Clinical Chemistry and Clinical Toxicology Devices Panel - December 6, 2006
On December 6, 2006, the Clinical Chemistry and Clinical Toxicology Devices Panel discussed general issues concerning lipoprotein (HDL and LDL) subfraction assays. The Panel addressed potential uses of the assays, potential impact on treatment, how to establish accuracy and determine reference ranges, and lack of standardization and any risk this may cause to patients. The Panel also considered the value of particle size versus particle number in assessing lipid subfractions.
In general, the Panel felt lipid subfractions have some utility in assessing a patient's risk of developing cardiovascular disease and in aiding in the diagnosis of dyslipidemia, with certain populations. However, they felt that the tests should be used in conjunction with other traditional risk assessment tools and clinical judgment.
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