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  1. Article ; Online: Federal Oversight of Laboratory-Developed Tests.

    Pierce, Virginia M / Humphries, Romney M

    The New England journal of medicine

    2024  Volume 390, Issue 5, Page(s) 482–483

    Language English
    Publishing date 2024-01-31
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2314290
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  2. Article ; Online: How New Regulation of Laboratory-Developed Antimicrobial Susceptibility Tests Will Affect Infectious Diseases Clinical Practice.

    Wolfe, Kaleb H / Pierce, Virginia M / Humphries, Romney M

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2024  Volume 78, Issue 5, Page(s) 1140–1147

    Abstract: Antimicrobial resistance (AMR) affects 2.8 million Americans annually. AMR is identified through antimicrobial susceptibility testing (AST), but current and proposed regulatory policies from the United States Food and Drug Administration (FDA) jeopardize ...

    Abstract Antimicrobial resistance (AMR) affects 2.8 million Americans annually. AMR is identified through antimicrobial susceptibility testing (AST), but current and proposed regulatory policies from the United States Food and Drug Administration (FDA) jeopardize the future availability of AST for many microorganisms. Devices that perform AST must be cleared by the FDA using their susceptibility test interpretive criteria, also known as breakpoints. The FDA list of breakpoints is relatively short. Today, laboratories supplement FDA breakpoints using breakpoints published by the Clinical and Laboratory Standards Institute, using legacy devices and laboratory-developed tests (LDTs). FDA proposes to regulate LDTs, and with no FDA breakpoints for many drug-bug combinations, the risk is loss of AST for key clinical indications and stifling innovation in technology development. Effective solutions require collaboration between manufacturers, infectious diseases clinicians, pharmacists, laboratories, and the FDA.
    MeSH term(s) Humans ; United States ; United States Food and Drug Administration ; Microbial Sensitivity Tests/standards ; Microbial Sensitivity Tests/methods ; Anti-Bacterial Agents/pharmacology ; Communicable Diseases/drug therapy ; Drug Resistance, Bacterial
    Language English
    Publishing date 2024-05-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciae075
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Guiding antimicrobial stewardship through thoughtful antimicrobial susceptibility testing and reporting strategies: an updated approach in 2023.

    Pierce, Virginia M / Bhowmick, Tanaya / Simner, Patricia J

    Journal of clinical microbiology

    2023  Volume 61, Issue 11, Page(s) e0007422

    Abstract: Antimicrobial susceptibility test and report guidelines are an important tool for antimicrobial stewardship programs. Since 1972, Tables 1 within the Clinical and Laboratory Standards Institute (CLSI) M100 document have provided a general framework upon ... ...

    Abstract Antimicrobial susceptibility test and report guidelines are an important tool for antimicrobial stewardship programs. Since 1972, Tables 1 within the Clinical and Laboratory Standards Institute (CLSI) M100 document have provided a general framework upon which clinical microbiologists and antimicrobial stewardship teams can build algorithms for susceptibility testing and reporting that meet the specific needs of their institution. Many changes were made to Tables 1 in M100-Ed33 to modernize the content to reflect the landscape of current clinical practice, including the growing armamentarium of antimicrobial agents, the emergence of new mechanisms of antimicrobial resistance, the increasing prevalence of infections caused by multidrug-resistant organisms, and updated consensus recommendations for first-choice and alternative agents for treatment. With these items in mind, the CLSI Table 1
    MeSH term(s) Humans ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Antimicrobial Stewardship ; Gram-Negative Bacteria ; Anti-Infective Agents/pharmacology ; Anti-Infective Agents/therapeutic use ; Microbial Sensitivity Tests
    Chemical Substances Anti-Bacterial Agents ; Anti-Infective Agents
    Language English
    Publishing date 2023-09-28
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/jcm.00074-22
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Setting Antimicrobial Susceptibility Testing Breakpoints: A Primer for Pediatric Infectious Diseases Specialists on the Clinical and Laboratory Standards Institute Approach.

    Pierce, Virginia M / Mathers, Amy J

    Journal of the Pediatric Infectious Diseases Society

    2021  Volume 11, Issue 2, Page(s) 73–80

    Abstract: Breakpoints are the values used by clinical microbiology laboratories to interpret the results of antimicrobial susceptibility testing (AST) and classify isolates as susceptible or resistant. Whether the breakpoints applied by laboratories accurately ... ...

    Abstract Breakpoints are the values used by clinical microbiology laboratories to interpret the results of antimicrobial susceptibility testing (AST) and classify isolates as susceptible or resistant. Whether the breakpoints applied by laboratories accurately predict the likelihood of successful treatment with a particular antimicrobial is an issue of critical importance to quality clinical care. In the United States, the Food and Drug Administration (FDA) sets breakpoints, and globally, breakpoints are also set by 2 standards development organizations, the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST); individual laboratories may choose which breakpoints to implement. Many CLSI breakpoints are recognized by FDA, facilitating their incorporation into widely used commercial AST devices. The CLSI Subcommittee on AST's consensus approach to establishing (and as needed, revising) breakpoints involves integration of currently available microbiological, pharmacokinetic-pharmacodynamic, and clinical data. Here, an overview of the CLSI process for establishing breakpoints is provided.
    MeSH term(s) Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Child ; Communicable Diseases/drug therapy ; Humans ; Laboratories ; Microbial Sensitivity Tests ; United States
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2021-11-23
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2668791-4
    ISSN 2048-7207 ; 2048-7193
    ISSN (online) 2048-7207
    ISSN 2048-7193
    DOI 10.1093/jpids/piab106
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  5. Article: It's Not You, It's SOSA: A Case Study on Breaking Up With an FDA-Cleared Susceptibility Testing System's Oxacillin Results for

    Yang, Christine / Anahtar, Melis N / Pierce, Virginia M

    Open forum infectious diseases

    2022  Volume 9, Issue 9, Page(s) ofac421

    Abstract: Background: In 2021, the Clinical and Laboratory Standards Institute revised its susceptible oxacillin minimum inhibitory concentration (MIC) breakpoint for : Methods: We retrospectively reviewed and assessed the yield of PBP2a testing for 189 SOSA ... ...

    Abstract Background: In 2021, the Clinical and Laboratory Standards Institute revised its susceptible oxacillin minimum inhibitory concentration (MIC) breakpoint for
    Methods: We retrospectively reviewed and assessed the yield of PBP2a testing for 189 SOSA isolates with discordant (when applying the FDA susceptible oxacillin breakpoint of ≤0.25 µg/mL) VITEK 2 oxacillin and cefoxitin results, and then prospectively incorporated PBP2a testing for isolates with oxacillin MICs of 0.5 µg/mL and positive cefoxitin screens into our algorithm.
    Results: Compared with accepting the VITEK 2 AES interpretation, PBP2a testing substantially improved the accuracy of
    Conclusions: Although detection of
    Language English
    Publishing date 2022-08-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofac421
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  6. Article ; Online: The growing threat of NDM-producing E. coli with penicillin-binding protein 3 mutations in the United States - is there a potential role for durlobactam?

    Aitken, Samuel L / Pierce, Virginia M / Pogue, Jason M / Kline, Ellen G / Tverdek, Frank P / Shields, Ryan K

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2024  

    Abstract: We report identification of 5 patients with infections caused by NDM-5-producing E. coli harboring PBP3 mutations that showed reduced susceptibility to aztreonam-avibactam and cefiderocol. Durlobactam, a novel diazabicyclooctane β-lactamase inhibitor, ... ...

    Abstract We report identification of 5 patients with infections caused by NDM-5-producing E. coli harboring PBP3 mutations that showed reduced susceptibility to aztreonam-avibactam and cefiderocol. Durlobactam, a novel diazabicyclooctane β-lactamase inhibitor, demonstrated minimum inhibitory concentrations ranging from 0.5 to 2 µg/mL supporting future investigations into a potential role in clinical management.
    Language English
    Publishing date 2024-04-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciae229
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  7. Article: The carbapenem inoculum effect provides insight into the molecular mechanisms underlying carbapenem resistance in

    Cartagena, Alexis Jaramillo / Taylor, Kyra L / Smith, Joshua T / Manson, Abigail L / Pierce, Virginia M / Earl, Ashlee M / Bhattacharyya, Roby P

    bioRxiv : the preprint server for biology

    2023  

    Abstract: Carbapenem- ... ...

    Abstract Carbapenem-resistant
    Language English
    Publishing date 2023-10-04
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.05.23.541813
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  8. Article ; Online: Case 21-2016: A Man in an Unresponsive State.

    Luther, Jay / Pierce, Virginia M

    The New England journal of medicine

    2016  Volume 375, Issue 17, Page(s) 1697

    MeSH term(s) Humans ; Male
    Language English
    Publishing date 2016--27
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1610229
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  9. Article ; Online: Prediction of Antimicrobial Resistance in Clinical Enterococcus faecium Isolates Using a Rules-Based Analysis of Whole-Genome Sequences.

    Anahtar, Melis N / Bramante, Juliet T / Xu, Jiawu / Desrosiers, Lisa A / Paer, Jeffrey M / Rosenberg, Eric S / Pierce, Virginia M / Kwon, Douglas S

    Antimicrobial agents and chemotherapy

    2021  Volume 66, Issue 1, Page(s) e0119621

    Abstract: Enterococcus faecium is a major cause of clinical infections, often due to multidrug-resistant (MDR) strains. Whole-genome sequencing (WGS) is a powerful tool to study MDR bacteria and their antimicrobial resistance (AMR) mechanisms. In this study, we ... ...

    Abstract Enterococcus faecium is a major cause of clinical infections, often due to multidrug-resistant (MDR) strains. Whole-genome sequencing (WGS) is a powerful tool to study MDR bacteria and their antimicrobial resistance (AMR) mechanisms. In this study, we used WGS to characterize E. faecium clinical isolates and test the feasibility of rules-based genotypic prediction of AMR. Clinical isolates were divided into derivation and validation sets. Phenotypic susceptibility testing for ampicillin, vancomycin, high-level gentamicin, ciprofloxacin, levofloxacin, doxycycline, tetracycline, and linezolid was performed using the Vitek 2 automated system, with confirmation and discrepancy resolution by broth microdilution, disk diffusion, or gradient diffusion when needed. WGS was performed to identify isolate lineage and AMR genotype. AMR prediction rules were derived by analyzing the genotypic-phenotypic relationship in the derivation set. Phylogenetic analysis demonstrated that 88% of isolates in the collection belonged to hospital-associated clonal complex 17. Additionally, 12% of isolates had novel sequence types. When applied to the validation set, the derived prediction rules demonstrated an overall positive predictive value of 98% and negative predictive value of 99% compared to standard phenotypic methods. Most errors were falsely resistant predictions for tetracycline and doxycycline. Further analysis of genotypic-phenotypic discrepancies revealed potentially novel
    MeSH term(s) Anti-Bacterial Agents/pharmacology ; Drug Resistance, Bacterial/genetics ; Enterococcus faecium ; Gram-Positive Bacterial Infections/drug therapy ; Gram-Positive Bacterial Infections/microbiology ; Humans ; Microbial Sensitivity Tests ; Phylogeny
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2021-10-25
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 217602-6
    ISSN 1098-6596 ; 0066-4804
    ISSN (online) 1098-6596
    ISSN 0066-4804
    DOI 10.1128/AAC.01196-21
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  10. Article ; Online: Comparison of the GenMark Diagnostics eSensor respiratory viral panel to real-time PCR for detection of respiratory viruses in children.

    Pierce, Virginia M / Hodinka, Richard L

    Journal of clinical microbiology

    2012  Volume 50, Issue 11, Page(s) 3458–3465

    Abstract: A novel eSensor respiratory viral panel (eSensor RVP) multiplexed nucleic acid amplification test (GenMark Diagnostics, Inc., Carlsbad, CA) was compared to laboratory-developed real-time PCR assays for the detection of various respiratory viruses. A ... ...

    Abstract A novel eSensor respiratory viral panel (eSensor RVP) multiplexed nucleic acid amplification test (GenMark Diagnostics, Inc., Carlsbad, CA) was compared to laboratory-developed real-time PCR assays for the detection of various respiratory viruses. A total of 250 frozen archived pediatric respiratory specimens previously characterized as either negative or positive for one or more viruses by real-time PCR were examined using the eSensor RVP. Overall agreement between the eSensor RVP and corresponding real-time PCR assays for shared analytes was 99.2% (kappa = 0.96 [95% confidence interval {CI}, 0.94 to 0.98]). The combined positive percent agreement was 95.4% (95% CI, 92.5 to 97.3); the negative percent agreement was 99.7% (95% CI, 99.4 to 99.8). The mean real-time PCR threshold cycle (C(T)) value for specimens with discordant results was 39.73 (95% CI, 38.03 to 41.43). Detection of coinfections and correct identification of influenza A virus subtypes were comparable between methods. Of note, the eSensor RVP rhinovirus assay was found to be more sensitive and specific than the corresponding rhinovirus real-time PCR. In contrast, the eSensor RVP adenovirus B, C, and E assays demonstrated some cross-reactivity when tested against known adenovirus serotypes representing groups A through F. The eSensor RVP is robust and relatively easy to perform, it involves a unique biosensor technology for target detection, and its multiplexed design allows for efficient and simultaneous interrogation of a single specimen for multiple viruses. Potential drawbacks include a slower turnaround time and the need to manipulate amplified product during the protocol, increasing the possibility of contamination.
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Diagnostic Errors/statistics & numerical data ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Molecular Diagnostic Techniques/methods ; Respiratory Tract Infections/virology ; Sensitivity and Specificity ; Virology/methods ; Virus Diseases/diagnosis ; Virus Diseases/virology ; Viruses/classification ; Viruses/genetics ; Viruses/isolation & purification ; Young Adult
    Keywords covid19
    Language English
    Publishing date 2012-08-08
    Publishing country United States
    Document type Evaluation Study ; Journal Article
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.01384-12
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