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Performance Evaluation of the Elecsys Growth Hormone and Insulin-Like Growth Factor 1 Assay by Soo-Kyung Kim, Tae-Dong Jeong

Background: Growth hormone (GH) and insulin-like growth factor 1 (IGF-1) are important biomarkers for diagnosis and follow-up of growth-related disorders. Performance of Elecsys hGH and Elecsys IGF-1 (Roche Diagnostics) was evaluated.
Methods: The performance of the Elecsys hGH and Elecsys IGF-1 assays on a Roche Cobas e 801 modular analyzer were evaluated. Repeatability, within-laboratory imprecision, and linearity were assessed. Elecsys hGH was compared to hGH [I-125] IRMA (Izotop), and Elecsys IGF-1 was compared to IRMA IGF-1 (Immunotech).
Results: The coefficient of variation of within-laboratory imprecision for Elecsys hGH and IGF-1 was less than 1.7%. The linearity values for Elecsys hGH and IGF-1 were confirmed over a range of 0.05 - 24.70 ng/mL and 40.41 - 687.53 ng/mL, respectively. The mean difference between Elecsys hGH and IRMA, and Elecsys IGF-1 and IRMA was 0.284 ng/mL and 14.21 ng/mL, respectively.
Conclusions: The analytical performance of Elecsys hGH and Elecsys IGF-1 was clinically acceptable.

DOI: 10.7754/Clin.Lab.2019.191149