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Infliximab Anti-drug Antibody for IBD
Test Code36301
CPT Codes
83520
Preferred Specimen
1 mL serum collected in a red-top tube (no gel)
Patient Preparation
For up to 48 hours before blood draw, do not take multivitamins or dietary supplements containing biotin or vitamin B7. Fasting not required.
Minimum Volume
0.3 mL
Transport Container
Quest Diagnostics Standard Transport Tube
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen -20° C: 28 days
Frozen -70° C: 70 days
Refrigerated: 7 days
Frozen -20° C: 28 days
Frozen -70° C: 70 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Serum separator tube (SST) • Grossly icteric
Methodology
Enzyme Linked Immunosorbent Assay (ELISA)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon, Tues, Thurs-Sat; Report available: 2-3 days
Reference Range
<10 AU
Clinical Significance
When treatment of inflammatory bowel disease with infliximab or its biosimilar fails, a physician may need to consider treatment options, such as adjusting dose or dosing intervals, switching to a different TNF blocker, or switching to a different drug agent, i.e. a non-TNF blocker. This assay specifically detects antibodies to infliximab and infliximab-dyyb (inflectra) that may reduce serum levels of the drug, as well as its clinical efficacy.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
