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Genetic Analysis Systems in the Clinical Mainstream
Genetic Analysis Systems in the Clinical Mainstream
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> > > HER-2/neu ELISA

HER-2/neu ELISA

HER-2/neu ELISA
General Information
VendorWILEX Inc.
ItemHER-2/neu ELISA
ApprovalFDA-cleared IVD
Product Number06489876
Sensitivity1.5 ng p105/mL serum
Instrumentation NeededMicrotiter plate reader capable of measuring absorbance in 96-well plates at a wavelength of 490 nm
Test MethodELISA
PricingRequest Quote     
Product Description
The Oncogene Science® HER-2/neu ELISA 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 regimens has not been fully established.

The HER-2/neu ELISA is a sandwich enzyme immunoassay that utilizes a mouse monoclonal antibody for capture and a different biotinylated mouse monoclonal antibody for the detection of human HER-2/neu protein. Both capture and detector reagents specifically bind to the extracellular domain of HER-2/neu protein. The Capture Antibody has been immobilized on the interior surface of microtiter plate wells. To perform the test, an appropriate volume of specimen is incubated in the coated well to allow binding of the antigen by the Capture Antibody. The immobilized antigen is then reacted with the detector antiserum. The amount of Detector Antibody bound to antigen is measured by binding it with a streptavidin/horseradish peroxidase Conjugate, which then catalyzes the conversion of the chromogenic Substrate o-phenylenediamine (OPD)into a colored product. The colored reaction product is quantitated by spectrophotometry and is related to the amount of HER-2/neu protein in the sample. For instructions, see the Detailed Protocol and Evaluation of Results sections of the assay protocol.

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