The preparation of the quality control material of D-dimer and the evaluation of its function
10.3969/j.issn.1673-4130.2018.07.003
- VernacularTitle:D-二聚体质控品的制备及性能评价
- Author:
Qingtang YANG
1
;
Lixiang WU
;
Yang ZHANG
Author Information
1. 重庆大学附属肿瘤医院/重庆市肿瘤研究所/重庆市肿瘤医院检验科
- Keywords:
quality control material;
D-dimer;
stability
- From:
International Journal of Laboratory Medicine
2018;39(7):776-778,783
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare a liquid composite quality control material of D-dimer,and then to inves-tigate its stability.Methods Pooled human serum without infection[negative for the antibodies to human im-munodeficiency virus(HIV),hepatitis C virus(HCV)and hepatitis B surface antigen(HBsAg),TP-IgG]was used as the medium for the composite quality control material preparation to investigate its precision and sta-bility.Results The within-run precision of our product was 1.83% which was < 1/4 CLIA'88 acceptable per-formance range.The between-run precision was 3.02% which was < 1/3 CLIA'88 acceptable performance range.The quality control material was stable for 12 months at -20 ℃.The stability[coefficient of variation (CV%)of each item of the quality control material was<1/2 CLIA'88 acceptable performance range.Conclu-sion T he liquid composite lipid quality control material has good homogeneity and stability,and it can be used for D-dimer testing the internal quality control.
