Ustekinumab & Anti-Ustekinumab Ab USTEKINUMAB

Synonyms

Allscripts (AEHR) Order Name

Ustekinumab & Anti-Ustekinumab Ab

Sunrise Clinical Manager (SCM) Order Name

Ustekinumab and Anti-Ustekinumab Ab

EPIC Order Name

Ustekinumab and Anti-Ustekinumab Antibody

Clinical Info

rovides 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.
Limitations
Drug concentration should be interpreted with confirmation of specimen collection timing.
Non‐trough concentrations may be misleading.
Trough blood collection (just before or within 24 hrs. of next dose) is suitable because target ranges and therapeutic cut‐offs have been established in clinical studies using trough concentration.
The drug half‐life should be taken into consideration when interpreting results from non‐perfect trough collections.
Some primary non‐responders have inadequate clinical response despite adequate trough levels.
As with other biologics, the optimal ustekinumab concentration depends upon patient‐specific factors including co‐morbidities, disease and desired therapeutic endpoint.
Positive anti‐ustekinumab antibodies should be interpreted in the context of the concomitant free ustekinumab drug level.
High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

Specimen Type

Blood

Specimen Volume

2 mL serum (1 mL min)

Container

Gold Top Tube

Collection Instructions

Container/Tube: Gold Top Tube or Red Top Tube
Specimen: 2 mL serum ( 1 mL min)
Transport Temperature: Refrigerated
Collection: Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection.

Transport Instructions

Specimen Stability

14 Days Room Temperature
14 Days Refrigerated
14 Days Frozen

Methodology

Electrochemiluminescence immunoassay (ECLIA)

Days Performed

TAT: 11-26 Days

Performing Laboratory

LabCorp

CPT

80299
82397

PDM

235038

Result Interpretation

Ustekinumab drug level: <0.1 μg/mL

• Result ≥0.1 μg/mL indicates 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: <40 ng/mL

• Result ≥40ng/mL indicates detection of anti-ustekinumab antibodies.

Forms

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