The test kit Vitrotest® HE4 is an enzyme linked immunosorbent assay (ELISA) for the quantitative determination of antigen HE4 in human serum or plasma.

Determination of concentration antigen HE4 in the test kit Vitrotest® HE4 is based on a solid-phase “sandwich” ELISA.

○ ТК107 – 96 tests

  • Solid phase: breakable microplate ELISA is coated with monoclonal antibodies specific to antigen HE4.
  • Conjugate: a monoclonal antibodies to antigen HE4 conjugated to horseradish peroxidase.
  • Chromogen: ready to use TMB solution.
  • Volume of sample for analysis: 10 μl.
  • Assay time: 1h 15 min.

Ovarian cancer ranks as the second leading cause of cancer-related deaths among women worldwide. Only about 20% of ovarian cancer cases are detected at an early stage. When ovarian cancer is diagnosed at an early stage, approximately 94% of patients survive longer than five years after diagnosis. However, more than 70% of cases are diagnosed at an advanced stage, which significantly worsens the prognosis.

For the detection of ovarian cancer in patients without symptoms, two screening tests are most commonly used: transvaginal ultrasound and a blood test for the CA125 tumor marker. However, elevated CA125 levels can be found in 1-2% of healthy women and in patients with other conditions and diseases, including the first trimester of pregnancy, menstruation, endometriosis, uterine fibroids, acute salpingitis, liver disease, and peritonitis. To improve the sensitivity and specificity of laboratory diagnostic tools in patients with benign tumors, the combined determination of serum levels of two tumor markers, CA125 and HE4, is currently used.

HE4 (Human Epididymis Protein 4) is a secretory low-molecular-weight glycoprotein predominantly expressed in the epithelial cells of the fallopian tube, as well as normally in the epithelium of the mammary glands, reproductive system organs, intestines, and lungs. Although the physiological functions of this protein have not been fully studied, overexpression of HE4 is observed in serous and endometrioid ovarian carcinomas. Elevated levels of this tumor marker are found both in the early stages of ovarian cancer and in endometrial cancer. Unlike CA125, HE4 levels do not increase in endometriosis, benign gynecological diseases, or ovarian cysts.

The serum level of HE4 is an informative marker not only for screening patients for ovarian cancer but also as an important prognostic marker. High concentrations of HE4 in plasma are an independent preoperative marker of poor prognosis for ovarian cancer patients.

To improve the assessment of laboratory tests, the Risk of Ovarian Malignancy Algorithm (ROMA) was developed, which is a mathematical model that analyzes HE4 in combination with CA125, taking into account the patient’s menopausal status. The ROMA algorithm allows for a high probability of distinguishing malignant tumors from benign neoplasms in postmenopausal women.

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