User Guide SARS-CoV-2 Antibody Profiling: K417N, E484K, N501Y, D614G Spike S1 Antigen Published on September 8th, 2021 This workflow and its products described here are for research use only and is not to be used for any other purposes, including, but not limited to, in vitro diagnostics, clinical diagnostics, or use in humans. The document and its content are proprietary to Fluidic Analytics and is intended for use only in connection with the products described herein and for no other purposes. download user guide 1. Intended Use This user guide describes microfluidic affinity antibody profiling (MAAP) against the SARS‑CoV‑2 S1 (K417N, E484K, N501Y, D614G) protein directly in serum samples by use of the Fluidity One‑W Serum instrument. 2. Background COVID‑19 is a respiratory disease caused by the coronavirus SARS‑CoV‑2 that produces mild symptoms in most individuals. However, dependent on underlying health issues and other factors such as age, gender, or genetic makeup, symptoms can vary dramatically in severity. A complete and accurate immune response assessment of COVID‑19 patients or vaccinated individuals based on the two key determining factors, namely antibody concentration and affinity, is key to: Understanding the differences in disease severity Assessing the strength and duration of acquired immunity Evaluating the mechanisms and immunological effects of virus-neutralizing antibodies Characterizing cross-reactivity with other, less harmful, coronaviruses Quantify the effect of immunization Evaluate different virus variants This user guide describes affinity-based antibody profiling against the SARS‑CoV‑2 S1 (K417N, E484K, N501Y, D614G) for a comprehensive immune response assessment in COVID‑19 patients or vaccinated individuals. download user guide 3. Microfluidic affinity antibody profiling – assay principle This user guide describes all steps required to characterize the immune response against the SARS‑CoV‑2 S1 (K417N, E484K, N501Y, D614G) directly in minimally diluted serum samples. After SARS‑CoV‑2 S1 (K417N, E484K, N501Y, D614G) labeling, three independent serum titration curves are measured to enable the simultaneous determination of antibody affinity and concentration. 4. Before you start Good laboratory practice when working with serum samples For use of this user guide, we recommend working with serum rather than plasma. Serum collected from COVID‑19 patients (whether newly infected or recovered), and uninfected people who could still harbor infectious agents must be handled using a high level of precaution and at the required biosafety level for your country’s regulations. In addition, all serum samples should be handled as if capable of transmitting infectious agents. For the full protocol download the user guide below download user guide Download user guide Fill out the form below to download the full user guide "SARS‑CoV‑2 Antibody Profiling: K417N, E484K, N501Y, D614G Spike S1 Antigen". We hope that this user guide is useful to all in some capacity to help with the COVID‑19 pandemic.