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Numerous non-traditional cardiovascular biomarkers have been proposed for improving cardiovascular risk estimates. These potential risk factors fall into several general categories, including lipid markers, non-lipid markers, radiologic measures, inflammatory measures, metabolic parameters, and genetic markers. Expanded cardiovascular risk panels may contain markers and/or measures from one or all of the above categories and may also include additional risk factors. Some expanded cardiovascular risk panels are relatively limited, including a few markers in addition to standard lipids. Others include a wide variety of potential risk factors from a number of different categories, often including both genetic and non-genetic risk factors. Other panels are composed entirely of genetic markers. Risk panels report the results of multiple individual tests, in contrast to quantitative risk scores, which combine the results of multiple markers into one score.
Laboratory-developed tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA). Premarket approval from the U.S. Food and Drug Administration (FDA) is not required when the assay is performed in a laboratory that is licensed by CLIA for high-complexity testing. Examples of commercially available expanded cardiovascular risk panels include but are not limited to the following]:
Definitions
Simple lipid panels are generally composed of the following standard lipid measures: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Certain calculated ratios, such as the total/HDL cholesterol may be reported as part of a simple lipid panel. Other types of lipid testing (e.g., apolipoproteins, lipid particle size and number, lipoprotein[a]) are not considered to be components of a simple lipid panel.
Expanded cardiovascular risk panels are composed of multiple individual markers and/or measures intended to assess cardiac risk, other than simple lipid panels.
Expanded cardiovascular risk panels (i.e., cardiovascular risk panels other than simple lipid panels) are considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating the impact of these tests on improved health outcomes.
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Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
