Adalimumab Quantitative with Reflex to Antibody, Serum
Order Code: ADALX
Test Summary
Therapeutic drug monitoring of adalimumab, 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 including reflex testing for antibodies to adalimumab
Aliases
- Humira
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.5 mL serum collected in a serum separator tube
Minimum Volume
0.35 mL
Instructions
Draw blood immediately before the next dose of drug administration (trough specimen). Transfer serum to a plastic vial.
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)
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated
Specimen Stability
- Room Temperature = Unacceptable
- Refrigerated = 28 days
- Frozen = 28 days
Limitations
This test does not differentiate between the originator and biosimilar products.
Other Acceptable Specimens
Serum collected in a red top tube
Unacceptable Specimens
Heat-treated specimen
Order Code
ADALX
EPIC (Premier) Code
LAB6769
Includes
N/A
CPT Code
- 80145
- reflex 83520 if appropriate
Billing Code
- 650051
CPT Statement
Methodology
Enzyme Linked Immunosorbent Immunoassay (ELISA)
FDA Status
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.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Mayo Clinic Laboratories -- Rochester Superior Drive
3050 Superior Drive NW
Rochester MN, 55901
3050 Superior Drive NW
Rochester MN, 55901
Department
Reference Testing
Reference Range
ADALIMUMAB QUANTITATIVE: Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific. ADALIMUMAB ANTIBODY: <14.0 AU/mL
Setup Schedule / Expected Turnaround Time
Monday, Wednesday,Friday; Report available: 2 - 4 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.5 mL serum collected in a serum separator tube
Minimum Volume
0.35 mL
Instructions
Draw blood immediately before the next dose of drug administration (trough specimen). Transfer serum to a plastic vial.
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)
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated
Specimen Stability
- Room Temperature = Unacceptable
- Refrigerated = 28 days
- Frozen = 28 days
Limitations
This test does not differentiate between the originator and biosimilar products.
Other Acceptable Specimens
Serum collected in a red top tube
Unacceptable Specimens
Heat-treated specimen
Result Information
Methodology
Enzyme Linked Immunosorbent Immunoassay (ELISA)
Testing Laboratory
N/A
Reference Range
ADALIMUMAB QUANTITATIVE: Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific. ADALIMUMAB ANTIBODY: <14.0 AU/mL
Setup Schedule / Expected Turnaround Time
Monday, Wednesday,Friday; Report available: 2 - 4 days