In fact, it was reported that high testing and screening rates would be more effective in reducing SARS-CoV-2 infection rates than revaccination campaigns 8. With growing evidence of the waning effectiveness of current vaccines over time 6, along with the high transmissibility of emerging SARS-CoV-2 variants 7, increased testing is crucial to prevent further infections. Clearly, the true scale of COVID-19 is bounded by low PCR test rates, which is primarily due to the availability of key supplies and low adoption rates of new viral gene targets 5. For example, in the United States alone, it is estimated that for every reported case, there are 3–20 undiagnosed cases 4. However, the incidence of disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is believed to be underdiagnosed and thus underreported. Since its first occurrence in Wuhan province of China in December 2019 1, 2, coronavirus disease 2019 (COVID-19) has reached, as of 10 June 2023, a grim landmark of over 767 million confirmed cases worldwide, including 6.9 million deaths 3. Furthermore, the bandage can be easily adjusted and optimized to detect different viral infections as they arise by simply selecting appropriate antigens related to pandemics and outbreaks. The adhesive bandage-like construction is an example of the design of rapid, low-cost, disposable, and easy-to-use tests for large-scale detection and screening in households.
The assay, comprising a vertically stacked plasma/serum separation membrane, conjugate pad, and detection (readout) zone, utilizes gold nanoparticles (AuNPs) conjugated with SARS-CoV-2 S and N proteins to effectively capture IgM and IgG antibodies from a pinprick (~15 µL) of blood in just one step and provides results of no immune IgM−/IgG−, early immune IgM+/IgG−, active immune IgM+/IgG+ or immune IgM−/IgG+ in a short amount of time (minutes). This paper outlines the development steps of a novel hybrid (vertical-lateral-vertical) flow assay in the form of a finger-stick point-of-care device, similar to an adhesive bandage, designed for the timely detection and screening of IgM and IgG immune responses to SARS-CoV-2 infections. These antibodies are highly specific to the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus. Immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies are important biomarkers used for the diagnosis and screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in both symptomatic and asymptomatic individuals.
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