Regional interlaboratory standardization of determinations of cholesterol, high-density lipoprotein cholesterol, and triglycerides

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 36; no. 1; pp. 145 - 149
• Main Authors: Tetrault, GA, Miller, WG, Chinchilli, VM
• Format: Journal Article
• Language: English
• Published: Washington, DC Am Assoc Clin Chem 01.01.1990; American Association for Clinical Chemistry
• Subjects: Analytical, structural and metabolic biochemistry; Biological and medical sciences; Blood Specimen Collection; Chemistry, Clinical - standards; Cholesterol - blood; Cholesterol - standards; Cholesterol, HDL - blood; Cholesterol, HDL - standards; Fundamental and applied biological sciences. Psychology; Humans; Laboratories - standards; Lipids; National Health Programs; Other biological molecules; Specimen Handling; Triglycerides - blood; Triglycerides - standards; Virginia; Virginia; Human; Freeze drying; Cholesterol HDL; Standardization; Lipids; Serum; Triglyceride; Cholesterol; Freezing
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1093/clinchem/36.1.145

The Clinical Chemistry Forum of Central Virginia initiated a lipid standardization program to help ensure that its members meet the current National Cholesterol Education Program guidelines for cholesterol testing, and to standardize assays of high-density lipoprotein (HDL) cholesterol and triglycerides so as to provide accurate lipid profiles. We found that freshly collected, never-frozen human sera must be used to assess interlaboratory accuracy for cholesterol, HDL cholesterol, and triglycerides assays, and that at least 23 samples are required to detect a 3% bias with 90% power when the between-laboratory imprecision (CV) is 3%. After recalibration, all 12 laboratories had a mean HDL cholesterol bias less than or equal to 5%, nine of 10 laboratories had a mean HDL cholesterol bias less than or equal to 40 mg/L for samples with values less than or equal to 570 mg/L, and 10 of 12 laboratories had a mean triglycerides bias less than or equal to 10% for fresh human sera split between participants and the Centers for Disease Control. Pools of frozen human sera were shown to have matrix biases greater than 3% for cholesterol in seven of 11 laboratories, and greater than 40 mg/L for HDL cholesterol in six of nine laboratories.