12/2/2023 0 Comments Same day pcr covid test atlantaFour days later, he returned to the ED with encephalopathy, progressive generalized weakness, and inadequate oral intake requiring admission to the inpatient medical ward. He was discharged from the ED with oral antibiotics to his assisted living facility (ALF). He did not initially undergo a NP RT-PCR for SARS-CoV-2 on admission due to restrictions on testing at that time. He was diagnosed with a possible urinary tract infection owing to an otherwise negative workup including a computed tomography (CT) head and chest radiograph (CXR). Ī 90-year-old male with hypertension (HTN), well-controlled type 2 diabetes mellitus (DM2), hyperlipidemia (HLD), coronary artery disease, mild Alzheimer's dementia, and chronic kidney disease (CKD) stage 3 presented to the emergency department (ED) with generalized weakness and recurrent falls for the past few days. The following case is of an elderly male who presented with metabolic encephalopathy and failure to thrive that was found to have persistently positive NP RT-PCR for SARS-CoV-2 over several weeks despite a lack of symptoms typically attributed to SARS-CoV-2 infection. We hope a deeper understanding of testing validation, and results will improve our medical communities' ability to make a true diagnosis of clinically significant COVID-19 disease or lack thereof and open up future research of more validated tests. In an effort to guide clinicians through this unparalleled time, we present three case reports to support detailed and individualized interpretations of patient presentations in the context of both positive and negative RT-PCR tests for SARS-CoV-2. We advocate a thorough assessment of a patient's clinical picture without isolated interpretation of RT-PCR test results for SARS-CoV-2. This article brings forth the potential for misinformation and misinterpretation that could lead to undesired patient outcomes. It is important for all providers to understand these constraints and the potentially misleading test results in the clinical context of their patients. Paramount to this topic is the often misquoted “sensitivity and specificity” of the RT-PCR detection assays, a nonexistent test property for SARS-CoV-2 due to the lack of a gold standard for verification and validation. We aim to lay an intellectual framework for the rapid expansion of SARS-CoV-2 testing via EUA FDA “authorized” studies and emphasize the limitations of rapid bedside interpretation. In an unprecedented world of SARS-CoV-2 infection, a medley of non-FDA-approved tests has been thrust upon providers who are now challenged with their complex and potentially inconsistent interpretation. Here we present three challenging cases requiring cautious interpretation of the newest generation of RT-PCR molecular detection assays, highlighting the major challenges faced by providers treating patients potentially infected with SARS-CoV-2. These tests therefore do not have clinically applicable sensitivity and specificity because they lack a “gold standard” for diagnosis. Despite the exceptionally high rates of agreement, caution is advised as the RT-PCR tests approved under the COVID-19 EUA are in vitro analyses developed with samples artificially doped with SARS-CoV-2 RNA. These newly developed and approved SARS-CoV-2 RT-PCR tests boast impressive positive and negative agreement rates nearing 100%. Expectantly, the development and deployment of SARS-CoV-2 testing including RT-PCR expanded rapidly in the weeks following the EUA expansion. Unfortunately, effective mitigation efforts were thwarted early in the outbreak resulting in an expansion of the initial EUA on February 29, 2020, to improve accessibility to in vitro diagnostic testing. On February 2, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that the public health emergency justified the development and emergency use of “in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19” by activating the Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act. The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is estimated to have affected 6.2 million people in the United States and 27.5 million people worldwide as of September 9, 2020.
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