The study of serum cardiac troponin I control materials
10.3969/j.issn.1673-4130.2015.14.005
- VernacularTitle:血清肌钙蛋白I质控物的研究
- Author:
Jianxin WANG
;
Chao WANG
;
Xiuying SI
;
Huimin WANG
- Publication Type:Journal Article
- Keywords:
serum cTnI;
control;
stability;
homogeneity
- From:
International Journal of Laboratory Medicine
2015;(14):1969-1970
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare a set of serum cardiac troponin I quality control materials for testing and evaluate the homoge‐neity and stability .Methods Mixed serum were collected ,filtered ,distributed ,storaged at -20 ℃ according to the experimental design .The homogeneity of serum pools was evaluating according to the CNAS‐GL03 Guidance .The stability of cTnI in human ser‐um was examined using an accelerated stability testing protocol according to the Arrhenius equation .Further ,the effect of stability was verified by long term test .Results In the homogeneity evaluation the results showed that there were insignificant difference between the control materials (P>0 .05) .Stability analysis ,the control should not exceed 2 times by freeze‐thawing ;constant tem‐perature accelerated test results showed that the serum levels of cTnI degraded in accordance with the change of chemical first‐order reaction kinetics .Arrhenius‐plots indicated that the cTnI control materials were stable for at least 7 days at 4 ℃ and 19 months at-20 ℃ ,respectively .Control materials were monitored for 9 months ,the results are stable ,and consistent with the constant tem‐perature acceleration .Conclusion The homogeneity and stability of serum cTnI is good and can be used in clinical quality control .
