期刊
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
卷 -, 期 -, 页码 -出版社
WALTER DE GRUYTER GMBH
DOI: 10.1515/cclm-2023-0972
关键词
growth hormone; reference values; dried blood spot; newborn; growth hormone deficiency
This study developed a new analytical method using dried blood spots (DBS) to estimate the reference values for growth hormone (GH) in newborns. The reference values obtained using this method were consistent with previous studies using ELISA, and can help confirm the clinical suspicion of GH deficiency in neonates.
Objectives: 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.Methods: 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.Results: 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 mu g/L) and high (10 mu g/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 mu g/L (90 %CI 3.8-5.1), 5.9 mu g/L (90 %CI 5.4-6.4) and 7.0 mu g/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).Conclusions: 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.
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