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Comparison of NCEP performance specifications for triglycerides, HDL-, and LDL-cholesterol with operating specifications based on NCEP clinical and analytical goals

¹ Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison, WI 53792.

² Department of Clinical Biochemistry, University Hospital, Reykjavik, Iceland.

^3
4 Nonstandard abbreviations: NCEP, National Cholesterol Education Program; OPSpecs, operating specifications for allowable imprecision (CV), allowable inaccuracy (bias), and necessary QC; TE_a, total allowable analytical error; D_int, clinical decision interval; s_wsub, within-subject biological variation; TRIG, triglycerides; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol
^a Author for correspondence. Fax (608)263-1568; e-mail jo.westgard{at}hosp.wisc.edu

The National Cholesterol Education Program (NCEP) performance specifications for methods that measure triglycerides, HDL-cholesterol, and LDL-cholesterol have been evaluated by deriving operating specifications from the NCEP analytical total error requirements and the clinical requirements 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 procedures having 2 and 4 control measurements per run, and then compared these estimates with the NCEP guidelines. The NCEP imprecision specifications meet the operating imprecision necessary to assure meeting the NCEP clinical quality requirements for triglycerides and HDL-cholesterol 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 indicate that the NCEP recommendations fail to adequately consider the quality-control requirements necessary to detect medically important systematic errors.

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