摘要
目的分析2018年中孕期母体血清产前筛查抑制素A检测室间质量调查结果,以改进和提高产前筛查实验室抑制素A检测的质量。方法卫生部临床检验中心于2018年3月向全国94家产前筛查实验室发放3个批号质控样本(批号201811~201813)。实验室自愿参加此次调查活动,并按照规定格式上报结果、测定方法、仪器和试剂等相关信息。采用Clinet EQA程序和Microsoft Excel 2010等软件,对各实验室检测结果进行统计分析,并对质控样本是否符合预期结果情况进行描述性评价。结果共有55家实验室回报结果,回报率为58.5%(55/94)。55家中,52家(94.5%)3个批号全部符合预期结果,3家(5.5%)3个批号均不符合预期结果,且各实验室3个批号质控样本检测结果的偏移均位于同一侧(2家所有的3个批号均为负向偏移,1家3个批号的检测结果均为正向偏移)。结论通过本次抑制素A检测室间质量调查结果发现大部分实验室均能获得满意的结果,但仍有部分实验室存在与预期不符合的结果。有必要将中孕期母血清产前筛查抑制素A纳入为正式的室间质量评价计划,定期监测其检测质量水平。
Objective To evaluate the external quality assessment results of prenatal screening for maternal serum inhibin A in the second trimester in 2018 and to improve the accuracy of prenatal screening. Methods National Center for Clinical Laboratories provided three batches of quality control urine sample (Lot: 201811-201813) to 94 prenatal screening laboratories nationwide in March 2018. Laboratories participated in the assessment voluntarily and reported the results, methods, equipment, reagents and other related information as required. Clinet EQA and Microsoft Excel 2010 were used for statistical analysis of the laboratory test results and for descriptive evaluation of the accuracy rate. Results A total of 55 laboratories submitted their testing results giving a return rate of 58.5%(55/94), of which 52 (94.5%) were consistent with the expected results, while none of the results submitted by the other three laboratories was accurate. At the mean time, the bias of all three batches in each laboratory fell into the same side (two laboratories showed negative bias and one positive bias). Conclusions The results of the external quality assessment of prenatal screening for maternal serum inhibin A are generally satisfactory except for a few laboratories. It is necessary to incorporate prenatal screening for maternal serum inhibin A in the second trimester into the formal external quality assessment plan and regularly monitor the level of its detection quality.
作者
杜雨轩
冯健明
王薇
何法霖
钟堃
袁帅
刘佳丽
张志新
王治国
Du Yuxuan;Feng Jianming;Wang Wei;He Falin;Zhong Kun;Yuan Shuai;Liu Jiali;Zhang Zhixin;Wang Zhiguo(National Center of Gerontology, Beijing Hospital/National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China;Guangzhou Fenghua Bio-engineering Co., LTD, Guangzhou 510730, China)
出处
《中华围产医学杂志》
CAS
CSCD
北大核心
2019年第5期341-344,共4页
Chinese Journal of Perinatal Medicine
关键词
抑制素类
产前诊断
临床实验室技术
质量控制
妊娠中期
Inhibins
Prenatal diagnosis
Clinical laboratory techniques
Quality control
Pregnancy trimester, second
