a Supervised self-collection is not available in the following states due to state regulations: AK, AL, AZ, CA, DC, DE, HI, KS, KY, LA, ME, MI, MN, MS, MT, ND, OK, OR, RI, UT, VT, WA, and WY. Supervised self-collection may be available only at select Patient Service Centers in all other states. Contact your Quest representative for a list of Patient Service Centers offering supervised self-collection in those states.
b If patients are experiencing severe symptoms such as a high-grade fever of 102 °F or more that has lasted for 48 hours or severe and constant shortness of breath, they will need to consult a healthcare provider and will not be eligible for testing at a Patient Service Center.
c Molecular tests include polymerase chain reaction (PCR) and transcription mediated amplification (TMA) tests.
d This is directional data. It is based on 2020 HealthLeaders membership data of private third-party payers at the Managed Care Organization (MCO) level, as well as Quest internal data. Information is believed to be accurate as of January 1, 2020; however, it is subject to change. Does not include Kaiser Permanente access data.
e Where available.
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.
References
1. CDC. Nucleic Acid Amplification Tests (NAATs). Updated June 14, 2021. Accessed July 20, 2022. https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html
2. FDA. SARS-CoV-2 reference panel comparative data. Updated December 07, 2020. Accessed March 25, 2022. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data
Test codes may vary by location. Please contact your local laboratory for more information.
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