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The OSDI HER-2/neu Assay is an in vitro, diagnostic device intended for use in the quantitative determination of serum HER-2/neu in women with metastatic breast cancer who have an initial value of 15 ng/ml or greater. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the serum measurement of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regiments has not been fully established.

The HER-2/neu ELISA is a sandwich enzyme immunoassay, which utilizes two monoclonal antibodies to quantitate the extracellular domain (ECD) of the HER-2/neu protein in serum. The capture antibody (NB-3) has been immobilized on the interior surface of the microtiter plate wells. To perform the assay, an appropriate volume of serum is incubated in the coated well to allow binding of the antigen by the capture antibody. The captured HER-2/neu ECD is then reacted with a different anti-HER-2/neu antibody designated TA-1. The TA-1 antibody is biotinylated. The detection of the ECD of HER-2/neu is with a streptavidin horseradish peroxidase conjugate, which then catalyzes the conversion of the chromogenic substrate o-phenylenediamine into a colored product. The colored reaction product is quantitated by spectrophotometry (read absorbance at 490 mm) and is related to the amount of the HER-2/neu ECD in the serum sample. Six prepared HER-2/neu standards (0, 2.5, 7.5, 15, 25 and 35 ng/ml) allow construction of a standard curve for subsequent quantification of HER-2/neu in serum samples. Also available from OSDI is a set of HER-2/neu controls (10-CVX) designed to be used in conjunction with the ELISA for quality monitoring of assay performance. This control set consists of three (3) control levels at 2.9, 9.1 and 24.0 ng/mL HER-2/neu protein.