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.