新生儿遗传代谢病筛查室间质量评价结果分析

EVALUATION ON THE EXTERNAL QUALITY ASSESSMENT OF NEWBORN SCREENING FOR INHERITED METABOLIC DISEASE LABORATORY

目的对本实验室连续6年参加卫生部临检中心新生儿遗传代谢病筛查实验室室间质量评价的结果进行回顾分析，总结实验过程中的问题。提高质控水平。方法分别采用荧光法和时间分辨荧光分析法（DELFIA）对卫生部临检中心分发的各批次质评样本进行检测，项目包括苯丙氨酸（Phe）和促甲状腺激素（TSH），对反馈结果进行总结分析。结果6年来共接受卫生部临检中心18批次共计90份的质评样本，测定Phe和TSH结果偏倚范围分布较广（分别为-62．50％-66．67％和-66．67％～54．31％），相对偏倚平均值分别为8．62％和10．18％；90份质评样本中，85份Phe测定值和84份TSH测定值偏倚在允许范围内，定量判断符合率分别为94．44％和93．33％；90份Phe与TSH定性判断结果均与反馈的质评结果一致，定性判断符合率均为100％；所有项目评分结果均大于80％。结论实验室的室间质评结果于控制限内；接受卫生部临验中心实验室质量监控，有助于评估实验室检验能力，即时发现并改正检验过程中存在的问题，从而使检测质量得到提高，实验结果的准确性和可靠性得到有效保证。

Objective To evaluate our results of external quality assessment （EQA） program of the newborn screening laboratory for 6 years, summarize the problems in the screening measurement and improve the quality of measurement. Methods The phenylalanine （Phe） and thyrotropin （TSH） values in dried blood spot specimens on filter paper distributed by national center were measured by fluorometric method and time - resolved fluorescence im- munoassay （DELFIA） respectively. The results sent by national center were analyzed. Results In the 90 specimens of 18 batches, the bias range of Phe and TSH measurement was wide （ -62.50% -66.67% and -66.67% -54.31% respectively） and their average values were 8.62% and 10.18% respectively; 85 quantitative results of Phe and 84 quantitative results of TSH measurement were in the quality control, accounting for 94. 44% and 93.33 % respective- ly. The qualitative analysis of 90 Phe and TSH specimens all conformed to the expected results, accounting for 100%. The result of every batch was up to 80%. Conclusion Our neonatal screening laboratory is in control and it is useful to evaluate the measurement competence, find out the problems in the Phe and TSH measurement and re- solve them in time through participated in the national EQA in neonatal screening laboratory, so as to improve the quality of t and ensure the accuracy and reliability of results