PCR Test for COVID-19: What It Is, How Its Done, What The Results Mean Positive test result: individual isolates. 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. 162 0 obj <>stream CDC twenty four seven. 1 Identify testing demand and complete application, Identify testing demand in your community or organization, 6 Ship collected samples for processing. Isolation is what you do if you have COVID-19 symptoms, or have tested positive for COVID-19. Based on preliminary data and expert opinion. =Qd"kQxqsjmNM!| k0V_~Up!_Al;_DuL#Iy{)IoTv%hs$Tm)Eo\W}Yg1lT,(i ,K-%?T3qR\Ma\/?Y @1$=0WPQuo8?Iri_n3fvuK$O`d.9~O&%B7MKTHYSw*nF5 (X(96gFl:)d9okmDDg~*)%1fSK/H{`6T4qbb$Nt!6Q\UHGEz5Xu1ss!pAr.t_egF;1(=Q$5eCAL}j=Qrjty@Pdn?.-i~A6i{tv|kLw1mK%vC%lHXn?r4ve7uJd*. The intent of screening tests is to identify infected people before they develop symptoms or who may never develop symptoms so that steps can be taken to prevent those people from infecting others. S knjOysbSM$hoQc_=yICS~?{!>o7QmZ&&ddN CYb5A>;+SGc"obM5I{>hP85:dBAl His boss, whom he admires, is waiting to meet with him about the big project. All information these cookies collect is aggregated and therefore anonymous. A negative test result means that antigen for COVID-19 was not detected in the specimen. It is very specific - it will be negative in >99.9% of people who did not have an infection. Tests offered prior to or without an EUA, as described in the Policy for Coronavirus Disease-2019 Tests, are limited, under CLIA, to use in laboratories certified under CLIA that meet requirements to perform high-complexity testing, including testing at the point-of-care (POC) where the site is covered by such a laboratory's CLIA certificate. %PDF-1.6 % 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?
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