Ustekinumab and anti-Ustekinumab antibody-15272

Test info

  
Ustekinumab and anti-Ustekinumab antibody
  
15272
  
LAB15272
  
USTEK
  
Anti-interleukin antibody drug, Anti-IL12, IL23 inhibitor
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.

Specimen

  
Serum
  
3.0 mL
  
1.0 mL
Submission of the minimum volume does not allow for repeat testing
  

Immediately following collection, mix sample thoroughly by gentle inversion, 5 times

  
  1. Allow sample to clot for a minimum of 30 minutes
  2. Spin within two (2) hours of sample collection
  3. Transfer serum to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as serum
  4. Freeze
  
EDTA plasma
Heparin plasma
  

Lavender (EDTA), 4mL

Dk green heparin (Li or Na), no gel

  

 

  

Lavender/Dk green:

Immediately following collection, mix sample thoroughly by gently inverting 8 - 10 times, to prevent clotting

  
  1. Spin within two (2) hours of sample collection
  2. Transfer plasma to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as the appropriate plasma type
  3. Freeze
  

 

 

  

Frozen (preferred) - 14 days

Refrigerated - 14 days

Ambient- 14 days

Freeze/thaw cycles: Stable x 6

Performance

  
LabCorp Esoterix (504594): R-LC
  
1 day per week
  
25 days
  

Electrochemiluminescence immunoassay (ECLIA)

Clinical and Interpretive info

  

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.

Billing

  
80299
82397

Tracking

  
11/14/2019
  
06/25/2024
  
06/25/2024