Infliximab and Anti-Infliximab Antibody, DoseASSURE™ IFX
CPT:
80230; 82397
Synonyms
- Anti-TNF-alpha Drug
- DoseASSURE
- IFD
- Remicade
Test Includes
This test includes serial monitoring.
Expected Turnaround Time
5 - 10 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 (preferred) or plasma
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing).
Container
Red-top tube, gel-barrier tube or plasma from green-top tube
Collection
Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.
Storage Instructions
Frozen (preferred) or refrigerated
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 7 days |
Frozen | 359 days |
Freeze/thaw cycles | Stable x6 |
Test Details
Use
Provides infliximab drug concentration levels as well as levels of anti-infliximab antibodies.
In the absence of anti-infliximab antibodies, the infliximab drug level typically reflects the total infliximab concentration in serum. In the presence of anti-infliximab antibodies, the infliximab drug level typically reflects the antibody-unbound fraction of infliximab concentration in serum. The presence of infliximab drug, even at concentrations well above target treatment levels (>50 ug/mL), does not interfere with the anti-infliximab antibody detection. This assay may be helpful for any patients on infliximab therapy for diseases such as Crohn's disease, inflammatory bowel disease, ulcerative colitis, rhematoid arthritis, or other autoimmune conditions. This test includes long-term serial monitoring of results.
Limitations
Failure of infliximab therapy may not always be due to the presence of anti-infliximab antibodies. In addition, the absence of anti-infliximab antibodies does not guarantee positive response to treatment.
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 503870 | Infliximab Drug + Antibody | 503772 | Infliximab Drug Level | ug/mL | 39803-2 | |
| 503870 | Infliximab Drug + Antibody | 503773 | Anti-Infliximab Antibody | ng/mL | 72623-2 |
| Reflex Table for Anti-Infliximab Antibody | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504107 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex Table for Anti-Infliximab Antibody | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504107 | Serial Monitoring | 511958 | 80563-0 | ||
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