Name (date of birth) Retrieval Code MELLA,RODRIGO ANDRES (1986-07-25) 4aLM7HYBA2E1 ‘SARS-CoV-2 (COVID-19) Qualitative PCR SARS-CoV-2 (COVID-19) ‘Qual PCR Result ‘SARS-CoV-2 (COVID-19) ‘Qual PCR interpretation Date collected Date resulted ‘Specimen type (Ordering Provider Performing Laboratory None detected ‘This is a negative result. Laboratory testing alone cannot rule out infection, particularly in the presence of clinical risk factors such as symptoms or exposure history Performed using the Panther (H) SARS CoV-2 Transcription Mediated Amplification (TMA) assay, a nucleic acid amplification test (NAAT) method with equivalent sensitivity to RT-PCR. ‘Additional details available here: hittps:/testguide labmed.umedy/NCVLT. Sample pooled (1:5) resulting ina slight decrease in analytical sensitivity. This tests not yet approved ‘or cleared by the United States FDA. When there are no FDA-approved of cleared tests available, and other criteria are met, FDA can make tests, available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this testis supported by the ‘Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection andlor diagnosis ofthe virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration ofthe COVID-19 declaration justifying emergency of IVDs, unless itis terminated or revoked by FDA (ater which the test may no longer be used). Tuesday, Sep 14, 2021 at 10:11 AM ‘Tuesday, Sep 14, 2021 at 21:55 PM ‘Sayre Michael Richard,MD University of Washington Department of Laboratory Medicine & Pathology 1616 Eastlake Ave E Suite 320 ‘Seattle, WA 98102-2795 (tel:98102-3795) ‘cAP 24637-01, 24637-18, 4637-19, 24837-30, 24637-35, of 24639-01, For performing lab information see htpsdlmp.uw.edupatent-carelep- aectedttion Iabmed un edulresut