Evaluation of a Manual ELISA Kit for Determination of HER2/neu in Serum of Breast Cancer Patients

Abstract

Background: Our aim was to conduct an analytical validation in a routine laboratory setting of the cerb-B2/c-neu ELISA assay kit from Calbiochem® used to measure the extracellular domain (ECD) of HER2/neu in the serum of breast cancer patients. Materials and Methods: The evaluation was based on three different production lots used in a routine laboratory setting. The reference value was based on a population of 217 patients with breast cancer not overexpressing HER2. Results: The detection limit, below that given by the manufacturer, was 0.34 ng ml^-1 and the quantification limit was 0.90 ng ml^-1. Reproducibility and repeatability were at least 95%, precision coefficients of variation varied between 6 and 8.5% and trueness measured by dilution tests and the standard additions method varied between 97 and 107% . The threshold was estimated at 5 ng ml^-1. Conclusion: This technique presents satisfactory levels of accuracy for routine laboratory use.