Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)
This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
Plasma and Serum samples will be retained for reference testing and banking.
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|United States, Georgia|
|St. Joseph's Research Institute|
|Atlanta, Georgia, United States, 30342|
|United States, Michigan|
|Heart and Vascular Research Center of Northern Michigan|
|Petoskey, Michigan, United States, 49770|