摘要
目的对全自动免疫分析仪检测全血纸片促甲状腺素(TSH)进行分析性能验证,并探讨其筛查新生儿先天性甲状腺功能低下症的初步临界值。方法根据美国临床和实验室标准化协会(CLSI)文件及参考国际标准化组织(ISO)15189相关要求,采用标准品、美国CDC室间质评样本对TSH精密度、正确度进行验证,采用平均斜率法评价线性;检测2017年1月-6月经临床明确诊断的792例新生儿全血纸片样本和该时间段随机抽取的735例新筛查样本的TSH水平,综合ROC曲线和百分位数分析初步确定其临界值。结果标准品变异系数(CV)均低于厂家声明的CV;CDC室间质评标本TSH的检测值与靶值的偏倚均符合允许范围;线性检测结果斜率为1.027,相关系数为0.999,仪器检测线性良好。TSH为7.495μU/ml时,ROC曲线下面积最大,为0.990;735例新筛查样本的TSH 99百分位数结果为6.67μU/ml,99.5百分位数为7.3μU/ml。结论 GSP全自动免疫分析仪检测全血纸片TSH时精密度、准确度、线性通过性能验证,均符合临床检验的要求,初步确定GSP检测本地区新生儿全血纸片TSH临界值为7.0μU/ml。
Objective To analyze the performance of GSP automated immunoassay analyzer for detecting peripheral blood Thyrotropin(TSH) with filter paper in neonatal screening and discuss its initial cut-off value. Methods According to the clinical and Laboratory Standards Institute(CLSI) international standard documents and refer to The International Standard Organization(ISO) 15189, the precision and accuracy of GSP automated immunoassay analyzer for detecting TSH were verified with standards and American CDC interventricular quality assessment specimen, linearity range of TSH were analyzed and verified by mean slope method. The TSH levels of 792 neonatal blood paper samples and 735 new screening samples randomly selected from January 2017 to June were detected, and the cut-off value was preliminarily established by ROC curve and percentile analysis. Results The variation coefficients(CV) of TSH were lower than the manufacturer declared. The detected bias of TSH and the target value were in line with the allowable range. The value of slope was 1.027(r=0.999), showing good linearity. When the TSH was 7.495 μU/ml, the area under the ROC curve was the largest at 0.990;the 99 percentile of TSH of the 735 new screening samples was 6.67 μU/ml and the 99.5 percentile was 7.3 μU/ml. Conclusion The precision, accuracy and linearity range of GSP automatic immunoassay analyzer in the detection of TSH passed the performance verification, and were in line with the requirements of clinical examination. It was preliminarily determined that the cut-off value of TSH for whole blood plasma of newborns in Ningbo region was 7.0 μU/ml.
作者
庄丹燕
潘婕文
王飞
潘小莉
葛丽莎
ZHUANG Dan-yan;PAN Jie-wen;WANG Fei;PAN Xiao-li;GE Li-sha(Ningbo Municipal Key Laboratory of Comprehensive Prevention and Treatment of Birth Defects,Ningbo Women and Childrens Hospital,Ningbo、Zhejiang 315012,China)
出处
《中国卫生检验杂志》
CAS
2019年第23期2870-2872,2875,共4页
Chinese Journal of Health Laboratory Technology
基金
生殖医学品牌学科(PPXK2018-06)
宁波市自然基金(2019A610378)
