全国新生儿疾病筛查实验室室间质量评价5年回顾

Review of China national external quality assessment for neonatal screening laboratory for 5 years

目的：回顾分析5年来参加卫生部新生儿疾病筛查实验室室间质量评价的反馈结果。总结实验过程中的问题。方法：分别采用荧光法和时间分辨荧光免疫分析法（DELFIA）对卫生部临检中心分发的各批次质评样本的苯丙氨酸（Phe）和促甲状腺激素（TSH）值进行检测，对反馈结果进行总结分析。结果：5年来共接受卫生部临检中心分发的15批次共计75份质评样本，Phe测定结果偏倚分布范围在-30．0％～33．33％之间，相对偏倚平均值为11．99％；TSH测定结果偏倚分布范围在-61．11％～105．56％之间，相对偏倚平均值为17．09％；75份质评样本中，2份Phe测定结果和9份TSH测定结果失控（偏倚≥30％或≤-30％）。失控率分别为2．7％（2／75）和12．0％（9／75）；75份Phe质评样本中。阴性19份，阳性56份。定性判断结果符合率为100％（75／75）；75份TSH质评样本中，阴性38份。阳性37份，定性判断结果出现1例假阳性，符合率为98．67％（74／75）；每一批次项目评分结果均≥80％，室间质量评价合格。结论：参加全国新生儿疾病筛查实验室苯丙氨酸和促甲状腺激素检测室间质量评价，有助于评估实验室的检测能力，及时发现和解决筛查实验过程中存在的问题，从而提高检测质量，减小实验误差。保证筛查结果的准确性。

Objective： To review the results of national external quality assessment （EQA） in neonatal screening laboratory for 5 years, and summarize the problems in the screening measurement. Methods; The phenylalanine （Phe） and thyrotropin （TSH） values in dried blood spot specimens on filter paper distributed by national center for clinical laboratory were measured by fluorometric method and time -resolved fluorescence immunoassay （DELFIA） respectively. The results sent by national center for clinical laboratory were analyzed. Results： Five specimens were distributed by EQA organizer each time, and 3 times each year. In the 75 specimens of 15 batches, the bias ranges of Phe and TSH measurement were wide and their average values were 11. 99% and 17. 09% respectively. Two quantitative results of Phe measurement and nine quantitative results of TSH measurement were out of quality control （ bias≥30% or ≤- 30% ）, accounting for2. 7% （2/75） and 12. 0% （9/75） respectively. In the 75 Phe specimens, 19 were negative and 56 were positive. The qualitative analysis of specimens conformed to the expected results （75/75）. In the 75 TSH specimens, 38 were negative and 37 were pesitive. The qualitative analysis of 74 specimens conformed to the expected results （74/75）, there was one false positive （1/75）. 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 and resolve them in time through participated in the national EQA in neonatal screening laboratory. Consequently, it is useful to improve the quality of measurement, reduce the error and ensure the accuracy of results.