CAJ | 학술논문

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9975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＝0．8352、0．8185），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。
목적：완선타극막사（FK506）실내질공품수평，미보상용질공품감측맹구。방법관찰1년내FK506검측결과，평고자제저치질공품용우림상적가행성；운용림상환자표본자제저치실내질공품（ZCON-L）화자제중치실내질공품（ZCON-M），검측기일내、일간상대표준차（RSD％），병여저치상용질공품（Level 1）、중치상용질공품（Level 2）비교，병회제실내질공도；장ZCON-M화Level 2주통계학분석，평고자제질공품여상용질공품시부유차이；장ZCON-L、ZCON-M분별방우4、25화37℃배경내련속검측7 d，관찰불동온도배경대기영향；경무균분장후적자제질공품치우-30℃보존，매주취1지복융후수일상공작검측，검측완필후치4℃보존，경10개월련속검측，관찰기은정성。결과1년내9975인차적FK506검측중，약유28．4％처우상용질공품감측맹구；ZCON-L、ZCON-M적일내RSD분별위4．5％、5．3％，일간RSD분별위7．06％、5．37％，부합ARCHITECT i1000전자동면역분석의적성능지표급《중국약전》생물표본분석방법RSD＜15％적요구；ZCON-L、ZCON-M여Level 1、Level 2적상관성교호（r2＝0．8352、0．8185），병차재질공도중주세일치；ZCON-M여Level 2경t검험，이자지간차이무통계학의의（P＞0．05）；4、25화37℃배경온도재7 d내대자제질공품영향교소；경련속10개월관찰， ZCON-L、ZCON-M총RSD분별위7．56％、4．97％。결론자제FK506실내질공품은정성호，여상용질공품무차이，여상용질공품연합응용우림상，가미보상용질공적감측맹구，완선실내질량공제수평。
Objective To improve tacrolimus (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 1 0 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-Mwere 4.5%,5.3%and 7.06%,5.37% respectively,conforming to the performance indicators of ARCHITECT i1 000 automatic immunoassay analyzer and the requirement of RSD<1 5%of biological sample analysis method in the Chinese Pharmacopoeia.The correlations between ZCON-L,ZCON-M and Level 1 ,Level 2 were good (r2 =0.835 2 and 0.81 8 5),and their trends were consistent in the internal quality control chart.ZCON-Mand 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 RSD of ZCON-L and ZCON-M in 1 0 months were 7.56% and 4.97%.Conclusions The stability of self-made FK506 internal quality control material is good,it has no difference with commercial ones,it can be used in the clinical determination,so it can remedy the monitoring blind of commercial internal quality control materials and make up the internal quality control.