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In Vitro Diagnostic COVID-19 Tests

In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to coronavirus diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health. The companies listed below have developed IVDs that have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. To date, 131 COVID-19 IVDs have received EUAs.

To learn more about these tests and their availability, please visit the links below to access each company’s COVID-19 test information portal.

Antigen Tests (4)

Tests to confirm an active infection by detecting viral proteins ("antigens") shed in a patient sample.

Molecular Diagnostic Tests (88)

Tests to confirm an active infection by detecting the virus' genetic material (RNA) in a patient sample.

Next Generation Sequencing (1)

Tests to confirm an active infection by detecting the virus' genetic material (RNA) in a patient sample.

Serology Tests (37)

Blood-based tests that can be used to identify whether individuals have been exposed to COVID-19 by examining the presence of antibodies to the virus.  Serology testing will be a key component of a national strategy to safely get Americans back to work.

EUA Tests Specific to Clinical Care of COVID-19 Patients (1)

  • Roche: Elecsys IL-6 (This test can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation)