CAJ | 학술논문

目的：探讨自制血清质控品在临床实验室甲状腺激素检测室内质量控制工作中应用的可行性。方法把甲状腺激素检测结果高值患者血清，按一定比例与健康人群血清混合，配成血清质控品，分装后－20℃保存，每次和原装配套质控品同时检测游离甲状腺素（FT4）、游离三碘甲状腺原氨酸（FT3）、促甲状腺激素（TSH）、甲状腺球蛋白（TG）、甲状腺微球蛋白抗体（TMA）、甲状腺球蛋白抗体（TGA）等6项甲状腺激素项目，检测前观察质控品外观，连续检测6个月，观察其稳定性；利用 EX‐CELL做J‐L图，统计6个月内各项目均值、CV和失控次数，评价其在室内质量控制应用中的价值。结果6个月内自制血清质控品冻溶后外观澄清透明、无沉淀及浑浊；第1、3、6、10、15、30、45、60、90、120天各项甲状腺激素量值未见明显变化；与原装质控品相比，CV值较低。在应用室内质量控制的6个月中，各项目第1、3、6个月及6个月累计结果无明显差异；项目均值及6个月累积均值间比较，未出现漂移或趋势变化；项目CV和累积CV 均在控制允许范围内（CV＜1／3倍总误差）；6个月室内质控工作中出现4次失控：13 s 2次，22 s 1次，R4 s 1次。结论自制甲状腺激素血清质控品冷冻保存有较好的稳定性，可替代其进口质控品；在日常室内质控活动，通过EXCELL作J‐L图能检测结果的精密度，发现不稳定因素，及时纠正处理以确保甲状腺功能检测结果可靠，有一定的临床应用价值。
목적：탐토자제혈청질공품재림상실험실갑상선격소검측실내질량공제공작중응용적가행성。방법파갑상선격소검측결과고치환자혈청，안일정비례여건강인군혈청혼합，배성혈청질공품，분장후－20℃보존，매차화원장배투질공품동시검측유리갑상선소（FT4）、유리삼전갑상선원안산（FT3）、촉갑상선격소（TSH）、갑상선구단백（TG）、갑상선미구단백항체（TMA）、갑상선구단백항체（TGA）등6항갑상선격소항목，검측전관찰질공품외관，련속검측6개월，관찰기은정성；이용 EX‐CELL주J‐L도，통계6개월내각항목균치、CV화실공차수，평개기재실내질량공제응용중적개치。결과6개월내자제혈청질공품동용후외관징청투명、무침정급혼탁；제1、3、6、10、15、30、45、60、90、120천각항갑상선격소량치미견명현변화；여원장질공품상비，CV치교저。재응용실내질량공제적6개월중，각항목제1、3、6개월급6개월루계결과무명현차이；항목균치급6개월루적균치간비교，미출현표이혹추세변화；항목CV화루적CV 균재공제윤허범위내（CV＜1／3배총오차）；6개월실내질공공작중출현4차실공：13 s 2차，22 s 1차，R4 s 1차。결론자제갑상선격소혈청질공품냉동보존유교호적은정성，가체대기진구질공품；재일상실내질공활동，통과EXCELL작J‐L도능검측결과적정밀도，발현불은정인소，급시규정처리이학보갑상선공능검측결과가고，유일정적림상응용개치。
Objective To investigate the feasibility of self‐control materials serum thyroid hormone detected in the clinical labo‐ratory internal quality control in applications .Methods The serum thyroid hormone test results in patients with high‐value ,the ser‐um was mixed with a certain proportion of the healthy population ,dubbed serum control materials ,after aliquots -20 ℃ .Every o‐riginal supporting quality control and simultaneous detection of free thyroxine (FT4) ,three free triiodothyronine (FT3) ,thyroid stimulating hormone (TSH) ,thyroglobulin (TG) ,thyroid‐microglobulin antibody (TMA) ,thyroglobulin antibodies (TGA) and other thyroid hormone six items detected before the appearance of control samples was observed continuously detected six months to observe stability ;used EXCELL do J‐L maps ,statistical mean of each project within six months ,CV and uncontrolled number of observed values in the internal quality control applications .Results Within 6 months after the product was frozen homemade quali‐ty control serum soluble appearance clear and transparent ,no precipitation and turbidity ;1 ,3 ,6 ,10 ,15 ,30 ,45 ,60 ,90 ,120 day of the first magnitude and no significant changes in thyroid hormone ;compared with the original quality control materials ,low CV values . In the six months internal quality control applications ,the cumulative results of each project without 1 ,3 ,6‐month and six months significantly different ;project and six months mean cumulative comparison between the mean drift or change in trend did not ap‐pear ;items and cumulative CV were in control of the allowable range (CV <1/3 times within total variation );6 months of internal quality control work ,runaway alarm :13s ,2 times ,22s ,1 times ,R4s ,1 times .Conclusion Serum thyroid hormone homemade frozen control samples have better stability ,and can replace its import control materials ;internal quality control in their daily activities , through EXCELL test results for J‐L diagram precision can find instability timely corrective treatment to ensure that thyroid func‐tion test results are reliable ,worthy of clinical application .