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Journal of Clinical Microbiology
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diagnostics

  • Open Access
    Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood)
    Virology
    Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood)

    Remote areas of many low and middle income (LMI) countries have poor access to HIV viral load (HIV VL) testing. The SAMBA II (simple amplification-based assay) Semi-Q whole-blood test (Diagnostics for the Real World [DRW], Cambridge, UK) is a point-of-care assay, which uses leucodepletion technology to allow whole-blood testing in remote settings.

    Gary Brook, Tetiana Stepchenkova, Innocent M. Ali, Sandra Chipuka, Neha Goel, Helen Lee
  • Open Access
    Diagnostic Accuracy Study of a Novel Blood-Based Assay for Identification of Tuberculosis in People Living with HIV
    Mycobacteriology and Aerobic Actinomycetes
    Diagnostic Accuracy Study of a Novel Blood-Based Assay for Identification of Tuberculosis in People Living with HIV

    A nonsputum triage test to rule out tuberculosis (TB) disease is a WHO high-priority diagnostic, and a combinatory score based on a 3-gene host signature has shown promise in discriminating TB from other illnesses. We evaluated the accuracy of an early-prototype cartridge assay (“Xpert MTB Host Response” or Xpert-MTB-HR-Prototype) of this 3-gene signature on biobanked blood samples from people living with HIV (PLHIV) against a...

    Erik Södersten, Stefano Ongarello, Anna Mantsoki, Romain Wyss, David H. Persing, Sara Banderby, Linda Strömqvist Meuzelaar, Jacqueline Prieto, Devasena Gnanashanmugam, Purvesh Khatri, Samuel G. Schumacher, Claudia M. Denkinger
  • Open Access
    Comparative Analytical Evaluation of Four Centralized Platforms for the Detection of <span class="named-content genus-species" id="named-content-1">Mycobacterium tuberculosis</span> Complex and Resistance to Rifampicin and Isoniazid
    Mycobacteriology and Aerobic Actinomycetes
    Comparative Analytical Evaluation of Four Centralized Platforms for the Detection of Mycobacterium tuberculosis Complex and Resistance to Rifampicin and Isoniazid

    Failure to rapidly identify drug-resistant tuberculosis (TB) increases the risk of patient mismanagement, the amplification of drug resistance, and ongoing transmission. We generated comparative analytical data for four automated assays for the detection of TB and multidrug-resistant TB (MDR-TB): Abbott RealTime MTB and MTB RIF/INH (Abbott), Hain Lifescience FluoroType MTBDR (Hain), BD Max MDR-TB (BD), and Roche cobas MTB and...

    Margaretha de Vos, Lesley Scott, Anura David, Andre Trollip, Harald Hoffmann, Sophia Georghiou, Sergio Carmona, Morten Ruhwald, Wendy Stevens, Claudia M. Denkinger, Samuel G. Schumacher
  • Open Access
    Variable Sensitivity of SARS-CoV-2 Molecular Detection in European Expert Laboratories: External Quality Assessment, June and July 2020
    Virology
    Variable Sensitivity of SARS-CoV-2 Molecular Detection in European Expert Laboratories: External Quality Assessment, June and July 2020

    During the ongoing coronavirus disease 2019 (COVID-19) outbreak, robust detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a key element for clinical management and to interrupt transmission chains. We organized an external quality assessment (EQA) of molecular detection of SARS-CoV-2 for European expert laboratories. An EQA panel composed of 12 samples, containing either SARS-CoV-2 at different concentrations...

    Carlo Fischer, Ramona Mögling, Angeliki Melidou, Arne Kühne, Edmilson F. Oliveira-Filho, Thorsten Wolff, Janine Reiche, Eeva Broberg, Christian Drosten, Adam Meijer, Katrin Leitmeyer, Jan Felix Drexler, Chantal B. E. M. Reusken
  • Free
    COVID-19 Serology at Population Scale: SARS-CoV-2-Specific Antibody Responses in Saliva
    Immunoassays
    COVID-19 Serology at Population Scale: SARS-CoV-2-Specific Antibody Responses in Saliva

    Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of an ongoing pandemic that has infected over 36 million and killed over 1 million people. Informed implementation of government public health policies depends on accurate data on SARS-CoV-2 immunity at a population scale. We hypothesized that detection of SARS-CoV-2 salivary antibodies could serve as a noninvasive alternative to serological testing for monitoring...

    Nora Pisanic, Pranay R. Randad, Kate Kruczynski, Yukari C. Manabe, David L. Thomas, Andrew Pekosz, Sabra L. Klein, Michael J. Betenbaugh, William A. Clarke, Oliver Laeyendecker, Patrizio P. Caturegli, H. Benjamin Larman, Barbara Detrick, Jessica K. Fairley, Amy C. Sherman, Nadine Rouphael, Srilatha Edupuganti, Douglas A. Granger, Steve W. Granger, Matthew H. Collins, Christopher D. Heaney
  • Free
    Comparison of Upper Respiratory Viral Load Distributions in Asymptomatic and Symptomatic Children Diagnosed with SARS-CoV-2 Infection in Pediatric Hospital Testing Programs
    Virology
    Comparison of Upper Respiratory Viral Load Distributions in Asymptomatic and Symptomatic Children Diagnosed with SARS-CoV-2 Infection in Pediatric Hospital Testing Programs

    The distribution of upper respiratory viral loads (VL) in asymptomatic children infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unknown. We assessed PCR cycle threshold (Ct) values and estimated VL in infected asymptomatic children diagnosed in nine pediatric hospital testing programs. Records for asymptomatic and symptomatic patients with positive clinical SARS-CoV-2 tests were reviewed. Ct values were (i...

    Larry K. Kociolek, William J. Muller, Rebecca Yee, Jennifer Dien Bard, Cameron A. Brown, Paula A. Revell, Hanna Wardell, Timothy J. Savage, Sarah Jung, Samuel Dominguez, Bijal A. Parikh, Robert C. Jerris, Sue C. Kehl, Aaron Campigotto, Jeffrey M. Bender, Xiaotian Zheng, Emily Muscat, Matthew Linam, Lisa Abuogi, Christiana Smith, Kelly Graff, Ariel Hernandez-Leyva, David Williams, Nira R. Pollock
  • Free
    Metagenomic Sequencing To Detect Respiratory Viruses in Persons under Investigation for COVID-19
    Virology
    Metagenomic Sequencing To Detect Respiratory Viruses in Persons under Investigation for COVID-19

    Broad testing for respiratory viruses among persons under investigation (PUIs) for SARS-CoV-2 has been performed inconsistently, limiting our understanding of alternative viral infections and coinfections in these patients. RNA metagenomic next-generation sequencing (mNGS) offers an agnostic tool for the detection of both SARS-CoV-2 and other RNA respiratory viruses in PUIs. Here, we used RNA mNGS to assess the frequencies of...

    Ahmed Babiker, Heath L. Bradley, Victoria D. Stittleburg, Jessica M. Ingersoll, Autum Key, Colleen S. Kraft, Jesse J. Waggoner, Anne Piantadosi
  • Open Access
    Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease
    Mycology
    Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease

    High cryptococcal antigen (CrAg) titers in blood are associated with subclinical meningitis and mortality in CrAg-positive individuals with advanced HIV disease (AHD). We evaluated a novel semiquantitative lateral flow assay (LFA), CryptoPS, that may be able to identify individuals with high CrAg titers in a cohort of AHD patients undergoing CrAg screening. In a prospective cohort of patients with AHD (CD4 cell count, ≤200/μl) receiving...

    Mark W. Tenforde, Timothée Boyer-Chammard, Charles Muthoga, Leabaneng Tawe, Thandi Milton, Ikanyeng Rulaganyang, Kwana Lechiile, Ivy Rukasha, Tshepo B. Leeme, Nelesh P. Govender, Julia Ngidi, Madisa Mine, Síle F. Molloy, Thomas S. Harrison, Olivier Lortholary, Joseph N. Jarvis
  • Open Access
    Rapid Diagnostic Tests for <span class="named-content genus-species" id="named-content-1">Trypanosoma cruzi</span> Infection: Field Evaluation of Two Registered Kits in a Region of Endemicity and a Region of Nonendemicity in Argentina
    Parasitology
    Rapid Diagnostic Tests for Trypanosoma cruzi Infection: Field Evaluation of Two Registered Kits in a Region of Endemicity and a Region of Nonendemicity in Argentina

    Infection by Trypanosoma cruzi (Chagas disease [ChD]) affects around 7 million people in the Americas, most of whom are unaware of their status due to lack of clinical manifestations and poor access to diagnosis. Rapid diagnostic tests (RDTs) are widely used for screening for different infections (HIV, hepatitis B, and syphilis), and their application for ChD would...

    Constanza Lopez-Albizu, Emmaría Danesi, Pablo Piorno, Mariana Fernandez, Francisco García Campos, Karenina Scollo, Favio Crudo
  • Open Access
    Analysis of Inactivation of SARS-CoV-2 by Specimen Transport Media, Nucleic Acid Extraction Reagents, Detergents, and Fixatives
    Virology
    Analysis of Inactivation of SARS-CoV-2 by Specimen Transport Media, Nucleic Acid Extraction Reagents, Detergents, and Fixatives

    The COVID-19 pandemic has necessitated a multifaceted rapid response by the scientific community, bringing researchers, health officials, and industry together to address the ongoing public health emergency. To meet this challenge, participants need an informed approach for working safely with the etiological agent, the novel human coronavirus SARS-CoV-2. Work with infectious SARS-CoV-2 is currently restricted to high-containment...

    Stephen R. Welch, Katherine A. Davies, Hubert Buczkowski, Nipunadi Hettiarachchi, Nicole Green, Ulrike Arnold, Matthew Jones, Matthew J. Hannah, Reah Evans, Christopher Burton, Jane E. Burton, Malcolm Guiver, Patricia A. Cane, Neil Woodford, Christine B. Bruce, Allen D. G. Roberts, Marian J. Killip

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