Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Endocrinol Metab (Seoul). 2020 Dec;35(4):960-964. doi: 10.3803/EnM.2020.732. Epub 2020 Nov 20.
Appropriate reference intervals of serum insulin-like growth factor I (IGF-I) is important for diagnosing and monitoring patients with growth hormone-related diseases. To establish reference intervals, adult individuals (n=1,334, 680 men and 654 women) were divided into six age groups (20-29, 30-39, 40-49, 50-59, 60-69, ≥70). Serum IGF-I was measured by chemiluminescence immunoassay (Liaison). Concordance of patient classification based on reference intervals, manufacturer's intervals, and standard deviation score (SDS) was evaluated. New reference intervals had higher upper and lower limits than those specified by the manufacturer. The agreement between classification using new reference interval and the manufacturer's reference interval, and that using new reference interval and SDS was 75.0% (weighted kappa, 0.17), 91.9% (weighted kappa, 0.51) in men and 91.0% (weighted kappa, 0.41), 92.5% (weighted kappa, 0.53) in women, respectively. Reference intervals should be established not only based on age and sex, but also on ethnicity and assay method.
血清胰岛素样生长因子 I(IGF-I)的适当参考区间对于诊断和监测与生长激素相关疾病的患者非常重要。为了建立参考区间,将成年个体(n=1334,680 名男性和 654 名女性)分为六个年龄组(20-29、30-39、40-49、50-59、60-69、≥70)。使用化学发光免疫分析(Liaison)测量血清 IGF-I。评估了基于参考区间、制造商区间和标准差评分(SDS)的患者分类的一致性。新的参考区间的上限和下限高于制造商规定的值。在男性中,使用新的参考区间和制造商参考区间的分类之间的一致性为 75.0%(加权kappa,0.17),使用新的参考区间和 SDS 的分类之间的一致性为 91.9%(加权kappa,0.51),而在女性中,这两种分类之间的一致性分别为 91.0%(加权 kappa,0.41)和 92.5%(加权 kappa,0.53)。参考区间的建立不仅应基于年龄和性别,还应基于种族和检测方法。