Ortho Clinical Diagnostics and Quest Diagnostics to Broaden Availability of COVID-19 Antibody Testing
Quest will use Ortho's VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) to test patients for detectable levels of SARS-CoV-2 antibodies, which are generated by the body in response to infection. Ortho's test, among only a small number in the world to be granted Emergency Use Authorization by the
"Together with Quest,
"Antibody testing can play an important role in helping individuals understand if they've been exposed to the virus that causes COVID-19 and may have mounted an immune response," said
Quest offers two ways to access COVID-19 antibody testing. Healthcare providers can order testing on behalf of their patients, or individuals can initiate physician-directed testing online, without visiting a doctor's office, through QuestDirect.
Ortho currently offers two COVID-19 antibody tests. Ortho's total antibody test, granted Emergency Use Authorization on
Both of Ortho's tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
The tests run on Ortho's high-throughput, fully automated analyzers including its flagship VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and will soon be available on VITROS® ECi/ECiQ Immunodiagnostic Systems. VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the
Ortho began shipping its antibody tests weeks ago to hotspot areas with highest priority and continues to ramp up its production. Ortho plans to manufacture several million COVID-19 IgG antibody tests each month for
Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://orthoclinical.info/2YQVREO. For more information on Quest Diagnostics COVID-19 testing, visit: www.QuestDiagnostics.com
Ortho's COVID-19 IgG antibody tests are 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.
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have 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 or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are 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.
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