Department of Women and Children's Health, King's College London, London.
Department of Women and Children's Health, King's College London, London; Guy's and St. Thomas' NHS Foundation Trust, London.
Pregnancy Hypertens. 2022 Mar;27:96-102. doi: 10.1016/j.preghy.2021.12.008. Epub 2021 Dec 23.
The objective of this study was to explore and validate thresholds for Placental growth factor (PlGF) and soluble fms-like tyrosine-kinase 1 (s-Flt-1) (as s-Flt-1: PlGF ratio), to rule-in and rule-out disease in women with suspected pre-eclampsia, using DELFIA® Xpress PlGF1-2-3 and sFlt-1 assays.
369 samples from women with suspected or confirmed pre-eclampsia were analysed from a prospective cohort study.
Serum PlGF and sFlt-1: PlGF were quantified using DELFIA® Xpress PlGF1-2-3 and DELFIA® Xpress sFlt-1 tests. Performances were evaluated at established and exploratory thresholds. Low PlGF concentration and sFlt-1: PlGF AUROC were compared.
PlGF 1-2-3 concentration thresholds were confirmed to have high performance for rule-in (<50 pg/ml) and rule-out (≥150 pg/ml) pre-eclampsia within seven days (20-33 Weeks <50 pg/ml: Negative predictive value (NPV) 90.7% (95% CI 83.9, 95.3); ≥150 pg/ml: NPV 94.8% (95% CI 88.4, 98.3)) and 28 days (20-33 Weeks <50 pg/ml: Negative predictive value (NPV) 83.9% (95% CI 76.0, 90.0); ≥150 pg/ml: NPV 92.8% (95% CI 85.7, 97.0)). Optimal sFlt-1: PlGF thresholds for rule-in were ≥ 70 before 34 weeks and ≥ 90 after 34 weeks, and <50 to rule-out pre-eclampsia. Low PlGF alone had comparable performance to sFlt-1: PlGF, but test performance for both was reduced in women with Kidney Disease.
DELFIA® Xpress PlGF1-2-3 and sFlt-1 assays for pre-eclampsia rule-in and rule-out have comparable performance to other established assays, and could be an alternative for clinical use. Performance was not enhanced by use of sFlt-1: PlGF ratio, suggesting that PlGF alone could provide a cheaper alternative to dual biomarker testing.
本研究旨在探索和验证胎盘生长因子（PlGF）和可溶性 fms 样酪氨酸激酶 1（s-Flt-1）（即 s-Flt-1:PlGF 比值）的阈值，以用于疑似子痫前期妇女的疾病确诊和排除，使用 DELFIA® Xpress PlGF1-2-3 和 sFlt-1 检测。
对前瞻性队列研究中的 369 例疑似或确诊子痫前期妇女的样本进行分析。
采用 DELFIA® Xpress PlGF1-2-3 和 DELFIA® Xpress sFlt-1 检测试剂盒定量检测血清 PlGF 和 sFlt-1:PlGF。在既定和探索性阈值下评估性能。比较低 PlGF 浓度和 sFlt-1:PlGF 的 AUROC。
证实 PlGF 1-2-3 浓度阈值在 7 天内（20-33 周 <50 pg/ml：阴性预测值（NPV）90.7%（95%CI 83.9, 95.3）；≥150 pg/ml：NPV 94.8%（95%CI 88.4, 98.3））和 28 天内（20-33 周 <50 pg/ml：NPV 83.9%（95%CI 76.0, 90.0）；≥150 pg/ml：NPV 92.8%（95%CI 85.7, 97.0））用于子痫前期的确诊和排除具有较高的性能。对于 34 周前的子痫前期确诊，最佳的 sFlt-1:PlGF 阈值为≥70，而对于 34 周后的子痫前期确诊，最佳的 sFlt-1:PlGF 阈值为≥90；对于子痫前期的排除，最佳的 sFlt-1:PlGF 阈值为<50。低 PlGF 单独与 sFlt-1:PlGF 具有相当的性能，但在患有肾脏疾病的女性中，两种方法的检测性能均降低。
DELFIA® Xpress PlGF1-2-3 和 sFlt-1 检测试剂盒用于子痫前期的确诊和排除，与其他已建立的检测方法具有相当的性能，可为临床应用提供替代方法。使用 sFlt-1:PlGF 比值并不能提高性能，这表明 PlGF 单独就可以提供比双生物标志物检测更经济的选择。
