HER-2/<i>neu</i>, Quantitative, ELISA
| HER-2/neu, Quantitative, ELISA | | | |
| Number | | 480136 |
| CPT | | 83950 |
| Synonyms | | HER-2/neu Shed Antigen; HER-2 Extracellular Domain
(ECD) |
| Special Instructions | | Direct any questions regarding this test to oncology
customer service at 800-533-0567. |
| Specimen | | Serum, frozen |
| Volume | | 1 mL |
| Minimum Volume | | 0.2 mL |
| Container | | Red-top tube or gel-barrier tube |
| Collection | | Transfer serum to screw-cap tube for shipping. Freeze specimen at -20°C and ship on dry ice. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. |
| Storage Instructions | | Freeze |
| Causes for Rejection | | Hemolysis; defrosted or freeze-thawed specimen |
| Use | | Quantitative measure of HER-2/neu in human serum. 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 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. |
| Limitations | | Elevated levels of serum HER-2/neu are observed in a subset of patients with HER-2/neu-positive tumors. Approximately 25% to 30% of breast cancers demonstrate overexpression of the HER-2/neu protein. |
| Methodology | | Enzyme-linked immunosorbent assay (ELISA) |
| References | | Fehm T, Maimonis P, Weitz S, et al, “Influence of Circulating c-erbB-2 Serum Protein on Response to Adjuvant Chemotherapy in Node-Positive Breast Cancer Patients,” Breast Cancer Res Treat, 1997, 43(1):87-95. Molina R, Jo J, Filella X, et al, “C-erbB-2 Oncoprotein in the Sera and Tissue of Patients With Breast Cancer. Utility in Prognosis,” Anticancer Res, 1996, 16(4B):2295-300. |
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