Ortho plans to manufacture several million COVID-19 total antibody tests each month in Rochester, New York and Pencoed, Wales. 

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. 

Ortho’s COVID-19 total antibody test is designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options. 

Ortho launched the test to market in the U.S. on April 3, 2020. It received U.S. Food and Drug Administration (FDA) Emergency Use Authorization on April 14, 2020.   

The VITROS Anti-SARS-CoV-2 Total test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests. The test has been authorized only for the detection of total antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.