Hitachi 7600-110에 의한 Lipoprotein(a) 정량검사의 평가

Abstract

The Lipoprotein(a), [Lp(a)] is one of the atherogenic lipoproteins and it is known to be the independent risk factor on premature atherosclerosis and cardiovascular disease(CHD). It is an atherogenic lipoprotein that is assembled from a Low density lipoprotein(LDL). Traditional methods for measuring Lp(a) are ELISA and immuno electrophoresis. However these method have slow reaction and no easy work measurement for Lp(a). Recently, the development of specific and sensitive assays for Lp(a) using specific polyclonal antibodies for Lp(a) were done, including radioimmunoassay, nephelometric assay(NA), and turbidimetric immunoassay(TIA). We evaluated the Hitachi7600-110 (HitachiCo., Japan) using the TIA [TAC-3 Test Lp(a) (MBL Co., Japan) ] in the measurement of LP(a) and compared. Its results to those of the one-step sandwich ELISA (IMMUNOZYM Lp(a): Immuno GMBH.Co., Germany) using nephelometer in order to replace the Hitachi 7600-110 for quantitative analysis of Lp(a). Lp(a) were measured by the Hitachi 7600-110 using TIA and the one-step sandwich ELISA using nephelometer in the sera from 60 patients. The performance characteristics were evaluated, linearity, in comparison with one-step sandwich ELISA. Also, precision were evaluated, three level pooled serum throughput following NCCLS evaluation protocols (EPlO-A).The reference range was determined by Hitachi 7600-110 from 120 healthy subjects. When the Lp(a) value of 26.3119.01(mean, SD)mg/dL by the Hitachi7600-110 was compared with that of 26.31 19.01 (mean, SD)mg/dL by ELISA, coefficients of correlation of 0.9858 was obtained. The regression equation was Y(Hitachi7600-110)=0.773x (ELISA)-0.189(r=0.9858, n=60). CVs of Lp(a) measured by Hitachi 7600-110 was2.97% at 10. 85mg/dL, 1.15% at 35.53mg.dL, and 1.32% at 68.l3mg/dL. The precision was excellent in each group. The linearity was acceptable. The reference range in this study was 0-28.9mg/dL Lp(a). The Hitachi 7600-110® using TIA compared with the one-step sandwich ELISA using Nephelometer, showed good coefficient of correlation and precision. Therefore the Hitachi 7600-110® can replace the one-step sandwich ELISA for quantitative analysis of Lp(a).