检验医学 ›› 2026, Vol. 41 ›› Issue (5): 470-475.DOI: 10.3969/j.issn.1673-8640.2026.05.009

• 论著 • 上一篇    下一篇

2024年全国子痫前期筛查室间质量调查结果分析

陈星彤, 张津铭, 王薇, 钟堃, 袁帅, 杜雨轩, 何法霖()   

  1. 北京医院国家老年医学中心 国家卫生健康委临床检验中心 老年疾病国家临床医学研究中心 国家卫生健康委老年医学重点实验室 中国医学科学院老年医学研究院,北京 100730
  • 收稿日期:2024-03-18 修回日期:2026-01-04 出版日期:2026-05-30 发布日期:2026-05-29
  • 通讯作者: 何法霖,E-mail:hefalin@126.com。
  • 作者简介:陈星彤,女,2001年生,硕士,主要从事产前筛查质量评价工作。
  • 基金资助:
    国家重点研发计划(2021YFC1005304)

External quality assessment result analysis of preeclampsia screening in China,2024

CHEN Xingtong, ZHANG Jinming, WANG Wei, ZHONG Kun, YUAN Shuai, DU Yuxuan, HE Falin()   

  1. National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology; National Clinical Research Center for Gerontology; Key Laboratory of Geriatrics of National Health Commission; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences,Beijing 100730,China
  • Received:2024-03-18 Revised:2026-01-04 Online:2026-05-30 Published:2026-05-29

摘要:

目的 分析2024年全国子痫前期筛查室间质量调查结果,评估临床实验室胎盘生长因子(PlGF)和可溶性血管内皮生长因子受体-1(sFlt-1)检测能力,为提高和优化子痫前期筛查质量提供参考。方法 收集2024年国家卫生健康委临床检验中心(简称临检中心)PlGF和sFlt-1项目室间质量调查结果。临检中心向全国139家产前筛查实验室发放5个批号的质控样本,要求参评实验室上报检测结果、使用的检测方法、设备等相关信息。结果 有120家(86.3%)回报PlGF结果,其中113家(94.2%)检测结果合格,不合格率为5.8%(7/120);7家不合格实验室中,有1家质控样本检测结果存在正、负偏移(2个批号显示负向偏移,1个批号显示正向偏移),其他6家检测结果均偏向同一侧(3家2~4个批号显示负向偏移,3家2~3个批号显示正向偏移)。有89家(64.0%)实验室回报sFlt-1结果,其中84家(94.4%)检测结果合格,不合格率为5.6%(5/89);5家不合格实验室质控样本的检测结果均为正向偏移。结论 目前仍有一定比例的临床实验室PlGF和sFlt-1项目检测能力不符合要求,建议在子痫前期筛查中,将PlGF和sFlt-1项目纳入正式的室间质量评价计划,以建立全面的质控体系,确保检测结果的准确和可靠。

关键词: 胎盘生长因子, 可溶性血管内皮生长因子受体-1, 子痫前期, 质量控制, 产前诊断

Abstract:

Objective To analyze the external quality assessment results during the national screening for preeclampsia in 2024,and to evaluate the determination capabilities of clinical laboratories for placental growth factor (PlGF) and soluble Fms-like tyrosine kinase-1(sFlt-1),in order to provide a reference for improving and optimizing the quality of preeclampsia screening. Methods The external quality assessment results of PlGF and sFlt-1 projects conducted by the National Center for Clinical Laboratories in 2024 were collected. The 5 batches of quality control samples distributed by the National Center for Clinical Laboratories to 139 prenatal screening laboratories were required to report the determination results,the used methods,equipments and other relevant information. Results Totally,120 laboratories(86.3%)reported PlGF results,among which 113 laboratories(94.2%)met the qualified standards,with an unqualified rate of 5.8%(7/120). Among the 7 unqualified laboratories,1 laboratory had positive and negative deviations in the determination results of the quality control samples(2 batches showed negative deviation and 1 batch showed positive deviation),and the other 6 laboratories had deviation in the same direction(3 laboratories showed negative deviation for 2 to 4 batches;3 laboratories showed positive deviation for 2 to 3 batches). Totally,89 laboratories(64.0%) reported sFlt-1 results,among which 84 laboratories (94.4%) met the qualified standards,with an unqualified rate of 5.6% (5/89). The determination results of the quality control samples in the 5 unqualified laboratories all showed deviation in the same direction (all positive deviation). Conclusions Currently,a certain proportion of laboratories still do not meet the requirements for PlGF and sFlt-1 determination capabilities. It is recommended to include the PlGF and sFlt-1 projects in the formal external quality assessment to establish a comprehensive quality control system to ensure the accuracy and reliability of the determination results.

Key words: Placental growth factor, Soluble Fms-like tyrosine kinase-1, Preeclampsia, Quality control, Prenatal diagnosis

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