Comparison of the Status of Internal Quality Control and Industry Standard of Different Platforms for Second Trimester Prenatal Screening in China
10.3969/j.issn.1671-7414.2018.05.041
- VernacularTitle:我国中孕期产前筛查不同检测系统室内质量控制现状与行业标准的比较
- Author:
Fa-Lin HE
1
;
Wei WANG
;
Kun ZHONG
;
Shuai YUAN
;
Yu-Xuan DU
;
Zhi-Guo WANG
Author Information
1. 北京医院国家老年医学中心卫生部临床检验中心/北京市临床检验工程技术研究中心
- Keywords:
prenatal diagnosis;
down's syndrome;
quality control
- From:
Journal of Modern Laboratory Medicine
2018;33(1):154-157,160
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyzed the differences between the status of internal quality control and industry standard of different platforms in second trimester prenatal screening,so as to provide recommendations to improve prenatal screening quality control.Methods Collected the coefficient of variation in control and accumulated coefficient of variation in control of 468 prenatal screening laboratory in September 2016,and the proportion of the laboratory that meet the industry standard and analyze the proportion of different platforms that meet the manufacturers standards and industry standards.Results For AFP,34.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 25 ％ ～ 78 ％ meet the industry standards;for total HCG,59.2％ ～81.6％ of the laboratory meeted the manufacturers standards and 24.5 ％ ～30.6％ meeted the industry standards,for free β-hCG,38.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 27.3 ％ ～ 63.0 ％ meeted the industry standards,for β-hCG,14.3％～68.8％ of the laboratory meeted the manufacturers standards and 14.3％～61.3 ％ meeted the industry standards.For uE3,19.7 ％ ～ 100％ of the laboratory meeted the manufacturers standards and 11.1~54.8％ meeted the industry standards.Conclusion Failure to meet the industry standards happens to all platforms.Prenatal screening laboratories need to pay attention to internal quality control to ensure the performance of the platforms meet the quality requirements of prenatal screening.
