HER-2/neu, Quantitative, ELISA

CPT: 83950
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  • HER-2 Extracellular Domain (ECD)
  • HER-2/neu Shed Antigen

Expected Turnaround Time

5 days

Related Documents

Specimen Requirements


Serum, frozen


1 mL

Minimum Volume

0.2 mL


Red-top tube or gel-barrier tube


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


Causes for Rejection

Hemolysis; defrosted or freeze-thawed specimen

Test Details


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.


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.


Enzyme-linked immunosorbent assay (ELISA)


Fehm T, Maimonis P, Weitz S, Teramoto Y, Katalinic A, Jäger W. Influence of circulating c-erbB-2 serum protein on response to adjuvant chemotherapy in node-positive breast cancer patients. Breast Cancer Res Treat. 1997 Mar; 43(1):87-95. 9065602
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 Jul-Aug; 16(4B):2295-2300.8694559


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480136 HER-2/neu Quantitative ELISA 480134 Her-2/neu Quantitative ELISA ng/mL 42914-2
480136 HER-2/neu Quantitative ELISA 511958 PDF 80563-0

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