Journal of Clinical Microbiology最新文献

{"title":"Characterization of carbapenem-resistant Enterobacterales and <i>Pseudomonas aeruginosa</i> carrying multiple carbapenemase genes-Antimicrobial Resistance Laboratory Network, 2018-2022.","authors":"Sarah Sabour, Kristin R V Harrington, Ellen Martinson, Amelia S Bhatnagar, Jennifer Y Huang, Dustin Duffy, Katie Bantle, Joseph D Lutgring, Maria Karlsson, Allison C Brown","doi":"10.1128/jcm.01220-24","DOIUrl":"10.1128/jcm.01220-24","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant &lt;i&gt;Pseudomonas aeruginosa&lt;/i&gt; (CRPA) are significant public health threats, particularly when harboring carbapenemases. Literature describing the frequencies and phenotypic and genotypic characteristics of isolates harboring multiple carbapenemase genes is limited. Using data collected from the Antimicrobial Resistance Laboratory Network (AR Lab Network) in 2018-2022, we describe CRE and CRPA isolates that harbor multiple acquired carbapenemase genes. Clinical laboratories submitted CRE and CRPA isolates to AR Lab Network public health laboratories for additional characterization that included antimicrobial susceptibility testing and detection of five targeted carbapenemase genes. Isolates were classified as non-carbapenemase producing (non-CP) when negative for carbapenemase production and all targeted carbapenemase genes, or positive for a single-CP (SCP) or multiple-carbapenemase (MCP) targeted gene. Among 79,799 CREs tested, 27,599 (35%) were SCP and 611 (1%) were MCP. MCP-CRE most often carried &lt;i&gt;bla&lt;/i&gt;&lt;sub&gt;KPC&lt;/sub&gt;/&lt;i&gt;bla&lt;/i&gt;&lt;sub&gt;NDM&lt;/sub&gt; (&lt;i&gt;n&lt;/i&gt; = 285, 47%). Both SCP-CRE and MCP-CRE were most commonly &lt;i&gt;Klebsiella&lt;/i&gt; spp. &lt;i&gt;Enterobacter&lt;/i&gt; spp. and &lt;i&gt;Escherichia coli&lt;/i&gt; isolates harboring MCP were detected at slightly higher frequencies (18% and 15%; &lt;i&gt;n&lt;/i&gt; = 109 and &lt;i&gt;n&lt;/i&gt; = 88, respectively) than &lt;i&gt;Enterobacter&lt;/i&gt; spp. and &lt;i&gt;Escherichia coli&lt;/i&gt; isolates harboring SCP (13% and 13%; &lt;i&gt;n&lt;/i&gt; = 3,653 and 3,471, respectively). The number of MCP-CRE detected increased from 54 of 5,105 (1%) in 2018 to 223 of 6,994 (3%) in 2022. Among 54,490 CRPA tested, 2% (&lt;i&gt;n&lt;/i&gt; = 1,249) were SCP and 31 were MCP. MCP-CRPA most often carried &lt;i&gt;bla&lt;/i&gt;&lt;sub&gt;VIM&lt;/sub&gt;/&lt;i&gt;bla&lt;/i&gt;&lt;sub&gt;IMP&lt;/sub&gt; (&lt;i&gt;n&lt;/i&gt; = 13, 42%). A higher proportion of MCP-CRE (97%, &lt;i&gt;n&lt;/i&gt; = 330) isolates were categorized as resistant to meropenem, compared to SCP-CRE (79%; &lt;i&gt;n&lt;/i&gt; = 11,227) and non-CP (13%; &lt;i&gt;n&lt;/i&gt; = 2,683). Although MCP organisms represent a small proportion of total CP detected in the AR Lab Network, there is a need for continued monitoring and additional research.IMPORTANCECarbapenemase-producing organisms are of significant clinical and public health concerns, and rapid detection and containment of such threats are vital to preventing their spread. In this article, we used a collection of over 130,000 contemporary isolates to evaluate frequencies and phenotypic and genotypic properties of CRE and CRPA isolates harboring multiple carbapenemase genes across the United States, from 2018 to 2022. Of note, 95% and 100% of CRE and CRPA isolates co-harbored at least one metallo-β-lactamase gene, respectively, indicating a high proportion of isolates originating from patients with difficult-to-treat infections. Both clinical and public health professionals across the nation can use these data and key findings to better understand the molecular landscape of these isolates. Timely d","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0122024"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675982","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: PAS- and GMS-positive filamentous branching organisms in an immunocompromised patient.","authors":"Veronica Vine Nicholas, Iain Miller, Jordan Mah, Kerri E Rieger, Indre Budvytiene, Niaz Banaei","doi":"10.1128/jcm.00387-24","DOIUrl":"10.1128/jcm.00387-24","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"62 12","pages":"e0038724"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807353","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":"A novel multiplex and glycoprotein-based immunochromatographic serologic IgM test for the rapid diagnosis of <i>Escherichia coli</i> O157 and O145 causing bloody diarrhea and hemolytic uremic syndrome.","authors":"Stella M Landivar, Luciano J Melli, Cynthia Maiztegui, Carla Schesi, Ariela Baschkier, Valeria Francisetti, Isabel Chinen, Elizabeth Miliwebsky, Marta Rivas, Diego J Comerci, Juan E Ugalde, Andrés E Ciocchini","doi":"10.1128/jcm.01003-24","DOIUrl":"10.1128/jcm.01003-24","url":null,"abstract":"<p><p>Shiga toxin-producing <i>Escherichia coli</i> (STEC) are the main etiological agents of hemolytic uremic syndrome (HUS). Good clinical management of STEC infections and HUS depends on early, rapid, and accurate diagnosis. Here, we have developed and evaluated the first multiplex and glycoprotein-based immunochromatographic test for the detection of IgM antibodies against the O-polysaccharide of the lipopolysaccharide of <i>E. coli</i> O157 and O145 in human serum samples. A retrospective study was carried out resulting in a diagnostic sensitivity of the <i>E. coli</i> O157/O145 LFIA (lateral flow immunoassay) of 97.1% and 98.9% for O157 and O145, respectively, and 97.9% for both serogroups. The diagnostic specificity was 98.7% for O157 and O145, and the overall specificity 97.4%. In samples obtained before 3 days after the onset of diarrhea, the detection percentage was 83%, increasing to 100% from 3 days onward. Finally, the association of bloody diarrhea (BD) or HUS cases to an STEC infection increased from 22.8% to 77.2% when stool culture and <i>stx</i>/Stx detection were combined with serology by LFIA. Our results demonstrate that the <i>E. coli</i> O157/O145 LFIA is a highly accurate and serospecific test for the early and rapid diagnosis of <i>E. coli</i> O157 and O145 infections in BD or HUS cases. This test allows the detection of specific IgM antibodies very early in the course of the infection, making it an ideal diagnostic tool to be implemented in pediatric emergencies and, thus, avoid delays in the application of the correct supportive or specific treatment and prevent complications associated with HUS.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0100324"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545764","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":"Retrospective analysis of antimicrobial susceptibility profiles of non-<i>diphtheriae Corynebacterium</i> species from a tertiary hospital and reference laboratory, 2012-2023.","authors":"Ryan B Khodadadi, Said El Zein, Christina G Rivera O'Connor, Ryan W Stevens, Audrey N Schuetz, Omar M Abu Saleh, Madiha Fida","doi":"10.1128/jcm.01199-24","DOIUrl":"10.1128/jcm.01199-24","url":null,"abstract":"<p><p>A total of 1,925 <i>Corynebacterium</i> isolates were tested for antimicrobial susceptibility at the Mayo Clinic Microbiology laboratory (Rochester, Minnesota) from January 2012 to March 2023, with <i>C. striatum</i> (35.6%) and <i>C. amycolatum</i> (24.4%) identified as the predominant species. Species known to potentially carry diphtheria toxin were excluded. Common sources of isolation included skin and soft tissue (56.8%), bone and/or native joint synovial fluid (14.2%), urine (13.1%), sputum (6.1%), and blood (5.9%). For penicillin, susceptibility decreased from 47.5% (58 of 122) in 2012 to 20.6% (14 of 68) in 2023. Isolates also showed a decrease in susceptibility to erythromycin from 22.4% (26 of 116) in 2012 to 13.2% (9 of 68) in 2023. Susceptibility to trimethoprim-sulfamethoxazole averaged around 50% throughout the period. Notably, linezolid and vancomycin were universally effective <i>in vitro</i> against all species. The highest susceptibility rates among tested oral agents were to linezolid and doxycycline for non-<i>C</i>. <i>striatum</i> species. Daptomycin minimal inhibitory concentrations (MICs) of >256 µg/mL were observed for one <i>C. amycolatum</i> isolate, one <i>C. tuberculostearicum</i> isolate, and for seven <i>C. striatum</i> isolates, all from patients with prior daptomycin exposure. Daptomycin MICs of 2 µg/mL (nonsusceptible) were observed in one <i>C. striatum</i> isolate recovered from a daptomycin-naïve patient and in six <i>C. jeikeium</i> isolates, from both daptomycin-exposed and non-exposed patients. Significant variation in susceptibility profiles across different <i>Corynebacterium</i> species underscores the importance of performing antimicrobial susceptibility testing to guide effective treatment. Moreover, multidrug resistance observed in <i>C. striatum</i> poses substantial therapeutic challenges especially in patients requiring prolonged or chronic antibiotic suppression.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0119924"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647979","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":"Evaluation of the KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit and Carbapenem-Resistant K.N.I.V.O. Detection K-Set in detecting KPC variants.","authors":"Aline Valério de Lima, Keila de Oliveira Lima, Paola Cappellano, Sebastian Cifuentes, Nilton Lincopan, Suely Carlos Ferreira Sampaio, Jorge Luiz Mello Sampaio","doi":"10.1128/jcm.01123-24","DOIUrl":"10.1128/jcm.01123-24","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0112324"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621317","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":"A simplified pyrazinamidase test for <i>Mycobacterium tuberculosis</i> pyrazinamide antimicrobial susceptibility testing.","authors":"Hsin-Hua Chan, Yu-Chen Wang, Ruwen Jou","doi":"10.1128/jcm.01227-24","DOIUrl":"10.1128/jcm.01227-24","url":null,"abstract":"<p><p>Pyrazinamide (PZA) is an important first-line drug for tuberculosis (TB) treatment by eradicating the persisting <i>Mycobacterium tuberculosis</i> complex (MTBC). Due to cost and technical challenges, end TB strategies are hampered by the lack of a simple and reliable culture-based PZA antimicrobial susceptibility testing (AST) for routine use. We initially developed a simplified chromogenic pyrazinamidase (PZase) test in the TB reference laboratory using a training set MTBC isolates with various drug-resistant profiles, and validated its performance using consecutive BACTEC MGIT 960 (MGIT)-culture-positive culture in 10 clinical laboratories. The <i>pncA</i> gene Sanger sequencing results were used as the reference, and compared to the MGIT-PZA AST. Differential diagnosis of <i>Mycobacterium bovis</i> was conducted using patented in-house real-time PCR. Of the 106 training isolates, the PZase test and MGIT-PZA AST showed 100.0% and 99.1% concordance as compared to Sanger sequencing, respectively. We found 32.1% (34/106) isolates harbored <i>pncA</i> mutations, including one isolate with silent mutation S65S. For validation, 1,793 clinical isolates were tested including 150 duplicate isolates from specimens of the same cases and 16 isolates with uncharacterized drug resistance (UDR)-associated mutations. Excluding duplicated and UDR isolates, we identified 2.6% (43/1,627) PZA-resistant isolates, including 1.3% (21/1,627) <i>M</i>. <i>bovis</i> isolates. The kappa values were 0.851-1.000. In addition, the accuracy of the PZase test conducted by 10 laboratories was 98.5%-100.0%. Our simplified PZase test demonstrated high concordance with Sanger sequencing and MGIT-PZA AST. Integrating the PZase test into routine first-line AST is effortless and represents an improvement in laboratory services for ending TB.</p><p><strong>Importance: </strong>We developed and validated a simple pyrazinamidase (PZase) test for pyrazinamide (PZA) antimicrobial susceptibility testing (AST). Our results demonstrated that the PZase test had high agreement with the <i>pncA</i> gene sequencing and MGIT-PZA AST. Integrating PZase test into routine AST is effortless and represents an improvement in laboratory services for ending TB.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0122724"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647977","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":"An update on novel taxa and revised taxonomic status of bacteria isolated from domestic companion and agricultural animals described in 2023.","authors":"Sara D Lawhon, Claire R Burbick, Trinity Krueger, Elena Ruiz-Reyes, Erik Munson","doi":"10.1128/jcm.01041-24","DOIUrl":"10.1128/jcm.01041-24","url":null,"abstract":"<p><p>With the proliferation of abundant bacterial genomic data comes the recognition of new organisms as well as a better understanding of the relatedness of known bacteria. Recognizing the associated taxonomic changes enhances communication and understanding about the significance of novel organisms and deeper understanding of known pathogens. This review addresses the addition of multiple gastrointestinal bacteria that form the normal microbiota in a variety of animals including honeybees as well as novel bacteria from domestic animals including an alpha-hemolytic <i>Streptococcus</i> species from guinea pigs, two <i>Moraxella</i> spp. from cows and goats, a new <i>Capnocytophaga</i> species from cats, a thermophilic <i>Campylobacter</i> species from pigs, and the new <i>Exercitatus</i> genus in Family <i>Pasteurellaceae</i>. Several revisions to the nomenclature also appeared in 2023 including the change of <i>Clostridium spiroforme,</i> which causes anorexia and diarrhea in domestic rabbits, to <i>Thomasclavelia spiroformis</i> comb. nov. and <i>Mannheimia ovis</i> to <i>Mannheimia pernigra</i>.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0104124"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567499","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":"Evaluation of Fungitell (1,3)-β-D-glucan assay in tear samples for rapid diagnosis of fungal keratitis.","authors":"Yamini Tawde, Sourav Das, Shreya Singh, Soham Basak, Savitri Sharma, Amit Gupta, Shivaprakash M Rudramurthy, Geetika Yadav, Anup Ghosh","doi":"10.1128/jcm.01200-24","DOIUrl":"10.1128/jcm.01200-24","url":null,"abstract":"<p><p>Fungal keratitis (FK) is a serious suppurative and ulcerative corneal infection leading to blindness and vision loss. Rapid diagnosis of FK can contribute to prompt clinical management with early recovery. The study aimed to standardize the detection of (1,3)-β-D-glucan (BDG) and establish the diagnostic cut-off concentration in tears of suspected FK patients along with non-infected controls. This prospective multicentric study was conducted between the period of August 2022 and April 2024. Samples were collected from three tertiary eye-care facilities across India. All suspected FK patients were enrolled in the study. Prior to tear collection, the eye and eyelid were gently cleansed using sterile normal saline (NS) and lint-free tissue paper. Subsequently, 50 µL of sterile NS was instilled into the eye, followed by tear sample collection after 60 s using sterile fine microtips. Tear samples were collected from the contralateral eyes of the FK patients, and those from healthy volunteers served as controls. The concentration of BDG in tears in varying dilutions was quantitatively measured using the Fungitell Assay Kit (Associates of Cape Cod, East Falmouth, Massachusetts). A total of 53 tear samples were analyzed at 1:10 and 1:20 dilutions. The receiver operating curve revealed an area under the curve (AUC) of 0.919 for the 1:10 dilution, with a cut-off value of 123 pg/mL, yielding a sensitivity of 100% and specificity of 84.85%. The corresponding Youden Index was 0.798. At the 1:20 dilution, the AUC was 0.898 with a cut-off of 84 pg/mL, achieving a sensitivity of 70% and specificity of 96.88% with a Youden Index of 0.670. Given the higher specificity at the 1:20 dilution, it was further validated in 145 tear samples. The validation cohort demonstrated a sensitivity of 95.56%, specificity of 83%, positive predictive value (PPV) of 71.67%, negative predictive value (NPV) of 97.65%, and diagnostic odds ratio of 112.4. Notably, a significantly higher BDG concentration (<i>P</i> < 0.0001) was observed in infected tear samples compared to controls (270.6 ± 128.5 vs 37.31 ± 31.32). Detection of BDG in tear samples is a new, non-invasive, and rapid technique showing excellent performance and can be effectively implemented for diagnosing FK in laboratories.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0120024"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583226","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":"The Brief Case: Hidden in plain sight-<i>Exophiala jeanselmei</i> subcutaneous phaeohyphomycosis of hand masquerading as a hematoma.","authors":"Cara P Heath, Poonam C Sharma, Sumit Sontakke, Dallas J Smith, Tulip A Jhaveri","doi":"10.1128/jcm.01068-24","DOIUrl":"10.1128/jcm.01068-24","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"62 12","pages":"e0106824"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807354","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":"Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2 <i>plus</i> test on nasal and nasopharyngeal swabs.","authors":"Alexander L Greninger, Allan Larcena, Amrish Patel, Brian Webster, Christina Ulen, Dallas F Green, Dana King, Deepesh Rubin Patel, Erin McElvania, Glenn Harnett, Imad Jandali, Jane Gibson, Jennifer Killion, Jibran Atwi, Kelly Bergmann, Lance Slade, Mary Allen Staat, Matthew Faron, Megan Washington, Rahul Patel, Rajasekaran Annamalai, Ronald Ackerman, William P Stewart, Yuliet Mora Amador, Deepa Rao, Xiaohong Liu, Aarthi Raman","doi":"10.1128/jcm.01219-24","DOIUrl":"10.1128/jcm.01219-24","url":null,"abstract":"<p><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues its largely aseasonal spread with millions of cases per year. Highly sensitive, point-of-care testing is critical for rapid detection of coronavirus disease 2019 (COVID-19) cases and initiation of antiviral therapy to avert adverse health outcomes and reduce onward transmission of the virus. While hundreds of COVID-19 diagnostics received emergency use authorization from the FDA during the pandemic, significantly fewer have navigated the course to FDA clearance or approval. Here, we determined the clinical performance of the Cepheid Xpert Xpress CoV-2 <i>plus</i> for detection of SARS-CoV-2 in 3,750 anterior nasal swab (NS) specimens and nasopharyngeal swab (NPS) from 32 sites in comparison to the FDA-authorized BioFire Respiratory Panel 2.1. Three-quarters of specimens collected were tested on the Xpert Xpress CoV-2 <i>plus</i> in the point-of-care setting. Overall positive percent agreement (PPA) was 98.1% (95% CI: 96.7%-98.9%) and negative percent agreement (NPA) was 98.3% (97.7%-98.7%). Performance of the Xpert Xpress CoV-2 <i>plus</i> was slightly improved in NS compared to NPS specimens, with PPA of 99.3% versus 97.0% (Fisher's exact test, <i>P</i> = 0.06) and NPA of 98.3% versus 98.2% (<i>P</i> = 0.89), respectively. Assay PPA was similar between untrained and trained users (98.7% vs 97.3%, <i>P</i> = 0.75), while NPA was slightly improved for untrained users (99.0% vs 97.6%, <i>P</i> = 0.0003). This study showed that Cepheid Xpert Xpress COV-2 <i>plus</i> is highly sensitive and specific/has high PPA and NPA for detection of SARS-CoV-2 from both NS and NPS specimens.</p><p><strong>Importance: </strong>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause millions of infections and tens of thousands of deaths per year in the United States. While the FDA authorized hundreds of SARS-CoV-2 tests during the public health emergency, significantly fewer have made the transition to being cleared or approved. There continues to be a need for FDA-authorized point-of-care SARS-CoV-2 testing that can be performed by untrained users. We conducted a large prospective study of the Cepheid Xpert Xpress CoV-2 <i>plus</i> test for detection of SARS-CoV-2 in both nasal and nasopharyngeal swabs by trained and untrained users. The assay demonstrated excellent clinical performance characteristics and, as a result of this study, was cleared by the FDA.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0121924"},"PeriodicalIF":6.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583239","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}