A Rapid and Sensitive Microfluidics-Based Tool for Seroprevalence Immunity Assessment of COVID-19 and Vaccination-Induced Humoral Antibody Response at the Point of Care

Abstract

As of 8 August 2022, SARS-CoV-2, the causative agent of COVID-19, has infected over 585 million people and resulted in more than 6.42 million deaths worldwide. While approved SARS-CoV-2 spike (S) protein-based vaccines induce robust seroconversion in most individuals, dramatically reducing disease severity and the risk of hospitalization, poorer responses are observed in aged, immunocompromised individuals and patients with certain pre-existing health conditions. Further, it is difficult to predict the protection conferred through vaccination or previous infection against new viral variants of concern (VoC) as they emerge. In this context, a rapid quantitative point-of-care (POC) serological assay able to quantify circulating anti-SARS-CoV-2 antibodies would allow clinicians to make informed decisions on the timing of booster shots, permit researchers to measure the level of cross-reactive antibody against new VoC in a previously immunized and/or infected individual, and help assess appropriate convalescent plasma donors, among other applications. Utilizing a lab-on-a-chip ecosystem, we present proof of concept, optimization, and validation of a POC strategy to quantitate COVID-19 humoral protection. This platform covers the entire diagnostic timeline of the disease, seroconversion, and vaccination response spanning multiple doses of immunization in a single POC test. Our results demonstrate that this platform is rapid (~15 min) and quantitative for SARS-CoV-2-specific IgG detection.

Post-Vaccination Detection of SARS-CoV-2 Antibody Response with Magnetic Nanoparticle-Based Electrochemical Biosensor System

“…Examining the objectives of existing qualitative tests is an approach to distinguish between natural infection and vaccination-induced immunity, and to monitor the effectiveness of immunity and decide on the need for revaccination. For example, the BNT162b2 vaccine (Pfizer) induces an Ab response only against the S protein, whereas natural infections induce Abs at least against both S and N proteins [ 28 ]. Currently, enzyme-linked immunosorbent assay (ELISA) is one of the most common approaches for COVID-19 serology testing, but it has shortcomings such as being labor intensive and requiring large equipment.…”

<strong>Efficacy of COVID-19 Vaccines Against the Omicron Variant of SARS-CoV-2</strong>

“…[73][74][75] Studies show that a key feature of the new VOC was reduction in post vaccination protection, as a factor of duration since the last vaccine dose, underlying immunocompromised status and others factors. 8,76 Based on significant body of research the CDC recommended a third and fourth doses for protection against breakthrough infections and severe disease owing to waning immunity associated with the aforementioned factors. 8…”

Efficacy of COVID-19 Vaccines against the Omicron Variant of SARS-CoV-2: A Review

“…[62][63][64] Studies show that a key feature of the new VOC was reduction in post-vaccination protection, as a factor of duration since the last vaccine dose, underlying immunocompromised status and others factors. 6, 65 Based on a significant body of research, the Center for Disease Control and Prevention recommended a third and fourth dose for protection against breakthrough infections and severe disease owing to waning immunity associated with the aforementioned factors. 6…”