Analytical validation of a novel panel of biomarkers for a test for preeclampsia

Abstract

Preeclampsia is a serious condition responsible for much pregnancy-related morbidity and mortality. Diagnosis of preeclampsia is difficult due to the non-specific and subjective nature of symptoms of the disease. To reduce the subjective decision making and management of preeclampsia, we identified a panel of biomarkers representing multiple and different pathogenic pathways implicated in the etiology of preeclampsia, and developed a test referred to as Preecludia™. An algorithm based on eight biomarkers (cluster of differentiation 274 (CD274), decorin, endoglin, fibroblast growth factor-21 (FGF21), soluble fms-related tyrosine kinase 1 (sFlt-1), kidney injury molecule-1 (KIM-1), free placental growth factor (PlGF), and total PlGF) and gestational age at the time of sample collection was constructed to rule out preeclampsia in women presenting with signs and symptoms of preeclampsia. The analytical performance of each of the individual biomarker assays that comprise the Preecludia™ test was evaluated. Herein we report the test’s precision, analytical range, analytical sensitivity, parallelism, linearity, interference, analytical specificity, analytical accuracy, and stability. The data indicate that these biomarker assays exhibit a high level of inter-run precision of less than 15%, with minimal interference.