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Test ID FUAUA Ustekinumab and Anti-Ustekinumab Antibodies, Serum

Necessary Information


Specimen Required

Specimen Type: SST Serum

Container/Tube: SST

Specimen Volume: 2-3 mL SST Serum

Collection Instructions:  Collect 7 mL blood in a serum gel tube(s), plain red-top tube(s) is NOT acceptable. Centrifuge specimen and ship serum gel tube refrigerated (DO NOT ALIQUOT). 

Method Name

Automated ELISA Quantitative Stelara Comprehensive TDM Inform TX

Reporting Name

Ustekinumab and Anti-Ustekinumab Ab

Specimen Type

Serum SST

Specimen Minimum Volume

1.5 mL SST Serum

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Refrigerated (preferred) 7 days
  Ambient  48 hours

Reference Values

Clinically Reportable Ranges:

Ustekinumab 0.1 - 10 ug/mL

Anti-Ustekinumab antibody 5 - 100 AU/mL

Day(s) and Time(s) Performed

Monday through Friday

Performing Laboratory

Inform Diagnostics, Inc

Test Classification

This test was developed by and its performance characteristics determined by Inform Diagnostics. The test has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. Inform Diagnostics is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Test results are not diagnostic and should be used to supplement clinical findings from the ordering physician's workup.

CPT Code Information



LOINC Code Information

Test ID Test Order Name Order LOINC Value
FUAUA Ustekinumab and Anti-Ustekinumab Ab Not Provided


Result ID Test Result Name Result LOINC Value
Z4994 Dose mg 18817-7
Z4995 Interval weeks Not Provided
Z4996 Ustekinumab Drug Level 87408-1
Z4997 Anti-Ustekinumab Antibody 87409-9

NY State Approved