Serology tests for COVID-19

Serology testing for SARS-CoV-2 continues to be in high demand because it can help to better quantify the total number of cases of COVID-19 to date. This type of testing is valuable because it can identify those who may have been asymptomatic and recovered. Serology tests measure the levels of specific antibodies in the blood, revealing whether a person has been exposed to a particular pathogen by looking at their immune response. 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.

The Johns Hopkins Center for Health released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. You can find this report here.

This page provides up-to-date information on serology tests that have received emergency use authorization (EUA) available for use. These tests are not approved for diagnosis of acute, active SARS-CoV-2 infection, but may indicate previous exposure to the virus. Negative results do not rule out prior or current infection. Active infection should be diagnosed using an antigen or molecular diagnostic test.

Disclaimer

This list is updated twice weekly, and only includes tests that have received a US Food and Drug Administration EUA. It only includes tests for which data and documentation is available and for which their stated intended use aligns with their regulatory status. This site is not intended to be used as a reference for funding or grant proposals. Noninclusion in this list should not be interpreted as judgment on validity or legitimacy of tests.

Note on sensitivity and specificity data

The manufacturer-reported sensitivity and specificity data is listed, where available. A highly sensitive test should capture all true positive results. A highly specific test should rule out all true negative results. These measures are not independently validated by the Johns Hopkins Center for Health Security. If a sensitivity or specificity is not listed, it was not listed/available at the time of posting. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description in the extended versions of the tables.

The terms “sensitivity” and “specificity” may not appear in the manufacturers’ information sheets, but rather these values are often reported as “positive percent agreement” and “negative percent agreement.” The US FDA recommends that manufacturers use these terms to indicate that a non-reference standard was used when evaluating the test.

More information on serology tests:

• What types of serology tests are there and how do they work?
• What kinds of serology tests are on the market?
• Common types of serology assays

This page was last updated on March 30, 2022.

Tests that have been authorized for use

Download the complete list of tests authorized for use (xlsx). Included in the complete list are descriptions and phase of development.