To learn more about each medication's EUA, visit the FDA's website and read the authorized Paxlovid and the Lagevrio fact sheets.Mayo Clinic Evaluation of the Cue COVID-19 Test Abstract Antiviral medications are subject to availability and patient eligibility and must be started within 5 days of symptom onset. These medications are for adults and some children with mild-to-moderate symptoms of COVID-19 who are not in the hospital but who are at high risk of getting more serious symptoms. Treatment may include antiviral medications, such as Paxlovid and Lagevrio, available by prescription through Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). Same-day delivery is not offered on the following holidays: Labor Day, Thanksgiving, Christmas Eve, Christmas Day, and New Year’s Day. Some exceptions may apply, depending on location and medication availability. Orders placed after these times will be delivered the next day. Same-day delivery for prescription orders received before 4pm Monday through Friday or 12pm Saturday through Sunday (local time zones). Medication requires prescription and is subject to availability. Antiviral oral treatments are for adults and some children with mild-to-moderate COVID-19 symptoms who are at high risk of getting more serious symptoms. See the Cue Care Terms of UseĪ Cue Care telehealth consultation with a licensed health care provider is required to determine whether prescriptions or treatment referrals are appropriate. In case of an emergency, please call 911. This service does not address life-threatening conditions. is not legally affiliated with any pharmaceutical manufacturer.
Medication requires prescription and is subject to availability and patient eligibility. The Cue website may depict certain of our future planned care offerings which are subject to completion of development and may require regulatory authorization, clearance, or approval before they can be commercialized.Ĭue Care ™ includes a virtual care visit with a qualified health provider who will help determine whether a prescription or treatment referral is right for you. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. The emergency use of this product is 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 infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
This product has been authorized only for the detection of nucleic acid from monkeypox virus, not for any other viruses or pathogens. The Cue Mpox (Monkeypox) Molecular Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. The emergency use of this product is 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Read the reportĬue’s COVID-19 test has not been FDA cleared or approved but has been authorized by FDA under an EUA. The Cue COVID-19 Test demonstrated very good positive and negative percent agreement with central laboratory tests and will be useful in settings where accurate POC testing is needed to facilitate management of patients suspected of COVID‑19. Negative percent agreement was 98.4% (239/243), and there were 25 (8.6%) invalid or canceled results. Positive percent agreement between Cue COVID-19 and reference SARS-CoV-2 test was 91.7% (22/24) or 95.7% (22/23) when one patient with no tie-breaker method was excluded. We conducted a clinical validation study of the Cue Health POC nucleic acid amplification test (NAAT) using the Cue lower nasal swab, compared to a reference NAAT using standard nasopharyngeal swab, in 292 symptomatic and asymptomatic outpatients for SARS-CoV-2 detection in a community drive-through collection setting. Point-of-care (POC) tests are in high demand in order to facilitate rapid care decisions for patients suspected of SARS-CoV-2. Mayo Clinic Evaluation of the Cue COVID-19 Test Abstract
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