摘要
目的 分析妊娠早期母血清学产前筛查的室间质量评价和室内质量控制结果,探讨提高筛查质量的方法. 方法 在2013年5月和10月参加卫生部临床检验中心的妊娠早期母血清学筛查室间质量评价的实验室中,根据所采用试剂,分为珀金埃尔默（PerkinElmer,PE）组（n=44）和罗氏组（n=14）.每次向各实验室发放5个批号的人血清质量控制样本,检测游离β-人绒毛膜促性腺激素（β-human chorionic gonadotropin,β-hCG）、妊娠相关血浆蛋白A（pregnancy-associated plasma proteinA,PAPP-A）,计算每一批号检测结果的M、P25和P75,稳健变异系数=[0.7413×（P75-P25）]/M×100％.如果某个实验室每次室间质量评价,5个批号的检测结果中,均有4个及以上批号的检测结果在M（1±30％）范围内,判定该实验室合格.各实验室回报2013年5月的在控变异系数和累积在控变异系数. 结果 （1）室间质量评价结果：不同批号之间,游离β-hCG采用PE试剂和罗氏试剂检测的稳健变异系数分别为5.0％-7.2％和9.5％-188.4％.PAPP-A采用PE试剂和罗氏试剂检测的稳健变异系数分别为6.4％-116.9％和10.5％-165.3％.2次室间质量评价游离β-hCG合格的实验室占94.8％（55/58）,PAPP-A合格的实验室占75.8％ （44/58）.（2）室内质量控制结果：回报了游离β-hCG和PAPP-A室内质量控制数据的实验室分别为28和26个.2013年5月在控变异系数与累积在控变异系数＜5％的实验室比例,游离β-hCG分别为55.1％（18/28）和50.0％（14/28）,PAPP-A分别为57.7％（15/26）和50.0％（13/26）. 结论 目前我国妊娠早期母血清学产前筛查的检测质量存在差异.开展室间质量评价和室内质量控制,有利于帮助实验室发现问题,提高检测水平,保证检测结果的一致性.
Objective To analyze the results of external quality assessment （EQA） and internal quality control （IQC） of first trimester maternal serum prenatal screening,and to investigate methods to improve the quality of prenatal screening.Methods Based on the reagent,laboratories which participated in the EQA project by National Center for Clinical Laboratories in May and October in 2013 were divided into PerkinElmer （PE） group （n=44） and Roche group （n=14）.Five human serum quality control samples were distributed to each laboratory in every session to test free β-human chorionic gonadotropin （β-hCG） and pregnancy associated plasma protein A （PAPP-A）.The M,P75 and P25 of each sample were calculated.The robust coefficient of variation （CV） was defined as [0.7413 × （P75-P25）]/M× 100%.In five samples of each EQA session,if the results of four or more samples were within the M （1± 30%）,the laboratory passed the session.If the laboratory passed both sessions,the laboratory passed the EQA project of 2013.The CV of in control quality control and cumulative CV of in control quality control results in May 2013 session were gathered.Results （1） Results of EQA：The robust CVs of all samples of two sessions were 5.0%-7.2% for free β-hCG in PE group,and 9.5%-188.4% in Roche group.The robust CVs were 6.4%-116.9% for PAPP-A in PE group,and 10.5%-165.3% in Roche group.Fifty five （94.8%,55/58） laboratories passed the EQA project of 2013 for free β-hCG.Forty four （75.8%,44/58） laboratories passed the EQA project of 2013 for PAPP-A.（2） Results of IQC：Twenty eight and twenty six laboratories reported IQC results for free β-hCG and PAPP-A respectively.In eighteen （55.1%,18/28） and fourteen （50.0%,14/28） laboratories,the CV of in control quality control and cumulative CV of in control quality control results for free β-hCG were less than 5% respectively.In Fifteen （57.7%,15/26） and thirteen （50.0%,13/26） laboratories,the CV of in control quality control and cum
出处
《中华围产医学杂志》
CAS
CSCD
2015年第8期621-624,共4页
Chinese Journal of Perinatal Medicine
基金
北京市自然科学基金（7143182）
关键词
妊娠初期
产前诊断
血清学试验
质量控制
Pregnancy trimester, first
Prenatal diagnosis
Serologic tests
Quality control
