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Quantifying Neutralizing Antibodies in Patients with COVID-19 by a Two-Variable Generalized Additive Model.
Liu, Kuan-Ting; Gong, Yu-Nong; Huang, Chung-Guei; Huang, Peng-Nien; Yu, Kar-Yee; Lee, Hou-Chen; Lee, Sun-Che; Chiang, Huan-Jung; Kung, Yu-An; Lin, Yueh-Te; Hsiao, Mei-Jen; Huang, Po-Wei; Huang, Sheng-Yu; Wu, Hsin-Tai; Wu, Chih-Ching; Kuo, Rei-Lin; Chen, Kuan-Fu; Hung, Chuan-Tien; Oguntuyo, Kasopefoluwa Y; Stevens, Christian S; Kowdle, Shreyas; Chiu, Hsin-Ping; Lee, Benhur; Chen, Guang-Wu; Shih, Shin-Ru.
  • Liu KT; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Gong YN; Graduate Institute of Biomedical Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Huang CG; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Huang PN; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Yu KY; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Lee HC; Department of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Lee SC; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Chiang HJ; Division of Infectious Diseases, Department of Pediatrics, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Kung YA; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Lin YT; Graduate Institute of Biomedical Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Hsiao MJ; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Huang PW; Department of Medicine, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Huang SY; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Wu HT; Graduate Institute of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Wu CC; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Kuo RL; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Chen KF; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Hung CT; Graduate Institute of Biomedical Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Oguntuyo KY; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Stevens CS; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Kowdle S; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Chiu HP; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Lee B; Graduate Institute of Biomedical Science, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Chen GW; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
  • Shih SR; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung Universitygrid.145695.a, Taoyuan, Taiwan.
mSphere ; 7(1): e0088321, 2022 02 23.
Article in English | MEDLINE | ID: covidwho-1673356
ABSTRACT
Considering the urgent demand for faster methods to quantify neutralizing antibody titers in patients with coronavirus (CoV) disease 2019 (COVID-19), developing an analytical model or method to replace the conventional virus neutralization test (NT) is essential. Moreover, a "COVID-19 immunity passport" is currently being proposed as a certification for people who travel internationally. Therefore, an enzyme-linked immunosorbent assay (ELISA) was designed to detect severe acute respiratory syndrome CoV 2 (SARS-CoV-2)-neutralizing antibodies in serum, which is based on the binding affinity of SARS-CoV-2 viral spike protein 1 (S1) and the viral spike protein receptor-binding domain (RBD) to antibodies. The RBD is considered the major binding region of neutralizing antibodies. Furthermore, S1 covers the RBD and several other regions, which are also important for neutralizing antibody binding. In this study, we assessed 144 clinical specimens, including those from patients with PCR-confirmed SARS-CoV-2 infections and healthy donors, using both the NT and ELISA. The ELISA results analyzed by spline regression and the two-variable generalized additive model precisely reflected the NT value, and the correlation between predicted and actual NT values was as high as 0.917. Therefore, our method serves as a surrogate to quantify neutralizing antibody titer. The analytic method and platform used in this study present a new perspective for serological testing of SARS-CoV-2 infection and have clinical potential to assess vaccine efficacy. IMPORTANCE Herein, we present a new approach for serological testing for SARS-CoV-2 antibodies using innovative laboratory methods that demonstrate a combination of biology and mathematics. The traditional virus neutralization test is the gold standard method; however, it is time-consuming and poses a risk to medical personnel. Thus, there is a demand for methods that rapidly quantify neutralizing antibody titers in patients with COVID-19 or examine vaccine efficacy at a biosafety level 2 containment facility. Therefore, we used a two-variable generalized additive model to analyze the results of the enzyme-linked immunosorbent assay and found the method to serve as a surrogate to quantify neutralizing antibody titers. This methodology has potential for clinical use in assessing vaccine efficacy.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / Neutralization Tests / Models, Statistical / Models, Immunological / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: MSphere Year: 2022 Document Type: Article Affiliation country: Msphere.00883-21

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / Neutralization Tests / Models, Statistical / Models, Immunological / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: MSphere Year: 2022 Document Type: Article Affiliation country: Msphere.00883-21