【摘要】 目的:通过分析同一地区筛查标本量相近的两家单位的筛查结果,探讨采血质量对先天性甲状腺功能低下症(congenital hypothyroidism,CH)结果假阳性的影响。方法:选取某地区A、B两家单位2006~2013年共93 387例新生儿为研究对象,于新生儿出生72 h经充分哺乳后,采集足跟血,制成干血片,递送至新生儿疾病筛查中心实验室通过时间分辨荧光免疫分析法(DEFLIA)检测血促甲状腺激素(thyroid stimulating hormone,TSH)值,对于TSH≥9 m U/L的可疑病例立即召回复检并确诊。结果:2006~2013年该地区A单位新生儿筛查标本总数为49 660例,初筛阳性1 408例,确诊26例,发病率为0.524‰,假阳性率为98.15%。B单位新生儿筛查标本总数为43 727例,初筛阳性331例,确诊17例,发病率为0.389‰,假阳性率为94.86%。两家单位初筛阳性率比较差异有统计学意义(χ2=549.59,P<0.05);新生儿发病率比较差异无统计学意义(χ2=0.92,P>0.05);新生儿假阳性率比较差异有统计学意义(χ2=10.70,P<0.05)。结论:通过对该地区93 387例新生儿筛查结果的分析认识到采血环节的重要性,为今后筛查工作中降低假阳性率和制定本实验室的切值提供参考依据。更多还原

【Abstract】 Objective: To explore the effect of quality of blood collection on screening result of congenital hypothyroidism( CH) by analyzing the screening results of CH in two medical institutions with the similar quantity of samples in the same area. Methods: A total of93 387 neonates from A and B medical institutions in a region from 2006 to 2013 were selected as study respondents,after 72 hours after birth and fully breastfeeding,heel blood samples were collected to prepare dried blood spots,blood thyroid stimulating hormone( TSH) levels were detected by time- resolved fluorescence immunoassay( DEFLIA) in laboratory of Neonatal Screening Center,the suspected neonates with TSH ≥ 9 m U / L were recalled immediately for definite diagnosis. Results: A total of 49 660 neonates in A institution were screened from 2006 to 2013,1 408 neonates were positive in preliminary screening,and 26 neonates were diagnosed definitely,the incidence rate of CH was 0. 524‰,the false positive rate was 98. 15%. A total of 43 727 neonates in B institution were screened from 2006 to 2013,331 neonates were positive in preliminary screening,and 17 neonates were diagnosed definitely,the incidence rate of CH was 0. 389‰,the false positive rate was 94. 86%. There was statistically significant difference in the positive rate of preliminary screening between A institution and B institution( χ2= 549. 59,P < 0. 05); there was no statistically significant difference in the incidence rate of CH between A institution and B institution( χ2= 0. 92,P > 0. 05); there was statistically significant difference in the false positive rate between A institution and B institution( χ2= 10. 70,P < 0. 05). Conclusion: Through analyzing the screening results of 93 387 neonates in the region,the importance of blood collection is recognized,which provides reference basis for reducing false positive rate in screening work in the future and making the cut- off value of the laboratory.更多还原