Diagnosis of preeclampsia and fetal growth restriction with the sFlt-1/P1GF ratio: Diagnostic accuracy of the automated immunoassay Kryptor®

Objective: We aimed to characterize the diagnostic accuracy of the Kryptor (R) assay for sFlt-1 and PIGF 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 PIGF 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, P1GF level as well as the sFlt-1/PIGF ratio was analysed with the Kryptor (R) 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 PIGF level in healthy pregnancies were in line with those levels measured with other immunoassays. Comparison of the sFlt-1/PIGF 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. (C) 2017 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.