Direct Detection of 4-Dimensions of SARS-CoV-2: Infection (vRNA), Infectivity (Antigen), Binding Antibody, and Functional Neutralizing Antibody in Saliva.

Journal: Research square
Published Date: Dec 28, 2023

Abstract

We developed a 4-parameter clinical assay using Electric Field Induced Release and Measurement (EFIRM) technology to simultaneously assess SARS-CoV-2 RNA (vRNA), nucleocapsid antigen, host binding (BAb) and neutralizing antibody (NAb) levels from a drop of saliva with performance that equals or surpasses current EUA-approved tests. The vRNA and antigen assays achieved lower limit of detection (LOD) of 100 copies/reaction and 3.5 TCID₅₀/mL, respectively. The vRNA assay differentiated between acutely infected (n=10) and infection-naïve patients (n=33) with an AUC of 0.9818, sensitivity of 90%, and specificity of 100%. The antigen assay similarly differentiated these patient populations with an AUC of 1.000. The BAb assay detected BAbs with an LOD of 39 pg/mL and distinguished acutely infected (n=35), vaccinated with prior infection (n=13), and vaccinated infection-naïve patients (n=13) from control (n=81) with AUC of 0.9481, 1.000, and 0.9962, respectively. The NAb assay detected NAbs with an LOD of 31.6 Unit/mL and differentiated between COVID-19 recovered or vaccinated patients (n=31) and pre-pandemic controls (n=60) with an AUC 0.923, sensitivity of 87.10%, and specificity of 86.67%. Our multiparameter assay represents a significant technological advancement to simultaneously address SARS-CoV-2 infection and immunity, and it lays the foundation for tackling potential future pandemics.

Authors

  • Aida Mohammadi
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • Samantha Chiang
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • Feng Li
    Department of General Surgery, Shanghai Traditional Chinese Medicine (TCM)-INTEGRATED Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China.
  • Fang Wei
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • Chang S Lau
    GenScript USA Inc.
  • Mohammad Aziz
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • Francisco J Ibarrondo
    Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
  • Jennifer A Fulcher
    Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
  • Otto O Yang
    Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
  • David Chia
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • Yong Kim
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.
  • David T W Wong
    School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.

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