Lumipulse G HE4 Immunoreaction Cartridges:
Product # 234174
Lumipulse G HE4 Calibrators:
Product # 234181
For in vitro diagnostic use.
Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of HE4 in human serum and plasma (lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.
The assay is to be used as an aid in monitoring recurrence or progressive disease in patientswith epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring epithelial ovarian cancer.