Method Name
A short description of the method used to perform the test
Electrochemiluminescence immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Golimumab and Anti-Gol Ab
Aliases
Lists additional common names for a test, as an aid in searching
Golimumab
DoseASSURE
FGAGA
Simponi
Specimen Type
Describes the specimen type validated for testing
Serum
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Specimen Type: Serum
Container/Tube: SST or Red
Specimen Volume: 3 mL
Collection Instructions: Draw blood in a serum gel tube(s), plain red-top tube(s) is acceptable. Serum must be separated from cells within 45 minutes of venipuncture. Spin down and send 3 mL of serum frozen in a plastic vial.
To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
1 mL (Note: This volume does not allow for repeat testing.)
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Gross hemolysis | Gross reject; Mild OK |
Gross lipemia | Reject |
Gross icterus | NA |
Other/Tissue/Swab | Specimens other than indicated |
Specimen Type |
Temperature |
Time |
Special Container |
Serum |
Frozen (preferred) |
7 days |
|
|
Ambient |
7 days |
|
|
Refrigerated |
7 days |
|
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.
Golimumab:
Quantitation Limit: <0.5 ug/mL
Results of 0.5 ug/mL or higher indicate detection of Golimumab
In the presence of serum anti-golimumab antibodies, the golimumab drug level reflects the antibody-unbound (free) fraction of golimumab in serum
Anti-Golimumab Antibody:
Quantitation Limit: <20 ng/mL
Results of 20 or higher indicate detection of anti-Golimumab antibodies.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Failure of golimumab therapy may not always be due to the presence of anti-golimumab antibodies. Conversely, the absence of anti-golimumab antibodies does not guarantee response to treatment.
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.
Test Id |
Test Order Name |
Order LOINC Value
|
FGAGA |
Golimumab and Anti-Gol Ab |
Not Provided |
Result Id |
Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
Z5639 |
Golimumab |
87406-5 |
Z5640 |
Anti-Golimumab Antibody |
87407-3 |
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Excel |
Pdf
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
SI Normal Reports |
SI Abnormal Reports