儿童血清降钙素原参考区间的调查

Investigation of the reference interval of serum procalcitonin among children

目的调查14岁及以下儿童血清降钙素原(PCT)生物参考区间。方法采用BECKMAN-COULTER的UniCel DxI800免疫分析系统(微粒子酶促化学发光法)检测400例符合入选标准的儿童参考个体(以眼科及耳鼻咽喉头颈外科患者为主)血清降钙素原水平,按美国临床和实验室标准化协会(CLSI)、国际临床化学和实验室医学联盟(IFCC)推荐的方法和程序对不同性别和年龄段患者进行比较分析。根据分布特征选取适当方法计算生物参考区间。另选取80例符合纳入标准的儿童进行参考区间验证。结果儿童PCT检测结果呈偏态分布,在不同年龄和性别间比较差异无统计学意义(P>0.05),生物参考区间以95%分位数为上限确定的为≤0.46 ng/mL,大于健康成人PCT参考区间(PCT≤0.05 ng/mL)。80例参考个体都通过了参考区间验证。结论儿童PCT水平明显高于成人,目前临床上常用的成人参考区间不能用来诊断儿童是否存在细菌感染,每个实验室应根据自己的其检测系统和患者人群建立适当的参考区间。

Objective To investigate the biological reference interval of serum procalcitonin among childen aged 14 years and younger.Methods The serum procalcitonin levels were measured by BECKMAN-COULTER UniCel DxI800 immunoassay system(microparticle enzymatic chemiluminescence method)among 400 children patients(mainly from ophthalmology and otolaryngologic department).Gender and age groups were compared according to the methods and procedures recommended by CLSI and IFCC.According to the distribution characteristics,appropriate methods were selected to calculate the reference interval,and the reference interval was validated among another 80 child patients who met the inclusion criteria.Results The results of serum procalcitonin among people aged 14 years and younger showed skewed distribution,with no significant difference between different age and gender groups(P>0.05),and the biological reference interval determined with 95%quantile as the upper limit was≤0.46 ng/mL,which was higher than the reference interval of healthy adults(0.05 ng/mL).All 80 reference individuals passed the validation of reference interval.Conclusion The level of serum procalcitonin among children is significantly higher than that in adults.Reference intervals commonly used in adult cannot be used to diagnose whether children have bacterial infections.Each laboratory should establish appropriate reference intervals according to its own detection system and patient population.