使用sFlt-1/PlGF比值诊断子痫前期和胎儿生长受限：全自动免疫分析系统Kryptor®的诊断准确性
Diagnosis of preeclampsia and fetal growth restriction with the sFlt-1/PlGF ratio: Diagnostic accuracy of the automated immunoassay Kryptor®.
作者信息
Dröge Lisa Antonia, Höller Alice, Ehrlich Laura, Verlohren Stefan, Henrich Wolfgang, Perschel Frank Holger
机构信息
Department of Obstetrics, Charité Universitätsmedizin Berlin, Germany.
Department of Obstetrics, Charité Universitätsmedizin Berlin, Germany.
出版信息
Pregnancy Hypertens. 2017 Apr;8:31-36. doi: 10.1016/j.preghy.2017.02.005. Epub 2017 Mar 1.
OBJECTIVE
We aimed to characterize the diagnostic accuracy of the Kryptor® assay for sFlt-1 and PlGF in maternal serum samples of uneventful singleton pregnancies and subjects with preeclampsia (PE) and PE-related outcomes such as fetal growth restriction (FGR). Longitudinal reference ranges of the sFlt-1 and PlGF level in the course of normal pregnancies were generated.
METHODS
A cohort of subjects with PE and PE-related outcomes including FGR in the third trimester was compared to a cohort of women with uneventful outcome. Serum levels of sFlt-1, PlGF level as well as the sFlt-1/PlGF ratio was analysed with the Kryptor® assay and compared between the case- and control groups. Cut-off values were generated and diagnostic accuracy examined.
RESULTS
Longitudinal reference ranges of the sFlt-1 and PlGF level in healthy pregnancies were in line with those levels measured with other immunoassays. Comparison of the sFlt-1/PlGF ratio between PE-related outcomes including FGR or PE and healthy controls showed a high diagnostic accuracy with an area under the curve (AUC) of 0.917 for PE-related outcomes and 0.919 for PE.
目的
我们旨在评估Kryptor®检测法检测单胎妊娠结局正常的孕妇血清样本以及子痫前期（PE）患者血清样本中可溶性血管内皮生长因子受体-1（sFlt-1）和胎盘生长因子（PlGF）的诊断准确性，以及与PE相关的结局，如胎儿生长受限（FGR）。我们还生成了正常妊娠过程中sFlt-1和PlGF水平的纵向参考范围。
方法
将一组患有PE及包括孕晚期FGR在内的PE相关结局的受试者与一组妊娠结局正常的女性进行比较。采用Kryptor®检测法分析血清sFlt-1水平、PlGF水平以及sFlt-1/PlGF比值，并在病例组和对照组之间进行比较。确定临界值并检验诊断准确性。
结果
健康妊娠中sFlt-1和PlGF水平的纵向参考范围与其他免疫检测法测得的水平一致。PE相关结局（包括FGR或PE）与健康对照之间的sFlt-1/PlGF比值比较显示，诊断准确性较高，PE相关结局的曲线下面积（AUC）为0.917，PE的曲线下面积为0.919。
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