Development of a magnetic particle chemiluminescence immunoassay for creatine kinase MM
10.3760/cma.j.cn114452-20230921-00157
- VernacularTitle:建立一种磁微粒化学发光免疫分析法检测肌酸激酶MM型的方法
- Author:
Shu ZHANG
1
;
Chunyan ZHANG
;
Yujun ZHOU
;
Xiuli XU
;
Yuxuan CHENG
;
Yang SHU
;
Shiwen WU
;
Yaping TIAN
Author Information
1. 解放军总医院第一医学中心神经内科医学部，北京 100853
- Keywords:
Creatine kinase, MM form;
Muscular dystrophy, Duchenne;
Neonatal screening
- From:
Chinese Journal of Laboratory Medicine
2024;47(6):667-671
- CountryChina
- Language:Chinese
-
Abstract:
Objectives:Aimed to establish a rapid, high-throughput, automated method for determining the creatine kinase (CK-MM) isoform levels.Methods:Magnetic beads labeled with anti-CK-MM antibodies were combined with alkaline phosphatase-based chemiluminescence detection. Clinical and diagnostic performance validation of the assay was determined by analysis of 998 and 75 dried blood spot samples from healthy newborns and Duchenne muscular dystrophy (DMD) patients, respectively, and the CK activity was also determined. The blank and detection limits, cross-reactivity, recovery rate of the method, intra-and inter-assay coefficient, and the hook effect were evaluated.Results:Blank and detection limits were 17.4 and 39.3 ng/ml, respectively. Cross-reactivity toward CK-MB and CK-BB isoforms was 0.2% and 0.02%, respectively. Intra-and inter-assay coefficients of variation were<1%. Mean recovery was 100.32%, with no hook effect in CK-MM levels<50 000 ng/ml. Overall, the mean CK-MM concentrations in newborns and DMD patients were (27.05±0.97) and (3 720±300.5) ng/ml, respectively. A significant positive correlation between the dried blood spot detected CK-MM levels and total CK enzyme activity, evaluated in corresponding serum samples from the 75 DMD patients, was observed ( r=0.91, P<0.001), ?which is in good agreement with the clinical. Conclusions:An assay for rapid quantitative determination of CK-MM that meets clinical newborn screening requirements was established. It had a good value for application.
