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Journal of Clinical Microbiology
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verification

  • Free
    Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization
    Commentary
    Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

    Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning...

    Elitza S. Theel, Marc Roger Couturier, Laura Filkins, Elizabeth Palavecino, Stephanie Mitchell, Sheldon Campbell, Michael Pentella, Susan Butler-Wu, Kurt Jerke, Vaishali Dharmarha, Peggy McNult, Audrey N. Schuetz
    and on behalf of the American Society for Microbiology Clinical and Public Health Microbiology Committee, Subcommittee on Laboratory Practices
  • Expert Opinion on Verification of Antimicrobial Susceptibility Tests
    Letter to the Editor
    Expert Opinion on Verification of Antimicrobial Susceptibility Tests
    Jean B. Patel, Richard B. Thomson, Kevin Alby, Esther Babady, Karissa Culbreath, Marcelo F. Galas, Shawn R. Lockhart, Brian V. Lubbers, Margie Morgan, Sandra S. Richter, Susan Sharp, Ribhi M. Shawar, Ana Maria Cardenas, German Esparza, Nicole Hubbard, Mark G. Papich, Audrey N. Schuetz
  • Free
    Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA
    Special Issue Commentary
    Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA

    The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an...

    Stephanie L. Mitchell, Kirsten St. George, Daniel D. Rhoads, Susan M. Butler-Wu, Vaishali Dharmarha, Peggy McNult, Melissa B. Miller
    and on behalf of the American Society for Microbiology Clinical and Public Health Microbiology Committee
  • Verification Is an Integral Part of Antimicrobial Susceptibility Test Quality Assurance
    Letter to the Editor
    Verification Is an Integral Part of Antimicrobial Susceptibility Test Quality Assurance
    Romney M. Humphries, Patricia J. Simner
  • Bringing Antimicrobial Susceptibility Testing for New Drugs into the Clinical Laboratory: Removing Obstacles in Our Fight against Multidrug-Resistant Pathogens
    Commentary
    Bringing Antimicrobial Susceptibility Testing for New Drugs into the Clinical Laboratory: Removing Obstacles in Our Fight against Multidrug-Resistant Pathogens

    There are now several new antibiotics available to treat multidrug-resistant pathogens, and susceptibility testing methods for these drugs are increasingly available at the time of drug approval. However, lack of clarity regarding verification requirements remains a formidable barrier to introducing such testing in clinical laboratories, making these drugs practically unavailable for patient use.

    James E. Kirby, Thea Brennan-Krohn, Kenneth P. Smith
  • Free
    Bacteriology
    Real-Time Electronic Tracking of Diarrheal Episodes and Laxative Therapy Enables Verification of Clostridium difficile Clinical Testing Criteria and Reduction of Clostridium difficile Infection Rates
    Cynthia Y. Truong, Saurabh Gombar, Richard Wilson, Gopalakrishnan Sundararajan, Natasa Tekic, Marisa Holubar, John Shepard, Alexandra Madison, Lucy Tompkins, Neil Shah, Stan Deresinski, Lee F. Schroeder, Niaz Banaei
  • Bacteriology
    Improved Accuracy of Cefepime Susceptibility Testing for Extended-Spectrum-Beta-Lactamase-Producing Enterobacteriaceae with an On-Demand Digital Dispensing Method
    Kenneth P. Smith, Thea Brennan-Krohn, Susan Weir, James E. Kirby
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