Stuart Campbell, Brooke Taylor, Dimitrios Menouhos, Jann Hennessy, Mark Mayo, Robert Baird, Bart J Currie, Ella M Meumann
{"title":"Performance of MALDI-TOF MS, real-time PCR, antigen detection, and automated biochemical testing for the identification of <i>Burkholderia pseudomallei</i>.","authors":"Stuart Campbell, Brooke Taylor, Dimitrios Menouhos, Jann Hennessy, Mark Mayo, Robert Baird, Bart J Currie, Ella M Meumann","doi":"10.1128/jcm.00961-24","DOIUrl":"10.1128/jcm.00961-24","url":null,"abstract":"<p><p><i>Burkholderia pseudomallei</i> is the causative agent of melioidosis, a disease highly endemic to Southeast Asia and northern Australia, though the area of endemicity is expanding. Cases may occur in returning travelers or, rarely, from imported contaminated products. Identification of <i>B. pseudomallei</i> is challenging for laboratories that do not see this organism frequently, and misidentifications by matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) and automated biochemical testing have been reported. The <i>in vitro</i> diagnostic database for use with the Vitek MS has recently been updated to include <i>B. pseudomallei</i> and we aimed to validate the performance for identification in comparison to automated biochemical testing with the Vitek 2 GN card, quantitative real-time polymerase chain reaction (qPCR) targeting the type III secretion system, and capsular polysaccharide antigen detection using a lateral flow immunoassay (LFA). We tested a \"derivation\" cohort including geographically diverse <i>B. pseudomallei</i> and a range of closely related <i>Burkholderia</i> species, and a prospective \"validation\" cohort of <i>B. pseudomallei</i> and <i>B. cepacia</i> complex clinical isolates. MALDI-TOF MS had a sensitivity of 1.0 and specificity of 1.0 for the identification and differentiation of <i>B. pseudomallei</i> from related <i>Burkholderia</i> species when a certainty cutoff of 99.9% was used. In contrast, automated biochemical testing for <i>B. pseudomallei</i> identification had a sensitivity of 0.83 and specificity of 0.88. Both qPCR and LFA correctly identified all <i>B. pseudomallei</i> isolates with no false positives. Due to the high level of accuracy, we have now incorporated MALDI-TOF MS into our laboratory's <i>B. pseudomallei</i> identification workflow.IMPORTANCE<i>Burkholderia pseudomallei</i> causes melioidosis, a disease associated with high morbidity and mortality that disproportionately affects rural areas in Southeast Asia and northern Australia. The known area of endemicity is expanding and now includes the continental United States. Laboratory identification can be challenging which may result in missed or delayed diagnoses and poor patient outcomes. In this study, we compared mass spectrometry using an updated spectral database with multiple other methods for <i>B. pseudomallei</i> identification and found mass spectrometry highly accurate. We have therefore incorporated this fast and cost-effective method into our laboratory's workflow for <i>B. pseudomallei</i> identification.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0096124"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132880","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}
Erik Munson, Claire R Burbick, Sara D Lawhon, Trinity Krueger, Elena Ruiz-Reyes
{"title":"Valid and accepted novel bacterial taxa isolated from non-domestic animals and taxonomic revisions published in 2023.","authors":"Erik Munson, Claire R Burbick, Sara D Lawhon, Trinity Krueger, Elena Ruiz-Reyes","doi":"10.1128/jcm.01042-24","DOIUrl":"10.1128/jcm.01042-24","url":null,"abstract":"<p><p>Continued investigation into the bacteria associated with non-domestic animals provides important information for recognizing normal flora, assessing the health status of these unique species of animals, and identifying new or emerging pathogens of concern. In this summary of novel taxa and taxonomic revisions, considerable additions have been made toward understanding fecal and mucosal flora in multiple wild animal species. In addition, novel pathogenic bacteria are discussed, including multiple <i>Chlamydia</i> spp. causing disease in a hawk and crocodile, two <i>Corynebacterium</i> spp. causing oral lesions in penguins and a lesser-known genus, <i>Mergibacter</i> within Family <i>Pasteurellaceae</i>, causing disease in multiple wild bird species. Finally, a few revisions to bacteria isolated from normal non-domestic animal body sites are mentioned.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0104224"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481486/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347644","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}
Nkuchia M M'ikanatha, Zoe S Goldblum, Nicholas Cesari, Erin M Nawrocki, Yezhi Fu, Jasna Kovac, Edward G Dudley
{"title":"Outbreak-associated <i>Salmonella</i> Baildon found in wastewater demonstrates how sewage monitoring can supplement traditional disease surveillance.","authors":"Nkuchia M M'ikanatha, Zoe S Goldblum, Nicholas Cesari, Erin M Nawrocki, Yezhi Fu, Jasna Kovac, Edward G Dudley","doi":"10.1128/jcm.00825-24","DOIUrl":"10.1128/jcm.00825-24","url":null,"abstract":"<p><p>Non-typhoidal <i>Salmonella</i> is a common cause of gastroenteritis worldwide, but current non-typhoidal <i>Salmonella</i> surveillance is suboptimal. Here, we evaluated the utility of wastewater monitoring to enhance traditional surveillance for this foodborne pathogen. In June 2022, we tested raw sewage collected twice a week from two treatment plants in central Pennsylvania for non-typhoidal <i>Salmonella</i> and characterized isolates using whole-genome sequencing. We recovered 43 <i>Salmonella</i> isolates from wastewater samples, differentiated by genomic analysis into seven serovars: 16 Panama (37.2%), 9 Senftenberg (20.9%), 8 Baildon (18.6%), and 3 or fewer of four other serovars. We assessed genetic relatedness and epidemiologic links between these wastewater isolates with those from patients with salmonellosis. All <i>S</i>. Baildon isolates from wastewater were genetically similar to those associated with a known contemporaneous salmonellosis outbreak. <i>S</i>. Baildon from wastewater and 42 outbreak-related isolates in the national outbreak detection database had the same core genome multilocus sequence typing, and outbreak code differed by zero or one single polynucleotide polymorphism. One of the 42 outbreak-related isolates was obtained from a patient residing in the wastewater sample collection catchment area, which serves approximately 17000 people. <i>S</i>. Baildon is a rare serovar (reported in <1% cases nationally, over five years). Our study underscores the value of monitoring sewage from a defined population to supplement traditional surveillance methods for the evidence of <i>Salmonella</i> infections and to determine the extent of outbreaks.IMPORTANCEDuring the COVID-19 pandemic, monitoring for SARS-CoV-2 in wastewater was highly effective in identifying the variants of concern earlier than clinical surveillance methods. Here, we show that monitoring domestic sewage can also augment traditional reporting of foodborne illnesses to public health authorities. Our study detected multiple <i>Salmonella enterica</i> serovars in samples from two wastewater treatment plants in central Pennsylvania. Using whole-genome sequencing, we demonstrated that the isolates of variant <i>S</i>. Baildon clustered with those from a foodborne salmonellosis outbreak that occurred in a similar time frame. Cases were primarily from Pennsylvania, and one individual lived within the wastewater treatment catchment area. This study highlights the effectiveness of domestic sewage testing as a proactive public health strategy to track and respond to infectious disease outbreaks.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0082524"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142288321","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}
Lidewij W Rümke, Matthew A Davies, Stefan M T Vestjens, Boas C L van der Putten, Wendy C M Bril-Keijzers, Marlies A van Houten, Nynke Y Rots, Alienke J Wijmenga-Monsuur, Arie van der Ende, Brechje de Gier, Bart J M Vlaminckx, Nina M van Sorge
{"title":"Nationwide upsurge in invasive disease in the context of longitudinal surveillance of carriage and invasive <i>Streptococcus pyogenes</i> 2009-2023, the Netherlands: a molecular epidemiological study.","authors":"Lidewij W Rümke, Matthew A Davies, Stefan M T Vestjens, Boas C L van der Putten, Wendy C M Bril-Keijzers, Marlies A van Houten, Nynke Y Rots, Alienke J Wijmenga-Monsuur, Arie van der Ende, Brechje de Gier, Bart J M Vlaminckx, Nina M van Sorge","doi":"10.1128/jcm.00766-24","DOIUrl":"10.1128/jcm.00766-24","url":null,"abstract":"<p><p>Since 2022, many countries have reported an upsurge in invasive group A streptococcal (iGAS) infections. We explored whether changes in <i>Streptococcus pyogenes</i> carriage rates or emergence of strains with potentially altered virulence, such as <i>emm</i>1 variants M1<sub>UK</sub> and M1<sub>DK</sub>, contributed to the 2022/2023 surge in the Netherlands. We determined <i>emm</i> (sub)type distribution for 2,698 invasive and 351 <i>S</i>. <i>pyogenes</i> carriage isolates collected between January 2009 and March 2023. Genetic evolution of <i>emm</i>1 was analyzed by whole-genome sequencing of 497 <i>emm</i>1 isolates. The nationwide iGAS upsurge coincided with a sharp increase of <i>emm</i>1.0 from 18% (18/100) of invasive isolates in Q1 2022 to 58% (388/670) in Q1 2023 (Fisher's exact test, <i>P</i> < 0.0001). M1<sub>UK</sub> became dominant among invasive <i>emm</i>1 isolates in 2016 and further expanded from 72% in Q1 2022 to 96% in Q1 2023. Phylogenetic comparison revealed evolution and clonal expansion of four new M1<sub>UK</sub> clades in 2022/2023. DNase Spd1 and superantigen SpeC were acquired in 9% (46/497) of <i>emm</i>1 isolates. <i>S. pyogenes</i> carriage rates and <i>emm</i>1 proportions in carriage isolates remained stable during this surge, and the expansion of M1<sub>UK</sub> in iGAS was not reflected in carriage isolates. During the 2022/2023 iGAS surge in the Netherlands, expansion of four new M1<sub>UK</sub> clades was observed among invasive isolates, but not carriage isolates, suggesting increased virulence and fitness of M1<sub>UK</sub> compared to contemporary M1 strains. The emergence of more virulent clades has important implications for public health strategies such as antibiotic prophylaxis for close contacts of iGAS patients.IMPORTANCEThis study describes the molecular epidemiology of invasive group A streptococcal (iGAS) infections in the Netherlands based on >3,000 <i>Streptococcus pyogenes</i> isolates from both asymptomatic carriers and iGAS patients collected before, during, and after the COVID-19 pandemic period (2009-2023) and is the first to assess whether changes in carriage rates or carried <i>emm</i> types contributed to the alarming post-COVID-19 upsurge in iGAS infections. We show that the 2022/2023 iGAS surge coincided with a sharp increase of <i>emm</i>1, particularly the toxicogenic M1<sub>UK</sub> variant, in invasive isolates, but not in carriage isolates. These findings suggest that increased virulence and fitness of M1<sub>UK</sub> likely contributes to an increased dissemination between hosts. The emergence of a more virulent and fit lineage has important implications for iGAS control interventions such as antibiotic prophylaxis for close contacts of iGAS patients and calls for a reappraisal of iGAS control interventions and guidelines.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0076624"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080486","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}
Rebekah E Dumm, Elizabeth M Marlowe, Logan Patterson, Paige M K Larkin, Rosemary C She, Laura M Filkins
{"title":"The foundation for the microbiology laboratory's essential role in diagnostic stewardship: an ASM Laboratory Practices Subcommittee report.","authors":"Rebekah E Dumm, Elizabeth M Marlowe, Logan Patterson, Paige M K Larkin, Rosemary C She, Laura M Filkins","doi":"10.1128/jcm.00960-24","DOIUrl":"10.1128/jcm.00960-24","url":null,"abstract":"<p><p>Diagnostic stewardship (DxS) has gained traction in recent years as a cross-disciplinary method to improve the quality of patient care while appropriately managing resources within the healthcare system. Clinical microbiology laboratorians have been highly engaged in DxS efforts to guide best practices with conventional microbiology tests and more recently with molecular infectious disease diagnostics. Laboratories can experience resistance to their role in DxS, especially when the clinical benefits, motivations for interventions, and underlying regulatory requirements are not clearly conveyed to stakeholders. Clinical laboratories must not only ensure ethical practices but also meet obligatory requirements to steward tests responsibly. In this review, we aim to support clinical microbiology laboratorians by providing the background and resources that demonstrate the laboratory's essential role in DxS. The heart of this review is to collate regulatory and accreditation requirements that, in essence, mandate DxS practices as a long-standing, core element of high-quality laboratory testing to deliver the best possible patient care. While examples of the clinical impact of DxS are plentiful in the literature, here, we focus on the operational and regulatory justification for the laboratory's role in stewardship activities.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0096024"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347643","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}
Benjamin Berinson, Emma Davies, Jessie Torpner, Linnea Flinkfeldt, Jenny Fernberg, Amanda Åman, Johan Bergqvist, Håkan Öhrn, Jonas Ångström, Cecilia Johansson, Klara Jäder, Helena Andersson, Ehsan Ghaderi, Maria Rolf, Martin Sundqvist, Holger Rohde, Teresa Fernandez-Zafra, Christer Malmberg
{"title":"A multicenter evaluation of a novel microfluidic rapid AST assay for Gram-negative bloodstream infections.","authors":"Benjamin Berinson, Emma Davies, Jessie Torpner, Linnea Flinkfeldt, Jenny Fernberg, Amanda Åman, Johan Bergqvist, Håkan Öhrn, Jonas Ångström, Cecilia Johansson, Klara Jäder, Helena Andersson, Ehsan Ghaderi, Maria Rolf, Martin Sundqvist, Holger Rohde, Teresa Fernandez-Zafra, Christer Malmberg","doi":"10.1128/jcm.00458-24","DOIUrl":"10.1128/jcm.00458-24","url":null,"abstract":"<p><p>Common phenotypic methods for antimicrobial susceptibility testing (AST) of bacteria are slow, labor intensive, and display considerable technical variability. The QuickMIC system provides rapid AST using a microfluidic linear gradient. Here, we evaluate the performance of QuickMIC at four different laboratories with regard to speed, precision, accuracy, and reproducibility in comparison to broth microdilution (BMD). Spiked (<i>n</i> = 411) and clinical blood cultures (<i>n</i> = 148) were tested with the QuickMIC Gram-negative panel and compared with BMD for the 12 on-panel antibiotics, and 10 defined strains were run at each site to measure reproducibility. Logistic and linear regression analysis was applied to explore factors affecting assay performance. The overall essential agreement and categorical agreement between QuickMIC and BMD were 95.6% and 96.0%, respectively. Very major error, major error, and minor error rates were 1.0%, 0.6%, and 2.4%, respectively. Inter-laboratory reproducibility between the sites was high at 98.9% using the acceptable standard of ±1 twofold dilution. The mean in-instrument analysis time overall was 3 h 13 min (SD: 29 min). Regression analysis indicated that QuickMIC is robust with regard to initial inoculum and delay time after blood culture positivity. We conclude that QuickMIC can be used to rapidly measure MIC directly from blood cultures in clinical settings with high reproducibility, precision, and accuracy. The microfluidics-generated linear gradient ensures high reproducibility between laboratories, thus allowing a high level of trust in MIC values from single testing, at the cost of reduced measurement range compared to BMD.</p><p><strong>Importance: </strong>Increasing antimicrobial resistance underscores the need for new diagnostic solutions to guide therapy, but traditional antimicrobial susceptibility testing (AST) is often inadequate in time-critical diseases such as sepsis. This work presents a novel and rapid AST system with a rapid turnaround of results, which may help reduce the time to guided therapy, possibly allowing early de-escalation of broad-spectrum empirical therapy as well as rapid adjustments to treatments when coverage is lacking.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0045824"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347665","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 case-control study and molecular epidemiology of yersiniosis in Aotearoa New Zealand.","authors":"Lucia Rivas, Beverley Horn, Bridget Armstrong, Jackie Wright, Hugo Strydom, Jing Wang, Shevaun Paine, Kristin Thom, Ashley Orton, Beth Robson, Susan Lin, Jimmy Wong, Cheryl Brunton, Debbie Smith, Jess Cooper, Loushy Mangalasseril, Craig Thornley, Brent Gilpin","doi":"10.1128/jcm.00754-24","DOIUrl":"10.1128/jcm.00754-24","url":null,"abstract":"<p><p>The objective of this study was to determine risk factors and sources attributed to yersiniosis in Aotearoa New Zealand (NZ). A risk factor questionnaire was administered to 247 notified yersiniosis cases and 258 control participants from the Canterbury and/or Wellington regions of NZ. <i>Yersinia</i> sp. isolates from clinical cases and a range of food sources were whole-genome sequenced and genetically compared. <i>Yersinia enterocolitica</i> (YE) bioserotype 2/3, O:9 [McNally multi-locus sequence type (ST) 12] and YE Biotype (BT) 1A (46 different STs) predominated within the consented cases (45 and 27%, respectively). Exposure to pork was identified as a significant risk factor for cases associated with YE ST12. The presence of YE ST12 was confirmed in retail raw meat, primarily raw pork. Single-nucleotide polymorphism (SNP) analysis identified multiple genomically very closely related clusters (0-5 SNPs) of YE ST12, predominately from raw pork with clinical cases from one or both regions. Risk factors associated with YE BT 1A included the consumption of cooked seafood, sushi, tofu, and some vegetable types. Analysis of specific risk factors and SNP analysis, combined, indicate that raw pork is a significant risk factor for exposure and infection to pathogenic YE cases, but not BT 1A cases.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0075424"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142288392","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}
Freddy A Medina, Frances Vila, Laura E Adams, Jaime Cardona, Jessica Carrion, Elaine Lamirande, Luz N Acosta, Carlos M De León-Rodríguez, Manuela Beltran, Demian Grau, Vanessa Rivera-Amill, Angel Balmaseda, Eva Harris, Zachary J Madewell, Stephen H Waterman, Gabriela Paz-Bailey, Stephen Whitehead, Jorge L Muñoz-Jordán
{"title":"Comparison of the sensitivity and specificity of commercial anti-dengue virus IgG tests to identify persons eligible for dengue vaccination.","authors":"Freddy A Medina, Frances Vila, Laura E Adams, Jaime Cardona, Jessica Carrion, Elaine Lamirande, Luz N Acosta, Carlos M De León-Rodríguez, Manuela Beltran, Demian Grau, Vanessa Rivera-Amill, Angel Balmaseda, Eva Harris, Zachary J Madewell, Stephen H Waterman, Gabriela Paz-Bailey, Stephen Whitehead, Jorge L Muñoz-Jordán","doi":"10.1128/jcm.00593-24","DOIUrl":"10.1128/jcm.00593-24","url":null,"abstract":"<p><p>The Advisory Committee on Immunization Practices (ACIP) recommended that dengue pre-vaccination screening tests for Dengvaxia administration have at least 98% specificity and 75% sensitivity. This study evaluates the performance of commercial anti-DENV IgG tests to identify tests that could be used for pre-vaccination screening. First, for seven tests, we evaluated sensitivity and specificity in early convalescent dengue virus (DENV) infection, using 44 samples collected 7-30 days after symptom onset and confirmed by RT-PCR. Next, for the five best-performing tests and two additional tests (with and without an external test reader) that became available later, we evaluated performance to detect past dengue infection among a panel of 44 specimens collected in 2018-2019 from healthy 9- to 16-year-old children from Puerto Rico. Finally, a full-scale evaluation was done with the four best-performing tests using 400 specimens from the same population. We used virus focus reduction neutralization test and an in-house DENV IgG ELISA as reference standards. Of seven tests, five showed ≥75% sensitivity in detecting anti-DENV IgG in early convalescent specimens with low cross-reactivity to the Zika virus. For the detection of previous DENV infections, the tests with the highest performance were the Euroimmun NS1 IgG ELISA (sensitivity 84.5%, specificity 97.1%) and CTK Dengue IgG rapid test R0065C with the test reader (sensitivity 76.2% specificity 98.1%). There are IgG tests available that can be used to accurately classify individuals with previous DENV infection as eligible for dengue vaccination to support safe vaccine implementation.</p><p><strong>Importance: </strong>The Advisory Committee on Immunization Practices (ACIP) has set forth recommendations that dengue pre-vaccination screening tests must exhibit at least 98% specificity and 75% sensitivity. Our research rigorously assesses the performance of various commercial tests against these benchmarks using well-characterized specimens from Puerto Rico. The findings from our study are particularly relevant given FDA approval and ACIP recommendation of Sanofi Pasteur's Dengvaxia vaccine, highlighting the need for accurate pre-vaccination screening tools.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0059324"},"PeriodicalIF":6.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080485","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}
Erik Munson1Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USAAlexander J. McAdam
{"title":"2024 American Society for Microbiology Awards and Prize Program: clinical microbiology honorees","authors":"Erik Munson1Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USAAlexander J. McAdam","doi":"10.1128/jcm.01261-24","DOIUrl":"https://doi.org/10.1128/jcm.01261-24","url":null,"abstract":"Journal of Clinical Microbiology, Ahead of Print. <br/>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"210 1","pages":""},"PeriodicalIF":9.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142260952","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}
Katharine H. D. CrawfordMary Lynn BanieckiElizabeth G. DushinCassandra A. TierneyShunjie GuanLaurence L. StenslandAilyn C. Perez-OsorioAlexander L. Greninger1Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA2Pfizer, Inc., Cambridge, Massachusetts, USA3Pfizer, Inc., Groton, Connecticut, USA4Vaccine and Infectious Disease Division, Fred Hutchinson Research Center, Seattle, Washington, USARandall Hayden
{"title":"Specimen adequacy assay controls in nucleic acid amplification tests do not correlate with nasopharyngeal swab collection method","authors":"Katharine H. D. CrawfordMary Lynn BanieckiElizabeth G. DushinCassandra A. TierneyShunjie GuanLaurence L. StenslandAilyn C. Perez-OsorioAlexander L. Greninger1Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA2Pfizer, Inc., Cambridge, Massachusetts, USA3Pfizer, Inc., Groton, Connecticut, USA4Vaccine and Infectious Disease Division, Fred Hutchinson Research Center, Seattle, Washington, USARandall Hayden","doi":"10.1128/jcm.00975-24","DOIUrl":"https://doi.org/10.1128/jcm.00975-24","url":null,"abstract":"Journal of Clinical Microbiology, Ahead of Print. <br/>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":"85 1","pages":""},"PeriodicalIF":9.4,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142260947","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}