T LDL Cholesterol (Direct) 320

Expected Values

Serum/Plasma

The following NCEP cutpoints for patient classification are used for the prevention and management of coronary heart disease :

 Note:

Expected range varies from population to population. It is therefore  recommended that each laboratory should establish its own normal range.

Performance Characteristics Linearity

With AutoPure T LDL C  the assay is linear upto

450 mg/dl (11.637 mmo1/1). Determine samples with higher concentrations via the rerun function. On analyzers without rerun function, manually dilute sample with higher concentrations using 0.9% NaCI or distilled / deionized water (e.g. 1 + 4). Multiply the result by the appropriate dilution factor (e.g. 5).

Interference

There is no significant interference in samples containing upto 20 mg/dl of conjugated & unconjugated bilirubin, 1293 mg/di of triglycerides, 500 mg/dl of haemoglobin, 50 mg/di ascorbic acid & 5000 mg/dl gamma globulins

 Precision

Reproducibility was determined using three levels of pooled human sera as shown below :

 Co-Relation Studies

A comparison of LDL-C determination using AutoPure T LDL-C and the Reference method gave the following co-relation (mg/d[) :

Linear regression

y = 0.95x -1- 3.02

r = 0.96

No. of samples measured : 54

References

• Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological and Biomedical Laboratories", 1988.
• National Committee for Clinical Laboratory Standards, Preparation and Testing of Reagent Water in the Clinical Laboratory Third edition: Approved Guideline NCCLS Document C3-A3, 1997.
• Gotta, A.M. Lipoprotein Metabolism and the Etiology of Hyperlipidemia. Hospital Practice 1988; 23 Suppl:1 4-13.
• Crouse, J.R. et al. Studies of Low Density Lipoprotein molecular weight in human beings with coronary artery disease. J. Lipid Res 1985; 26:566.
• Badimon, J.J. et al. Regression of Artherosclerotic Lesions by High Density Lipoprotein Plasma Fraction in the cholesterol-Fed Rabbit. J. Clin. Invest. 1990; 85:1234.
• Castel', W.P. et al. HDL Cholesterol and other lipids in Coronary Heart Disease, Circulation 1977; 55:767.
• Barr; D.P. et al. Protein-Lipid Relationships in Human Plasma. Am. J. Med. 1951; 11:480.
• Gordon, T. et al. High Density Lipoprotein as a Protective Factor Against Coronary Heart Disease. Am. J. Med. 1977; 62:707.
• Bachorik, P.S. et al. National Cholesterol Education Program Recommendations for Measurement of Low Density Lipoprotein Cholesterol: Executive Summary. Clin. Chem. 1995; 41(10):1414.
• National Committee for Clinical Laboratory Standards, Internal Quality Control Testing: Principles and Definitions, Approved Guideline NCCLS Document C24-A, Number 6, Vol. 11, 1991.
• National Committee for Clinical Laboratory Standards, Procedures for the Handling and Processing of Blood Specimens, Approved Guideline NCCLS Document H18-A, Number 12, Vol. 10, 1990.
• Tietz, N.W. Clinical Guide to Laboratory Tests, W.B. Saunders Co., Philadelphia, PA., 256(1986).
• National Committee for Clinical Laboratory Standards, National Evaluation Protocols for Interference Testing, Evaluation Protocol, Proposed Guideline NCCLS Document EP7-P Number 7, Vol. 6, No. 13, August 1986.
• Young, D.S. Effects of Drugs on Clinical Laboratory Tests, 3rd ed. AACC Press, Washington, D.C., 3-104 (1990).