External quality assessment and internal quality control analysis of maternal serum prenatal screening in first trimester
10.3760/cma.j.issn.1007-9408.2015.08.016
- VernacularTitle:全国妊娠早期母血清学筛查的室间质量评价和室内质量控制结果分析
- Author:
Falin HE
;
Wei WANG
;
Kun ZHONG
;
Yan ZHANG
;
Yan ZHAO
;
Guohua LI
;
Zhiguo WANG
- Publication Type:Journal Article
- Keywords:
Pregnancy trimester,first;
Prenatal diagnosis;
Serologic tests;
Quality control
- From:
Chinese Journal of Perinatal Medicine
2015;18(8):621-624
- CountryChina
- Language:Chinese
-
Abstract:
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 cumulative CV of in control quality control results for PAPP-A were less than 5％ respectively.Conclusions There are differences of the testing quality for first trimester maternal serum prenatal screening in China.EQA and IQC can help laboratories to find problems,improve quality and maintain the testing consistency.
