改良试剂瓶提高生化试剂开瓶稳定性的应用研究

Application Value of Improved Reagent Bottle that Enhance the Stability of Opened Biochemistry Reagent

目的研究改良试剂瓶对于提高生化试剂开瓶稳定性的应用价值。方法在全自动生化分析仪上使用改良试剂瓶对Cre，ALP，TBA，Lp（a），Na^＋等生化试剂进行开瓶稳定性、精密度及校准周期试验，并以普通试剂瓶设为对照组，观察测定结果的差异显著性。结果监测期内在相同条件下使用改良试剂瓶及普通试剂瓶保存Cre，ALP，TBA，Lp（a），Na^＋试剂，观察实验结果：①监测期末测定结果下降的偏差（％）分别为-3．84／-24．23，-2．47／-11．99，-1．75／-25．58，4．25／-7．35，1．17／8．6；②开瓶后的有效期（d）分别为15／7，30／15，60／15，72／30，7／4；③检测结果的日间变异CV（％）分别为1．57／5．14，1．10／4．41，4．01／9．51，3．4／3．55，1．0／3．18；④检测项目的校准周期（d）分另q为15／7，26／18，60／16，68／30，15／4；⑤改良试剂瓶在监测期内的测定结果与对照组有显著性差异，5组项目检测结果中除Lpa正常值水平差异无统计学意义（P〉0．05）外，其余差异均有统计学显著性意义（P〈0．01）。结论改良试剂瓶对于提高Cre，ALP，TBA，Lp（a），Na^＋等不同类型生化试剂开瓶后的稳定性、延长效期及减小室内检测结果日问变异效果显著，因此在实验室检验成本控制和检验质量控制方面具有较高的应用价值，可替代普通试剂瓶广泛应用于生化自动化分析。

Objective To investigate the application value of the improved reagent bottle which enhance the stability of the opened biochemistry reagent. Methods To test the stability, precision and calibration interval of several biochemistry reagents,by determining the contents of CRE, ALP, TBA,Lp （a） and Na＋ with Automatic Biochemistry Analyzer. Ordinary reagent bottle was used as the control method,for reviewing the distinct difference of the results. Results In the same condition,improved bottles and ordinary bottles were both used to store the reagents of Cre,ALP,TBA,Lp （a） and Na^＋ ,compare the differences between them in the monitoring period. （1）The result deviations were -3.84%,-2.47% - 1.75%,-4. 25% and 1.17% for the improved group. And -24.23%,-11.99%,-25.58%,-7.35% and 8.6% for the control group. （2） The validity days of the reagent opened in the improved group and the control group were 15/7,30/15, 60/15,72/30,7/4. （3）The results of inter-day CV（%） for the improved group and the control group were 1.57/5. 14,1.10/ 4.41,4.01/9.51,3.4/3.55,1.0/3, 18. （4）The calibration frequency were 15/7,26/18,60/16,68/30 and 15/4 for the improved group and the control group. （5）There were significantly different between the improved group and the control group（P〈0. 01）,except for Lp（a）（P〉0.05）. Conclusion Compared with ordinary bottles,the improved bottle has three significant advantages ：the stability of the biochemistry reagent opened in bottle can be enhanced ,the validity period would be extended ,and the inter-day CV reduced. Consequently,there is a high value in the cost control and quality control applications,the improved bottles would take place of ordinary ones and widly used in automatic biochemistry analyzing.