Performance verification of fully automated chemiluminescence immunoassay analyzer in measuring special sequence indicators of serum β-CTx
10.3969/j.issn.1672-8270.2025.08.011
- VernacularTitle:全自动化学发光免疫分析仪测定血清β-胶原特殊序列指标的性能验证
- Author:
Di LEI
1
;
Jian REN
;
Minjuan ZHANG
;
Xiaoning SUN
;
Yingjun LI
;
Xiaodong ZHANG
;
Cunlin LONG
Author Information
1. 青海省药品检验检测院医疗器械检验检测中心 西宁 810016
- Publication Type:Journal Article
- Keywords:
Chemiluminescence immunoassay analyzer;
β-Collagen(β-CTx);
Precision;
Linear interval;
Performance verification
- From:
China Medical Equipment
2025;22(8):57-60
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To verify the performance of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer in measuring special sequence of β-Collagen(β-CTx).Methods:Referring to a series of standards included WS/T 492-2016"Verification of performance for precision and trueness of quantitative measurements in clinical laboratories"and CNAS-GL037 2019"Guidance on the verification of quantitative measurement procedures used in the clinical chemistry",the precision,trueness,and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were verified in measuring β-CTx.Results:The intra batch precisions(repeatability)of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer were respectively 3.22%and 3.49%in measuring serum β-CTx samples with low and high values.The intermediate precisions(precision within laboratory)were respectively 4.35%and 3.29%,both of which met the requirements of laboratory.The results of trueness verification showed that the bias of samples with low concentration was-2.4%,and the bias of samples with high concentration was-2.1%.The expected values of the standards with low and high values were all between the corresponding up and low validation limits of them,which met the judgment criteria.The linear interval was 0.03-6.00 ng/mL,which was within the linear interval,and it can meet the requirements of manufacturer′s claim.Conclusion:The precision,trueness and linear interval of MAGLUMI 4000 fully automatic chemiluminescence immunoassay analyzer all passed the verification in measuring β-CTx,which indicates the performance of the project can meet the quality specifications.
