Test ID: FHER
HER-2/neu, Quantitative, ELISA
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
91518
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
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
Aliases Lists additional common names for a test, as an aid in searching
Her-2/neu Shed Antigen FORWARD
HER-2/neu, Quantitative FORWARD
HER-2/neu, Quantitative FORWARD
Specimen Type Describes the specimen type needed for testing
Serum Red
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. (Serum gel tube is acceptable.) Spin down and send 1mL serum in a screw-capped vial, shipped frozen.
Specimen 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
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Thawing | Warm reject; Cold reject |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Frozen | |
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
Test Performed By: LabCorp Burlington
1447 York Court
Burlington, NC 27215-2230
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.
Method Description Describes how the test is performed and provides a method-specific reference
Bayer Centaur/ACS methodology
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
LabCorp Burlington
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test 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
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| Z0985 | HER-2/neu Quantitative | 32966-1 |
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