Clinical Pathology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Endocrinology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Clin Chem Lab Med. 2023 Nov 24;62(5):939-945. doi: 10.1515/cclm-2023-0972. Print 2024 Apr 25.
Severe deficiency of growth hormone (GHD) of the newborn is a rare but potentially life-threatening disease. GH measured during the first week of life, using dried blood spots (DBS), may offer several advantages. Aim of the study was to estimate the reference values for GH in newborns by a new analytical method using DBS.
Using a new developed analytical method, GH was estimated from DBS of 1,036 healthy newborns attending the Neonatology Unit of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan in the period July-October 2021. Reference values for GH deficiency were estimated by the Harrell-Davis bootstrap method, with 90 %CI calculated by the bias-corrected and accelerated bootstrap method.
All GH measurements required 33 analytical sessions (8 months) with a CV% for calibration curve slopes equal to 6.9 %. Intermediate precision evaluated by measurement of low (3 μg/L) and high (10 μg/L) quality controls was, respectively, 14 and 6.5 %. GH reference values, estimated at percentiles 1.0st, 2.5th and 5.0th, and their 90 %CI, were, respectively, 4.5 μg/L (90 %CI 3.8-5.1), 5.9 μg/L (90 %CI 5.4-6.4) and 7.0 μg/L (90 %CI 6.7-7.3). GH levels were not associated with sex, standard deviation scores, birth weight, gestational age, type of delivery or mother's variables (age, smoking habit, gestational diabetes).
Validation data suggest that this method can be used to measured GH in newborns using DBS. The reference values estimated in this study are in accordance with previous published works using ELISA and may help confirming the clinical suspicion of neonatal GHD.
新生儿严重生长激素缺乏（GHD）是一种罕见但潜在危及生命的疾病。在生命的第一周使用干血斑（DBS）测量的 GH 可能具有多种优势。本研究的目的是使用 DBS 通过新的分析方法来估计新生儿 GH 的参考值。
使用新开发的分析方法，我们从 2021 年 7 月至 10 月在米兰 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico 的新生儿科就诊的 1036 名健康新生儿的 DBS 中估算 GH。使用 Harrell-Davis 自举法估计 GH 缺乏的参考值，90%CI 通过偏倚校正和加速自举法计算。
所有 GH 测量值均需要 33 次分析（8 个月），校准曲线斜率的 CV%等于 6.9%。通过测量低（3μg/L）和高（10μg/L）质量控制物评估中间精密度，分别为 14%和 6.5%。GH 参考值，估计在第 1.0st、2.5th 和 5.0th 百分位数及其 90%CI 分别为 4.5μg/L（90%CI 3.8-5.1）、5.9μg/L（90%CI 5.4-6.4）和 7.0μg/L（90%CI 6.7-7.3）。GH 水平与性别、标准差评分、出生体重、胎龄、分娩类型或母亲变量（年龄、吸烟习惯、妊娠糖尿病）无关。
验证数据表明，该方法可用于使用 DBS 测量新生儿的 GH。本研究中估计的参考值与使用 ELISA 发表的先前研究结果一致，这可能有助于确认新生儿 GHD 的临床怀疑。
