Abstract:

Objective To analyze the external quality assessment results during the national screening for preeclampsia in 2024，and to evaluate the determination capabilities of clinical laboratories for placental growth factor （PlGF） and soluble Fms-like tyrosine kinase-1（sFlt-1），in order to provide a reference for improving and optimizing the quality of preeclampsia screening. Methods The external quality assessment results of PlGF and sFlt-1 projects conducted by the National Center for Clinical Laboratories in 2024 were collected. The 5 batches of quality control samples distributed by the National Center for Clinical Laboratories to 139 prenatal screening laboratories were required to report the determination results，the used methods，equipments and other relevant information. Results Totally，120 laboratories（86.3%）reported PlGF results，among which 113 laboratories（94.2%）met the qualified standards，with an unqualified rate of 5.8%（7/120）. Among the 7 unqualified laboratories，1 laboratory had positive and negative deviations in the determination results of the quality control samples（2 batches showed negative deviation and 1 batch showed positive deviation），and the other 6 laboratories had deviation in the same direction（3 laboratories showed negative deviation for 2 to 4 batches；3 laboratories showed positive deviation for 2 to 3 batches）. Totally，89 laboratories（64.0%） reported sFlt-1 results，among which 84 laboratories （94.4%） met the qualified standards，with an unqualified rate of 5.6% （5/89）. The determination results of the quality control samples in the 5 unqualified laboratories all showed deviation in the same direction （all positive deviation）. Conclusions Currently，a certain proportion of laboratories still do not meet the requirements for PlGF and sFlt-1 determination capabilities. It is recommended to include the PlGF and sFlt-1 projects in the formal external quality assessment to establish a comprehensive quality control system to ensure the accuracy and reliability of the determination results.

Key words: Placental growth factor, Soluble Fms-like tyrosine kinase-1, Preeclampsia, Quality control, Prenatal diagnosis