Pediatric reference intervals for Free Testosterone, 17-OH Progesterone, Androstenedione, and IGF-1 with chemiluminescence immunoassay

The aim of the study was to produce age and sex specific pediatric reference intervals (RIs) on a fully automated chemiluminescent immunoassay (CLIA) system. A total of 1586 patients’ remnant sera were included in the study and free testosterone (FT), 17-OH progesterone (17OHP), androstenodione (A4) and insulin-like growth factor-1 (IGF-1) parameters were measured on MAGLUMI 2000 (Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe), Shenzhen, China) CLIA analyser. After appropriate age and gender partitioning, specific intervals were calculated according to Clinical Laboratory Standart Institute’s (CLSI) C28-A3 protocol. All analytes showed sex and age dependent concentrations requiring several subgroups with specific reference intervals. 17OHP and A4 were found high with birth, declined thereafter: 17OHP by the end of 12 months and A4 by 6 months. So this period was also partitioned for these two hormones. All showed gradual increases by the end of 18 years. 17OHP, A4 and IGF-1 of girls were higher than boys around puberty as the result of earlier sexual development and maturation. FT values of boys and girls didn’t differ from each other upto 10 years of age but boys had significantly higher values than girls afterwards. IGF-1 values gradually increase in both sexes upto the ages of 13, girls with significantly higher values than boys. In 13–18 years no significant gender difference was found. We present method specific pediatric RIs, which are comparable with medical literature, necessary for interpretation of patient results.