实验室内分泌项目测量不确定度的评定研究

Evaluation of measurement uncertainty of laboratory endocrine test items

目的 采用“自上而下”的方法评定内分泌试验检验项目的测量不确定度。方法 采用CNAS-CL01-G003:2021《医学实验室—测量不确定度的评定与表达》技术报告中的“自上而下”的方法,收集实验室的室内质控数据和2019—2021年北京市临床检验中心的室间质评结果,评定游离三碘甲状腺原氨酸(free triiodothyronine,FT_(3))、总三碘甲状腺原氨酸(total triiodothyronine,TT_(3))和游离甲状腺素(free thyroxine,FT_4)等11项内分泌试验检测指标的测量不确定度。结果 11项内分泌试验检测项目在低浓度水平时的相对扩展不确定度分别为FT_(3):12.658%、TT_(3):13.372%、FT_4:10.468%、总甲状腺素(total thyroxine,TT_4):32.382%、促甲状腺激素(thyroid stimulating hormone,TSH):8.594%、雌二醇(estradiol,E_(2)):18.656%、卵泡刺激素(follicle-stimulating hormone,FSH):14.650%、促黄体生成素(luteinizing hormone,LH):29.384%、孕酮(progesterone,PRO):28.806%、催乳素(prolactin,PRL):13.810%、睾酮(testosterone,TESTO):31.610%;在正常浓度水平时的相对扩展不确定度分别为FT_(3):12.424%、TT_(3):12.462%、FT_4:8.606%、TT_4:14.130%、TSH:12.536%、E_(2):19.586%、FSH:14.382%、LH:23.400%、PRO:38.346%、PRL:16.014%、TESTO:39.352%;在高浓度水平时的相对扩展不确定度分别为FT_(3):13.882%、TT_(3):14.096%、FT_4:11.040%、TT_4:8.614%、TSH:7.782%、E_(2):14.366%、FSH:13.436%、LH:14.804%、PRO:11.574%、PRL:17.742%、TESTO:39.322%。TT_4、LH在低浓度水平附近时、PRO在低浓度和正常浓度水平附近时、TESTO在3种浓度水平附近时的相对扩展测量不确定度高于目标不确定度(25%),其余项目均小于目标不确定度。结论 利用实验室的质控数据,可评定美国雅培i2000SR全自动化学发光免疫分析仪对FT_(3)、TT_(3)、FT_4等11个内分泌检测项目的测量不确定度,具有一定的临床应用价值。

Objective To evaluate the measurement uncertainty of endocrine test items by“top-down”method.Methods The“top-down”method in the technical report of CNAS-CL01-G003:2021“Medical Laboratory-Evaluation and Expression of Measurement Uncertainty”was used,collecting the laboratory's internal quality control data and the external quality assurance results of Beijing Clinical Laboratory Center from 2019 to 2021.To evaluate the measurement uncertainty of 11 endocrine tests including free triiodothyronine(FT3),total triiodothyronine(TT3)and free thyroxine(FT4).Results The relative expanded uncertainties of 11 endocrine test items in laboratory were FT3:12.658%,TT3:13.372%,FT4:10.468%,total thyroxine(TT4):32.382%,thyroid stimulating hormone(TSH):8.594%,estradiol(E2):18.656%,follicle-stimulating hormone(FSH):14.650%,luteinizing hormone(LH):29.384%,progesterone(PRO):28.806%,prolactin(PRL):13.810%and testosterone(TESTO):31.610%.At the normal concentration level,the relative expanded uncertainties were FT3:12.424%,TT3:12.462%,FT4:8.606%,TT4:14.130%,TSH:12.536%,E2:19.586%,FSH:14.382%,LH:23.400%,PRO:38.346%,PRL:16.014%and TESTO:39.352%.The relative expanded uncertainties at high concentration levels are FT3:13.882%,TT3:14.096%,FT4:11.040%,TT4:8.614%,TSH:7.782%,E2:14.366%,FSH:13.436%,LH:14.804%,PRO:11.574%,PRL:17.742%,TESTO:39.322%.The relative extended measurement uncertainty of TT4,LH near low concentration levels,PRO near low and normal concentration levels,and TESTO near three concentration levels was higher than the target uncertainty(25%),and the remaining items are less than the target uncertainty.Conclusion The quality control data in the laboratory can reflect the measurement uncertainty of 11 endocrine detection items including FT3,TT3 and FT4 in Abbott i2000SR automatic chemiluminescence immunoassay analyzer,which has important clinical application value.