Ustekinumab and anti-Ustekinumab antibody
Ustekinumab and anti-Ustekinumab antibody-15272
Biologic monitoring, therapeutic drug monitoring (TDM)
DoseASSURE
Immunogenicity testing, anti-drug antibody
Stelara
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.
Submission of the minimum volume does not allow for repeat testing
Immediately following collection, mix sample thoroughly by gentle inversion, 5 times
- Allow sample to clot for a minimum of 30 minutes
- Spin within two (2) hours of sample collection
- Transfer serum to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as serum
- Freeze
Heparin plasma
Lavender/Dk green:
Immediately following collection, mix sample thoroughly by gently inverting 8 - 10 times, to prevent clotting
- Spin within two (2) hours of sample collection
- Transfer plasma to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as the appropriate plasma type
- Freeze
Frozen (preferred) - 14 days
Refrigerated - 14 days
Ambient- 14 days
Freeze/thaw cycles: Stable x 6
Electrochemiluminescence immunoassay (ECLIA)
Ustekinumab: <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.
Drug assay:
The ustekinumab drug level typically reflects the antibody-unbound (the free fraction) of ustekinumab when serum anti-ustekinumab antibodies are present. In the absence of anti-ustekinumab antibodies, the ustekinumab drug level typically reflects the total ustekinumab concentration in serum.
Anti-drug antibody assay:
This anti-ustekinumab antibody assay is “drug-tolerant,” that is, the presence of serum ustekinumab does not impede the detection and quantitation of anti-ustekinumab antibodies. This anti-ustekinumab antibody assay is specific; antibodies against other biologic drugs do not cross-react with this assay. All positive anti-ustekinumab antibody results are verified by a confirmatory test.
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