新生儿遗传代谢病筛查室间质量评价5年回顾

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

目的分析昆明医科大学第一附属医院新筛中心2013年至2017年参加卫生部临床检验中心新生儿遗传代谢病筛查的实验室室间质量评价结果,总结实验过程中的问题。方法采用荧光法对室间质评标本的苯丙氨酸(Phe)和葡萄糖-6-磷酸脱氢酶(G6PD)进行检测,采用时间分辨荧光免疫分析法(DELFIA)对室间质评标本进行促甲状腺激素(TSH)检测,并对反馈结果进行总结分析。结果 5年共接受卫生部临床检验中心分发的TSH、Phe 15批次共计75份质评标本,G6PD 13批次共计65份质评标本。Phe定量偏倚范围-30.00%~45.00%,相对偏倚平均值14.00%;TSH定量偏倚范围-21.41%~34.92%,相对偏倚平均值11.56%;G6PD定量偏倚范围-23.33%~45.38%,相对偏倚平均值9.53%。分别有5份Phe、2份TSH和5份G6PD测定结果失控(偏倚≥30%或≤-30%),符合率分别是Phe 93.33%(70/75)、TSH 97.33%(73/75)、G6PD 92.31%(60/65)。Phe、TSH、G6PD分别有1份标本定性判断未通过,符合率分别是Phe 98.67%(74/75)、TSH 98.67%(74/75)、G6PD 98.46%(64/65)。所有项目评分结果均大于80%。结论实验室的室间质评结果均在控;接受卫生部临床检验中心对Phe、TSH和G6PD的实验室检测质量监控,能客观评估实验室的检测能力,及时发现问题,不断提高检测质量,保证筛查结果的准确性。

Objective To review the results of national external quality assessment（EQA）from the Ministry of Health clinical laboratory center in neonatal screening laboratory from 2013 to 2017 and summarize the problems in the screening measurement.Methods The phenylalanine（Phe）,glucose-6-phosphate dehydrogenase（G6 PD）and thyroid-stimulating hormone（TSH）values external quality assessment specimens were measured by fluorometric method and Dissociation Ehanced Lanthanide Fluoroimmunoassay（DELFIA）respectively,and the results sent by national center for clinical laboratory were analyzed.Results In5 years,there were 75 specimens of 15 batches of TSH and Phe,65 specimens of 13 batches of G6 PD in total.The bias ranges of Phe,TSH and G6 PD measurement were-30.00%-45.00%,-21.41%-34.92% and-23.33%-45.38%,respectively,and their bias average values were 14.00%,11.56% and 9.53%,respectively.Five quantitative results of Phe measurement,two quantitative results of TSH measurement and five quantitative results of G6 PD measurement were out of control（bias of or over30% or no more than-30%）.Their coincidence rate was 93.33%（70/75）,97.33%（73/75）and 92.31%（60/65）in Phe,TSH and G6 PD,respectively.There was one specimen not passing qualitative estimation in specimens of Phe,TSH and G6 PD,and their coincidence rate was 98.67%（74/75）,98.67%（74/75）and G6 PD 98.46%（64/65）,respectively.The result of every batch was up to 80%.Conclusion The results of laboratory quality assessment are within the control.Participating in the national external quality assessment（EQA）will help to assess the laboratory＇s ability to test and to detect some problems,so as to improve the quality of testing to ensure the accuracy of screening results.