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Journal of Clinical Microbiology
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validation

  • Development of a Duplex Real-Time PCR Assay for the Differentiation of <span class="named-content genus-species" id="named-content-1">Blastomyces dermatitidis</span> and <em>Blastomyces gilchristii</em> and a Retrospective Analysis of Culture and Primary Specimens from Blastomycosis Cases from New York (2005 to 2019)
    Mycology
    Development of a Duplex Real-Time PCR Assay for the Differentiation of Blastomyces dermatitidis and Blastomyces gilchristii and a Retrospective Analysis of Culture and Primary Specimens from Blastomycosis Cases from New York (2005 to 2019)

    Blastomycosis due to Blastomyces dermatitidis and Blastomyces gilchristii is a significant cause of respiratory mycoses in North America with occasional reported outbreaks. We developed a highly sensitive, specific, and reproducible TaqMan duplex real-time PCR assay for the differentiation of...

    Mitchell Kaplan, YanChun Zhu, Julianne V. Kus, Lisa McTaggart, Vishnu Chaturvedi, Sudha Chaturvedi
  • Direct PCR on Tissue Samples To Detect <span class="named-content genus-species" id="named-content-1">Mycobacterium tuberculosis</span> Complex: an Alternative to the Bacteriological Culture
    Mycobacteriology and Aerobic Actinomycetes
    Direct PCR on Tissue Samples To Detect Mycobacterium tuberculosis Complex: an Alternative to the Bacteriological Culture

    Bovine tuberculosis (bTB) is an ongoing issue in several countries within the European Union. Microbiological culture is the official confirmation technique for the presence of Mycobacterium tuberculosis complex (MTBC) members in bovine tissues, but several methodological issues, such as moderate sensitivity and long incubation times, require the development of more...

    V. Lorente-Leal, E. Liandris, M. Pacciarini, A. Botelho, K. Kenny, B. Loyo, R. Fernández, J. Bezos, L. Domínguez, L. de Juan, B. Romero
  • Despite Excellent Test Characteristics of the cobas 4800 CT/NG Assay, Detection of Oropharyngeal <span class="named-content genus-species" id="named-content-1">Chlamydia trachomatis</span> and <span class="named-content genus-species" id="named-content-2">Neisseria gonorrhoeae</span> Remains Challenging
    Bacteriology
    Despite Excellent Test Characteristics of the cobas 4800 CT/NG Assay, Detection of Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Remains Challenging

    Oropharyngeal Chlamydia trachomatis (CT) infections and, especially, Neisseria gonorrhoeae (NG) infections are common, but few commercial nucleic acid amplification tests (NAATs) specify extragenital samples for intended use. The test characteristics of the cobas 4800 CT/NG assay were evaluated for...

    J. M. van Niekerk, B. M. J. W. van der Veer, C. J. P. A. Hoebe, J. van de Bovenkamp, C. van Herk, I. H. M. van Loo, L. B. van Alphen, P. F. G. Wolffs
  • 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
  • Free
    Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution
    Special Issue Virology
    Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution

    The recent emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has posed formidable challenges for clinical laboratories seeking reliable laboratory diagnostic confirmation. The swift advance of the crisis in the United States has led to Emergency Use Authorization (EUA) facilitating the availability of molecular diagnostic assays without the more rigorous examination to which tests are normally...

    Atreyee Basu, Tatyana Zinger, Kenneth Inglima, Kar-mun Woo, Onome Atie, Lauren Yurasits, Benjamin See, Maria E. Aguero-Rosenfeld
  • Validation of an Epstein-Barr Virus Antibody Risk Stratification Signature for Nasopharyngeal Carcinoma by Use of Multiplex Serology
    Virology
    Validation of an Epstein-Barr Virus Antibody Risk Stratification Signature for Nasopharyngeal Carcinoma by Use of Multiplex Serology

    Serological testing for nasopharyngeal carcinoma (NPC) has recently been reinvigorated by the implementation of novel Epstein-Barr virus (EBV)-specific IgA and IgG antibodies from a proteome array. Although proteome arrays are well suited for comprehensive antigen selection, they are not applicable for large-scale studies. We adapted a 13-marker EBV antigen signature for NPC risk identified by proteome arrays to multiplex serology to...

    Julia Simon, Zhiwei Liu, Nicole Brenner, Kelly J. Yu, Wan-Lun Hsu, Cheng-Ping Wang, Yin-Chu Chien, Anna E. Coghill, Chien-Jen Chen, Julia Butt, Carla Proietti, Denise L. Doolan, Allan Hildesheim, Tim Waterboer
  • Validation of a New Rapid Detection Test for Detection of <span class="named-content genus-species" id="named-content-1">Neisseria meningitidis</span> A/C/W/X/Y Antigens in Cerebrospinal Fluid
    Bacteriology
    Validation of a New Rapid Detection Test for Detection of Neisseria meningitidis A/C/W/X/Y Antigens in Cerebrospinal Fluid

    Meningococcal meningitis remains a life-threatening disease worldwide, with high prevalence in the sub-Saharan meningitis belt. A rapid diagnosis is crucial for implementing adapted antimicrobial treatment. We describe the performances of a new immunochromatographic test (MeningoSpeed, BioSpeedia, France) for detecting and grouping Neisseria meningitidis....

    Cyrille H. Haddar, Aude Terrade, Paul Verhoeven, Berthe-Marie Njanpop-Lafourcade, Mireille Dosso, Fati Sidikou, Ali Elhaj Mahamane, Jean-Pierre Lombart, Aziza Razki, Eva Hong, Alain Agnememel, Evelyne Begaud, Yves Germani, Bruno Pozzetto, Muhamed-Kheir Taha
  • Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings
    Virology
    Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings

    The Alinity m HR HPV assay (Alinity) is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18, and HPV45 while reporting on 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening for cervical cancer was evaluated in population-based settings.

    Anja Oštrbenk Valenčak, Anja Šterbenc, Katja Seme, Mario Poljak
  • 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
  • Open Access
    Phylogenomic Pipeline Validation for Foodborne Pathogen Disease Surveillance
    Minireview
    Phylogenomic Pipeline Validation for Foodborne Pathogen Disease Surveillance

    Foodborne pathogen surveillance in the United States is transitioning from strain identification using restriction digest technology (pulsed-field gel electrophoresis [PFGE]) to shotgun sequencing of the entire genome (whole-genome sequencing [WGS]). WGS requires a new suite of analysis tools, some of which have long histories in academia but are new to the field of public health and regulatory decision making.

    Ruth E. Timme, Errol Strain, Joseph D. Baugher, Steven Davis, Narjol Gonzalez-Escalona, Maria Sanchez Leon, Marc W. Allard, Eric W. Brown, Sandra Tallent, Hugh Rand

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