Evaluation of A Non-competitive Immunosandwich Method for Detecting Serum 25(OH)D on the Basis of Anti-immunocomplex Antibodies
10.3969/j.issn.1671-7414.2025.06.035
- VernacularTitle:基于抗复合物抗体非竞争免疫夹心法检测血清25(OH)D水平的方法学评价
- Author:
Jingjing WANG
1
;
Xinli DENG
;
Meiliang GONG
;
Lin ZOU
Author Information
1. 解放军总医院第二医学中心 检验科,北京 100853
- Publication Type:Journal Article
- Keywords:
25-hydroxy vitamin D;
performance verification;
non-competitive immunosandwich method;
LC-MS/MS
- From:
Journal of Modern Laboratory Medicine
2025;40(6):190-195,200
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the performance of an non competitive immune sandwich method(candidate method)in detecting 25(OH)D,and evaluate the measurement agreement of candidate method with liquid chromatography tandem mass spectrometry(LC-MS/MS,reference method).Methods According to the comparison of documents such as China National Accreditation Service for Conformity Assessment(CNAS)-GL037,the precision,linear interval,lower limit of quantitation(LOQ)and accuracy of the method for detecting 25(OH)D were verified.1 073 residual serum samples were collected from March to July 2021 and 25(OH)D was detected by the two methods.Passing-bablok regression,concordance correlation coefficient(CCC),Bland altman plots and Kappa test were used to analyze the consistency and bias.Weighted Kappa test was conducted to evaluate the consistency of two methods for clinical assessment of vitamin D nutritional status.Results The performance of candidate method:the within-run CV was lower than 5%and the in laboratory CV were lower than 10%;test results between 2.88～52.45 ng/ml showed good linear relationship;the lower limit of quantitation was 2.26 ng/ml,the bias of candidate method measuring standard reference materials were within±6%and within 15%measuring vitamin D external quality assessment scheme(DEQAS)samples.The comparison method and the reference method showed good correlation(r=0.965,CCC=0.946)with an average deviation of-1.54 ng/ml(-7.42%).The two methods coincidence rate in judging vitamin D status was 85.96%(918/1 068),and the weighted kappa value was 0.801.Conclusions The candidate method measurement performance met the clinical requirements,and showed good correlation and consistency with the reference method.
