Intended Use

LEPZI ® Quanti PLGF/sFlt-1 Test is a fluorescence immunoassay for the quantitative determination of soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PLGF) in EDTA anticoagulated whole blood or plasma specimens.

The test is intended for use as an aid in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical information, as an aid in short-term prediction of preeclampsia (rule-out and rule-in) in pregnant women with suspicion of preeclampsia in conjunction with other diagnostic and clinical information.

Clinical Application

Predict of early-onset severe preeclampsia

Evaluate placental dysfunction

Identify early onset preeclampsia

Risk stratification and surveillance in early-onset preeclampsia

Screening and monitoring for fetal growth restriction

Specification

Test  Analyte: PLGF/sFlt-1

Specimen: EDTA anticoagulated human whole blood and plasma specimens

Reaction Time: 15 minutes in Single Cartridge Mode, 55 seconds in Multi Cartridge Mode

Storage: 2~8°C

Registration: NMPA

Advantages 

Fully Enclosed Test Area - Stable and reliable reaction

Ultrasonic Welded Seal - Tightly sealed and high precision

Easy to Use - No sample dilution and preparation