Sources of variation and establishment of Russian reference intervals for major hormones and tumor markers

Objectives A multicenter study was organized to explore sources of variation (SVs) reference values (RVs) for 22 major immunochemistry analytes and determine intervals (RIs) the Russian population. Methods According IFCC Committee on Reference Intervals Decision Limits (C-RIDL) protocol, 758 healthy volunteers were recruited in St. Petersburg, Moscow, Yekaterinburg. Serum samples tested five tumor markers, 17 hormones related tests by Beckman Coulter’s UniCel DxI 800 analyzer. SVs explored using multiple regression analysis ANOVA. Standard deviation ratio (SDR) 0.4 used as primary guide partitioning RIs gender age. Results SDR between-city difference <0.4 all analytes. Secondary exclusion individuals done under following conditions: female sex-hormones, those with contraceptives (8%); CA19-9, supposed have negative Lewis blood-group (10.5% males 11.3% females); insulin, BMI≥28 kg/m 2 (31%); thyroid panel, anti-thyroid antibodies (10.3% males; 24.5% females), CEA smoking habit (30% 16% females). Gender-specific required except CA15-3, thyroid-related tests, parathyroid hormone, insulin. Age-specific alpha-fetoprotein, CEA, sex-hormones females, FSH progesterone both sexes. generally derived parametric method after Gaussian transformation modified Box-Cox formula. Exceptions growth estradiol females postmenopause, premenopause, which nonparametric due bimodal distribution and/or insufficient detection limit. Conclusion markers specific population based up-to-date internationally harmonized protocol careful consideration analyte-specific SVs.