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Test ID USTEK Ustekinumab Quantitation with Antibodies, Serum

Specimen Required

Patient Preparation: Collect immediately before the next dose of drug administration (trough level)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Client Test Request (T728)

-Therapeutics Test Request (T831)

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

Profile Information

Test ID Reporting Name Available Separately Always Performed
USQN Ustekinumab QN, S No Yes
USTAB Ustekinumab Ab, S No Yes

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Ustekinumab QN with Antibodies, S

Specimen Type


Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values


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



Limit of quantitation is 10 AU/mL

Absent: <10 AU/mL

Present: ≥10 AU/mL

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 5 days

Performing 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. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information



LOINC Code Information

Test ID Test Order Name Order LOINC Value
USTEK Ustekinumab QN with Antibodies, S In Process


Result ID Test Result Name Result LOINC Value
USQN Ustekinumab QN, S 87408-1
USTAB Ustekinumab Ab, S 87409-9