Selected article for: "analytical sensitivity and screening assay"

Author: Thomas, Archana; Messer, William B; Hansel, Donna E; Streblow, Daniel N; Kazmierczak, Steven C; Lyski, Zoe L; Lu, Zhengchun; Slifka, Mark K
Title: Establishment of Monoclonal Antibody Standards for Quantitative Serological Diagnosis of SARS-CoV-2 in Low Incidence Settings
  • Cord-id: 6uf9apo7
  • Document date: 2021_2_2
  • ID: 6uf9apo7
    Snippet: BACKGROUND: Serological confirmation of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical for understanding the dynamics of the pandemic and determining seroprevalence rates within afflicted communities. Common challenges with SARS-CoV-2 serological assays include poor analytical specificity and sensitivity, and lack of a serological standard for quantitative assessment of antibody titers. METHODS: To overcome these obstacles,
    Document: BACKGROUND: Serological confirmation of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical for understanding the dynamics of the pandemic and determining seroprevalence rates within afflicted communities. Common challenges with SARS-CoV-2 serological assays include poor analytical specificity and sensitivity, and lack of a serological standard for quantitative assessment of antibody titers. METHODS: To overcome these obstacles, we developed a quantitative ELISA based on an optimized 2-dimensional screening assay that utilizes SARS-CoV-2 RBD (Receptor Binding Domain of spike protein) and SARS-CoV-2 spike S1 subunit. RESULTS: A total of 4 SARS-CoV-2-reactive monoclonal antibodies were evaluated for use as serum standards for calibrating assays performed on different days or by different laboratories. This approach provided quantitative analysis of hospitalized RT-PCR-confirmed COVID-19 cases that in some cases reached >100 μg/mL. The assay demonstrated 72% sensitivity based on time points ranging from 2-52 days post-symptom onset, with 100% sensitivity at time points measured ≥13 days post-symptom onset and 100% specificity. DISCUSSION: Using these optimized reagents and serological standards, we believe this approach will be useful for sensitive and specific determination of seroconversion rates and quantitatively measuring the durability of antiviral antibody responses following SARS-CoV-2 infection or vaccination.

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