荷兰Delfia Xpress系统与AutoDelfia系统在游离β-人绒毛膜促性腺激素（游离β-hCG）和妊娠相关血浆蛋白A（PAPP-A）分析方面的性能比较

Performance of free beta-human chorionic gonadotrophin (free beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) analysis between Delfia Xpress and AutoDelfia systems in The Netherlands.

作者信息

Linskens Ingeborg H, Levitus Marieke, Frans Anneke, Schielen Peter C J I, van Vugt John M G, Blankenstein Marinus A, Dijstelbloem Hilde M

机构信息

Department of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, The Netherlands.

出版信息

Clin Chem Lab Med. 2009;47(2):222-6. doi: 10.1515/CCLM.2009.042.

DOI:10.1515/CCLM.2009.042

PMID:19191730

Abstract

BACKGROUND

The VU University Medical Center (VUmc) was the first hospital in the Netherlands to introduce the Delfia Xpress for the analysis of free beta-human chorionic gonadotrophin (beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) in the first trimester screening program for Down syndrome. Since then, others have implemented this system. In this study, we tested the equality of measurements for free beta-hCG and PAPP-A between Delfia Xpress systems and one AutoDelfia system.

METHODS

A total of 40 serum samples were aliquoted and stored at -20 degrees C. Samples were analyzed by six Delfia Xpress systems and one AutoDelfia system over a time period of 2 years.

RESULTS

The relationships between free beta-hCG and PAPP-A were excellent for the different Delfia Xpress systems (r>0.99, p<0.0001). For PAPP-A, the agreement between the main system at VUmc and five other systems was linear with slopes between 0.99 and 1.06. Similarly, agreement for free beta-hCG was linear with slopes between 0.99 and 1.09. Likewise, agreement for PAPP-A and free beta-hCG was excellent for the AutoDelfia vs. the main Delfia Xpress at the VUmc (r>0.99, p<0.0001). For both PAPP-A and free beta-hCG, the relationships were linear with slopes of 1.08 and 1.07.

CONCLUSIONS

We demonstrate an excellent agreement for the analysis of PAPP-A and free beta-hCG between Delfia Xpress systems and one AutoDelfia system.

摘要

背景

阿姆斯特丹自由大学医学中心（VUmc）是荷兰第一家引入Delfia Xpress用于在唐氏综合征孕早期筛查项目中分析游离β-人绒毛膜促性腺激素（β-hCG）和妊娠相关血浆蛋白A（PAPP-A）的医院。自那时起，其他机构也采用了该系统。在本研究中，我们测试了Delfia Xpress系统和一台AutoDelfia系统之间游离β-hCG和PAPP-A测量结果的一致性。

方法

总共40份血清样本被分装并储存在-20℃。在2年的时间里，由6台Delfia Xpress系统和1台AutoDelfia系统对样本进行分析。

结果

不同Delfia Xpress系统之间游离β-hCG和PAPP-A的相关性非常好（r>0.99，p<0.0001）。对于PAPP-A，VUmc的主要系统与其他5个系统之间的一致性呈线性，斜率在0.99至1.06之间。同样，游离β-hCG的一致性也呈线性，斜率在0.99至1.09之间。同样，对于AutoDelfia与VUmc的主要Delfia Xpress系统，PAPP-A和游离β-hCG的一致性也非常好（r>0.99，p<0.0001）。对于PAPP-A和游离β-hCG，两者的关系均呈线性，斜率分别为1.08和1.07。