[From the Point of View of the Production of Reference Material]

In the international standardization of lipid measurement for TC, HDL-C, LDL-C, and TG in serum, the establishment of a measurement system and certified serum reference materials (CRM) are the most important fundamental factor. They have been fully established. Routine measurement procedures using manufacturers' reagent kits must be calibrated with the CRM and are standardized to maintain the commutability of measured values. In TC and HDL-C measurements, the commutability of measured values from reagent kits has been maintained by calibration with the CRM. However, it is likely that different values will be obtained due to the reactivity with abnormal specimens based on measurement principles and performance of the reagent kits. This different reactivity is a typical phenomenon in abnormal specimens on conducting lipid measurements. This phenomenon cannot be avoided using the CRM. On selection of the reagent kit, it is necessary to perform evaluation studies using abnormal specimens based on the comparison method. Direct methods standardized for LDL-C measurement are selected based on evaluation studies. In TG measurements for international standardization, it is necessary to change the procedure to measure the total glycerides instead of the elimination of free glycerol by the JSCC method. This is done to avoid the influence of LPL activity on heparin treatment for cardiovascular disease patients.