High Sensitivity C-Reactive Protein (hs-CRP) Testing for Cardiovascular Disease (CVD)
C-reactive protein (CRP) is produced by the liver. CRP is an acute phase reactant protein. Under normal conditions CRP is found in low levels in the blood. Levels of CRP can increase in response to inflammatory conditions, infections and other disease states where tissue necrosis occurs. CRP is a nonspecific marker of inflammation. Levels of CRP can fluctuate substantially from day to day. Blood specimens are collected by venipuncture.
Conventional methodologies for measuring CRP in acute inflammatory diseases have a detection limit of 3-5 mg/L. The average CRP reading is 1.5 mg/L, with lower levels being a possible indication of chronic inflammation. High sensitivity CRP (hs-CRP) immunoassays can measure levels of CRP as low as 0.175 mg/L. The results of these hs-CRP assays are being investigated in various settings for a possible association with cardiovascular disease screening, diagnosis and management.
High sensitivity C-reactive protein testing for the screening, diagnosis and management of cardiovascular disease is considered investigational.
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There is a lack of evidence to determine if measurement of C-Reactive Protein to assess cardiovascular risk results in improved patient outcomes.
American College of Cardiology / American Heart Association. (2014). 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Retrieved March 9, 2017 from the National Guideline Clearinghouse (NCG:010480).
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2017). Cardiovascular Risk Panels (2.04.100). Retrieved February 1, 2018 from BlueWeb. (25 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2018, October). MolDX: Biomarkers in cardiovascular risk assessment (L36129). Retrieved January 3, 2019 from https://www.cms.gov.
Ferket, B. Van Kempen, B., Hunink, M., Agarwa, I., Kavous, M., Franco, O., et al. (2014). Predictive Value of Updating Framingham Risk Scores with Novel Risk Markers in the U.S. General Population. PLoS One, 9 (2), e88312. (Level 3 evidence)
Hou, J., Li, J., Wang, J., Lu, D., Wang, R., Huang, J., et al. (2015). The prediction of high-sensitivity C reactive protein for peripheral arterial sclerosis in middle-aged population. Zhonghua Yu Fang Yi Xue Za Zhi, 49 (10), 883-887. Abstract retrieved April 26, 2016 from PubMed database.
Tajfard, M., Tavakoly Sany, S.B., Avan, A., Latiff, L.A., Rahimi, H.R., Moohebati, M., et al. doi: 10.1000/jcp.27945. [Epub ahead of print]. Abstract retrieved January 3, 2019 from PubMed database.
U. S. Preventive Services Task Force. (July 2018). Cardiovascular disease: risk assessment with nontraditional risk factors. Retrieved January 3, 2019 from https://www.uspreventiveservicestaskforce.org/.
ORIGINAL EFFECTIVE DATE: 9/1/2003
MOST RECENT REVIEW DATE: 2/14/2019
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