Evaluation of a manual ELISA kit for determination of HER2/neu in serum of breast cancer patients.

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.