify <i>S. suis</i>-like isolates. We analyzed 61 isolates from diseased swine and three from cows: all were classified as <i>S. suis</i> by MALDI-TOF MS but tested negative by the <i>recN</i> PCR. Exposing a major gap in current diagnostic frameworks, whole-genome sequencing revealed that most isolates were not <i>S. suis</i> sensu stricto but instead belonged to other recognized or recently proposed <i>Streptococcus</i> species. Most swine isolates were recovered from normally sterile sites, suggesting potential but unconfirmed pathogenic relevance. We provide genomic evidence supporting the proposal of a structured <i>S. suis</i> complex and identify <i>S. suis</i> sensu stricto-specific markers that may inform improved molecular diagnostics in the future. Our findings emphasize the need to modernize diagnostics to account for the true diversity
{"title":"Genomic re-evaluation of clinical isolates reveals a structured <i>Streptococcus suis</i> complex.","authors":"Kevin Li, Sonia Lacouture, Lucy A Weinert, Tsutomu Sekizaki, Daisuke Takamatsu, Antony T Vincent, Ján Matiašovic, Han Zheng, Hubert Gantelet, Marcelo Gottschalk, Nahuel Fittipaldi","doi":"10.1128/jcm.01030-25","DOIUrl":"10.1128/jcm.01030-25","url":null,"abstract":"<p><p>Accurate species-level identification among <i>Streptococcus suis</i> and its close relatives remains challenging due to limited resolution of existing diagnostic tools and incomplete taxonomic frameworks. We investigated 61 isolates from diseased swine and three from cows identified as <i>S. suis</i> by MALDI-TOF MS, but which tested negative by a <i>recN</i> gene-based PCR assay commonly used for species confirmation. Whole-genome sequencing revealed that only four isolates were <i>S. suis</i> sensu stricto, while most others belonged to <i>Streptococcus parasuis</i>, <i>Streptococcus ruminantium</i>, <i>Streptococcus iners</i>, <i>Streptococcus suivaginalis</i>, <i>Streptococcus hepaticus</i>, and several other newly proposed <i>Streptococcus</i> species. Core genome phylogenies consistently resolved these novel taxa as monophyletic and taxonomically coherent. However, phylogenies based on the <i>recN</i> gene did not reliably track species boundaries due to limited resolution and recombination, which also affects diagnostic assays. As a proof of concept, we identified 38 genes conserved in ≥95% of <i>S. suis</i> sensu stricto genomes that may support future marker-based diagnostics. Our results confirm extensive taxonomic diversity among <i>S. suis</i>-like organisms, support the recognition of a broader <i>S. suis</i> complex, demonstrate the need for genome-based methods to distinguish its members, and provide evidence supporting the potential clinical significance of several newly recognized and recently proposed species within this complex.</p><p><strong>Importance: </strong>Several new species closely related genetically to <i>Streptococcus suis</i> have recently been formally recognized or proposed, raising the possibility that they form a broader, previously unrecognized <i>S. suis</i> complex. Yet most clinical laboratories still report such isolates simply as <i>S. suis</i>, due to the limited resolution of current diagnostic tools. Here, we show that two widely used methods, MALDI-TOF MS and a <i>recN</i>-based PCR used for molecular confirmation of MALDI-TOF MS results, can misidentify <i>S. suis</i>-like isolates. We analyzed 61 isolates from diseased swine and three from cows: all were classified as <i>S. suis</i> by MALDI-TOF MS but tested negative by the <i>recN</i> PCR. Exposing a major gap in current diagnostic frameworks, whole-genome sequencing revealed that most isolates were not <i>S. suis</i> sensu stricto but instead belonged to other recognized or recently proposed <i>Streptococcus</i> species. Most swine isolates were recovered from normally sterile sites, suggesting potential but unconfirmed pathogenic relevance. We provide genomic evidence supporting the proposal of a structured <i>S. suis</i> complex and identify <i>S. suis</i> sensu stricto-specific markers that may inform improved molecular diagnostics in the future. Our findings emphasize the need to modernize diagnostics to account for the true diversity ","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0103025"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145421894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-10-29DOI: 10.1128/jcm.00894-25
Elin Folkesson, Fariba Foroogh, Linn Kleberg, Vera Kjellgren, Mathilda Jakobsson, Lisann Grunewald, Jens Hellberg, Jennifer Ryberg, Zahra Maher, Carolina Sousa Silva, Maia S Gower, Hans Grönlund, Margarida Correia-Neves, Bartek Makower, Gunilla Källenius, Judith Bruchfeld, Christopher Sundling
<p><p>Tuberculosis (TB) remains a major global health challenge, with current diagnostic tools unable to reliably distinguish between individuals at different stages of the TB spectrum of infection (TBI) and disease (TBD). Interferon-gamma release assays (IGRAs), while commonly used, are limited by their reliance on a single cytokine and inability to differentiate disease states. In this study, we evaluated a multiplex FluoroSpot assay that simultaneously detects interferon gamma (IFNγ), interleukin (IL)2, and tumor necrosis factor (TNF)-secretion in response to <i>Mycobacterium tuberculosis</i> (<i>Mtb</i>) antigens ESAT-6, CFP-10, and EspC. PBMCs from individuals with TBD (<i>n</i> = 24), TBI (<i>n</i> = 64), and IGRA-negative controls (<i>n</i> = 26) were analyzed. The assay demonstrated high sensitivity and specificity, particularly through the detection of triple cytokine-secreting T cells (IFNγ/IL-2/TNF), minimizing false-positive rates. Moreover, distinct cytokine secretion patterns were associated with different stages of infection. Individuals with TBD had more IFNγ/TNF-producing cells, while those with TBI had more cells producing IFNγ/IL-2 or IL-2/TNF. Separating individuals with TBI based on time since likely Mtb exposure revealed that more recent infection was associated with reduced IFNγ responses and a higher proportion of IL-2/TNF-secreting cells. The use of spot volume analysis provided semi-quantitative insights into cytokine production. These findings suggest that multiplex cytokine profiling can improve TB diagnostics and offer a deeper understanding of host immune responses across the TB spectrum. Including non-IFNγ responses may be particularly valuable in identifying individuals at higher risk of disease progression, such as recently infected individuals, and in populations where current diagnostics underperform.IMPORTANCEAccurate diagnosis of <i>Mycobacterium tuberculosis</i> (<i>Mtb</i>) infection remains a cornerstone in tuberculosis (TB) control. Current interferon-gamma release assays (IGRAs) lack the ability to distinguish between individuals at different stages of the TB infection spectrum, limiting their utility. This study evaluates a multiplex FluoroSpot assay that simultaneously detects interferon gamma (IFNγ), interleukin 2, and tumor necrosis factor secretion in response to <i>Mtb</i>-specific antigens ESAT-6, CFP-10, and EspC. The assay demonstrated improved performance compared to standard IGRA methods, particularly through the identification of triple cytokine-secreting T cells. Importantly, it revealed distinct cytokine profiles associated with different stages of TB infection, offering potential for improved risk stratification and infection monitoring. These findings support the FluoroSpot assay as a promising tool for enhancing TB diagnostics and understanding host immune responses. Its application could be especially valuable in contact tracing, where <i>Mtb</i>-specific T-cell responses may not yet pro
{"title":"A multiplex Mtb-specific FluoroSpot assay measuring IFNγ, IL-2, and TNF-secreting cells can improve accuracy and differentiation across the tuberculosis spectrum.","authors":"Elin Folkesson, Fariba Foroogh, Linn Kleberg, Vera Kjellgren, Mathilda Jakobsson, Lisann Grunewald, Jens Hellberg, Jennifer Ryberg, Zahra Maher, Carolina Sousa Silva, Maia S Gower, Hans Grönlund, Margarida Correia-Neves, Bartek Makower, Gunilla Källenius, Judith Bruchfeld, Christopher Sundling","doi":"10.1128/jcm.00894-25","DOIUrl":"10.1128/jcm.00894-25","url":null,"abstract":"<p><p>Tuberculosis (TB) remains a major global health challenge, with current diagnostic tools unable to reliably distinguish between individuals at different stages of the TB spectrum of infection (TBI) and disease (TBD). Interferon-gamma release assays (IGRAs), while commonly used, are limited by their reliance on a single cytokine and inability to differentiate disease states. In this study, we evaluated a multiplex FluoroSpot assay that simultaneously detects interferon gamma (IFNγ), interleukin (IL)2, and tumor necrosis factor (TNF)-secretion in response to <i>Mycobacterium tuberculosis</i> (<i>Mtb</i>) antigens ESAT-6, CFP-10, and EspC. PBMCs from individuals with TBD (<i>n</i> = 24), TBI (<i>n</i> = 64), and IGRA-negative controls (<i>n</i> = 26) were analyzed. The assay demonstrated high sensitivity and specificity, particularly through the detection of triple cytokine-secreting T cells (IFNγ/IL-2/TNF), minimizing false-positive rates. Moreover, distinct cytokine secretion patterns were associated with different stages of infection. Individuals with TBD had more IFNγ/TNF-producing cells, while those with TBI had more cells producing IFNγ/IL-2 or IL-2/TNF. Separating individuals with TBI based on time since likely Mtb exposure revealed that more recent infection was associated with reduced IFNγ responses and a higher proportion of IL-2/TNF-secreting cells. The use of spot volume analysis provided semi-quantitative insights into cytokine production. These findings suggest that multiplex cytokine profiling can improve TB diagnostics and offer a deeper understanding of host immune responses across the TB spectrum. Including non-IFNγ responses may be particularly valuable in identifying individuals at higher risk of disease progression, such as recently infected individuals, and in populations where current diagnostics underperform.IMPORTANCEAccurate diagnosis of <i>Mycobacterium tuberculosis</i> (<i>Mtb</i>) infection remains a cornerstone in tuberculosis (TB) control. Current interferon-gamma release assays (IGRAs) lack the ability to distinguish between individuals at different stages of the TB infection spectrum, limiting their utility. This study evaluates a multiplex FluoroSpot assay that simultaneously detects interferon gamma (IFNγ), interleukin 2, and tumor necrosis factor secretion in response to <i>Mtb</i>-specific antigens ESAT-6, CFP-10, and EspC. The assay demonstrated improved performance compared to standard IGRA methods, particularly through the identification of triple cytokine-secreting T cells. Importantly, it revealed distinct cytokine profiles associated with different stages of TB infection, offering potential for improved risk stratification and infection monitoring. These findings support the FluoroSpot assay as a promising tool for enhancing TB diagnostics and understanding host immune responses. Its application could be especially valuable in contact tracing, where <i>Mtb</i>-specific T-cell responses may not yet pro","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0089425"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145389935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-11-19DOI: 10.1128/jcm.01145-25
Koray K Demir, Gavin Anderson, Indre Budvytiene, Niaz Banaei
Bronchoalveolar lavage fluid (BAL) is commonly obtained for diagnosing invasive mold disease (IMD) in immunocompromised patients. This study investigated the accuracy, turnaround time, and clinical actionability of mold polymerase chain reaction (PCR) on BAL. All BAL tested with mold PCR and fungal culture during the study period were included in this study. The mold PCR detected Aspergillus species, Mucorales agents, Fusarium species, and Scedosporium spp./Lomentospora prolificans. Cases were classified per the EORTC/MSGERC definitions. The sensitivity, specificity, turnaround time, and actionability of the mold PCR were measured. Out of 1,958 BAL samples tested, mold PCR was positive in 160 (8.2%) and culture in 75 (3.8%). Mold PCR was most commonly positive for Aspergillus species (77.5%), followed by Scedosporium spp./L. prolificans (20.0%), Mucorales agents (8.3%), and Fusarium species (1.2%). The sensitivity and specificity of the mold PCR using culture as the reference standard were 92.0% (69/75, 95% CI 83.4-97.1) and 95.2% (1794/1883, 95% CI 94.2-96.2), respectively. In 32 proven IMD cases, the sensitivity of mold PCR panel and culture was 90.6% (29/32, 95% CI 74.9-98.1) and 56.3% (18/32, 95% CI 37.7-73.7) (P < 0.001), respectively. The median time to positivity for mold PCR and culture was 1 day (interquartile range [IQR] 1-2) and 3 days (IQR 2-4) (P < 0.001), respectively. Among positive mold PCR results that provided a new finding (n = 91), 65.9% were clinically actionable. Mold PCR performed on BAL was more sensitive and rapid compared with fungal culture, and positive results were highly actionable.IMPORTANCEInvasive mold disease (IMD) in immunocompromised patients is associated with high morbidity and mortality. Bronchoalveolar lavage fluid (BAL) is commonly obtained for diagnosing pulmonary IMD, but rapid and accurate diagnosis of IMD is challenging with conventional diagnostics. The aim of this study was to investigate the accuracy, turnaround time, and clinical actionability of a BAL mold PCR assay detecting the five most common genera causing IMD. The BAL mold PCR was highly sensitive and specific compared to BAL fungal culture used as the reference method. In patients with proven pulmonary IMD, the BAL mold PCR was highly sensitive and significantly more sensitive compared with fungal culture. The BAL mold PCR was significantly more rapid than fungal culture, and the results were highly actionable. Overall, findings indicate the BAL mold PCR is highly accurate, rapid, and actionable for diagnosis of pulmonary IMD.
支气管肺泡灌洗液(BAL)通常用于诊断免疫功能低下患者的侵袭性霉菌病(IMD)。本研究探讨了霉菌聚合酶链反应(PCR)在BAL上的准确性、周转时间和临床可操作性。所有在研究期间用霉菌PCR和真菌培养检测的BAL均纳入本研究。霉菌PCR检测到曲霉属、毛霉属、镰刀菌属和增厚绵孢菌属。病例根据EORTC/MSGERC定义进行分类。检测霉菌PCR的敏感性、特异性、周转时间和可操作性。在测试的1958份BAL样本中,160份(8.2%)霉菌PCR阳性,培养75份(3.8%)霉菌PCR阳性。霉菌PCR最常见的是曲霉菌(Aspergillus)的阳性(77.5%),其次是Scedosporium sp ./L。繁殖菌(20.0%)、毛霉菌(8.3%)和镰刀菌(1.2%)。以培养物为参比标准的霉菌PCR灵敏度和特异性分别为92.0% (69/75,95% CI 83.4 ~ 97.1)和95.2% (1794/1883,95% CI 94.2 ~ 96.2)。在32例确诊的IMD病例中,霉菌PCR面板和培养的敏感性分别为90.6% (29/32,95% CI 74.9 ~ 98.1)和56.3% (18/32,95% CI 37.7 ~ 73.7) (P < 0.001)。霉菌PCR和培养的中位阳性时间分别为1 d(四分位数范围[IQR] 1 ~ 2)和3 d (IQR 2 ~ 4) (P < 0.001)。在霉菌PCR阳性结果中有新发现(n = 91), 65.9%具有临床可操作性。与真菌培养相比,在BAL上进行霉菌PCR检测更为灵敏和快速,阳性结果具有较高的可操作性。侵袭性霉菌病(IMD)在免疫功能低下患者中具有高发病率和死亡率。支气管肺泡灌洗液(BAL)通常用于诊断肺部IMD,但传统诊断方法对IMD的快速准确诊断具有挑战性。本研究的目的是研究BAL霉菌PCR检测五种最常见的引起IMD的菌株的准确性、周转时间和临床可操作性。与作为参考方法的BAL真菌培养相比,BAL霉菌PCR具有较高的敏感性和特异性。在证实为肺部IMD的患者中,BAL霉菌PCR高度敏感,明显高于真菌培养。BAL霉菌PCR比真菌培养快得多,结果具有很强的可操作性。总的来说,研究结果表明BAL霉菌PCR诊断肺IMD是高度准确、快速和可操作的。
{"title":"Accuracy and actionability of mold PCR on bronchoalveolar lavage fluid for diagnosis of invasive mold disease.","authors":"Koray K Demir, Gavin Anderson, Indre Budvytiene, Niaz Banaei","doi":"10.1128/jcm.01145-25","DOIUrl":"10.1128/jcm.01145-25","url":null,"abstract":"<p><p>Bronchoalveolar lavage fluid (BAL) is commonly obtained for diagnosing invasive mold disease (IMD) in immunocompromised patients. This study investigated the accuracy, turnaround time, and clinical actionability of mold polymerase chain reaction (PCR) on BAL. All BAL tested with mold PCR and fungal culture during the study period were included in this study. The mold PCR detected <i>Aspergillus</i> species, Mucorales agents, <i>Fusarium</i> species, and <i>Scedosporium</i> spp./<i>Lomentospora prolificans</i>. Cases were classified per the EORTC/MSGERC definitions. The sensitivity, specificity, turnaround time, and actionability of the mold PCR were measured. Out of 1,958 BAL samples tested, mold PCR was positive in 160 (8.2%) and culture in 75 (3.8%). Mold PCR was most commonly positive for <i>Aspergillus</i> species (77.5%), followed by <i>Scedosporium</i> spp./<i>L. prolificans</i> (20.0%), Mucorales agents (8.3%), and <i>Fusarium</i> species (1.2%). The sensitivity and specificity of the mold PCR using culture as the reference standard were 92.0% (69/75, 95% CI 83.4-97.1) and 95.2% (1794/1883, 95% CI 94.2-96.2), respectively. In 32 proven IMD cases, the sensitivity of mold PCR panel and culture was 90.6% (29/32, 95% CI 74.9-98.1) and 56.3% (18/32, 95% CI 37.7-73.7) (<i>P</i> < 0.001), respectively. The median time to positivity for mold PCR and culture was 1 day (interquartile range [IQR] 1-2) and 3 days (IQR 2-4) (<i>P</i> < 0.001), respectively. Among positive mold PCR results that provided a new finding (<i>n</i> = 91), 65.9% were clinically actionable. Mold PCR performed on BAL was more sensitive and rapid compared with fungal culture, and positive results were highly actionable.IMPORTANCEInvasive mold disease (IMD) in immunocompromised patients is associated with high morbidity and mortality. Bronchoalveolar lavage fluid (BAL) is commonly obtained for diagnosing pulmonary IMD, but rapid and accurate diagnosis of IMD is challenging with conventional diagnostics. The aim of this study was to investigate the accuracy, turnaround time, and clinical actionability of a BAL mold PCR assay detecting the five most common genera causing IMD. The BAL mold PCR was highly sensitive and specific compared to BAL fungal culture used as the reference method. In patients with proven pulmonary IMD, the BAL mold PCR was highly sensitive and significantly more sensitive compared with fungal culture. The BAL mold PCR was significantly more rapid than fungal culture, and the results were highly actionable. Overall, findings indicate the BAL mold PCR is highly accurate, rapid, and actionable for diagnosis of pulmonary IMD.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0114525"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710319/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145549539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Photo Quiz: An uncommon culprit in a young woman with headaches-a numb face and a fungal trace.","authors":"Tsung-Yu Tsai, Tzu-Ching Su, Pei-Lun Sun, Pei-Wen Wu, Tzong-Yow Wu, Liang-En Hwang, Aristine Cheng, Kuan-Yin Lin, Yee-Chun Chen","doi":"10.1128/jcm.01127-25","DOIUrl":"10.1128/jcm.01127-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"63 12","pages":"e0112725"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145768331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17Epub Date: 2025-11-13DOI: 10.1128/jcm.01358-25
A J Fenwick, A Misra, I Martin
{"title":"Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings.","authors":"A J Fenwick, A Misra, I Martin","doi":"10.1128/jcm.01358-25","DOIUrl":"10.1128/jcm.01358-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0135825"},"PeriodicalIF":5.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145504102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}