Test Code ADALX Adalimumab Quantitative with Reflex to Antibody, Serum
Ordering Guidance
If both quantitation and antibody testing are needed, regardless of the quantitation results, order ADALP / Adalimumab Quantitative with Antibody, Serum
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: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL Serum
Collection Instructions:
1. Draw blood immediately before the next dose of drug administration (trough specimen).
2. Centrifuge and aliquot serum into a plastic vial.
CMH Collection : 1 mL in Red Gel vacutainer
Specimen Minimum Volume
Serum: 0.35 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 28 days |
| Frozen | 28 days |
Testing Algorithm
If the result is 8.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| ADLAB | Adalimumab Ab, S | No | No |
Useful For
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
This test does not differentiate between the originator and biosimilar products.
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
| Heat-treated specimen | Reject |
Day(s) Performed
Monday, Wednesday, Friday
Report Available
2 to 4 daysReporting Name
Adalimumab QN with Reflex to Ab, SReference Values
ADALIMUMAB QUANTITATIVE:
Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.
ADALIMUMAB ANTIBODY:
<14.0 AU/mL
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80145
83520 (if appropriate)