Saad Antonio F, Haas David M, Chang Eugene, Shainker Scott A, Denbo Miriah, Silasi Michelle, Saade George, Rana Sarosh, Kawakita Tetsuya, Pacheco Luis D, Powers Carson Jennifer, Dietl Angela, Allegranza Deirdre, Guo Ge, Stamilio David
Inova Maternal Fetal Medicine, Inova Health, Fairfax, VA, United States.
Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN, United States.
J Appl Lab Med. 2025 Jul 1;10(4):937-948. doi: 10.1093/jalm/jfaf063.
The serum soluble fms-like tyrosine kinase-1 (sFlt-1) to placental growth factor (PlGF) ratio is an established tool for predicting preeclampsia in many countries but is not widely adopted in the United States. This study aimed to determine reference ranges for the Elecsys® sFlt-1/PlGF ratio and the sFlt-1 and PlGF immunoassays (Roche Diagnostics International Ltd) in a diverse US population of healthy pregnant women.
This was a prospective, noninterventional sample and data collection study performed between November 2022 and November 2023 at 9 collection sites and one measurement site in the United States. Evaluable women were ≥18 years old, apparently healthy, between 23 + 0 to 40 + 6 gestational weeks with a singleton pregnancy and had one serum sample collected. Reference ranges for 23 + 0 to 40 + 6 gestational weeks and 5 gestational windows within this range were determined using a nonparametric method.
Of 818 recruited women, 561 were evaluable for the analysis and were representative of the US population in terms of self-reported race, ethnicity, and maternal age. Reference ranges for the sFlt-1/PlGF ratio, as determined by the 2.5th and 97.5th percentiles (90% CIs), were 0.9 (0.7, 1.0) to 13.5 (11.6, 14.9) for a US intended use population at 23 + 0 to 34 + 6 gestational weeks (n = 380) and 0.9 (0.7, 1.1) to 40.8 (29.0, 47.2) for the entire evaluable population at 23 + 0 to 40 + 6 gestational weeks.
Reference ranges were determined for sFlt-1/PlGF and the sFlt-1 and PlGF immunoassays in a diverse, healthy US population of pregnant women at 23 + 0 to 40 + 6 gestational weeks.
血清可溶性fms样酪氨酸激酶-1（sFlt-1）与胎盘生长因子（PlGF）的比值在许多国家是预测子痫前期的既定工具，但在美国并未广泛采用。本研究旨在确定美国不同种族健康孕妇群体中，Elecsys® sFlt-1/PlGF比值以及sFlt-1和PlGF免疫测定法（罗氏诊断国际有限公司）的参考范围。
这是一项前瞻性、非干预性样本和数据收集研究，于2022年11月至2023年11月在美国的9个采集点和1个测量点进行。可评估的女性年龄≥18岁，表面健康，单胎妊娠，孕周在23 + 0至40 + 6周之间，并采集了一份血清样本。使用非参数方法确定了23 + 0至40 + 6孕周以及该范围内5个孕周窗口的参考范围。
在818名招募的女性中，561名可用于分析，在自我报告的种族、民族和产妇年龄方面代表了美国人群。sFlt-1/PlGF比值的参考范围，由第2.5和第97.5百分位数（90%置信区间）确定，对于孕周在23 + 0至34 + 6周的美国目标使用人群（n = 380）为0.9（0.7，1.0）至13.5（11.6，14.9），对于孕周在23 + 0至40 + 6周的整个可评估人群为0.9（0.7，1.1）至40.8（29.0，47.2）。
确定了美国不同种族、健康的孕妇群体在孕周23 + 0至40 + 6周时sFlt-1/PlGF以及sFlt-1和PlGF免疫测定法的参考范围。
