Journal of Clinical Microbiology最新文献

{"title":"AveloMask, a novel breath aerosol collection kit for airborne <i>Mycobacterium tuberculosis</i>: a proof-of-principle assessment.","authors":"Patricia Risch, Tobias Broger, Zandile Booi, Katie Tiseo, Harshitha Santhosh Kumar, Jamie van Schalkwyk, Theresa Heinrich, Reto Willi, Stefan M Botha, Peter Sander, Adithya Cattamanchi, Stephan Hubold, Claudia M Denkinger, Grant Theron, Christina Fialová, Christian Adlhart, Rouxjeane Venter","doi":"10.1128/jcm.00546-25","DOIUrl":"10.1128/jcm.00546-25","url":null,"abstract":"<p><p>Tuberculosis (TB) remains the world's deadliest infectious disease, with many active cases missed due to challenges in sputum collection. Exhaled breath aerosols (XBA), a major route of <i>Mycobacterium tuberculosis</i> (MTB) transmission, offer a promising non-invasive alternative. This study evaluated the diagnostic accuracy and feasibility of the AveloMask-a novel point-of-care breath aerosol collection kit-for detecting active pulmonary TB using quantitative PCR (qPCR). In a pilot diagnostic accuracy study, 61 symptomatic, adult outpatients in Cape Town, South Africa, wore the mask for 45 min, coughing deeply at the start and end. XBAs were collected on integrated fiber filters transferred into stabilizing buffer via a simple push step and biobanked. XBA's were batch-analyzed by qPCR targeting the MTB-specific <i>IS6110</i> sequence. Diagnostic accuracy was assessed against sputum Xpert MTB/RIF Ultra (SXRS) and a composite microbiological reference standard (MRS), including culture. Of the 58 evaluable participants, 59% (34/58) had confirmed TB. Compared with SXRS, mask qPCR showed 71.0% (95% confidence interval [CI]: 53.4%-83.9%) sensitivity and 92.3% (95% CI:75.9%-97.9%) specificity. Against MRS, sensitivity was 64.7% (95% CI: 47.9%-78.5%) and specificity 91.7% (95% CI: 74.2%-97.7%). Sensitivity increased with bacterial load, reaching 100% in sputum with high MTB concentrations. MTB <i>IS6110</i> copy numbers in XBAs were low overall (175 copies [4-2,147]), likely due to insufficient DNA recovery or low aerosol bacilli. The mask sampling was well-tolerated by users. The AveloMask Kit shows promising diagnostic accuracy for TB and is feasible for point-of-care use. Further optimization and larger validation studies are warranted.IMPORTANCETuberculosis (TB) remains the world's deadliest infectious disease, yet diagnosis still relies heavily on sputum, which many patients struggle to produce. This study introduces the AveloMask Kit, a user-friendly, non-invasive face mask that captures exhaled aerosols and transfers them into a buffer tube for molecular detection of respiratory tract infections. In a clinical proof-of-principle study, AveloMask detected TB with promising accuracy and demonstrated feasibility in outpatient settings. By offering a non-invasive alternative to sputum, the AveloMask Kit addresses a critical diagnostic gap and could expand access to TB testing, particularly in resource-limited or primary care settings. Its simplicity enables use by minimally trained staff, and its stabilizing buffer allows ambient-temperature transport and biobanking, supporting broader case finding, safer sample collection, and future aerobiology research.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0054625"},"PeriodicalIF":5.4,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955913","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":"Emerging technologies for rapid phenotypic antimicrobial susceptibility testing of clinical isolates of bacteria.","authors":"Jacob Rattin, Malcolm Boswell, Daniel Rhoads","doi":"10.1128/jcm.00674-25","DOIUrl":"10.1128/jcm.00674-25","url":null,"abstract":"<p><p>Providing timely and accurate antimicrobial susceptibility testing (AST) results is a crucial component of clinical microbiology practice. Commercial rapid AST (RAST) is an emerging and quickly expanding area. These phenotypic RAST systems use various novel methods to monitor bacterial growth and replication in order to shorten the duration of time required for testing. Implementation of RAST has the potential to expedite antimicrobial therapeutic optimization, which can improve patient care. This minireview describes the current state of commercial phenotypic RAST including tests designed to report antimicrobial susceptibilities directly from clinical specimens.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0067425"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a commercial multiplex pathogen panel for the diagnosis of pediatric <i>Kingella kingae</i> joint infections.","authors":"Philippe Bidet, Stéphane Bonacorsi, Matthis Lingua, Anne-Laure Simon, Marie Parizot, Marion Caseris, André Birgy","doi":"10.1128/jcm.01039-25","DOIUrl":"10.1128/jcm.01039-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0103925"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to \"Evaluation of a commercial multiplex pathogen panel for the diagnosis of pediatric <i>Kingella kingae</i> joint infections\".","authors":"Laura M Filkins, Lawson Copley","doi":"10.1128/jcm.01060-25","DOIUrl":"https://doi.org/10.1128/jcm.01060-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0106025"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Name changes for fungi of medical importance, 2022-2024.","authors":"Andrew M Borman, Alireza Abdolrasouli, Elizabeth M Johnson","doi":"10.1128/jcm.02041-24","DOIUrl":"10.1128/jcm.02041-24","url":null,"abstract":"<p><p>The current article summarizes the changes in nomenclature for fungi of medical importance published in the years 2022-2024, including new species and genera and revised names for existing ones. Most of the revised names have been widely adopted without further discussion. However, those that concern common pathogens of humans may take longer to achieve general usage, with new and current names reported together to engender increasing familiarity with the correct taxonomic classification.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0204124"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":" Clinical performance of a syndromic panel for direct identification of pathogens and antimicrobial resistance markers in pediatric osteoarticular and pleural space infections.","authors":"B C Sanchez, H Sayeed, D T Niles, J J Dunn","doi":"10.1128/jcm.00621-25","DOIUrl":"https://doi.org/10.1128/jcm.00621-25","url":null,"abstract":"<p><p>The recovery of microbial pathogens from sterile body fluids in children poses challenges, including the low sensitivity of conventional culture. Pre-treatment with empiric antimicrobials can render the pathogen non-viable. In such cases, and with fastidious organisms like <i>Kingella kingae</i>, molecular methods are useful for identification of the causative agent. This study evaluated the clinical performance of the bioMérieux BIOFIRE Joint Infection (JI) Panel to standard-of-care (SOC) diagnostic techniques in pediatric osteoarticular and pleural fluid and abscess specimens. A total of 136 specimens (77 joint and 59 pleural), were tested with the JI Panel. SOC methods included a lab-developed, real-time PCR assay (Laboratory-developed PCR [LDT-PCR]), routine culture and ancillary testing. Compared to the composite SOC methods, the JI Panel had a positive percent agreement (PPA) of 90.1% and negative percent agreement (NPA) of 99.9% for the detection of on-panel organisms in osteoarticular specimens. For pleural specimens, the JI Panel had a PPA of 93.8% and NPA of 99.6%. False negatives by the JI Panel in both specimen types were detected by the LDT-PCR with cycle thresholds ≥35, which may suggest a low burden of microorganisms in these specimens. The JI Panel demonstrated good performance for the detection of <i>K. kingae</i> (PPA = 93.8%) in osteoarticular specimens and <i>Streptococcus pneumoniae</i> (PPA = 95.2%) in pleural specimens, the most common pediatric pathogens identified in these respective specimen types. The JI Panel has the potential to impact the treatment and management of pediatric patients, especially in culture-negative cases.</p><p><strong>Importance: </strong>The identification of the causative agents of osteoarticular and pleural space infections in children is challenging, as routine bacterial cultures often yield no growth. The BIOFIRE Joint Infection Panel is a rapid, multiplex PCR assay that detects a wide range of microorganisms and antimicrobial resistance genes. This study demonstrates that the panel has good agreement with standard of care methods for the detection of common pediatric pathogens and may aid in the rapid diagnosis of osteoarticular and pleural space infections in children. However, it is recommended that the assay be used in conjunction with standard bacterial cultures and results interpreted within the context of the clinical presentation, since false-negative and false-positive results may occur.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0062125"},"PeriodicalIF":5.4,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance and workflow comparison of the VITEK MS PRIME and Bruker Biotyper MALDI-TOF MS systems.","authors":"Rachel E Bosserman, Nicole J Tarlton, Kelly Alvarado, Brittany Roemmich, Melanie L Yarbrough","doi":"10.1128/jcm.00211-25","DOIUrl":"10.1128/jcm.00211-25","url":null,"abstract":"<p><p>Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is widely used for rapid identification of bacteria and yeast in clinical labs. The VITEK MS PRIME (\"PRIME\") is the latest MALDI-TOF MS system from bioMérieux. This study evaluated PRIME's performance and workflow timing against the MALDI Biotyper CA System by Bruker (\"Biotyper\"). We compared a collection of 154 bacteria and yeast clinical isolates from various specimen types using three methods: Biotyper target with a toothpick, PRIME target with the PICKME nib, and PRIME target with a loop. Positive blood culture isolates were also analyzed using these methods, with high-experience (HEU, <i>n</i> = 300) and low-experience users (LEU, <i>n</i> = 50) after short (6-8 h) and routine (18-24 h) incubation on agar plates. Workflow timing, from sample processing to organism identification, was assessed to identify time savings. PRIME identified 96% (PICKME) and 95% (Loop) of challenge isolates to genus level, compared with Biotyper at 99%. Short incubation of positive blood culture isolates demonstrated similar species-level identification rates across all methods (Biotyper: 84%, PRIME PICKME: 80%, PRIME Loop: 81%), although more repeats were needed compared with routine incubation. No difference in species identification occurred between users for any method at short incubation (89%-91%, HEU, vs 79%-85% LEU). Single-target process times were comparable for all methods (55-59 min), whereas PRIME methods had shorter hands-on times for analysis of multiple targets (Biotyper: 53 min, PRIME PICKME: 39 min, PRIME Loop: 40 min). These findings highlight the comparable performance of the PRIME and Biotyper systems while demonstrating the potential for time savings with PRIME workflows, particularly in high-throughput settings.IMPORTANCEThis study provides a critical evaluation of the new VITEK MS PRIME MALDI-TOF MS system, comparing its performance and workflow efficiency against the Bruker MALDI Biotyper. The study investigates the success rate of isolate identification from short incubation of positive blood cultures, illustrating the utility of this technique for downstream workflows such as faster reporting of results for patient management and isolate identification for interpretation of rapid phenotypic AST. Analysis of different workflows demonstrated areas for potential time savings, particularly in high-throughput settings. These findings highlight the importance of optimizing MALDI-TOF MS workflows in the era of workforce shortages and lab centralization to enhance rapid pathogen identification and improve patient care.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0021125"},"PeriodicalIF":5.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12345239/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333166","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":"Re-evaluation of penicillin and ceftriaxone MIC results to predict susceptibility to the oral cephalosporin, cefpodoxime, in <i>Streptococcus pneumoniae</i> clinical isolates from the United States according to CLSI guidelines (2019-2021).","authors":"Rodrigo E Mendes, Jessica V Pierce, Kelly Wright, Michael D Huband, Mariana Castanheira","doi":"10.1128/jcm.00027-25","DOIUrl":"10.1128/jcm.00027-25","url":null,"abstract":"<p><p>Clinical and Laboratory Standards Institute (CLSI) M100Ed24 (2024) states that <i>Streptococcus pneumoniae</i> susceptible to oral penicillin can be considered susceptible to various β-lactams, including oral cephalosporins. However, surrogacy guidance is not available for isolates nonsusceptible to oral penicillin. Instead, such isolates require specific MIC testing and interpretations for reporting susceptibility to oral cephalosporins, for which susceptibility testing is limited in most automated systems, and consequently restricts information pertaining to oral cephalosporins at an individual institution. This study evaluated the ability of the penicillin breakpoints to predict cefpodoxime and ceftriaxone susceptibilities against a recent collection of <i>S. pneumoniae</i> from United States hospitals according to CLSI guidelines. The susceptible breakpoint for oral penicillin (≤0.06 mg/L) predicted susceptibility to cefpodoxime and ceftriaxone. However, when isolates were nonsusceptible to oral penicillin (MIC, >0.06 mg/L), susceptibility to cefpodoxime could not be predicted due to a low categorical agreement (CA) (78.4%). Parenteral penicillin breakpoints also could not predict cefpodoxime susceptibility due to the elevated number of very major errors and a CA of 76.8%; however, these breakpoints could still be used as a surrogate marker to predict ceftriaxone susceptibility. Finally, ceftriaxone could be used for surrogate testing of cefpodoxime by applying breakpoints (≤0.25 mg/L for susceptible; 0.5 mg/L for intermediate; ≥1 mg/L for resistant) lower than the current clinical cutoffs. These analyses showed that isolates nonsusceptible to oral penicillin cannot be considered susceptible to cefpodoxime, and caution should be used when prescribing oral cephalosporins for the empiric treatment of community-acquired bacterial pneumonia.IMPORTANCESusceptibility results to oral cephalosporins are rarely available to guide therapy due to the limited number of drugs evaluated on common automated antimicrobial susceptibility testing (AST) systems (i.e., Vitek 2, MicroScan, and Phoenix). In addition, disk diffusion methods for determining <i>Streptococcus pneumoniae</i> susceptibility to β-lactam agents are not reliable, and a quantitative method, such as broth microdilution or gradient strips, is required. In addition, the epidemiology and serotypes of <i>S. pneumoniae</i> are constantly evolving; therefore, this work provides a re-evaluation of surrogacy testing for β-lactam agents against <i>S. pneumoniae</i> recently recovered from United States laboratories. The data provide the possible use of ceftriaxone MIC for determining cefpodoxime susceptibility. This should be of interest to microbiology laboratories and the scientific community.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0002725"},"PeriodicalIF":5.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12345151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144475472","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":"Accuracy of plasma cell-free DNA PCR for non-invasive diagnosis of mucormycosis.","authors":"Jordan Mah, Anthony Lieu, Veronica Nicholas, Angel Moreno, Kanagavel Murugesan, Indre Budvytiene, Niaz Banaei","doi":"10.1128/jcm.00796-25","DOIUrl":"10.1128/jcm.00796-25","url":null,"abstract":"<p><p>Diagnosis of mucormycosis poses a substantial challenge due to the lack of a non-invasive biomarker and limitations of conventional diagnostics using invasive specimens. The aim of this study was to characterize the performance of Mucorales plasma cell-free DNA (cfDNA) PCR in immunosuppressed and non-immunosuppressed patients with pulmonary, disseminated, and localized mucormycosis. Patients with Mucorales plasma cfDNA test results were retrospectively categorized as proven or probable for sensitivity analysis and as no Mucorales infection for specificity analysis. In total, 85 positive and 212 negative Mucorales plasma cfDNA test results in unique patients were included in this study. Per the expert definitions, 47 patients had proven or probable mucormycosis, and 171 did not have invasive Mucorales infection. The Mucorales plasma cfDNA PCR had an overall sensitivity and specificity of 85.1% (40/47, 95% CI, 71.7-93.8) and 92.9% (158/170, 95% CI, 88.0-96.3), respectively. The sensitivity was 92.1% (35/38, 95% CI, 78.6-98.3) and 55.6% (5/9, 95% CI, 21.2-86.3) in patients with and without immunosuppression, respectively, and 100% (14/14, 95% CI, 76.8-100), 89.5% (17/19, 95% CI, 66.9-98.7), and 64.3% (9/14, 95% CI, 35.1-87.2) in patients with disseminated, pulmonary, and localized mucormycosis, respectively. Mucorales plasma cfDNA PCR is a sensitive and specific non-invasive testing modality for the diagnosis of mucormycosis in immunosuppressed patients and those with pulmonary and disseminated infection.IMPORTANCEMucormycosis is an invasive mold infection associated with high morbidity and mortality. Early diagnosis and effective antifungal treatment are critical for improving clinical outcomes. However, diagnosis of mucormycosis is often delayed due to the lack of a non-invasive biomarker and insensitivity of culture and non-specificity of histopathology performed on invasive specimens. Mucorales plasma cell-free DNA (cfDNA) PCR is a novel testing modality that allows non-invasive diagnosis of mucormycosis. In the current study, we evaluated the clinical performance of a pre-analytically optimized Mucorales plasma cfDNA PCR in immunosuppressed and non-immunosuppressed patients with pulmonary, disseminated, and localized infections. We show that Mucorales plasma cfDNA PCR is highly sensitive and specific in immunosuppressed patients with pulmonary and disseminated infections. Thus, the Mucorales plasma cfDNA PCR represents an accurate diagnostic tool for non-invasive diagnosis of mucormycosis, which may enable early treatment and improved outcomes in immunosuppressed patients with mucormycosis.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0079625"},"PeriodicalIF":5.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12345248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591308","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":"First description of the performance of the VITEK MITUBE device used with MALDI-TOF mass spectrometry to achieve identification of gram-negative bacteria directly from positive blood culture broth.","authors":"Daniel D Rhoads, Nancy D Hanson, Kaley Reedy, Johanne Gafsi, Yun X Ying, Dwight J Hardy","doi":"10.1128/jcm.00122-25","DOIUrl":"10.1128/jcm.00122-25","url":null,"abstract":"<p><p>Improving the rapidity of identification of bacteria causing bacteremia continues to be a focus for quality improvement within the discipline of clinical microbiology. This multicenter study was used to obtain In Vitro Diagnostic Regulation Conformite Europeenne (CE) mark in Europe and describes the performance of the VITEK MITUBE to matrix-assisted laser desorption/ionization (MALDI) workflow for identification of 10 species of gram-negative bacteria directly from positive blood culture broth without subculture. One hundred twenty-five (125) prospective clinical samples, including <i>Escherichia coli</i> (69), <i>Klebsiella aerogenes</i> (4), <i>Klebsiella oxytoca</i> (3), <i>Klebsiella pneumoniae</i> (29), <i>Proteus mirabilis</i> (9), <i>Pseudomonas aeruginosa</i> (10), and <i>Serratia marcescens</i> (1), were included; and 123 (98.4%) were accurately identified using the VITEK MITUBE workflow. None were misidentified, and two (1.6%) <i>K. pneumoniae</i> were not identified. Contrived samples were also tested and reported in this study. When considering both the prospective clinical samples and the contrived samples, the workflow was able to identify the species 95% of the time. <i>Proteus vulgaris</i> accounted for 81% (13/16) of the samples that were unable to achieve an identification. A single misidentification error is reported in the contrived sample testing. The VITEK MITUBE to MALDI workflow enables accurate and reliable identification of commonly encountered gram-negative bacteria directly from positive blood culture broth.IMPORTANCEMITUBE is a new <i>in vitro</i> diagnostic device designed to meet a need in the clinical microbiology community for a simple, rapid, accurate, and inexpensive system to identify bacteria detected in blood cultures using MALDI-TOF and without the need for subculture.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0012225"},"PeriodicalIF":5.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12345195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659367","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}