Global Progress on COVID-19 Serology-Based Testing

Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response. In contrast, the RT-PCR tests currently being used globally to diagnose cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered. These tests can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus. This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagnosis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only. Disclaimer This website is updated twice weekly, and only includes tests for which data and documentation is available and for which their stated intended use aligns with their FDA (or relevant national regulatory body) status. This site does not include tests that are in subsection IV.D of the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, as these have not been approved by the FDA and may not have indicated to the FDA that they are pursuing EUA approval. This site is not intended to be used as a reference for funding or grant proposals. Non-inclusion in this list should not be interpreted as judgement on validity or legitimacy of tests.