Validation of a new kit for preeclampsia screening: A comprehensive analysis
Min Zhu,
Jumei Liu,
Jiali Cao,
Yan Ni,
Mengqi Chang,
Ruitong Chen,
Zhiying Su,
Weiwei Yu,
Huiming Ye
Affiliations
Min Zhu
Department of Laboratory Medicine, Fujian Key Clinical Specialty of Laboratory Medicine, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China
Jumei Liu
Department of Laboratory Medicine, Fujian Key Clinical Specialty of Laboratory Medicine, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China
Jiali Cao
Department of Laboratory Medicine, Fujian Key Clinical Specialty of Laboratory Medicine, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China
Yan Ni
Department of Obstetrics, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China
Mengqi Chang
School of Public Health, Xiamen University, Xiamen, China
Ruitong Chen
School of Public Health, Xiamen University, Xiamen, China
Zhiying Su
Department of Obstetrics, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China
Weiwei Yu
Department of Obstetrics, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China; Corresponding author. Department of Obstetrics, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, 361003, China.
Huiming Ye
Department of Laboratory Medicine, Fujian Key Clinical Specialty of Laboratory Medicine, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China; Corresponding author. Department of Clinical Laboratory, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, 361003, China.
Objectives: Preeclampsia is a common pregnancy complication that significantly contributes to maternal mortality, perinatal mortality, and preterm delivery. The sFlt-1/PlGF (fms-like tyrosine kinase-1/placental growth factor) ratio has demonstrated robust diagnostic value for preeclampsia. This study assessed the analytical performance and diagnostic accuracy of a novel quantitative determination kit for sFlt-1 and PlGF for the diagnosis of preeclampsia. Methods: The detection performance of the test kit was validated using the Center for Medical Device Evaluation (CMDE) and Clinical and Laboratory Standards Institute (CLSI) documents. The test results were compared to those of the Elecsys immunoassay (Roche Diagnostics). Independent discovery and validation sets were used to analyze the diagnostic efficacy of the preeclampsia kit. The area under the curve (AUC) for preeclampsia at different gestational ages was calculated. Results: Correlation analysis between the test and Roche kits revealed a strong concordance (sFlt-1: r = 0.9966, P < 0.0001; PlGF: r = 0.9935, P < 0.0001). The AUCs for sFlt-1, PlGF, and the sFlt-1/PlGF ratio in diagnosing preeclampsia were 0.749, 0.795, and 0.834, respectively, in the discovery set and 0.729, 0.811, and 0.831, respectively, in the validation set. The corresponding results from the Roche kit were 0.741, 0.795, and 0.829, respectively, and 0.761, 0.864, and 0.844, respectively. Conclusions: Quantitative sFlt-1 and PlGF kits exhibited high levels of consistency with the Roche kits in terms of quantitative outcomes and diagnostic performance for preeclampsia.
