The study is intended to use human tissue samples obtained from the nasal cavity in COVID-19 symptomatic subjects to establish the clinical sensitivity and specificity of the Panbio™ COVID-19 Ag Rapid Test by comparison to the reference method used by an central laboratory. The study will collect 2 nasal swabs from each subject enrolled, with one swab tested immediately after
collection and the other swab placed in viral transport medium (VTM) immediately after collection for shipment to a central lab for reference testing.
The research study is been conducted in people who may or may not have symptoms that could be due to coronavirus 2019-nCoV. The reason for this study is to collect nasal swab samples from people suspected of having the 2019-nCoV (coronavirus) to help make new tests for detecting this virus, and/or make current tests better.
This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).
The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.
Roughly 8-10 million patients complaining of chest pain come to an Emergency Department (ED) annually in the United States. Quickly determining if you are having a heart attack is critical for improving your chances of survival. Cardiac troponin is a protein that is used as a biomarker (biological marker) to indicate damage to the heart muscle. Cardiac troponin lab tests that are currently used in the United States do not have the ability to detect low levels of troponin. There are more sensitive troponin tests that are primarily used outside the US, that are able to detect lower levels of cardiac troponin within 90-180 minutes instead of 5 or 6 hours. This allows for the early identification of individuals at a higher risk for heart damage and these patients benefit from early diagnosis and treatment. Delaying the treatment of a heart attack increases the chance of dying or being permanently disabled. This study will collect blood samples from people coming to the Emergency Department complaining of chest pain in order to measure this troponin lab test's ability to accurately detect troponin levels.