Test Code INFXP Infliximab Quantitation with Antibodies to Infliximab, Serum
Additional Codes
Internal / External / Beaker: LAB5555
Specimen Required
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.2 mL Serum
Collection Instructions:
1. Draw blood immediately before next scheduled dose (trough specimen).
2. Within 2 hours of collection, centrifuge and aliquot serum into plastic vial.
Secondary ID
620151Useful For
Evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence (in inflammatory bowel disease), acute infusion reactions and proactive monitoring
These assays do not differentiate between the originator and biosimilar products.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| INFX | Infliximab, S | Yes, (INFXR) | Yes |
| INXAB | Infliximab Ab, S | No | Yes |
Testing Algorithm
When this test is ordered, infliximab quantitation and testing for antibodies to infliximab will always be performed.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Method Name
INFX: Selective Reaction Monitoring Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
INXAB: Electrochemiluminescent Bridging Immunoassay with Acid Dissociation
Reporting Name
Infliximab QN with Antibodies, SSpecimen Type
Serum RedSpecimen Minimum Volume
Serum: 0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Refrigerated (preferred) | 28 days |
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | Reject |
| Heat-Treated | Reject |
Reference Values
INFLIXIMAB QUANTITATION:
Limit of quantitation is 1.0 mcg/mL. Therapeutic ranges are disease specific.
Pediatric reference ranges are not established.
INFLIXIMAB ANTIBODIES
Absence of antibodies to infliximab (ATI) is defined as <50 U/mL
Presence of ATI is reported as positive when concentrations are ≥50 U/mL
Day(s) Performed
INFX: Monday through Friday
INXAB: Monday, Wednesday, Friday
Report Available
3 to 6 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
INFX-80230
INXA -82397
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| INFXP | Infliximab QN with Antibodies, S | 103791-0 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 63417 | Infliximab Ab, S | 72623-2 |
| 63000 | Infliximab, S | 39803-2 |
| 36847 | Interpretation | 59462-2 |
| 36654 | INXAB Interpretation | 59462-2 |
Forms
If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Test Request (T728) with the specimen.