Background: IGF-I is a useful tool in GH disorders diagnosis, however, the use of commercially available kits needs to be validated.
Objective: To validate the use of serum IGF-I concentrations measured by four immunoassays in the diagnosis of adult GH deficiency and acromegaly.
Design: Cross-sectional study.
Patients: Fifty GH-deficient (GHD) patients, 41 acromegaly patients and 405 controls.
Measurements: Serum IGF-I concentrations were measured by four commercial immunoassays: (1) RIA-NICHOLS; (2) ICMA-IMMULITE; (3) IRMA-IMMUNOTECH; and (4) non-extraction-IRMA-DSL. Reference values were established from the control population in six age groups. Individual results were transformed to standard deviation score (SD score) from the age-related reference population and reference data provided by each assay manufacturer. Diagnostic sensitivity for GH deficiency was calculated.
Results: IGF-I measured by the four assays differed significantly. In controls, assay 2 yielded the lowest results, followed by assays 1, 3 and 4 (P < 0.0001 for all comparisons). IGF-I declined with age, but no sex-related differences were observed. When IGF-I was standardized with respect to reference data obtained from the manufacturers, it showed better sensitivity in assays 1 and 2, than with our controls (65%vs. 77.5% and 58%vs. 70%, respectively) for GHD diagnosis. With assays 3 and 4, higher sensitivity was obtained when standardized with our controls (62%vs. 52% and 56%vs. 36%, respectively). In acromegaly, IGF-I was > 2 SD score with all assays.
Conclusions: IGF-I SD score for GHD diagnosis differed according to the normative data used. All assays proved to be useful for active acromegaly diagnosis.