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

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 43; no. 11; pp. 2164 - 2168
• Main Authors: Fallest-Strobl, Patricia C, Olafsdottir, Elin, Wiebe, Donald A, Westgard, James O
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Washington, DC Am Assoc Clin Chem 01.11.1997; American Association for Clinical Chemistry
• Subjects: Biological and medical sciences; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Humans; Investigative techniques, diagnostic techniques (general aspects); Medical sciences; Metabolic diseases; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Quality Control; Reference Standards; Reproducibility of Results; Sensitivity and Specificity; Triglycerides - blood; United States; United States; North America; America; Human; Cholesterol HDL; Laboratory investigations; Clinical biology; Cholesterol LDL; Measurement method; Triglyceride; Recommendation; Quantitative analysis
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1093/clinchem/43.11.2164

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.