The impact of ultra-sensitivity immunoassays: a change in diagnostic modalities
Jeffrey J. Bishop, Ph.D., RAC
Wednesday, September 9, 2015
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Chapters
Introduction
Corporate Overview
Singulex’s Single Molecule Counting Technology
SMC Technology Overview
SMC process: similar to conventional IA
First Generation technology: flow
Strong signal to noise ratio
Second generation technology: scanning
Second generation technology: scanning – Detection plate manufactured by Sony DADC
Singulex Clarity Instrument
Clinical Value of SMC Technology
SMC technology - the ability to quantify “healthy”
Progression of Cardiovascular Disease
Real World Use
Identify patients at risk if cTnI > 10 pg/mL
cTnI rules out development of HF over 11 years
cTnI rules out development of coronary disease
Typical pathway for CVD work-up
Sgx cTnI ruled out the need for stress imaging
Low cTnI = low risk for coronary artery disease
Typical Pathway for ruling out AMI
Earlier AMI rule out with high sensitivity cTnI
Low cTnI = lowest risk for worsening of Heart Failure
Endothelin-1 (ET-1), most < 3 pg/mL
Low ET-1 = lowest risk for disease progression
Low ET-1 = Low risk for hospitalization
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