Development of a rapid point-of-care test that measures neutralizing antibodies to SARS-CoV-2

Douglas F. Lake, Alexa J. Roeder, Erin Kaleta, Paniz Jasbi, Kirsten Pfeffer, Calvin Koelbela, Sivakumar Periasamy, Natalia Kuzmina, Alexander Bukreyev, Thomas E. Grys, Liang Wu, John R. Mills, Kathrine McAulay, Maria Gonzalez-Moa, Alim Seit-Nebi, Sergei Svarovsky

    Research output: Contribution to journalArticlepeer-review

    11 Scopus citations

    Abstract

    Background: After receiving a COVID-19 vaccine, most recipients want to know if they are protected from infection and for how long. Since neutralizing antibodies are a correlate of protection, we developed a lateral flow assay (LFA) that measures levels of neutralizing antibodies from a drop of blood. The LFA is based on the principle that neutralizing antibodies block binding of the receptor-binding domain (RBD) to angiotensin-converting enzyme 2 (ACE2). Methods: The ability of the LFA was assessed to correctly measure neutralization of sera, plasma or whole blood from patients with COVID-19 using SARS-CoV-2 microneutralization assays. We also determined if the LFA distinguished patients with seasonal respiratory viruses from patients with COVID-19. To demonstrate the usefulness of the LFA, we tested previously infected and non-infected COVID-19 vaccine recipients at baseline and after first and second vaccine doses. Results: The LFA compared favorably with SARS-CoV-2 microneutralization assays with an area under the ROC curve of 98%. Sera obtained from patients with seasonal coronaviruses did not show neutralizing activity in the LFA. After a single mRNA vaccine dose, 87% of previously infected individuals demonstrated high levels of neutralizing antibodies. However, if individuals were not previously infected, only 24% demonstrated high levels of neutralizing antibodies after one vaccine dose. A second dose boosted neutralizing antibody levels just 8% higher in previously infected individuals, but over 63% higher in non-infected individuals. Conclusions: A rapid, semi-quantitative, highly portable and inexpensive neutralizing antibody test might be useful for monitoring rise and fall in vaccine-induced neutralizing antibodies to COVID-19.

    Original languageEnglish (US)
    Article number105024
    JournalJournal of Clinical Virology
    Volume145
    DOIs
    StatePublished - Dec 2021

    Keywords

    • ACE2
    • Covid-19
    • Lateral flow assay
    • Neutralizing antibodies
    • RBD
    • Sars-cov-2

    ASJC Scopus subject areas

    • Virology
    • Infectious Diseases

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