The emergency use of these products is only authorized for the duration of the declarations that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with COVID-19 or 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. These products have been authorized only for the detection of nucleic acid from SARS-CoV-2 or monkeypox virus, respectively, not for any other viruses or pathogens. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories, and the Cue Mpox (Monkeypox) Molecular Test have not been FDA cleared or approved, but they have been authorized for emergency use by FDA under EUAs. 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. Follow instructions for individuals with COVID-19.Mayo Clinic Evaluation of the Cue COVID-19 Test Abstract You generally do not require a PCR test for confirmation and do not need to report your test results to Peel Public Health. If you test positive on a rapid antigen test, you can assume that you have COVID-19. They can be done at home and may be available for purchase at some pharmacies. Rapid antigen tests give results quickly and do not require processing by a lab. Get more information from the Ontario government on POC molecular tests. These tests are primarily used in rural and remote settings where access to lab-based PCR tests may be limited. Find out if you are eligible for a PCR test and where you can access a test. In Ontario, publicly funded PCR tests are only available to eligible individuals. Get more information from the Ontario government about PCR tests. Samples can be collected by a health care professional or at home using a self-collection lab-based PCR kit. Find out more about what your test result means and refer to instructions for individuals with COVID-19. If you test positive on any test, you have COVID-19. Molecular tests, which include Polymerase Chain Reaction (PCR) tests and rapid point-of-care (POC) molecular tests.There are 2 main types of COVID-19 tests in Ontario: Information on when to use different types of COVID-19 tests and how to access them.
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