Test Id : FGAGA
Golimumab and Anti-Golimumab Antibody, DoseASSURE GOL
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
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.
NOTE: High serum biotin concentrations in patients taking biotin supplements may cause an interference in this
assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
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 Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| 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.
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Tuesday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 account representative. 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.
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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
80299
82397
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| 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 |