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Journal of Clinical Microbiology
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limit of detection

  • Free
    Analytical Sensitivity of the Abbott BinaxNOW COVID-19 Ag Card
    Virology
    Analytical Sensitivity of the Abbott BinaxNOW COVID-19 Ag Card

    Multiple rapid antigen (Ag) tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have recently received emergency-use authorization (EUA) from the U.S. Food and Drug Administration (FDA).

    Garrett A. Perchetti, Meei-Li Huang, Margaret G. Mills, Keith R. Jerome, Alexander L. Greninger
  • 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
  • Development and Clinical Validation of a Pangenotypic PCR-Based Assay for the Detection and Quantification of Hepatitis E Virus (<em>Orthohepevirus</em> A Genus)
    Virology
    Development and Clinical Validation of a Pangenotypic PCR-Based Assay for the Detection and Quantification of Hepatitis E Virus (Orthohepevirus A Genus)

    The objective of this study was to design a pangenotypic PCR-based assay for the detection and quantification of hepatitis E virus (HEV) RNA from across the entire spectrum of described genotypes belonging to the Orthohepevirus A genus. The optimal conditions and the performance of the assay were determined by testing the WHO standard strain (6219/10) and the WHO HEV panel (8578/13). Similarly, performance comparisons were made...

    Mario Frías, Pedro López-López, Ismael Zafra, Javier Caballero-Gómez, Isabel Machuca, Ángela Camacho, María A. Risalde, Antonio Rivero-Juárez, Antonio Rivero
  • Free
    Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
    Virology
    Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays

    Analytical sensitivity for SARS-CoV-2 detection is a key performance metric for the evaluation of viral detection assays. We determined analytical limits of detection for seven SARS-CoV-2 assays using serial dilutions of pooled patient material quantified with droplet digital PCR. Limits of detection ranged from ≤10 to 74 copies/ml for commercial high-throughput laboratory analyzers (Roche Cobas, Abbott m2000, and Hologic Panther Fusion...

    Becky Fung, Allan Gopez, Venice Servellita, Shaun Arevalo, Coral Ho, Anne Deucher, Ed Thornborrow, Charles Chiu, Steve Miller
  • Open Access
    How Well Do Routine Molecular Diagnostics Detect Rifampin Heteroresistance in <span class="named-content genus-species" id="named-content-1">Mycobacterium tuberculosis</span>?
    Mycobacteriology and Aerobic Actinomycetes
    How Well Do Routine Molecular Diagnostics Detect Rifampin Heteroresistance in Mycobacterium tuberculosis?

    Rifampin heteroresistance—where rifampin-resistant and -susceptible tuberculosis (TB) bacilli coexist—may result in failed standard TB treatment and potential spread of rifampin-resistant strains. The detection of rifampin heteroresistance in routine rapid diagnostic tests (RDTs) allows for patients to receive prompt and effective multidrug-resistant-TB treatment and may improve rifampin-resistant TB control.

    Kamela C. S. Ng, Philip Supply, Frank G. J. Cobelens, Cyril Gaudin, Julian Gonzalez-Martin, Bouke C. de Jong, Leen Rigouts
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