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Test ID FUKAU Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE UST


Specimen Required


Specimen Type: Serum

Container/Tube: Red or SST

Specimen Volume: 3 mL

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube(s) is acceptable. Spin down and send 3 mL of serum frozen in a plastic vial.

To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.


Useful For

Provides ustekinumab drug concentration and anti-ustekinumab antibodies in order to optimize treatment and facilitate clinical decision-making.

 

This assay may be helpful in any patients on ustekinumab therapy for Crohn's disease, psoriasis, or other autoimmune conditions.

Method Name

Electrochemiluminescence immunoassay (ECLIA)

Reporting Name

Ustekinumab and Anti-Ustek Ab

Specimen Type

Serum

Specimen Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 14 days
  Ambient  14 days
  Refrigerated  14 days

Reference Values

Ustekinumab:

Quantitation Limit: <0.1 ug/mL

 

Results of 0.1 ug/mL or higher indicate detection of ustekinumab

In the presence of anti-ustekinumab antibodies, the ustekinumab drug level reflects the free, antibody-unbound fraction of ustekinumab in serum

 

Anti-Ustekinumab Antibody:

Quantitation Limit: <40 ng/mL

 

Results of 40 ng/mL or higher indicate detection of anti-ustekinumab antibodies.

Day(s) and Time(s) Performed

Wednesday

Performing Laboratory

Esoterix Endocrinology

Test Classification

These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.

CPT Code Information

80299

82397

LOINC Code Information

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

 

Result ID Test Result Name Result LOINC Value
Z5635 Ustekinumab 87408-1
Z5636 Anti-Ustekinumab Antibody 88992-3

NY State Approved

Yes