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HE4 assay kit Lumipulse® G HE4 (Human epididymis protein 4)
for ovarian cancerplasmaserum

HE4 assay kit
HE4 assay kit
HE4 assay kit
HE4 assay kit
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Characteristics

Applications
for ovarian cancer
Tested parameter
HE4
Sample type
plasma, serum
Analysis mode
CLEIA

Description

From the company that brought you CA125, Fujirebio now introduces HE4, the first new biomarker in 30 years for ovarian cancer management1 Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for in vitro diagnostics (IVD) use for the quantitative measurement of HE4 (Human epididymis protein 4) in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G system. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. CE marked Lumipulse® G HE4 Immunoreaction Cartridges Product number 234068 3 × 14 Tests Lumipulse® G HE4 Calibrators Product number 234075 1 × 2 Concentrations What is HE4? Human Epididymis protein 4 (HE4), a serum biomarker, is expressed in normal epithelial tissue. HE4 is detected in high levels in the serum of ovarian cancer patients. HE4 has shown to be a stable biomarker in which levels do not change in normal physiological conditions. HE4 is not evelevated during pregnancy2 in any phases of the menstruation cycle or with hormonal treatments3 with hormonal stimulation during IVF treatment4 Importance of specific biomarker for management of gynecologic diseases Cysts are a common occurrence, especially in premenopausal women, and the majority of cysts are benign: Up to 10% of women will have some form of surgery for ovarian mass5 Preoperative differentiation between the benign and the malignant ovarian mass in the premenopausal woman is problematic6

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