ABSTRACT
Monitoring the burden and spread of infection with the new coronavirus SARS-CoV-2, whether within small communities or in large geographical settings, is of paramount importance for public health purposes. Serology, which detects the host antibody response to the infection, is the most appropriate tool for this task, since virus-derived markers are most reliably detected during the acute phase of infection. Here we show that our ELISA protocol, which is based on antibody binding to the Receptor Binding Domain (RBD) of the S1 subunit of the viral Spike protein expressed as a novel fusion protein, detects antibody responses to SARS-CoV-2 infection and vaccination. We also show that our ELISA is accurate and versatile. It compares favorably with commercial assays widely used in clinical practice to determine exposure to SARS-CoV-2. Moreover, our protocol accommodates use of various blood- and non-blood-derived biospecimens, such as breast milk, as well as dried blood obtained with microsampling cartridges that are appropriate for remote collection. As a result, our RBD-based ELISA protocols are well suited for seroepidemiology and other large-scale studies requiring parsimonious sample collection outside of healthcare settings.
Subject(s)
Antibodies, Viral/blood , COVID-19/diagnosis , Dried Blood Spot Testing , Antibodies, Viral/immunology , Binding Sites , COVID-19/blood , COVID-19/immunology , Humans , VaccinationABSTRACT
Potential pitfalls in the development, deployment and interpretation of antibody tests for COVID-19 are discussed. Lessons learned from the experience with the introduction of antibody tests for HIV are highlighted.Each test will need to be separately vetted for performance and clinical implementation based upon rigorous clinical trial data. The issues we highlight will also be similarly important for vaccine and therapeutic drug efficacy trials.