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SARS-CoV-2 Serologic Assays in Control and Unknown Populations Demonstrate the Necessity of Virus Neutralization Testing.
Rathe, Jennifer A; Hemann, Emily A; Eggenberger, Julie; Li, Zhaoqi; Knoll, Megan L; Stokes, Caleb; Hsiang, Tien-Ying; Netland, Jason; Takehara, Kennidy K; Pepper, Marion; Gale, Michael.
Afiliación
  • Rathe JA; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Hemann EA; Department of Pediatric Infectious Disease, Seattle Children's Hospital/University of Washington, Seattle, Washington, USA.
  • Eggenberger J; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Li Z; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Knoll ML; Department of Statistics, University of Washington, Seattle, Washington, USA.
  • Stokes C; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Hsiang TY; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Netland J; Department of Pediatric Infectious Disease, Seattle Children's Hospital/University of Washington, Seattle, Washington, USA.
  • Takehara KK; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Pepper M; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
  • Gale M; Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington, Seattle, Washington, USA.
J Infect Dis ; 223(7): 1120-1131, 2021 04 08.
Article en En | MEDLINE | ID: mdl-33367830
BACKGROUND: To determine how serologic antibody testing outcome links with virus neutralization of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we evaluated individuals for SARS-CoV-2 antibody level and viral neutralization. METHODS: We compared serum Ig levels across platforms of viral antigens and antibodies with 15 positive and 30 negative SARS-CoV-2 controls followed by viral neutralization assessment. We then applied these platforms to a clinically relevant cohort of 114 individuals with unknown histories of SARS-CoV-2 infection. RESULTS: In controls, the best-performing virus-specific antibody detection platforms were SARS-CoV-2 receptor binding domain (RBD) IgG (sensitivity 87%, specificity 100%, positive predictive value [PPV] 100%, negative predictive value [NPV] 94%), spike IgG3 (sensitivity 93%, specificity 97%, PPV 93%, NPV 97%), and nucleocapsid protein (NP) IgG (sensitivity 93%, specificity 97%, PPV 93%, NPV 97%). Neutralization of positive and negative control sera showed 100% agreement. Twenty individuals with unknown history had detectable SARS-CoV-2 antibodies with 16 demonstrating virus neutralization. Spike IgG3 provided the highest accuracy for predicting serologically positive individuals with virus neutralization activity (misidentified 1/20 unknowns compared to 2/20 for RBD and NP IgG). CONCLUSIONS: The coupling of virus neutralization analysis to a spike IgG3 antibody test is optimal to categorize patients for correlates of SARS-CoV-2 immune protection status.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pruebas de Neutralización / Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Infect Dis Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pruebas de Neutralización / Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Infect Dis Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos