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CPT:
80299; 82397
Synonyms
- DoseASSURE
- Golimumab
- Simponi
Test Includes
This test includes serial monitoring.
Expected Turnaround Time
5 - 12 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
For more information, please view the literature below.
Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Flyer
Rheumatic Diseases Biologics (DoseASSURE™) Flyer
Biologic Therapeutic Drug Monitoring Q&A
Rheumatoid Arthritis (RA) Comprehensive Testing Brochure
Specimen Requirements
Specimen
Serum or plasma (EDTA)
Volume
3.0 mL
Minimum Volume
1.0 mL
Container
Serum-gel tube, red-top tube, or lavender-top (EDTA) tube
Collection
Serum/plasma must be separated from cells within 45 minutes of venipuncture. Send serum/plasma in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit seperate frozen specimens for each test requested.
Storage Instructions
Freeze.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 7 days |
Frozen | 7 days |
Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Gross hemolysis, gross lipemia
Test Details
Limitations
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.
Methodology
Electrochemiluminescence Immunoassay
Reference Interval
Golimumab drug level: <0.5 μg/mL
• Result ≥0.5 μg/mL indicates 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: <20 ng/mL
• Result ≥20ng/mL indicates detection of anti-golimumab antibodies.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 504563 | Golimumab Drug + Antibody | 504564 | Golimumab | ug/mL | 87406-5 | |
| 504563 | Golimumab Drug + Antibody | 504565 | Anti-Golimumab Antibody | ng/mL | 87407-3 |
| Reflex Table for Anti-Golimumab Antibody | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504108 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex Table for Anti-Golimumab Antibody | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504108 | Serial Monitoring | 511958 | 80563-0 | ||
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