血脂分析测试的国家指南.ppt
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1、National Guidelines on Lipid Profile Testing,E-mail:,Dr. Sheng-kai Yan , PhD Department of Laboratory Medicine, Peking Union Medical College Hospital Professor zhou xin Department of Laboratory Medicine, Zhongnan hospital of wuhan university.,Preface,Blood lipid analysis has a substantial importance
2、 towards the prevention and management of atherosclerosis and coronary heart disease (CHD). It is also being widely applied to the studies of many other related clinical conditions, such as diabetes mellitus, kidney diseases, and metabolic disorders in postmenopausal women.,Recently, the Lipid Exper
3、t Panel of the Chinese Society of Laboratory Medicine (CSLM) of the Chinese Medical Association (CMA) has come up with the practical guidelines and recommendations on lipid profile testing. lipid profile testing: total cholesterol (TC) triglycerides (TG) high density lipoproteincholesterol (HDL-C) l
4、ow density lipoprotein-cholesterol (LDL-C) apolipoprotein A1 (ApoA1) apolipoprotein B (ApoB) lipoprotein(a) Lp(a),The Guidelines include the content as follows,Preface Preanalytical factors affecting lipid test results Methods of lipid analysis Reagent selection criteria and practical guidelines Cli
5、nical significance of cutoff values in the interpretation of lipid profile results,See: Chin J Lab Med, 2003, 26(3): 182184 中华检验医学杂志,2003,26(3):182-184,Preanalytical Factors Affecting Lipid Test Results,A subjects lipid profile should be measured when the individual is in a steady metabolic state. S
6、ubjects should maintain their usual diet and weight for at least 2 weeks prior to the measurement of their lipids or lipoproteins. Subjects should not perform vigorous physical activity during the 24 hours prior to testing.,Recommendations for minimizing preanalytical variation,Multiple measurements
7、 should be performed whthin 2 months, at least one week apart, before making a medical decision about further action. Fasting or non-fasting specimens can be used for TC testing. However, a 12-h fasting specimen is required for TG and recommended for lipoproteins. The subject should be seated for at
8、 least 5 minutes before specimen collection. The tourniquet should not be kept on more than one minute during venipuncture.,Suggestions to reduce the preanalytical variations on blood lipid profile testing,Both serum and plasma are suitable for analysis. Serum is more common and convenient. The resu
9、lt obtained from EDTA plasma should be corrected for the dilution effect by a factor of 1.03. The separated serum should be processed as soon as possible. Samples that could not be analyzed within 24 hours, can be stored at 4 for one week or at -20 for several months and at -70 for at least half a y
10、ear. Repeated freeze and thaw should be avoided.,Suggestions to reduce the preanalytical variations on blood lipid profile testing,Methods of Lipid Analysis,Analytical Methods For routine lipid analysis,Serum TC: Enzymatic method(CHOD-PAP method) Serum TG: Enzymatic method( GPO-PAP method) Serum HDL
11、-C: Homogeneous methods Serum LDL-C: Homogeneous methods Serum ApoA1/ApoB and Lp(a): Immunoturbidimetry(ITA) method Immunonephelometry(INA) method (The first choice would be ITA, followed by INA),Serum HDL-C Homogeneous methods,Clearance method Synthetic polymer/ detergent HDL-C assay, SPD Daiichi P
12、ure Chemicals Co. Catalase HDL-C assay, CAT Denka Seiken Randox Co. Reference Diagnostics Polymedco,Serum HDL-C Homogeneous methods,PEG-modified enzyme HDL-C assay,PEGME Kyowa Medex Co. Roche Diagnostics Centronic GmbH,Immunoseparation method, IS International Reagents Corp HDL-C assay,IRC Internati
13、onal Reagents Co./Sysmex Antibody immunoseparation HDL-C assay ,AB Wako Pure Chemicals Industry,Serum HDL-C Homogeneous methods,Polyanion Polymer/ detergent HDL-C assay,PPD Daiichi Pure Chemicals Co. Genzyme Diagnostics,Serum HDL-C Homogeneous methods,Clearance method Surfactant LDL-C assay,SUR Daii
14、chi Pure Chemicals Co. Genzyme Diagnostics Catalase LDL-C assay,CAT Denka Seiken RANDOX Polymedco Kyowa Medex Roche,Serum LDL-C Homogeneous method,Protecting reagent LDL-C assay,PRO Wako Chemicals Sigma Diagnostics Calixarene LDL-C assay,CAL International Reagents Co./Sysmex Solubilization LDL-C ass
15、ay,SOL,Serum LDL-C Homogeneous method,Serum Lp(a) Immunoturbidimetry/immunonephelometry,The reagent should preferably be polyclonal or mixed monoclonal antibodies, that could recognize different epitopes of the Apo(a) molecule. ITA is more preferable than INA.,Spectrophotometers and semi-/automatic
16、biochemical analyzers would be suitable for analysis once verified for proper functioning. All samplers, dilutors, pipettes and micropipettes must be calibrated. Automatic biochemical analyzers (fully or semi-automatic) are recommended for use in blood lipid testing.,Requirements on Analytical Instr
17、uments,Parameters should be set according to the manufacturers instructions and assigned calibrator values on the package insert. The parameters should not be liberally changed.,Setting the Parameters,Laboratories should use accredited quality control (QC) materials with serum matrix as the internal
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