Atellica® VTLi hs cTnI Assay Emergency Department Clinical Sub Study Protocol: Reproducibility

Date Added
September 27th, 2022
PRO Number
Pro00123960
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

For the Reproducibility analysis, the intent is to evaluate the recoveries of high sensitivity Troponin I using two levels of quality control and plasma matrix with prepared concentrations across the measurement range. The study will be performed at three (3) clinical sites on the Atellica VTLi Analyzer over five (5) days with a minimum of two (2) runs per day. Each run will be performed by one (1)operator with a total of two (2) operators performing runs per day, with runs separated by at least two (2) hours.
A minimum of three (3) operators per site will perform testing on the Atellica VTLi Analyzers for a total of nine (9) operators across the study. For each operator, education/training, years of experience, and occupation will be documented.
Each site will receive five (5) Atellica VTLi test systems for testing in the Reproducibility study. If the site is currently participating in the Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study, at the discretion of the sponsor, the site may repurpose the existing five (5) Atellica VTLi test systems for study purposes.

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

Reference Range and Clinical Performance Evaluation of Elecsys IL-6 Assay in Neonatal Sepsis (US); Collection Study.

Date Added
June 22nd, 2022
PRO Number
Pro00119546
Researcher
Gary Headden

List of Studies


Keywords
Autoimmune disease
Summary

The study is an experimental laboratory test (Interleukin-6, abbreviated IL-6) for infection in your blood, called IL-6 Neonates_US. An IL-6 test is a laboratory test that has not been approved by the regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in your country. The results from experimental laboratory test used in this study will not be used to make a diagnosis or guide therapy.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Roche Diagnostics Solutions / "Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects with Symptoms of Acute Coronary Syndrome – PERFORM-TSIX Study"

Date Added
May 31st, 2022
PRO Number
Pro00119237
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The name of the study is PERFORM-TSIX. An investigational diagnostic test is a new diagnostic test, in this case a blood test.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Quidel Corporation / High Sensitivity Near Patient Cardiac Troponin (High Note)

Date Added
December 8th, 2021
PRO Number
Pro00115891
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this research study is to help detect a heart attack by measuring a protein called troponin. A company named Quidel is sponsoring a research study to see how a blood test that they make helps to diagnose heart attacks.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
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



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