Negative results mean that the virus was not detected at the time of the tests. Facilities, including point-of-care settings such as health clinics, that perform COVID-19 testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or. endstream endobj 153 0 obj <>>> endobj 154 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0 0 612 792]/Type/Page>> endobj 155 0 obj <>stream Amplifying those nucleic acids enables NAATs to detect very small amounts of SARS-CoV-2 RNA in a specimen, making these tests highly sensitive for diagnosing COVID-19. NAATs have been authorized for use in different settings, such as in laboratory facilities by trained personnel (laboratory-based) or in point-of-care (POC) settings. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Blood Specimen Collection Tube Shortage: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Medical Device Supply Chain Notifications During the COVID-19 Pandemic, Medical Device Shortages During the COVID-19 Public Health Emergency, Supplies of Medical Devices for COVID-19: Frequently Asked Questions, Medical Device Types to Help Determine Section 506J Notification Obligations, Non-contact Temperature Assessment Devices During the COVID-19 Pandemic, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, Contacts for Medical Devices During the COVID-19 Pandemic, COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2, Policy for Coronavirus Disease-2019 Tests, Q: In what settings can COVID-19 tests be offered or used? According to the Center for Disease Control (CDC), a presumptive positive result is when a patient has tested positive by a local public health laboratory, but results are still pending confirmation at a CDC lab. 254 0 obj <>stream According to the Center for Disease Control (CDC), a presumptive positive result is when a patient has tested positive by a local public health laboratory, but results are still pending.
Back Of Honus Wagner Card, John Belushi Julian California, Bailey Mccarthy Net Worth, Newham Local Election, Articles W