Journal of Clinical Microbiology最新文献

{"title":"Proceedings of the Clinical Microbiology Open 2024: artificial intelligence applications in clinical microbiology.","authors":"Jennifer Dien Bard, Andrea M Prinzi, Paige M K Larkin, David R Peaper, Daniel D Rhoads","doi":"10.1128/jcm.01804-24","DOIUrl":"10.1128/jcm.01804-24","url":null,"abstract":"<p><p>The Clinical Microbiology Open (CMO) is a meeting sponsored by the American Society for Microbiology (ASM) in collaboration with its Corporate Council and Clinical and Public Health Microbiology representatives, which is held to discuss topics that are relevant to both industry and practicing clinical microbiologists. The 2024 CMO was held in Oceanside, California on February 1 and 2. Participants included clinical and public health laboratory directors, representatives from government agencies, and biotechnology industry partners. The group engaged in discussions with the theme, \"The Lab of the Future.\" One of the primary topics discussed was artificial intelligence (AI) opportunities in clinical microbiology laboratories. This report summarizes the discussion and sentiment of the group regarding AI tools, opportunities and challenges of AI in clinical laboratories, and potential future directions for AI in clinical microbiology practice.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0180424"},"PeriodicalIF":6.1,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143719391","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":"Standard E TB-Feron ELISA and Standard F TB-Feron FIA positivity rates and agreement with QuantiFERON-TB Gold Plus among TB high-risk population in Bandung, Indonesia.","authors":"Dewi Kartika Turbawaty, Syifa Nur Maulida, Darin Rizka Anadhea, Mulyanusa Amarullah Ritonga, Basti Andriyoko, Rudi Wisaksana, Agnes Rengga Indrati, Nanny Natalia Mulyani Soetedjo, Laniyati Hamijoyo, Raspati Cundarani Koesoemadinata, Bachti Alisjahbana, Ida Parwati","doi":"10.1128/jcm.01486-24","DOIUrl":"10.1128/jcm.01486-24","url":null,"abstract":"<p><p>Tuberculosis (TB) remains a global public health problem. The determination of tuberculosis infection (TBI) using interferon-gamma release assay has now been used widely. We aim to evaluate the positivity rates of Standard E TB-Feron enzyme-linked immunosorbent assay (TB-Feron ELISA) and Standard F TB-Feron fluorescent immunoassay (TB-Feron FIA) and their agreement with QuantiFERON-TB Gold Plus (QFT-Plus) among TB high-risk populations in Bandung City, Indonesia. We conducted a cross-sectional study, including people with a high risk of acquiring TB. We screened subjects for TB symptoms and offered chest X-ray (CXR). Anyone with cough or CXR suggestive of TB was asked to give sputum samples for GeneXpert MTB/RIF Ultra test. The positivity rates and corresponding 95% confidence intervals (CI) were calculated among patients with bacteriologically confirmed TB and among patients with no evidence of TB, no history of TB, and no known contact with TB patient (low risk of TBI). The agreement with QFT-Plus was calculated using Cohen's κ score. We enrolled 527 subjects, and the proportion of positive results among bacteriologically confirmed TB patients were 8 (53.3%; 95% CI 26.6-78.7), 9 (60.0%, 95% CI 32.3-83.7), and 10 (66.7%, 95% CI 38.4-88.8) by TB-Feron FIA, TB-Feron ELISA and QFT-Plus. The agreement between TB-Feron FIA and QFT-Plus among all subjects was similar to that of TB-Feron ELISA and QFT-Plus (84.1%, κ = 0.66, 95% CI 0.59-0.72). TB-Feron FIA and TB-Feron ELISA showed an acceptable clinical performance compared with QFT-Plus. These tests are useful alternatives for detecting TB infection.IMPORTANCEThis study evaluates the performance of two alternative interferon-gamma release assays, Standard E TB-Feron enzyme-linked immunosorbent assay and Standard F TB-Feron fluorescent immunoassay, for diagnosing tuberculosis infection (TBI) among high-risk populations in Bandung, Indonesia. Both assays demonstrated comparable clinical performance to the widely used QuantiFERON-TB Gold Plus (QFT-Plus). Given the global burden of tuberculosis, particularly in resource-limited settings, these findings suggest that the TB-Feron assays could serve as reliable alternatives to QFT-Plus for TBI detection. This research highlights the potential for these assays to improve tuberculosis diagnosis, offering a more accessible and efficient screening tool, especially for high-risk populations, and supporting broader tuberculosis surveillance.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0148624"},"PeriodicalIF":6.1,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572815","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":"A call for healing and unity.","authors":"Patrick D Schloss","doi":"10.1128/jcm.00338-25","DOIUrl":"10.1128/jcm.00338-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0033825"},"PeriodicalIF":6.1,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515764","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 Brief Case: Complexity of laboratory diagnosis of <i>Mycobacterium genavense</i>-a classic case of an unusual pathogen.","authors":"Daniel Montelongo-Jauregui, Jessica McFarland, Jonathan Pham, Salika M Shakir","doi":"10.1128/jcm.01463-24","DOIUrl":"https://doi.org/10.1128/jcm.01463-24","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"63 4","pages":"e0146324"},"PeriodicalIF":6.1,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811169","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":"Establishment of epidemiological cutoff values for <i>Fonsecaea pedrosoi</i>, the primary etiologic agent of chromoblastomycosis, and eight antifungal medications.","authors":"Dallas J Smith, Marcia S C Melhem, Jessy Dirven, Conceição Maria Pedrozo E Silva de Azevedo, Sirlei Garcia Marques, Bruna Jacomel Favoreto de Souza Lima, Vania Aparecida Vicente, Maria da Glória Teixeira Sousa, James Venturini, Nathan P Wiederhold, Amir Seyedmousavitasieh, Philippe J Dufresne, Sybren de Hoog, Shawn R Lockhart, Ferry Hagen, Daniel Wagner de C L Santos","doi":"10.1128/jcm.01903-24","DOIUrl":"https://doi.org/10.1128/jcm.01903-24","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Chromoblastomycosis, a fungal neglected tropical disease, is acquired through traumatic inoculation and is clinically characterized by a chronic granulomatous infection of the skin and subcutaneous tissue. &lt;i&gt;Fonsecaea pedrosoi&lt;/i&gt; is the most commonly reported etiologic agent globally. Itraconazole is considered first-line therapy, but successful treatment with terbinafine, voriconazole, and posaconazole has been reported. &lt;i&gt;F. pedrosoi&lt;/i&gt; minimum inhibitory concentration (MIC) data are limited, and epidemiological cutoffs (ECVs) are lacking; such data are important to help monitor antifungal resistance trends and guide initial antifungal selection. Thus, we performed antifungal susceptibility testing (AFST) on &lt;i&gt;F. pedrosoi&lt;/i&gt; isolates and determined the MIC distributions and ECVs. AFST on &lt;i&gt;Fonsecaea pedrosoi&lt;/i&gt; isolates was conducted at six laboratories from October 2023 to June 2024. Species identification was previously confirmed by DNA sequence analysis. AFST was performed by CLSI M38 standard broth microdilution method for itraconazole, voriconazole, posaconazole, isavuconazole, ketoconazole, terbinafine, flucytosine, and amphotericin B. The ECVs were established using the iterative statistical method with ECOFFinder (version 2.1) following CLSI M57 guidelines. We analyzed MIC results from 148 &lt;i&gt;Fonsecaea pedrosoi&lt;/i&gt; isolates. The calculated ECVs were itraconazole, 0.5 µg/mL; voriconazole, 0.5 µg/mL; posaconazole, 0.5 µg/mL; isavuconazole, 1 µg/mL; ketoconazole, bimodal, no ECV determined; terbinafine, 0.25 µg/mL; flucytosine, rejected; and amphotericin, 8 µg/mL. These &lt;i&gt;Fonsecaea pedrosoi&lt;/i&gt; ECVs, obtained through a multicenter international effort, provide a baseline to better understand the &lt;i&gt;in vitro&lt;/i&gt; antifungal susceptibility profile of this species and monitor resistance. Clinicians and researchers can use these values to detect non-wild-type isolates with reduced susceptibility, reevaluate therapeutic options, and investigate potential clinical resistance if treatment failure occurs.IMPORTANCEChromoblastomycosis is a neglected tropical disease caused by an environmental, dematiaceous fungus. This fungal disease is acquired after a break in the skin that allows the fungus to enter, leading to a chronic infection in the skin and subcutaneous tissue. It is difficult to treat and often requires years of antifungal treatment. &lt;i&gt;Fonsecaea pedrosoi&lt;/i&gt; is the most reported causative agent globally. Limited antifungal susceptibility data exist for &lt;i&gt;F. pedrosoi&lt;/i&gt; making interpreting minimum inhibitory concentration (MIC) results difficult. We performed antifungal susceptibility testing on 148 &lt;i&gt;F&lt;/i&gt;. &lt;i&gt;pedrosoi&lt;/i&gt; isolates to establish MIC distributions and epidemiologic cutoff values (ECVs) for eight antifungals, including those commonly used to treat chromoblastomycosis. The calculated ECVs for the commonly used antifungals itraconazole and terbinafine were 0.5 and 0.25 µg/mL, respectively. ECVs can be helpful","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0190324"},"PeriodicalIF":6.1,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780150","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":"Accuracy of real-time PCR assays for human papillomavirus using urine samples: a systematic review and meta-analysis.","authors":"Byeong-Min Park, Soohyun Kim, Jieun Choi, Yoonkyung Song, Seungman Park","doi":"10.1128/jcm.01352-24","DOIUrl":"https://doi.org/10.1128/jcm.01352-24","url":null,"abstract":"<p><p>This study aims to assess the diagnostic accuracy of real-time PCR assays for detecting human papillomavirus (HPV) in urine samples through a systematic review and meta-analysis. A comprehensive search of PubMed, Embase, and Springer databases (2014-2024) was conducted. Studies comparing urine-based HPV tests with cervical samples as the reference standard were included. Diagnostic accuracy measures such as sensitivity, specificity, diagnostic odds ratio (DOR), likelihood ratios (LR+ and LR-), percent agreement, and Cohen's kappa were calculated. Heterogeneity was assessed using the Higgins' I² index, and subgroup analyses were performed based on HPV test type and urine volume. The study revealed that 15 studies met the inclusion criteria, with pooled sensitivity of urine-based HPV tests at 0.82 (95% CI, 0.78-0.86), specificity at 0.91 (95% CI, 0.87-0.94), positive LR at 9.5 (95% CI, 6.3-14.3), negative LR at 0.19 (95% CI, 0.16-0.24), DOR at 49 (95% CI, 32-75), and the area under the curve at 0.92 (95% CI, 0.90-0.94), with significant heterogeneity observed (I² >50%), particularly in sensitivity and specificity, and subgroup analysis indicating that urine volumes ≤20 mL demonstrated higher sensitivity compared to those >20 mL, despite this finding being based on a limited number of studies. Results suggest that urine-based HPV testing shows strong diagnostic accuracy and could be a viable alternative to cervical swabs, with potential benefits for increasing screening accessibility, especially in areas with limited healthcare resources, despite some variability and limitations in the data.IMPORTANCEThis study is significant as it thoroughly evaluates the diagnostic accuracy of real-time PCR assays for human papillomavirus (HPV) detection in urine samples through a rigorous systematic review and meta-analysis. By integrating data from multiple databases and comparing urine-based HPV tests with the established cervical sample reference standard, the study provides valuable insights into the effectiveness and reliability of non-invasive HPV screening methods. The findings demonstrate that urine-based tests exhibit high sensitivity and specificity, offering a promising alternative to traditional cervical swabs. This advancement has significant implications for increasing accessibility to HPV screening, particularly in under-resourced settings, thereby potentially enhancing cervical cancer prevention efforts on a broader scale. The study not only fills a critical gap in HPV screening methodologies but also supports the development of more inclusive and practical public health strategies for combating cervical cancer.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0135224"},"PeriodicalIF":6.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752949","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":"Determination of the performance of a novel diagnostic test for <i>Clostridioides difficile</i> toxins A and B using latent class analysis.","authors":"Jeremy Li, Nandini Dendukuri, Yves Longtin, Alice Banz, Charles Frenette, Philippe Gervais, Mark A Miller, Anne-Marie Bourgault, Noah L Dawang, Vivian G Loo","doi":"10.1128/jcm.01807-24","DOIUrl":"https://doi.org/10.1128/jcm.01807-24","url":null,"abstract":"<p><p>The diagnosis of <i>Clostridioides difficile</i> infection (CDI) remains challenging. Nucleic acid amplification tests (NAAT) targeting the <i>C. difficile</i> (CD) toxin B gene suffer from suboptimal specificity for CDI due to CD asymptomatic colonization. Enzyme immunoassays (EIAs) that detect the presence of CD toxins are more specific for CDI but suffer from low sensitivity. To address this challenge, assays detecting CD toxins were developed using single-molecule array (SIMOA) technology, which have much lower limits of toxin detection than conventional EIAs. In this study, stool specimens from 708 symptomatic patients were aliquoted for testing by cell cytotoxicity neutralization assay (CCNA), toxigenic culture, NAAT, conventional CD toxin EIA, and SIMOA CD toxin EIAs. Using latent class analysis, we calculated the sensitivity and specificity of each of these diagnostic tests for detecting, separately, the presence of CD bacterium, CD toxin gene, and CD toxin. We estimated that the prevalence of CDI in our cohort was 14% (95% credible interval [CI]: 0.11-0.17). While the specificity of NAAT for detecting the presence of CD toxin was 95% (95% CI: 0.94-0.97), its positive predictive value was poor due to the low prevalence of CDI. The specificity of the conventional CD toxin EIA for CDI was excellent, but the sensitivity was only 48% (95% CI: 0.41-0.55). In comparison, the sensitivities of the SIMOA toxins A and B EIAs were 76% (95% CI: 0.67-0.84) and 77% (95% CI: 0.67-0.84), respectively, while maintaining excellent specificity. We conclude that SIMOA CD toxin EIAs are significantly more sensitive than conventional CD toxin EIAs.</p><p><strong>Importance: </strong><i>Clostridioides difficile</i> infection (CDI) is the most important infectious cause of hospital-associated diarrhea worldwide, but its diagnosis remains challenging. Nucleic acid amplification tests (NAATs) targeting the <i>C. difficile</i> (CD) toxin B gene have suboptimal specificity due to the presence of CD asymptomatic colonization, while enzyme immunoassays (EIAs) that detect the toxin itself are much more specific but are limited by low sensitivity. New assays for detecting CD toxins were developed using single-molecule array (SIMOA) technology, which have much lower limits of toxin detection than conventional EIAs, potentially improving the sensitivity of these conventional EIAs while remaining highly specific. In this study, we use latent class analysis to evaluate the sensitivity and specificity of different diagnostic tests for CD, including the novel SIMOA toxin assays, in detecting the different CD targets: the presence of CD bacterium, the presence of CD toxin gene, and the presence of CD toxin.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0180724"},"PeriodicalIF":6.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752951","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":"Reaffirming DEI as a central value of JCM.","authors":"Romney M Humphries, Alexander J McAdam","doi":"10.1128/jcm.00372-25","DOIUrl":"https://doi.org/10.1128/jcm.00372-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0037225"},"PeriodicalIF":6.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752966","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":"Identification and characteristics of mutations promoting occult HBV infection by ultrasensitive HBsAg assay.","authors":"Shi Song, Qian Su, Ying Yan, Huimin Ji, Huizhen Sun, Kaihao Feng, Abudulimutailipu Nuermaimaiti, Shana Halemubieke, Ling Mei, Xinru Liu, Zhuoqun Lu, Le Chang, Lunan Wang","doi":"10.1128/jcm.02071-24","DOIUrl":"https://doi.org/10.1128/jcm.02071-24","url":null,"abstract":"<p><p>The significance of occult hepatitis B virus (HBV) infection (OBI) has been increasingly recognized while the underlying mechanisms remain incompletely understood. This study aimed to identify high-frequency OBI-related mutations in HBV surface antigen (HBsAg)-negative samples tested by the ultrasensitive Lumipulse G HBsAg-Quant assay. OBI samples were collected from 32 blood establishments across 14 provinces in China. Lumipulse G HBsAg-Quant assay was performed for the re-testing and reclassification of OBI. Mutations in genotypes B (GTB) and C (GTC) were analyzed to identify high-frequency single and combined mutations. Additionally, the efficacy of commercial reagents commonly employed in clinical diagnostics for detecting mutant HBsAg was evaluated. Western Blot was used for the confirmation of extracellular HBsAg as well as the detection of intracellular HBsAg. Hydrophilicity analysis and transmembrane distribution prediction of HBsAg were utilized for further validation. Single mutations at 17 sites and 9 combined mutations in GTB indicated a significantly elevated mutation frequency. In GTC, there were single mutations at 16 sites and 9 combined mutations. Several commercial reagents commonly demonstrated limited capacity toward mutant HBsAg with T123A/P, K141C, and P142R/I/K/L (GTB) and S114A/P (GTC). The findings indicated that mutations including T123A/C/K/S, S132G/Y, P142L/R/S/T, T143M, D144G, G145A, K160R+V168A, I4T+V168A, M103I+K122R, and M103I+Q181R (GTB), along with Q101H, M103I, R160K+C221Y (GTC), were associated with reduced levels of HBsAg both extracellularly and intracellularly. Additionally, K160R (GTB) and E2G (GTC) were associated with intracellular aggregation. This study elucidates the mutations associated with decreased extracellular HBsAg with ultrasensitive HBsAg assay, providing insight for further investigation into the mechanisms of OBI.</p><p><strong>Importance: </strong>The sensitivity of HBsAg detection reagents directly impacts the identification of occult hepatitis B virus (HBV) infection (OBI). This study aims to identify high-frequency OBI-related mutations in HBV surface antigen (HBsAg)-negative samples evaluated using a Fujirebio-Lumipulse ultrasensitive HBsAg assay and to investigate the implications of these mutations on the antigenicity of HBsAg, the detection capacities of various HBsAg assays, and the effects on intracellular and extracellular levels of HBsAg. Generally, our study offers a new perspective on OBI-related mutations by ultrasensitive HBsAg assay and lays the groundwork for further research on the OBI mechanism and the enhancement of HBsAg detection reagents.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0207124"},"PeriodicalIF":6.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752955","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":"Multi-center evaluation of the Selux next-generation phenotyping system for gram-negative direct-from-positive blood culture antimicrobial susceptibility testing.","authors":"Vincent Streva, Joseph Gajewski, Jacqueline Pento, Alamelu Chandrasekaran, Matt Green, Jill Lindley, Micahel Huband, Asmae El Ganbour, Kristen Roberts, Kelly Flentie, Jingzi Sherman, Eric Stern, Gregory J Berry","doi":"10.1128/jcm.01819-24","DOIUrl":"https://doi.org/10.1128/jcm.01819-24","url":null,"abstract":"<p><p>Accurate and rapid antimicrobial susceptibility test (AST) results from positive blood cultures are crucial for patient care and combatting antimicrobial resistance. Although recent advancements in rapid direct-from-positive blood culture (PBC) identification platforms have enabled the provision of species-level identification and some resistance marker information within hours after blood culture positivity, AST results required for clinical decision-making often require 48 h after blood culture positivity. This study evaluated the Selux next-generation phenotyping system, including an automated PBC Separator and the Selux AST system in a multicenter clinical trial for their ability to perform AST directly from PBCs for gram-negative bacilli. The PBC separator produces McFarland equivalent inocula from positive blood cultures within 1 h, facilitating direct processing on the Selux AST system. The study evaluated 162 fresh clinical PBC samples, 307 seeded clinical samples, and 87 seeded challenge samples across 4 sites for each of the 17 antimicrobials included in the panel. The results demonstrate that the Selux system's clinical performance, reproducibility, and analytical performances are consistent when using positive blood cultures held for up to 16 h after positivity on the BACTEC and BacT/ALERT 3D and BacT/ALERT VIRTUO blood culture systems, including all major BACTEC and BacT/ALERT blood culture bottle types. These findings suggest that the PBC Separator with the Selux AST system is a valuable addition to the arsenal of tools available for rapid sepsis diagnosis and management.IMPORTANCETechnologies that consistently and substantially shorten the time between blood bottle positivity, organism identification, and complete AST results are crucial for ensuring that antimicrobial therapy can be tailored. The Selux PBC Separator and the Selux AST system perform rapid AST directly from positive blood culture bottles. This substantially shortens the gap between obtaining a positive blood bottle and organism identification and the availability of a fully actionable AST result.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0181924"},"PeriodicalIF":6.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752964","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}