HER-2/neu, Quantitative, ELISA

CPT: 83950
Print Share

Test Details

Synonyms

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

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)

Specimen Requirements

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

Clinical Information

References

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

LOINC® Map

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

For Providers

Please login to order a test.

 

© 2018  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf