摘要
目的评价自制血清肌钙蛋白I(cTnI)质控物均匀性和稳定性。方法按实验设计收集混合血清,分装-20℃贮存。参照CNAS-GL03《能力验证样品均匀性和稳定性评价指南》,对质控物的均匀性进行评价;运用恒温加速试验研究稳定性。结果质控物均匀性差异无统计学意义(P>0.05)。恒温加速试验显示,血清cTnI降解随时间变化符合化学动力学一级反应,根据Arrhenius方程推测4℃贮存7d,-20℃贮存有效期为19个月;监测质控物9个月,与恒温加速试验结果一致。结论自制血清cTnI质控物均匀性、稳定性良好,可用于临床室内质量控制。
Objective To prepare a set of serum cardiac troponin I quality control materials for testing and evaluate the homogeneity 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 serum 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 2times by freeze-thawing;constant temperature 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 7days at 4 ℃ and 19 months at-20 ℃,respectively.Control materials were monitored for 9months,the results are stable,and consistent with the constant temperature acceleration.Conclusion The homogeneity and stability of serum cTnI is good and can be used in clinical quality control.
出处
《国际检验医学杂志》
CAS
2015年第14期1969-1970,共2页
International Journal of Laboratory Medicine
基金
南通大学自然科学项目(13Z018)
