摘要
目的分析7年来参加全国新生儿疾病筛查苯丙氨酸(Phe)和促甲状腺激素(TSH)室间质量评价的结果,评价实验室检测质量。方法对2010-2016年卫生部临检中心分发的各批次质评样本分别采用荧光法和时间分辨荧光免疫分析法进行Phe和TSH浓度检测,并对反馈结果进行总结分析。结果 (1)7年来共接受21批次共计105份质评样本,偏倚分布范围Phe(-66.67%~45.71%)、TSH(-62.5%~20.83%);相对偏倚平均值Phe 2.21%、TSH 0.98%。(2)定量结果分析:6份Phe和2份TSH测定结果失控(偏倚≥30%或≤-30%),失控率分别为Phe 5.71%(6/105)和TSH 1.9%(2/105)。(3)定性结果分析:Phe(阴性36份,阳性69份),TSH(阴性42份,阳性73份),临床判断结果全部通过,符合率为100%;每一批次项目评分结果均≥80%,室间质评合格。结论参加全国新生儿疾病筛查实验室室间质评活动,通过反馈结果评估实验室的检测能力,有助于及时发现和解决存在的问题,减少实验误差,提高检测水平,确保筛查结果的准确可靠。
Objective To review the phenylalanine(Phe)and thyrotropin(TSH)results of national external quality assessment(EQA)in neonatal screening laboratory for 7years,evaluate qualitity control level and summarize the problems in the screening measurement.Methods The Phe and TSH values in dried blood spot specimens on filter paper distributed by national center for clinical laboratory were measured by fluorometrie method and time-resolved fluorescence immunoassay respectively.The Phe and TSH EQA results from 2010 to 2016year were analyzed.Results Five specimens were distributed by EQA organizer each time,and 3times each year.(1)In the 105 specimens of 21 batches,the bias ranges of Phe and TSH measurement were wide and their average values were 2.21% and 0.98%respectively.(2)Quantitative results analysis:Six quantitative results of Phe measurement and two quantitative results of TSH measurement were out of aunty control(bias≥30% or≤-30%),accounting for 5.71%(6/105)and 1.9%(2/105)respectively.(3)Qualitative results analysis:The Phe and TSH qualitative analysis of specimens conformed to the expected results(100%).The result of every batch was up to 80%.Conclusion It is useful to evaluate the measurement competence,find out the problems in the Phe and TSH measurement in neonatal screening laboratory and resolve them in time.Consequently,it is useful to improve the quality of measurement,reduce the error and ensure the accuracy of results.
出处
《国际检验医学杂志》
CAS
2017年第13期1732-1734,1737,共4页
International Journal of Laboratory Medicine
基金
新疆维吾尔自治区人民医院科学基金(20140212)
