Harmonization of IGF1 immunoassay methods using an LC-MS/MS method and associated normative dataset.

Abstract

ObjectiveGeneration and testing of IGF1 reference materials (RM), suitable for the harmonization of immunoassay (IA) and LC-MS/MS methods for the IGF1 determination in blood. In addition, establishment of age related reference intervals for men and women. MethodsIn a split sample study of 42 patients, and 30 healthy volunteers we tested the commutability of four RMs for IGF1, using four commercial IAs and an LC-MS/MS method. A new set of age dependent reference intervals was established using Lifelines biobank samples, based on the IGF1 LC-MS/MS method. ResultsThe four RMs were found to be commutable, except the RM with the lowest concentration measured with the Siemens Immulite method. The value assignment of the RMs was based on the IGF1 LC-MS/MS method, which was calibrated against WHO international standard 02/254. LC-MS/MS results were on average about 0 to 60% lower than those of the immunoassays. Combining the recalculated IGF1 results in patient samples from a former study with the data from healthy volunteers in this study, showed a reduction in the variation of the data points (standard error of estimate) of 42% and 62% respectively. ConclusionCommutable RMs for IGF1 can be made from serum of healthy blood donors. However, it remains necessary to test the commutability of these RMs in IAs that were not included in this study. By harmonizing methods using the four RMs, the same age-related reference intervals can be used.