POC assessments have a lower barrier to implementation than lab-based assessments: if FDA cleared, POC assessments don’t require a trained professional to operate, so users have the power to perform all the actions of the test on their own. Indoximod (NLG-8189) IgG/IgM Rapid Test, and point-of-care assessments such as Abbott’s ID NOW COVID-19 Test. Antibody testing is especially important in understanding the prevalence of the virus in the community and to identify those who have gained immunity. We conclude by highlighting the future of COVID-19 diagnostics, which include the need for quantitative screening and the development of emerging biosensors as point-of-care assessments. Keywords: COVID-19, SARS-CoV-2, Diagnostic screening, RT-PCR, Immunoassay, Point-of-care, FDA-EUA Highlights ? Current standard-of-care for COVID-19 diagnosis is RT-PCR, used to Mouse monoclonal to KARS detect SARS-CoV-2 viral RNA. ? Serological assays for detection Indoximod (NLG-8189) of SARS-CoV-2 specific IgG and IgM antibodies are useful to assess computer virus prevalence. ? Point-of-care assessments for COVID-19 diagnoses can expedite results and alleviate the burden placed on healthcare providers. ? Future screening strategies include developing quantitative COVID-19 diagnostic tools. 1.?Introduction A novel coronavirus disease was first reported when an outbreak of unknown respiratory illnesses occurred in Wuhan, China on December 31, 2019 (CDC, 2020h). It was quickly identified as a novel betacoronavirus, indicating Indoximod (NLG-8189) a transfer of the disease from bats to humans with no obvious indication of an intermediate host (Lu et al., 2020). On January 30, 2020 the World Health Business (WHO) declared the coronavirus outbreak a general public health emergency of international concern (PHEIC). On February 11, 2020 the WHO named the disease as COronaVIrus Disease 2019, or COVID-19 (WHO, 2020b), and the International Committee on Taxonomy of Viruses officially named the computer virus, previously the 2019-novel Coronavirus (2019-nCoV), as SARS-CoV-2 on March 2, 2020 (Coronaviridae Study Group of the International Committee on Taxonomy of Viruses, 2020). The disease quickly spread throughout Southeast Asia, Europe and North America; WHO officially declared COVID-19 a pandemic on March 11, 2020 (WHO, 2020c). As of June 17, 2020, you will find over 8.2 million confirmed COVID-19 cases reported world-wide (Johns Hopkins University or college, 2020). COVID-19 can present from moderate to severe, and possibly fatal, with an increase in severity linked to age and underlying medical conditions (Guan et al., 2020). One major problem in evaluating and Indoximod (NLG-8189) monitoring the pandemic is the lack of diagnostic resources for COVID-19 (American Society of Microbiology, 2020). As the number of patients presenting with COVID-19 symptoms increase, Indoximod (NLG-8189) there has been a shortage of diagnostic resources, like swabs, polymerase chain reaction (PCR) reagents, RNA isolation packages, and a growing demand for quick, onsite diagnostics. A recent study showed that at least 35% of people are asymptomatic (CDC, 2020b), exposing an increased risk of quick community spread and need for common screening. With the quick spread of COVID-19, the FDA has begun to issue Emergency Use Authorizations (EUA) to several diagnostic assessments for COVID-19 (FDA, 2020a). Importantly, assessments with FDA-EUA status have not received full FDA approval; rather, the authorizations for these assessments are only in effect for the length of the pandemic. EUA assessments for COVID-19 range from Clinical Laboratory Improvement Amendments (CLIA) qualified assessments to quick diagnostics for clinical near-patient use. There has been a drive towards developing point-of-care (POC) assessments because the healthcare system is going through serious strain during the pandemic. In fact, the U.S. Department of Health and Human Support Biomedical Advanced Research and Development Expert (BARDA) granted a $13 million USD contract to Cue Health (Cue Health, 2020a, Cue Health, 2020b) and $750,000 to OraSure Technologies (OraSure Technologies, 2020) to develop portable COVID-19 diagnostic assessments. With the quickly changing scenery of available diagnostic assessments for COVID-19, it is necessary for any holistic evaluate and evaluation of diagnostic resources to be put together. The goal of this evaluate is to present an analysis of the current FDA-EUA diagnostic scenery for COVID-19, from individual specimen collection to commercially available diagnostic assessments and future directions. We will begin our review by highlighting the structure of SARS-CoV-2 and the suspected functions and diagnostic interest of its proteins. We then cover relevant patient specimen collection techniques and sample preparation necessary prior to diagnostic screening, specifically focusing on existing viral RNA isolation methods and commercially available packages. Finally, we will move into our analysis of the current FDA-EUA diagnostic scenery, covering commercially available COVID-19 diagnostic platforms, and discussing COVID-19 immunity and how it will shape retrospective diagnostic development as well as epidemiological studies. We conclude with a discussion.
POC assessments have a lower barrier to implementation than lab-based assessments: if FDA cleared, POC assessments don’t require a trained professional to operate, so users have the power to perform all the actions of the test on their own