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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-22.22%~40.00%之间,相对偏倚平均值为6.87%;TSH测定结果偏倚分布范围在-66.67%~66.67%之间,相对偏倚平均值为8.70%。75份phe质评样本中,阴性20份,阳性55份,定性判断结果符合率为100%(75/75);75份TSH质评样本中,阴性29份,阳性46份,定性判断结果符合率为100%(75/75),每一批次项目评分结果均为100%,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素检测室间质量评价是临床实验室全面质量管理的重要组成部分,实验室要使自己的检测结果准确,必须及时发现和解决实验中存在的问题,确保筛查工作的质量。
Objective To review and analyze the feedback results of inter-laboratory quality assessment of newborn disease screening laboratory of Ministry of Health in the past five years and summarize the problems in the experiment. Methods The phenylalanine (phe) and thyrotropin (TSH) values of each batch of quality evaluation samples distributed by the Clinical Laboratory of Ministry of Health were detected by fluorescence and time-resolved fluorescence immunoassay (DELFIA) The results of the summary analysis. Results A total of 75 quality assessment samples from 15 batches distributed by the Clinical Laboratory of the Ministry of Health over the past 5 years were obtained. The distribution of phe was between -22.22% and 40.00%, and the average relative bias was 6.87%. The TSH was biased Distribution range between -66.67% ~ 66.67%, the average relative bias of 8.70%. Among 75 samples of phe quality evaluation, 20 were negative and 55 were positive. The coincidence rate of qualitative judgment was 100% (75/75). Among 75 TSH samples, 29 were negative and 46 were positive. The results of qualitative judgment were consistent The rate was 100% (75/75). Each batch of items scored 100% and the inter-room quality evaluation passed. Conclusion To participate in the National Neonatal Screening Laboratory phenylalanine and thyroid stimulating hormone testing room quality assessment is an important part of the total quality management of clinical laboratories, laboratories to make their own test results accurate, we must promptly find and solve Problems in the experiment to ensure the quality of screening work.