The sponsor of this study is LightDeck Diagnostics. LightDeck has developed the LightDeck COVID-19 Antigen Test. This test operates outside the body (in-vitro). This is a point-of-care (POC) diagnostic test. It is intended to diagnose COVID-19 in people suspected of having COVID-19 by their healthcare provider within twelve (12) days of symptom onset, or in people who have no symptoms.
Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.
The purpose of this study is to use an investigational device called the Atellica® VTLi™ test system to test a substance in your blood called troponin that may help with the diagnosis of a heart attack
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.