The site of the Media Sphera Publishers contains materials intended solely for healthcare professionals.
By closing this message, you confirm that you are a certified medical professional or a student of a medical educational institution.

Warnick G.R.

Berkeley Heart Lab

Kimberly M.M.

Centers for Disease Control and Prevention

Waymack P.P.

Centers for Disease Control and Prevention

Leary E.T.

Pacific Biometrics Inc.

Myers G.L.

Myers Consulting, Smyrna

Standardization of measurements for cholesterol, triglycerides, and major lipoproteins

Authors:

Warnick G.R., Kimberly M.M., Waymack P.P., Leary E.T., Myers G.L.

More about the authors

Journal: Laboratory Service. 2021;10(3): 43‑57

Read: 4729 times


To cite this article:

Warnick GR, Kimberly MM, Waymack PP, Leary ET, Myers GL. Standardization of measurements for cholesterol, triglycerides, and major lipoproteins. Laboratory Service. 2021;10(3):43‑57. (In Russ.)
https://doi.org/10.17116/labs20211003143

Recommended articles:
The significance of exogenous nitrate and nitrite of plant origin for vascular health. Russian Journal of Preventive Medi­cine. 2024;(11):141-146
Psoriasis: analysis of como­rbid pathology. Russian Journal of Clinical Dermatology and Vene­reology. 2025;(1):16-21

References:

  1. Myers GL, Cooper GR, Greenberg N, et al.Standardization of lipidand lipoprotein measurements. In Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of Lipoprotein Testing. 2nd ed. Washington, DC: AACC Press; 2000;717-748. 
  2. Expert Panel on Detection, Evaluation,and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:2486-2497.
  3. Current status of blood cholesterol measurement in clinical laboratories in the United States: A report from the Laboratory Standardization Panel of the National Cholesterol Education Program. Clin Chem. 1988;34:193-201. 
  4. Bachorik PS, Ross JW. National Cholesterol Education Program Recommendations for low-density lipoprotein cholesterol: Executive summary. Clin Chem. 1995;41:1414-1420.
  5. Stein EA, Myers GL. National Cholesterol Education Program Recommendations for triglyceride measurement: Executive summary. Clin Chem. 1995;41:1321-1426.
  6. Warnick GR, Wood PD. National Cholesterol Education Program Recommendations for measurement of high-density lipoprotein cholesterol: Executive summary. Clin Chem. 1995;41:1427-1433.
  7. Nauck M, Warnick GR, Rifai N. Methods for measurement of low-density lipoprotein cholesterol: A critical assessment of direct measurement by homogeneous assay versus calculation. Clin Chem. 2002;48:236-254. 
  8. Mahley RW, Huang Y, Weisgraber KH. Putting cholesterol in its place: ApoE and reverse cholesterol transport. J Clin Invest. 2006;116:1226-1229.
  9. International Organization for Standardization(ISO). Invitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Metrological traceability of values assigned to calibrators and control materials. ISO. 17511:2003. Geneva, Switzerland; ISO, 2003.
  10. Rifai N, Dufour DR, Cooper GR. Preanalytical variation in lipid, lipoprotein, and apolipoprotein testing. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of Lipoprotein Testing. 2nd ed. Washington, DC: AACC Press; 2000;161-187. 
  11. Cooper GR, Smith SJ, Myers GL, et al. Estimating and minimizing effects of biological sources of variation by relative range when measuring the mean of serum lipids and lipoproteins. Clin Chem. 1994;40:227-232. 
  12. Eckfeldt JH, Copeland KR. Accuracy verification and identification of matrix effects. Arch Pathol Lab Med. 1993;117:338-386. 
  13. Miller WG. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta. 2003;327:25-37. 
  14. Miller WG. Matrix effects in the measurement and standardization of lipids and lipoproteins. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of Lipoprotein Testing. 2nd ed. Washington, DC: AACC Press; 2000;695-716. 
  15. Vesper HW, Miller WG, Myers GL. Reference materials and commutability. Clin Biochem Rev. 2007;28:139-147. 
  16. Clinical Laboratory Standards Institute (CLSI). Characterization and qualification of commutable reference materials for laboratory medicine; proposed guideline. CLSI document C-53P. Wayne, PA: CLSI;2008.
  17. Cohen A, Hertz HS, Mendel J, et al. Total serum cholesterol by isotope dilution — mass spectrometry: A candidate definitive method. Clin Chem. 1980;26:854-860. 
  18. Abell LL, Levy BB, Brodie RB, et al. Simplified method for the estimation of total cholesterol in serum, and demonstration of its specificity. J Biol Chem. 1952;195:357. 
  19. Armbruster, D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): A global approach to promote the standardization of clinical laboratory test results. Clin Biochem Rev. 2007;28:105-113. 
  20. Ellerbe P, Myers GL, Cooper GR, et al. A comparison of results for cholesterol in human serum obtained by the reference and by the definitive method of the National Reference System for Cholesterol. Clin Chem. 1990;36:370-375. 
  21. Bernert JT, Jr, Akins JR, Cooper GR, et al. Factors influencing the accuracy of the National Reference System total cholesterol reference method. Clin Chem. 1991;37:2053-2061.
  22. Kimberly MM, Leary ET, Cole TC, et al. Selection, validation, standardization, and performance of a designated comparison method for HDL cholesterol for use in the Cholesterol Reference Method Laboratory Network. Clin Chem. 1999;45:1803-1812.
  23. Hainline A Jr, Karon J, Lippel K, eds. Manual of Laboratory Operations: Lipid and Lipoprotein Analysis. 2nd ed. [HEW Pub. No. (NIH) 75-628 (rev.), US Government Printing Office Publication No. 1982-361-132:678.] Bethesda, MD: National Heart, Lung and Blood Institute, Lipid Research Clinics Program.
  24. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499-502. 
  25. Carlson LA, Wadstrom LB. Determination of glycerides in blood serum. Clin Chim Acta. 1959;4:197-205. 
  26. Carlson LA. Determination of serum triglycerides. J Ather Res. 1963;3:334-336. 
  27. Van Handel E, Zilversmit DB. Micromethod for the direct determination of triglycerides in serum. J Lab Clin Med. 1957;50:152-157. 
  28. Lofland HB, Jr. A semiautomated procedure for the determination of triglycerides in serum. Anal Biochem. 1964;9:393-400. 
  29. Ellerbe P, Sniegoski LT, Welch MJ. Isotope dilution mass spectrometry as a candidate definitive method for determining total glycerides and triglycerides in serum. Clin Chem. 1995;41:397-404. 
  30. Bernert JT, Jr, Bell CJ, McGuffey JE. Determination of free glycerol in human serum reference materials by isotope-dilution gas chromatography-mass spectrometry. J Chromatography. 1992;578:1-7. 
  31. Clinical Laboratory Standards Institute (CLSI). Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline. CLSI document C-37A. Wayne, PA: CLSI; 1999.
  32. Baadenhuijsen H, Steigstra H, Cobbaert C, et al. Commutability assessment of potential reference materials using a multicenter split-patient-sample between- fields-methods (Twin Study) design: Study within the framework of the Dutch project «Calibration 2000». Clin Chem. 2002;48:1520-1525.
  33. Cobbaert C, Weykamp C, Baadenhuijsen H, et al. Selection, preparation, and characterization of commutable frozen human serum pools as potential secondary reference materials for lipid and apolipoprotein measurements: Study within the framework of the Dutch Project «Calibration 2000». Clin Chem. 2002;48:1526-1538.
  34. Balbo-Enzi G, Baiocchi MR, Crepaldi G. Comparison of lipoprotein(a) assay methods in serum and in a plasminogen-free fraction. Clin Chim Acta. 1993;218:83-95. 
  35. Albers JJ, Marcovina SM. Lipoprotein(a) quantification: Comparison of methods and strategies for standardization. Current Opinion in Lipidology. 1994;5:417-421. 
  36. Marcovina SM, Albers JJ, Scanu AM, et al. Use of a reference material proposed by the International Federation of Clinical Chemistry and Laboratory Medicine to evaluate analytical methods for the determination of plasma lipoprotein(a). Clin Chem. 2000;46:1956-1967.
  37. Tate JR, Berg K, Couderc R, et al. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) standardization project for the measurement of lipoprotein(a). Phase 2. Selection and properties of a proposed secondary reference material for lipoprotein(a). Clin Chem Lab Med. 1999;37:949-958. 
  38. Boffa MB, Koschinsky ML, Berglund L. Lipoprotein(a): A unique risk factor for cardiovascular disease. Clin Lab Med. 2006;26:751-772. 
  39. Marcovina SM, Albers JJ, Gabel B, et al. Effect of the number of apolipoprotein(a) kringle 4 domains on immunochemical measurements of lipoprotein(a). Clin Chem. 1995;41:246-255. 
  40. Dati F, Tate JR, Marcovina SM, et al. First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay-Lp(a) SRM 2B. Clin Chem Lab Med. 2004;42:670-676. 
  41. Scanu AM, Hinman J, Pfaffinger D, et al. Successful utilization of lyophilized lipoprotein(a) as a biological reagent. Lipids. 2004;39:589-593. 
  42. Shepherd J, Rosseneu M, Vercaemst R, et al. Purification and certification of human apolipoprotein A-I and A-II reference materials (CRM 393 and 394). Community Bureau of Reference, 1991. (BCR Information series No. CD-NA-13393-EN-C, ISBN 92-826-2402-1.) Luxembourg: Commission of the European Communities; 1991;78. 
  43. Albers JJ, Marcovina SM. Standardization of apolipoprotein B and AI measurements. Clin Chem. 1989;35:1357-1361.
  44. Barr JR, Maggio VL, Patterson DG, et al. Isotope dilution--mass spectrometric quantification of specific proteins: Model application with apolipoprotein A-I. Clin Chem. 1996;42:1676-1682.
  45. Marcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry standardization project for measurement of apolipoproteins. III: Comparability of apoA-I values by the use of common reference material. Clin Chem. 1993;39:773-781. 
  46. Marcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. IV. Comparability of apolipoprotein B values by use of International Reference Material. Clin Chem. 1994;40:586-592. 
  47. Myers GL, Cooper GR, Winn CL, et al. The Centers for Disease Control- National Heart, Lung, and Blood Institute Lipid Standardization Program. An approach to accurate and precise lipid measurements. Clin Lab Med. 1989;9:105-135. 
  48. Cooper GR, Myers GL, Smith SJ, et al. Standardization of lipid, lipoprotein, and apolipoprotein measurements. Clin Chem. 1988;34:95-105. 
  49. Myers GL, Kimberly MM, Waymack PW, et al. A reference method laboratory network for cholesterol: A model for standardization and improvement of clinical laboratory measurements. Clin Chem. 2000;46:1762-1772.
  50. Clinical Laboratory Standards Institute. Method comparison and bias estimation using patient samples, approved guideline. (CLSI document EP9-A, ISBN 1-56238-283-7). Wayne, PA: CLSI; 1995.
  51. Public Law 100-578, October 31, 1988. Accessed 01.07.2021.
  52. https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf 
  53. Esteban-Salán M, Guimón-Bardesi A, de la Viuda-Unzueta JM, et al. Analytical and clinical evaluation of two homogeneous assays for LDL-cholesterol in hyperlipidemic patients. Clin Chem. 2000;46:1121-1131.
  54. Miller WG, Waymack PP, Anderson FP, et al. Performance of four homogeneous direct methods for LDL-cholesterol. Clin Chem. 2002;48:489-498. 
  55. Usui S, Kakuuchi H, Okamoto M, et al. Differential reactivity of two homogeneous LDL-cholesterol methods to LDL and VLDL subfractions, as demonstrated by ultracentrifugation and HPLC. Clin Chem. 2002;48:1946-1954.
  56. Thienpont LM, Van Landuyt KG, Stockl D, et al. Four frequently used test systems for serum cholesterol evaluated by isotope dilution gas chromatography-mass spectrometry candidate reference method. Clin Chem. 1996;42:531-535. 
  57. Warnick GR, Nauck M, Rifai N. Evolution of methods for measurement of HDL-cholesterol: From ultracentrifugation to homogeneous assays. Clin Chem. 2001;47:1579-1596.
  58. Rautela GS, Stater S, Arvon DA. Assessment of the need for triglyceride blank measurements. Clin Chem. 1973;19:1193-1195.
  59. Jessen R, Cass C, Eckfeldt J. Do enzymatic analyses of serum triglycerides really need blanking for free glycerol? Clin Chem. 1990;36:1372-1375.
  60. Cole T. Glycerol blanking in triglyceride assays: Is it necessary? Clin Chem. 1990;36:1267-1268.
  61. Myers GL, Ross JW, Smith SJ, et al. Evaluating lyophilized human serum preparations for suitability as proficiency testing materials for HDL cholesterol measurement. Arch Pathol Lab Med. 1995;119:686-694. 
  62. Holani KK, Miller WG, Waymack PP. Robustness of three triglyceride reagents for matrix effects of proficiency testing materials. Clin Chem. 1993;39:1126.

Email Confirmation

An email was sent to test@gmail.com with a confirmation link. Follow the link from the letter to complete the registration on the site.

Email Confirmation

We use cооkies to improve the performance of the site. By staying on our site, you agree to the terms of use of cооkies. To view our Privacy and Cookie Policy, please. click here.