新型“产前风险计算（PRC）”软件的初步分析

Preliminary analysis of the new 'Prenatal Risk Calculation (PRC)' software.

作者信息

Hörmansdörfer Cindy, Scharf A, Golatta M, Vaske B, Hillemanns P, Schmidt P

机构信息

Department of Obstetrics and Gynaecology, Medical University of Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.

出版信息

Arch Gynecol Obstet. 2009 Apr;279(4):511-5. doi: 10.1007/s00404-008-0743-z. Epub 2008 Aug 13.

DOI:10.1007/s00404-008-0743-z

PMID:18704469

Abstract

OBJECTIVES

In February 2007, the "Fetal Medicine Foundation Germany (FMF-D)" introduced its new calculation software for First Trimester Screening (FTS), called "Prenatal risk calculation (PRC)". The aim of this study was to retrospectively investigate the test performance of PRC in comparison to the "NT module of the JOY software (JOY)".

METHODS

A total of 3,516 combined first trimester screenings from 11 + 0 to 13 + 6 weeks of gestation were accomplished according to the FMF-standard. Adjusted risk calculation for aneuploidy was performed with PRC and JOY.

RESULTS

A total of 2,202 complete data sets of singleton pregnancies were analyzed, including 10 trisomy 21 cases, 4 trisomy 18 cases, and 1 trisomy 13 case. Risk calculation with PRC and JOY showed highly significant results (P value<0.0001). JOY attained, at a cut-off of 1:300 (sensitivity 82.4%, false-positive rate 3.6%, positive predictive value 15.2%) and at a cut-off of 1:230 (82.4, 2.4, 21.2%), a better test performance in comparison to PRC (76.5, 7.1, 7.7% and 76.5, 5.3, 10.2%, respectively). The differences were highly significant (P value<0.0001).

CONCLUSION

In this preliminary study, PRC demonstrated highly significant results in detecting aneuploidies in FTS. However, in comparison to JOY, its test performance was significantly inferior. A twice higher false positive rate would have doubled unnecessary invasive testing in a prospective setting. We therefore recommend a methodical revision of PRC.

摘要

目的

2007年2月，“德国胎儿医学基金会（FMF-D）”推出了用于孕早期筛查（FTS）的新计算软件，名为“产前风险计算（PRC）”。本研究的目的是回顾性调查PRC与“JOY软件的NT模块（JOY）”相比的检测性能。

方法

根据FMF标准，共完成了3516例孕11 + 0至13 + 6周的联合孕早期筛查。使用PRC和JOY对非整倍体进行调整后的风险计算。

结果

共分析了2202例单胎妊娠的完整数据集，包括10例21三体病例、4例18三体病例和1例13三体病例。PRC和JOY的风险计算结果显示出高度显著差异（P值<0.0001）。与PRC相比（分别为76.5%、7.1%、7.7%和76.5%、5.3%、10.2%），JOY在截断值为1:300（灵敏度82.4%，假阳性率3.6%，阳性预测值15.2%）和截断值为1:230（82.4%、2.4%、21.2%）时表现出更好的检测性能。差异高度显著（P值<0.0001）。