Journal of Clinical Microbiology最新文献

{"title":"Diagnostics and new treatment regimens for TB: can the Xpert MTB/XDR assay fill the gap for fluoroquinolone testing?","authors":"Derek T Armstrong, Emma C E Baird, Logan Pretty, Karen D'Agostino, Matthew Schwartz, Victoria L Campódonico, Nicole Parrish","doi":"10.1128/jcm.00643-25","DOIUrl":"https://doi.org/10.1128/jcm.00643-25","url":null,"abstract":"<p><p>Rapid diagnosis of resistance-conferring mutations to antibiotics used for the treatment of tuberculosis (TB) is critical for patient care and public health control efforts. Prior guidelines included the use of fluoroquinolones (FQs) for the treatment of drug-resistant TB, including multidrug-resistant TB, pre-extensively drug-resistant TB, and extensively drug-resistant TB. More recently, a short-course regimen for antibiotic-susceptible TB was introduced, which includes the use of a FQ, a drug class that diagnostic algorithms in the United States (US) typically do not test for if all first-line agents are susceptible. However, FQ mono-resistance has been documented by previous studies, and for this reason, we tested 319 archived <i>Mycobacterium tuberculosis</i> complex (MTBC) strains spanning a 14-year period of time using the Xpert MTB/XDR assay. Resistance to FQs was detected in 4.4% (14/319) of the isolates tested, with mutations predominating in the <i>gyrA</i> region (13/14; 92.9%). A single isolate (1/14; 7.1%) was found to have a <i>gyrB</i> mutation. A broth microdilution assay demonstrated the minimum inhibitory concentrations for resistant strains that ranged from 0.5 µg/mL to 8.0 µg/mL. Importantly, three strains were FQ mono-resistant and would have been completely missed by standard testing algorithms. Although currently unavailable in the US, the GeneXpert XDR assay has the potential to fill the significant diagnostic gap in susceptibility testing of MTBC resistance to FQs and support the use of the currently recommended short-course regimen.IMPORTANCE This study provides insight into the need for additional rapid testing for the detection of drug resistance (specifically to fluoroquinolones) in tuberculosis (TB) cases in the United States (US). The current regimens for TB treatment rely on knowing resistance patterns to optimize treatment, and missed resistance could have a negative impact on the health of the patient, as well as contribute to increased drug-resistance mutations in new TB cases. There are currently limited platforms for expanded rapid drug resistance testing for TB cases in the US, and this study looks at past TB cases that had drug resistance missed by routine testing.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0064325"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956100","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":"Antibiotic resistance profiles of seven genomospecies of <i>Corynebacterium jeikeium</i> analyzed by whole genome sequencing.","authors":"Michaela Fischer-Wellenborn, Frank Imkamp, Valéria Pereira Pires, Reinhard Zbinden, Nicolas Personnic","doi":"10.1128/jcm.00418-25","DOIUrl":"10.1128/jcm.00418-25","url":null,"abstract":"<p><p><i>Corynebacterium jeikeium</i> is an opportunistic human pathogen with high genomic diversity. In the past, multi-drug resistance has been considered a hallmark of <i>C. jeikeium</i>. However, some strains of <i>C. jeikeium</i> are fully susceptible and thus, their reclassification would avoid the empirical therapy with glycopeptides. One hundred eighty-six clinical isolates and four reference isolates identified as <i>C. jeikeium</i> between 1994-1999 and 2012-2019, respectively, were analyzed by matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) and 16S ribosomal RNA (16S rRNA) gene sequence analysis. A total of 153 confirmed <i>C. jeikeium</i> isolates was further analyzed by whole genome sequencing (WGS) and by disk diffusion antimicrobial susceptibility testing (AST). WGS and subsequent core genome single nucleotide polymorphism-based phylogenetic analysis segregated the isolates into seven phylogenetic clusters. The average nucleotide identity between the clusters was <u><</u>95%, qualifying them as separate <i>C. jeikeium</i> genomospecies. Overall, AST profiles of all 153 isolates were heterogeneous for six of the 16 antibiotics tested. Notably, genomospecies 6 and 7 displayed mainly comparably small inhibition zones. For the other 10 antibiotics, all genomospecies displayed either small or large inhibition zones, respectively. Our study of <i>C. jeikeium</i> clinical isolates revealed a relatively complex phylogenetic structure. As soon as clear phenotypic traits can be attributed to the seven genomospecies by routine diagnostic tests, genomospecies encompassing mainly antibiotic-susceptible strains should be reclassified to fine-tune potential treatment strategies.IMPORTANCE<i>Corynebacterium jeikeium</i> isolates typically display multi-drug resistance (MDR), frequently triggering empirical therapies with glycopeptides. However, some strains are susceptible to a broad range of antibiotics. In our study, analysis of a large collection of <i>C. jeikeium</i> by whole genome sequencing (WGS) and antibiotic resistance testing revealed genomic diversity, and some correlations between MDR phenotypes and specific genomospecies. While WGS is not yet a routine method, identification of MDR genomospecies may confirm the need for glycopeptide therapy. Identification of a less-resistant genomospecies would have even a higher clinical impact, as unnecessary therapies with glycopeptides are avoided, thereby reducing the selection for vancomycin-resistant enterococci. In the future, databases of diagnostic tools, e.g., MALDI-TOF, may be expanded to allow for the differentiation of genomospecies. Furthermore, rational taxonomic reclassification of some <i>C. jeikeium</i> genomospecies would help clinicians to fine-tune potential treatment strategies.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0041825"},"PeriodicalIF":5.4,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955902","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":"The laboratory billing process and its applications to molecular microbiology testing: guidance for laboratorians.","authors":"Meghan W Starolis, Hema Kapoor, Kristen L Jurcic Smith, Rachael M Liesman, Dawn R Zenefski","doi":"10.1128/jcm.00666-25","DOIUrl":"https://doi.org/10.1128/jcm.00666-25","url":null,"abstract":"<p><p>The processes used by laboratories to seek reimbursement for services performed are complex and often unclear to laboratorians, a key group that has the clinical and technical knowledge to influence reimbursement. In this review, we provide a comprehensive overview of laboratory billing processes for insurance billing and hospital inpatient services, as well as the various procedure codes used in these processes. Understanding the health plan landscape is also of critical importance, as health plan policies and coverage decisions have downstream effects on accessibility of testing for patients. A detailed overview of health plans and how coverage determinations are made and communicated is discussed in this review. Lastly, we present actionable areas of opportunity in clinical microbiology where laboratorians, as well as test manufacturers, can focus on improving reimbursement (syndromic panels, antimicrobial resistance, and next-generation sequencing) to expand access to these evolving technologies and encourage adoption in clinical laboratories.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0066625"},"PeriodicalIF":5.4,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956136","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":"Optimization of a molecularly defined tuberculin formulation: recombinant fusion proteins and epitope surgery.","authors":"Sonya Middleton, Mahavir Singh, Michael Coad, Si Palmer, Tom Holder, Sabine Steinbach, Rebecca Hardiman, H Martin Vordermeier, Gareth J Jones","doi":"10.1128/jcm.00552-25","DOIUrl":"https://doi.org/10.1128/jcm.00552-25","url":null,"abstract":"<p><p>Bovine tuberculosis is an infectious livestock disease of global economic and zoonotic importance. Surveillance programs are largely dependent on the skin test that utilizes purified protein derivatives (PPDs) of tuberculin. PPDs suffer from a number of limitations regarding their production, characterization, and performance. Recently, we developed a molecularly defined tuberculin (MDT) that overcame these limitations. The MDT formulation comprises eight antigens, initially presented as seven recombinant proteins (ESAT6, CFP10, Rv3615c, Rv3020c, Rv1789, Rv3478, and Rv3810) and one 20-synthetic peptide pool representing Rv3616c; the recombinant Rv3616c could not be produced. In this paper, we describe the steps taken to simplify the MDT formulation. First, seven of the eight proteins were formulated as three recombinant fusion proteins. Second, the non-immunogenic regions of Rv3616c were identified, using overlapping peptides to probe T-cells from infected cattle. A novel variant, Rv3616c-S4, was designed and then formulated (i) as a stand-alone protein in the MDT-S4 formulation and (ii) fused to Rv1789 for use in the MDT-F formulation. These novel MDT formulations gave comparable signal strength to PPD-B in experimentally infected animals. The MDT-F, comprising only fusion proteins, performed as well as the comparative cervical tuberculin skin test, in terms of relative sensitivity (>2 mm; 96%, 95% CI 80-100, <i>n</i> = 24) and specificity (>2 mm; 100%, 95% CI 89%-100%, <i>n</i> = 30). In conclusion, we have developed a novel, simplified MDT formulation that has significantly advanced our efforts toward licensure and which has the potential to replace the PPDs developed in the 1930s.</p><p><strong>Importance: </strong>Bovine tuberculosis is an infectious livestock disease of global economic and zoonotic importance. Surveillance programs are largely dependent on the skin test, which utilizes tuberculins. These are crude protein extracts of live bacterial cultures, which suffer from a number of limitations regarding their characterization, standardization, production, and performance. We aim to develop a skin test reagent composed of eight defined antigens that could replace the tuberculins. This study describes the refinement of this \"molecularly defined tuberculin\" (MDT) reagent into a fusion protein formulation comprising all eight antigens. The MDT is well defined, easily standardized, and delivers good test performance in experimentally infected, non-infected cattle and cattle sensitized to Johne's disease. The fusion protein formulation is an important step on the developmental pathway to a registered and marketable product.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0055225"},"PeriodicalIF":5.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956111","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":"Diagnostic stewardship applied to targeted fungal sequencing.","authors":"Jessica Hudson, Indre Budvytiene, Niaz Banaei","doi":"10.1128/jcm.00896-25","DOIUrl":"https://doi.org/10.1128/jcm.00896-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0089625"},"PeriodicalIF":5.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956082","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":"Comparison of core genome multi-locus sequencing typing pipelines for hospital outbreak detection of common bacterial pathogens.","authors":"Heather L Glasgow, Ying Zheng, Jessica N Brazelton, Li Tang, Randall T Hayden","doi":"10.1128/jcm.00646-25","DOIUrl":"https://doi.org/10.1128/jcm.00646-25","url":null,"abstract":"<p><p>Microbial whole genome sequencing (WGS)-based methods have replaced conventional methods for genomic relatedness analysis in the investigation of or surveillance for infectious outbreaks. Analysis of WGS by core genome multi-locus sequence typing (cgMLST) has been proposed for standardized strain comparisons at high resolution and for longitudinal outbreak surveillance. We compared three commercial cgMLST software pipelines, Ridom SeqSphere+, 1928 Diagnostics' platform, and Ares Genetics ARESdb, for the identification of related (clustered) strains among 255 isolates of common bacterial pathogens, including <i>Acinetobacter baumannii, Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus,</i> and <i>Serratia marcescens</i>. Isolates were previously identified as clustered with at least one other isolate collected from the same patient or different patients. Concordance with SeqSphere+ for differentiating clustered from non-clustered isolate pairs using suggested thresholds was 100% for the 1928 platform and 99.5% for ARESdb overall and 91.8%, 96.1%, and 100% among same-patient clustered, different-patient clustered, and different-patient non-clustered isolate pairs, respectively, in ARESdb. ARESdb showed significantly greater allelic distances than SeqSphere+ and 1928 among same-patient clustered isolate pairs (mean [standard deviation, SD], 7.6 [7.17], 1.18 [1.56], and 1 [1.59]) and different-patient clustered isolate pairs (mean [SD], 8.34 [4.31], 3.61 [2.26], and 3.91 [2.67]) (<i>P</i> < 0.0001), but not among non-clustered isolate pairs. For all species analyzed with sufficient sample size, allelic distances of clustered isolate pairs were significantly higher in ARESdb. CgMLST analysis using commercial pipelines may result in different allelic distances but showed concordance using suggested clustering thresholds to determine relatedness among strains.IMPORTANCEMicrobial genetic relatedness analysis is commonly used to investigate suspected outbreaks among different patients with infections caused by the same species of pathogen and, increasingly, for outbreak surveillance to uncover unsuspected healthcare-associated transmission events among patients, enabling early intervention by infection prevention and control specialists to prevent further spread. Here, we compared three commercial software tools for bacterial relatedness analysis, which perform gene-by-gene comparisons to determine the degree of relatedness for several species of common pathogens. Such software tools potentially allow clinical laboratories to perform rapid and routine analysis for infection control purposes without the need for in-house bioinformatic expertize. This study evaluates the comparability of three of these software tools, while presenting a model for comparative analytic pipeline evaluation.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0064625"},"PeriodicalIF":5.4,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955976","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":"Analytical evaluation of TriVerity, a rapid diagnostic and prognostic host gene expression test performed on the Myrna instrument using RT-LAMP.","authors":"Claudia Figueiredo-Pereira, Paul Fleming, Mikaela Nicole Alganes, Ran Bi, Ana Mafalda Cavaleiro, Diogo Cruz, Carlota Cunha-Matos, Margarita Davalos-Arias, Dana Farkas, Yehudit Hasin, Kevin Hu, Christos Kampouridis, Ragheb El Khaja, Graciano Leal, Jingyi Lu, Rita Madeira, Michael Mayhew, Breana McBryde, Daniela C Oliveira, Anna Passernig, Davion Pendleton, Elizabeth Popp, Shailee Rasania, Cristina Rebelo, Ana Santiago, Joshua R Shak, Vera P Silva, Ambika Srinath, Timothy E Sweeney, Rodrigo Vieira, Thang Vu, Chris Wilson, Boris Zybin, Natalie N Whitfield, Oliver Liesenfeld, Hjalmar R Bouma, Richard E Rothman, Edward A Michelson, Joao Fonseca","doi":"10.1128/jcm.00352-25","DOIUrl":"https://doi.org/10.1128/jcm.00352-25","url":null,"abstract":"<p><p>We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host messenger RNAs (mRNAs) measured quantitatively from PAXgene Blood RNA specimens using the TriVerity cartridge on the Myrna instrument. In approximately 30 minutes, 3 scores are generated from 29 host mRNAs for the likelihood of a bacterial infection, a viral infection, and illness severity (7-day need for ICU-level care), each falling into 1 of 5 interpretation bands (very low, low, moderate, high, and very high). Reproducibility, precision, limit of detection, linearity, interference, and sample and cartridge stability were determined per Clinical Laboratory Standards Institute standards. An operator survey assessed TriVerity's ease of use. Reproducibility demonstrated SDs meeting the acceptance criteria of <5.5 score units. The lowest concentration at which 100% of replicates showed measurable amplification was 1 × 10⁶ cp/mL of <i>in vitro</i> RNA transcripts; the limit of quantification and detection were equivalent to blood containing 500 leukocytes/µL. Interference was not observed for 17 potential interferents. The cartridge was stable at room temperature (RT) for 9 and 12 months using accelerated testing at 37°C. TriVerity results were equivalent using fresh and frozen PAXgene Blood RNA samples. All operators agreed or strongly agreed that the TriVerity test system was easy to use. In summary, the analytical performance presented here, along with diagnostic accuracy established in the SEPSIS-SHIELD trial, demonstrates that the TriVerity system is reliable and user friendly, assisting clinicians in managing patients with suspected acute infections and sepsis in acute care settings.</p><p><strong>Importance: </strong>The prompt diagnosis of acute infections and sepsis is critical for better patient outcomes. We introduce a groundbreaking messenger RNA-based test, the first of its kind, designed to diagnose the presence of infection and predict illness severity in adult patients with suspected acute infections or sepsis. Several key findings regarding the accuracy and robustness of the test system are presented, which will be relevant to laboratories or acute care settings implementing the test for patient care. Furthermore, these findings may assist clinical researchers in developing analytical trial protocols aimed at the combined evaluation of RNA-based multi-marker tests with both diagnostic and prognostic test characteristics.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0035225"},"PeriodicalIF":5.4,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955931","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 potential utility of the BioFire Joint Infection Panel with synovial fluid and joint tissue specimens.","authors":"Shivani Fox-Lewis, Marc Douglass, Sally Roberts","doi":"10.1128/jcm.00594-25","DOIUrl":"https://doi.org/10.1128/jcm.00594-25","url":null,"abstract":"<p><p>The BioFire Joint Infection Panel (BJIP) (bioMérieux) is a rapid sample-to-answer multiplex polymerase chain reaction (PCR) platform for the diagnosis of joint infections. This retrospective study evaluated its performance with synovial fluid and joint tissue specimens from native and prosthetic joints. Joint fluid and tissue specimens received from November 2023 to September 2024 were included. Some specimens were pooled prior to BJIP testing. BJIP results were compared to composite standard laboratory testing (culture, 16S rRNA gene PCR and sequencing [where performed], and concurrent microbiological results for that infection episode). Clinical data were collected (diagnosis, surgical history, antibiotic treatment). Subgroup analysis of native and prosthetic joint specimens was conducted. There were 224 specimens from 134 patients: 107 synovial fluids and 117 joint tissues. The most common organisms, reliably detected by the BJIP, were <i>Staphylococcus aureus</i> and <i>Streptococcus</i> spp. The on-panel positive percent agreement (PPA) was 90.5% for synovial fluids and 86.8% for joint tissues. There was no significant difference in the PPA for synovial fluids vs joint tissues, nor for native vs prosthetic joints. The additional diagnostic yield was one case. The absence of important pathogens in prosthetic joint infection, e.g., <i>Cutibacterium acnes</i>, reduces the overall PPA (74.5% synovial fluid, 77.6% joint tissue). The BJIP performs well in synovial fluid and joint tissue specimens, from native and prosthetic joints for on-panel organisms. There was minimal additional diagnostic yield. We suggest an implementation pathway using the BJIP upfront to provide rapid results to optimize patient care.IMPORTANCEThis study compared the BioFire Joint Infection polymerase chain reaction panel to standard culture-based methods for detecting organisms causing joint infections. This is a relatively new test, and the data published so far show it performs well with synovial fluid. There are limited published data using it for joint tissue specimens. We found that the BioFire Joint Infection Panel reliably detects pathogens in synovial fluid and joint tissue specimens, though its performance is limited by the absence of important pathogens associated with prosthetic joint infection, e.g., <i>Cutibacterium acnes</i>. We suggest using the panel to provide rapid diagnosis to optimize patient care.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0059425"},"PeriodicalIF":5.4,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956119","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}