Molecular testing to help diagnose COVID-19 (test code 39448)
Our current capacity is approximately 210,000 COVID-19 molecular diagnostic tests a day and we continue to scale up our capacity. As of September 10, 2020, we have reported results of 13.25 million COVID-19 molecular diagnostic tests for patients and providers in the United States.
At Quest, we continue to prioritize molecular testing and TAT for Priority patients. As of 8/18/2020, Priority testing parameters have been redefined as hospitalized, long-term care (LTC), and presurgical patients.
COVID-19 is unpredictable, and we will continue to monitor the situation closely should changing dynamics affecting demand, supplies, and other factors cause our expectations for turnaround time to slip.
As of 09/10/2020
Please contact your Quest representative to obtain the turnaround time at your specific laboratory location or for more information around COVID-19 testing.
COVID-19 testing statements
- The antibody tests and the molecular tests (together “All tests”) have not been FDA cleared or approved;
- All tests have been authorized by FDA under EUAs for use by authorized laboratories;
- The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- The molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses, pathogens; and,
- All tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.