Unit Code 91518:
HER-2/neu, Quantitative, ELISA
Method Name 
A short description of the method used to perform the test
Enzyme Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HER-2/neu Quantitative ELISA
Ordering Mnemonic An alternate Mayo code (to the Unit Code) for a test
FHER
Aliases Lists additional common names for a test, as an aid in searching
Her-2/neu Shed Antigen FORWARD
HER-2/neu, Quantitative FORWARD
Soft-FHER
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Draw blood in a plain, red-top tube(s). (Serum gel tube is
acceptable.) Spin down and send 1mL serum in a
screw-capped vial, shipped frozen.
Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
0.2 mL
The amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Transport Temperature Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) and unacceptable transport temperature(s) are also included. The preferred transport temperature is listed first, followed by the alternate acceptable temperature (if appropriate) and lastly, the unacceptable transport temperature(s).
Frozen\Refrig NO\Ambient NO
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
Hemolysis: Yes
Lipemia: N/A
Icteric:
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Reference Range: 0.0 - 15.0 ng/mL
The Oncogene Science (Cambridge, MA) HER-2 neu test kit
uses an enzyme linked Immunosorbent assay (ELISA) format
to detect and quantitate the HER-2/neu oncoprotein in serum samples.
Studies have shown that elevated levels of serum HER-2/neu
may be associated with clinical parameters such as patient prognosis,
disease progression and resistance to therapy. Elevated levels
of serum HER-2/neu are observed in a subset of patients with
tumors that overexpress HER-2/neu. Approximately 25-30% of breast
cancers demonstrate HER-2/neu protein overexpression.
The results of this test are not interchangeable with values obtained
by other methods or with other reagents.
The results of this test cannot be interpreted as evidence of the presence
or absence of malignant disease, and should only be used in
conjunction with other clinical and diagnostic procedures.
Test Performed By: LabCorp-Research Triangle Park
1912 Alexander Drive
P.O. Box 13973
Research Triangle Park, NC 27709
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Fehm T, Malmonis P, Weltz S, et al., Influence of circulating
c-erb-2 serum protein on response to adjuvant chemotherapy
in node-positive breast cancer patients. Breast Cancer Res
Treat 1997 43:87-95.
Molina R, Jo J, Fiella et al., c-erb-2 oncoprotein in the sera and
tissue of patients with breast cancer: Utility in prognosis. Anti-
cancer Research 1996 16:2295-2300.
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Tuesday, Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
3 days
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
4-8 days
Performing Laboratory Location The location of the laboratory that performs the test
List Fee Provides the Mayo Medical Laboratories list fee for performing the test
$211.20
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each unit code or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
83950
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