Performance Evaluation of the Elecsys Growth Hormone and Insulin-Like Growth Factor 1 Assay

Abstract

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 11-125] 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.