自制他克莫司室内质控品的制备及临床应用研究  

The preparation and clinical application research of self-made tacrolimus internal quality control material

作　　者：张丽萍[1] 刘元明[1] 张金红[1] 宋娜[1] 郝钦芳[1] 杨晓莉[1] 

机构地区：[1]武警总医院检验科,北京100039

出　　处：《检验医学》2013年第11期1021-1025,共5页Laboratory Medicine

摘　　要：目的完善他克莫司(FK506)室内质控品水平,弥补商用质控品监测盲区。方法观察1年内FK506检测结果,评估自制低值质控品用于临床的可行性;运用临床患者标本自制低值室内质控品(ZCON-L)和自制中值室内质控品(ZCON-M),检测其日内、日间相对标准差(RSD%),并与低值商用质控品(Level 1)、中值商用质控品(Level 2)比较,并绘制室内质控图;将ZCON-M和Level 2做统计学分析,评估自制质控品与商用质控品是否有差异;将ZCON-L、ZCON-M分别放于4、25和37℃环境内连续检测7 d,观察不同温度环境对其影响;经无菌分装后的自制质控品置于-30℃保存,每周取1支复融后随日常工作检测,检测完毕后置4℃保存,经10个月连续检测,观察其稳定性。结果 1年内9 975人次的FK506检测中,约有28.4%处于商用质控品监测盲区;ZCON-L、ZCON-M的日内RSD分别为4.5%、5.3%,日间RSD分别为7.06%、5.37%,符合ARCHITECT i1000全自动免疫分析仪的性能指标及《中国药典》生物标本分析方法 RSD<15%的要求;ZCON-L、ZCON-M与Level 1、Level 2的相关性较好(r2=0.835 2、0.818 5),并且在质控图中走势一致;ZCON-M与Level 2经t检验,二者之间差异无统计学意义(P>0.05);4、25和37℃环境温度在7 d内对自制质控品影响较小;经连续10个月观察,ZCON-L、ZCON-M总RSD分别为7.56%、4.97%。结论自制FK506室内质控品稳定性好,与商用质控品无差异,与商用质控品联合应用于临床,可弥补商用质控的监测盲区,完善室内质量控制水平。Objective To improve taerolimus （FK506） internal quality control material, and remedy the monitoring blind of commercial ones. Methods The results of FK506 were observed in 1 year, and the feasibility of self-made low-level quality control material was evaluated. By self-made internal quality control material of low level （ZCON-L） and self-made internal quality control material of middle level （ZCON-M）, the intra-day and inter-day relative standard deviations （ RSD% ） were determined. The differences between low-level and middle-level commercial internal quality control materials （ Level 1 and Level 2 ） and self-made ones were compared. The internal quality control chart was drawn,the ZCON-M and Level 2 were analyzed statistically, and the difference of self-made internal quality control material and commercial ones was analyzed. The ZCON-L and ZCON-M were put at 4,25 and 37 ℃ and monitored for 7 d, and the influence of temperature was observed. The self-made internal quality control material were subpackaged biocleanly and stored at - 30 ℃, someone was took out every week, after thawing, it was monitered following the routine works, and stored at 4 ℃. Monitoring for 10 months, the stability was observed and analyzed. Results Among 9 975 determinations of FK506 in 1 year, there was about 28.4% in the monitoring blind. The intra- day RSD and inter-day RSD of ZCON-L and ZCON-M were 4.5% ,5.3% and 7.06% , 5.37% respectively,conforming to the performance indicators of ARCHITECT il000 automatic immunoassay analyzer and the requirement of RSD 〈 15% of biological sample analysis method in the Chinese Phartnacopoeict. The correlations between ZCON-L, ZCON-M and Level 1, Level 2 were good （r2 = 0. 835 2 and 0. 818 5 ） , and their trends were consistent in the internal quality control chart. ZCON-M and Level 2 had no statistical significance by t test （P 〉0.05）. The temperatures （4,25 and 37 ℃ ） in 7 d had less effect to the self-made internal quality control material. The total

关 键 词：自制质控 室内质量控制 他克莫司 

分 类 号：R446.1[医药卫生—诊断学]