Coated tube를 사용한 CA19-9 측정용 IRMA 시약의 평가

Evaluation of Coated Tube CA19-9 IRMA kit

Purpose: TFB® CA19-9 IRMA kit uses beads coated with CA19-9 antibody. However, this mathod can not use automated equipment, and requires a long time test. Recently, CA19-9 IRMA kit developed by TFB® is coated with CA19-9 antibody to the polystyrene test tube and reaction at room temperature, and also reduced test time. This study evaluated the performance of a newly developed TFB® CA19-9 IRMA kit. Materials and Methods: This study were measured by using 56 patients sample of Boramae Medical Center and Seoul National University Hospital. We evaluated intra-and inter-assay precision, recovery rate, linearity, sensitivity and high dose hook effect of coated tube CA19-9 IRMA kit developed by TFB®. The values of CA19-9 measured by TFB® bead kit were compared with those measured by TFB® coated tube kit. Results: ntra-assay coefficients of variation on three different levels were 4.1%, 4.0% and 4.2%. Inter-assay coefficients of variation were 7.6%, 4.3% and 7.8%. Recovery tests on all three different levels showed within 100±10%. Linearity was good and sensitivity was 0.3 U/mL. High dose hook effect is not observed. There was strong correlation between bead kit and coated tube kit by TFB® CA19-9 IRMA kit. (y=0.9185x-0.953, R²=0.9779) Conclusion: Coated tube CA19-9 IRMA kit developed by TFB® showed satisfactory precision, recovery rate, linearity, sensitivity and high dose hook effect.