Verification for the performance of ox-LDL test kit based on ITMA
10.3969/j.issn.1672-8270.2025.08.012
- VernacularTitle:基于免疫比浊法的氧化型低密度脂蛋白检测试剂盒的性能验证
- Author:
Yichuan QIN
1
;
Yu LIU
1
;
Yungang PU
1
;
Jing BAI
1
Author Information
1. 首都医科大学附属北京同仁医院检验科 北京 100730
- Publication Type:Journal Article
- Keywords:
Oxidized low-density lipoprotein(ox-LDL);
Immunoturbidimetric assay(ITMA);
Reagent;
Performance verification
- From:
China Medical Equipment
2025;22(8):61-66
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To verify the performance of the immunoturbidimetric assay(ITMA)kit of detecting oxidized low-density lipoprotein(ox-LDL).Methods:In accordance with the requirements of China National Accreditation Service for Conformity Assessment[(CNAS)-GL037:2019]and the National Health Industry Standards,the precision,trueness,linear range and reportable range of ITMA test kit for ox-LDL were verified on AU5800 fully automatic biochemical analyzer,which were compared with enzyme linked immunosorbent assay(ELISA)of Mercodia comparison reagents for ox-LDL through experiment of methodological comparison.Results:The coefficients of variation(CV)values of within-run and between-run precisions of the two concentration levels of quality control materials in the ITMA reagent kit for ox-LDL were respectively(3.74%,3.36%)and(4.75%,5.49%).The trueness bias of the two concentration levels of standards were respectively 0.46%and 1.78%,and the linear range was(15-120 U/L),which verification regression coefficient was R2=0.999 5 with a slope of 0.989.The maximum dilution multiple was 4 times,and the upper limitation of the clinically reportable range was 240.00 U/L.The manufacturer-provided biological reference interval was 0-64.49 U/L,and the coincidence rate was 100%.The results of hemoglobin,bilirubin,triglycerides,high density lipoprotein(HDL),low density lipoprotein(LDL)and rheumatoid factor were respectively 10 mg/ml,342 μmol/L,10.0 mg/ml,100 mg/dl,200 mg/dl,<200 IU/ml.The stationary duration was there was not influence within 30 h after opened the kit.The correlation between ITMA and ELISA detection methods was excellent(R2=0.9766).The positive and negative coincidence rates of clinical identification were respectively 92.3%and 96.5%.Conclusion:The performances of ox-LDL ITMA test kit based on fully automatic biochemical analyzer can all meet the requirement of clinical application,which shows excellent consistency with the results of ELISA method.
