Ballerini María Gabriela, Chiesa Ana, Morelli Carina, Frusti Mauro, Ropelato María Gabriela
Centro de Investigaciones Endocrinológicas Dr. César Bergadá (CEDIE), CONICET - FEI, División de Endocrinología, Hospital de Niños Dr. Ricardo Gutiérrez, Buenos Aires, Argentina.
Horm Res Paediatr. 2014;81(2):118-25. doi: 10.1159/000356906. Epub 2013 Dec 21.
Reference intervals (RI) of serum 17α- hydroxyprogesterone (17OHP) are useful to confirm congenital adrenal hyperplasia (CAH) in neonates with abnormal screening results and nonclassical forms of CAH in symptomatic children. We aimed to establish serum 17OHP RI in normal children and adolescents using a current 17OHP radioimmunoassay (RIA).
Serum 17OHP was measured via a current RIA (Diasource) in children, i.e. 111 infants aged <1 year [before (NE-17OHP) and after extraction (E-17OHP)] and 216 children aged 1-17 years. Forty NE serum samples from subjects aged >1 year, covering the whole analytical range, were simultaneously measured to compare 17OHP RIA from Diagnostic System Laboratories (DSL) (withdrawn) and Diasource by Passing Bablok linear regression and ratio plot. The equation obtained was used to correct our own previous RI (DSL RIA) for infancy for the Diasource RIA. Samples from infants aged <1 year were used to verify the calculated RI with evaluator protocol C28-A3. The influence of age, gender, and Tanner's classification (T) was assessed in children aged >1 year by ANOVA.
E-17OHP as measured via the Diasource RIA was significantly lower than NE-17OHP in infants aged <1 year (p < 0.0001). The 17OHP measurement from the Diasource RIA was negatively biased compared to the value obtained using the DSL RIA (Diasource (ng/ml) = 0.85 DSL (ng/ml) -0.32 ng/ml, r = 0.952). Most infants (93%) had age- and gender-adjusted NE-17OHP and E-17OHP levels within the recalculated RI. Serum 17OHP significantly increased throughout prepuberty (p < 0.001). Sexual dimorphism was only observed at T IV-V.
When evaluating 17OHP during childhood, we recommend taking into account the extraction procedure in neonates, the method used, age, and the Tanner's stage.
血清17α-羟孕酮（17OHP）的参考区间（RI）有助于确诊筛查结果异常的新生儿先天性肾上腺皮质增生症（CAH）以及有症状儿童的非典型CAH。我们旨在使用当前的17OHP放射免疫分析（RIA）方法，建立正常儿童和青少年的血清17OHP参考区间。
通过当前的RIA（Diasource）测定儿童血清17OHP，即111名年龄小于1岁的婴儿[提取前（NE - 17OHP）和提取后（E - 17OHP）]以及216名年龄在1 - 17岁的儿童。同时检测40份年龄大于1岁受试者的NE血清样本，覆盖整个分析范围，通过Passing Bablok线性回归和比值图比较Diagnostic System Laboratories（DSL）（已停用）和Diasource的17OHP RIA。获得的方程用于将我们之前婴儿期的RI（DSL RIA）校正为Diasource RIA。使用评估方案C28 - A3，对年龄小于1岁婴儿的样本进行检测，以验证计算出的RI。通过方差分析评估年龄大于1岁儿童的年龄、性别和坦纳分期（T）的影响。
通过Diasource RIA测定的年龄小于1岁婴儿的E - 17OHP显著低于NE - 17OHP（p < 0.0001）。与使用DSL RIA获得的值相比，Diasource RIA的17OHP测量值存在负偏差（Diasource（ng/ml） = 0.85 DSL（ng/ml） - 0.32 ng/ml，r = 0.952）。大多数婴儿（93%）的年龄和性别校正后的NE - 17OHP和E - 17OHP水平在重新计算的RI范围内。血清17OHP在青春期前显著升高（p < 0.001）。仅在T IV - V期观察到性别差异。
在评估儿童期的17OHP时，我们建议考虑新生儿的提取程序、使用的方法、年龄和坦纳分期。
