A magnetic solid phase chemiluminescent immunoassay for quantification of Cystatin C in human serum

BMC Biotechnology

Research

Jian He¹  Tingting Wang²  Shuang Han³  Ping Liang⁴ 

[1] Department of Clinical Laboratory, Affiliated Children’s Hospital of Jiangnan University, Wuxi, China;Department of Clinical Laboratory, Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, China;Department of Pathology, Affiliated Hospital of Jiangnan University, 214062, Wuxi, Jiangsu, China;Department of Pathology, Affiliated Hospital of Jiangnan University, 214062, Wuxi, Jiangsu, China;Wuxi School of Medicine, Jiangnan University, Wuxi, China;

关键词: Cystatin C;    Chemiluminescent immunoassay;    Quantification detection;    Kit development;   

DOI  :  10.1186/s12896-023-00813-6

 received in 2023-08-01, accepted in 2023-09-15,  发布年份 2023

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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