Biosite Incorporated announced that it will be completing the clinical trial for its Cholestech LDX Cardiac hsCRP Test by November 2009.
Cholestech LDX Cardiac hsCRP test is a rapid diagnostic test intended for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma of individuals. It 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 multi-center study is designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test. The quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma of individuals will be assessed for any risk of cardiovascular disease. The results of this study are intended to be used for regulatory 510k filings for use as an in-vitro diagnostic test.