Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone deficiency (GHD) in children and young adults. It is important to have a robust method to determine the hGH peak of stimulation. This work aimed to compare three common automated immunoassays for hGH quantification and to ascertain whether there are still result-related differences which can impact clinical decision.
We analyzed the GH provocation test for 39 young subjects from pediatric department of Montpellier hospital, admitted for suspicion of growth hormone deficiency. The full range of measurements as well as the peak level of serum GH were compared using three automated immunoassays on three different immunoanalyzers: IDS-hGH on iSYS, LIAISON-hGH on Liaison XL and Elecsys ROCHE-hGH, on COBAS 8000.
A good correlation was obtained between methods for all measurements (r2>0.99) by using Passing–Bablok regression analysis. Bland–Altman analysis showed the best agreement between IDS-hGH and LIAISON-hGH systems (bias=−14.5%) compared to Elecsys ROCHE-hGH (bias=28.3%). When considering stratification of the study population and a unique cutoff, there were some discrepancies in interpretation of the results especially concerning the more recent Elecsys ROCHE-hGH assay. Nevertheless, when the adequate cutoff for each method was taken into account results were well correlated for all systems.
A cutoff for Elecsys Roche-hGH method was established to better explain the results. Clinician must be aware of the use of assay-specific cutoff to correctly integrate the results of GH tests in the GHD diagnosis.
We are grateful to Roche Diagnostics, Diasorin S.A. and IDS immunodiagnostic systems companies for kindly providing reagents and calibrants.
Research funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-profit sectors.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: The study protocol was approved by the local Ethics Committee of Montpellier university hospital (IRB ID: 202000578 and registered to ClinicalTrials.gov (identifier: NCT04508673).
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The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-1109).
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