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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)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


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

Serum

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

USTEKINUMAB QN, S:

Limit of quantitation is 0.3 mcg/mL

 

In inflammatory bowel disease, at post-induction measurement (week 8), concentrations above3.5 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

Day(s) and Time(s) Performed

Tuesday, Friday; 11:00 a.m.

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 U.S. Food and Drug Administration.

CPT Code Information

80299

83520

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

NY State Approved

Yes