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Journal of Clinical Microbiology
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specificity

  • Free
    Highly Sensitive and Specific Multiplex Antibody Assays To Quantify Immunoglobulins M, A, and G against SARS-CoV-2 Antigens
    Immunoassays
    Highly Sensitive and Specific Multiplex Antibody Assays To Quantify Immunoglobulins M, A, and G against SARS-CoV-2 Antigens

    Reliable serological tests are required to determine the prevalence of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to characterize immunity to the disease in order to address key knowledge gaps in the coronavirus disease 2019 (COVID-19) pandemic. Quantitative suspension array technology (qSAT) assays based on the xMAP Luminex platform overcome the limitations of rapid diagnostic tests and enzyme-...

    Carlota Dobaño, Marta Vidal, Rebeca Santano, Alfons Jiménez, Jordi Chi, Diana Barrios, Gemma Ruiz-Olalla, Natalia Rodrigo Melero, Carlo Carolis, Daniel Parras, Pau Serra, Paula Martínez de Aguirre, Francisco Carmona-Torre, Gabriel Reina, Pere Santamaria, Alfredo Mayor, Alberto L. García-Basteiro, Luis Izquierdo, Ruth Aguilar, Gemma Moncunill
  • Open Access
    Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2
    Virology
    Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2

    The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2...

    Peter Muench, Simon Jochum, Verena Wenderoth, Beatus Ofenloch-Haehnle, Michael Hombach, Matthias Strobl, Henrik Sadlowski, Christopher Sachse, Giulia Torriani, Isabella Eckerle, Alexander Riedel
  • Performance of a Modified Two-Tiered Testing Enzyme Immunoassay Algorithm for Serologic Diagnosis of Lyme Disease in Nova Scotia
    Immunoassays
    Performance of a Modified Two-Tiered Testing Enzyme Immunoassay Algorithm for Serologic Diagnosis of Lyme Disease in Nova Scotia

    Compared to the standard two-tiered testing (STTT) algorithm for Lyme disease serology using an enzyme immunoassay (EIA) followed by Western blotting, data from the United States suggest that a modified two-tiered testing (MTTT) algorithm employing two EIAs has improved sensitivity to detect early localized Borrelia burgdorferi infections without compromising...

    Ian R. C. Davis, Shelly A. McNeil, Wanda Allen, Donna MacKinnon-Cameron, L. Robbin Lindsay, Katarina Bernat, Antonia Dibernardo, Jason J. LeBlanc, Todd F. Hatchette
  • Open Access
    Clinical Validation of the Aptima Bacterial Vaginosis and Aptima <em>Candida/Trichomonas</em> Vaginitis Assays: Results from a Prospective Multicenter Clinical Study
    Bacteriology
    Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

    Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid...

    Jane R. Schwebke, Stephanie N. Taylor, Ronald Ackerman, Robert Schlaberg, Neil B. Quigley, Charlotte A. Gaydos, Steven E. Chavoustie, Paul Nyirjesy, Carmelle V. Remillard, Philip Estes, Byron McKinney, Damon K. Getman, Craig Clark
  • Open Access
    Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women
    Immunoassays
    Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women

    Measuring CD4 counts remains an important component of HIV care. The Visitect CD4 is the first instrument-free low-cost point-of-care CD4 test with results interpreted visually after 40 min, providing a result of ≥350 CD4 cells/mm3.

    Stanley Luchters, Karl Technau, Yasmin Mohamed, Matthew F. Chersich, Paul A. Agius, Minh D. Pham, Mary L. Garcia, James Forbes, Andrew Shepherd, Ashraf Coovadia, Suzanne M. Crowe, David A. Anderson
  • Free
    Sonication versus Tissue Sampling for Diagnosis of Prosthetic Joint and Other Orthopedic Device-Related Infections
    Bacteriology
    Sonication versus Tissue Sampling for Diagnosis of Prosthetic Joint and Other Orthopedic Device-Related Infections

    Current guidelines recommend collection of multiple tissue samples for diagnosis of prosthetic joint infections (PJI). Sonication of explanted devices has been proposed as a potentially simpler alternative; however, reported microbiological yield varies.

    Maria Dudareva, Lucinda Barrett, Mel Figtree, Matthew Scarborough, Masanori Watanabe, Robert Newnham, Rachael Wallis, Sarah Oakley, Ben Kendrick, David Stubbs, Martin A. McNally, Philip Bejon, Bridget A. Atkins, Adrian Taylor, Andrew J. Brent
  • Open Access
    Epidemiology
    Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis
    Jane R. Schwebke, Charlotte A. Gaydos, Paul Nyirjesy, Sonia Paradis, Salma Kodsi, Charles K. Cooper
  • Open Access
    Letter to the Editor
    The Repetitive Element RLEP Is a Highly Specific Target for Detection of Mycobacterium leprae
    S. Braet, K. Vandelannoote, C. J. Meehan, A. N. Brum Fontes, E. Hasker, P. S. Rosa, N. Lucena-Silva, L. Rigouts, P. N. Suffys, B. C. De Jong
  • Open Access
    Virology
    Evaluation of a Novel Reporter Virus Neutralization Test for Serological Diagnosis of Zika and Dengue Virus Infection
    Chao Shan, Daniel A. Ortiz, Yujiao Yang, Susan J. Wong, Laura D. Kramer, Pei-Yong Shi, Michael J. Loeffelholz, Ping Ren
  • Open Access
    Immunoassays
    Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan
    Syria Laperche, Silvia Sauleda, Maria Piron, Annelies Mühlbacher, Harald Schennach, Volkmar Schottstedt, Lucinda Queirós, Naoki Uno, Katsunori Yanagihara, Roland Imdahl, Ariann Hey, Markus Klinkicht, Walter Melchior, Peter Muench, Toshiki Watanabe

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