Lumipulse® G HE4 (Human epididymis protein 4)

Add diagnostic clarity on gynecological cancer using the Lumipulse G series

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.

 

About HE4 - Human Epididymis protein 4

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

 

Lumipulse G HE4 Immunoreaction Cartridges:

  • Art. no.  234068 (3 × 14 Tests) - This product is not available in the USA and in Canada.

Lumipulse G HE4 Calibrators:

  • Art. no. 234075 (1 × 2 Concentrations) - This product is not available in the USA and in Canada.

 

Assay technology

CLEIA - ChemiLuminescent Enzyme Immunoassay

  • Broad dynamic assay range: 20.0-1500 pmol/L.
  • LOD: 3.5 pmol/L.
  • Precision (CV): Within run <3,5% and total precision <3,2%.
  • 25 minute incubation time on the LUMIPULSE G1200, 30 minute incubation time on the LUMIPULSE G600II.
  • 30 days calibration stability.
  • Packaging: 42 tests per kit.
  • Unique cartridge concept.

  
Test principle: Two-Step sandwich assay

 

 

References

  1. Diamandis E, et al. Cancer Biomarkers: Can we turn recent failures into success? Cancer Inst. 2010; 102;1-6.
  2. Moore RG, Miller MC, Eklund EE, et al. Serum levels of the ovarian cancer biomarker HE4 are decreased in pregnancy and increase with age. Am J Obstet Gynecol. 2012;206(4):349.E1-7.

  3. Hallamaa M, Suvitie P, Huhtinen K, et al. Serum HE4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women. Gynecol Oncol. 2012;125(3):667-72.

  4. Hallamaa M, Huhtinen K, Suvitie P, Perheentupa A. Serum concentrations of HE4 change little during in vitro fertilization. Acta Obstet Gynecol Scand. 2014 Apr 15. doi: 10.1111/aogs.12393. [Epub ahead of print]

  5. Hilger WS, Magrina JF, Magtibay PM. Laparoscopic management of the adnexal mass. Clin Obstet Gynecol. 2006;49:535-548).

  6. Green-top Guideline No. 62, RCOG/BSGE Joint Guideline | November 2011

 

See the LUMIPULSE G1200 working in this video:

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