COMPARISON OF NCEP PERFORMANCE SPECIFICATIONS FOR TRIGLYCERIDES, HDL-CHOLESTEROL, AND LDL-CHOLESTEROL WITH OPERATING SPECIFICATIONS BASED ON NCEP CLINICAL AND ANALYTICAL GOALS

The National Cholesterol Education Program (NCEP) performance specific ations for methods that measure triglycerides, HDL-cholesterol, and LD L-cholesterol have been evaluated by deriving operating specifications from the NCEP analytical total error requirements and the clinical re quirements for interpretation of the tests. We determined the maximum imprecision and inaccuracy that would be allowable to control routine methods with commonly used single and multirule quality-control proced ures having 2 and 4 control measurements per run, and then compared th ese estimates with the NCEP guidelines. The NCEP imprecision specifica tions meet the operating imprecision necessary to assure meeting the N CEP clinical quality requirements for triglycerides and HDL-cholestero l but not for LDL-cholesterol. More importantly, the NCEP imprecision specifications are not adequate to assure meeting the NCEP analytical total error requirements for any of these three tests. Our findings in dicate that the NCEP recommendations fail to adequately consider the q uality-control requirements necessary to detect medically important sy stematic errors.