Clinical Agreement Study Protocol – LightDeck COVID-19 Antigen Test for Point of Care

Date Added
September 14th, 2021
PRO Number
Pro00113800
Researcher
Gary Headden

List of Studies


Keywords
Coronavirus
Summary

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.

Institution
MUSC
Recruitment Contact
Aja Bayo
8437927944
bayo@musc.edu

Clinical Evaluation of the i-STAT hs-TnI Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Date Added
August 3rd, 2021
PRO Number
Pro00110711
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

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.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study Protocol

Date Added
February 11th, 2021
PRO Number
Pro00105432
Researcher
Gary Headden

List of Studies


Keywords
Heart
Summary

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

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

PIVOTAL EVALUATION OF THE ACCESS NATRIURETIC PEPTIDE ASSAY(S) AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF SEVERITY OF ACUTE HEART FAILURE – EMERGENCY DEPARTMENT SUBJECT ENROLLMENT AND SPECIMEN COLLECTION

Date Added
February 17th, 2020
PRO Number
Pro00095805
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Heart
Summary

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.

Institution
MUSC
Recruitment Contact
Annelise Kauffman
843-792-3576
kauffmaa@musc.edu



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