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HelpTest Code USTEK Ustekinumab Quantitation with Antibodies, Serum
Specimen Required
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
Collection Instructions:
1. Draw blood immediately before the next dose of drug administration (trough level).
2. Centrifuge and aliquot serum into a plastic vial.
CMH COLLECTION: 2 mL in red gel vacutainer
Specimen Minimum Volume
0.35 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days |
Testing Algorithm
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Useful For
Evaluation of loss of response to therapy
Quantification of ustekinumab in human serum
Trough level quantitation for evaluation of patients treated with ustekinumab
Detection of antibodies to ustekinumab in human serum
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
| Heat-inactivated specimen | Reject |
Day(s) Performed
Monday, Wednesday, Friday
Report Available
2 to 5 daysReporting Name
Ustekinumab QN with Antibodies, SReference Values
USTEKINUMAB QN, S:
Limit of quantitation is 0.3 mcg/mL
In inflammatory bowel disease, at post-induction measurement (week 8), concentrations above 3.5 mcg/mL are associated with good outcomes.
For maintenance stages:
Concentrations ≥1.0 mcg/mL are associated with clinical response and clinical remission
Concentrations ≥4.5 mcg/mL are associated with mucosal healing
USTEKINUMAB AB, S:
Limit of quantitation is 10 AU/mL
Absent: <10 AU/mL
Present: ≥10 AU/mL
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80299
83520
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| USQN | Ustekinumab QN, S | No | Yes |
| USTAB | Ustekinumab Ab, S | No | Yes |