M.S. KATSYUBA^1,2, G.A. USMANOVA², G.Z. MURATOVA³, B.K. MAZITOV², R.Sh. KHASANOV^1,2

¹Kazan State Medical Academy, 36 Butlerov St., Kazan, Russian Federation, 420012

²Tatarstan Cancer Center, the Volga branch of Russian Cancer Research Center named after N.N. Blokhin, 29 Sibirskiy Trakt St., Kazan, Russian Federation, 420029

³Kazan (Volga region) Federal University, 18 Kremlevskaya St., Kazan, Russian Federation, 420061

Katsyuba M.S. — Assistant of the Department of Oncology and Surgery, tel. (843) 296-95-03, e-mail: mkatsuba@mail.ru

Usmanova G.A. — Head of immunologic laboratory, tel. (843) 519-27-61, e-mail: RKOD.ImmLab@tatar.ru

Muratova G.Z. — Senior Lecturer of the Department of Natural and Physical and Mathematical Sciences of the preparatory faculty for foreign students, tel. +7-917-264-16-24, e-mail: gulsijar@mail.ru

Mazitov B.K. — Head of the dispensary and preventive Department, tel. (843) 519-26-87, e-mail: bmazitov@gmail.com

Khasanov R.Sh. — D. Med. Sc., Professor, Head of the Department of Oncology and Surgery, Director of the Volga branch of Russian Cancer Research Center named after N.N. Blokhin, tel. (843) 519-26-00, e-mail: priemnaya.rkod@mail.ru

There was studied the distribution of serum concentration of HE4 (Human epididymis protein 4) tumor marker in healthy women of the Volga Region in Russia and determined the upper limit of the reference range for this population. The studied group consisted of 90 women — employees of a public enterprise in Kazan, Russia. Age of the studied participants was 23 to 64 years. 64 of 90 (71%) were premenopausal woman and 26 (29%) — postmenopausal women. HE4 serum concentrations was determined on the date of sampling using Chemiluminescent microparticle immunoassay (CMIA) on an analyzer Abbott Architect i2000SR (Abbot Diagnostics, Abbot Park, IL). Mean HE4 serum concentrations (± SEM) were 28,4 (± 0,6) pmol / l, the minimum value — 14.9 pmol / L, maximum — 45.1 pmol / l, the median — 28.05 pmol / l. The upper limit of the 95% reference interval corresponded to 41.2 (90% CI: 40.2-44.3) pmol/L. Therefore, reference limits of the HE4 protein tumor marker for healthy women of the Volga Region in Russia were detected to be much lower than recommended by the manufacturer. Additional studies are required to include healthy women of all age groups, followed by validation of reference boundaries in studies with the inclusion of patients with benign and malignant tumors.

Key words: HE4 tumor marker; ovarian cancer; reference range.

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