Abstract
A chemiluminescent immunoassay for human serum Cystatin C (Cys C) was established using a direct-antibody sandwich model. The immunoassay kit uses magnetic separation technology, using magnetic particles as the reaction solid phase, alkaline phosphatase as the marker enzyme, and a new chemiluminescent substrate APLS as the substrate. It has the characteristics of high sensitivity and short reaction time. This product uses high-affinity antibodies, resulting in a high specificity. The established method showed good accuracy, uniformity, and stability. The limit of detection was 2.39 ng/mL. The intra-assay coefficient of variation (CV) was 3.36%-6.00%, the interassay CV was 4.12%-5.35%, and the recovery rate was 99.07%. The correlation coefficient (r) of Cys-C kit was 0.999388 ≥ 0.9900. The accuracy of the developed method was tested by automatic chemiluminescence instrument (P > 0.05). The lowest titer was 0.92500, and the highest was 1.10000. The developed method showed a good correlation with the product from Roche by comparing these two kits in 240 clinical samples from China. In total, 1392 clinical patient from China samples were measured using the reagent kit developed in this study.