Test Directory

• Certolizumab Drug Level
• Anti-Certolizumab Ab Level

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making. This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.

Specimen Type: Serum

Collection Container: Gold Top, Serum Separator

Alternate Collection Container: Red Top, Plain

Desired Specimen Volume: 2 mL

1. Collect a gold top, serum separator tube via venipuncture.

1. Allow specimen to clot for 30-60 minutes.
2. Separate serum from cells within 2 hours of collection.
3. Transfer 2 mL of serum to a LabCorp PP transpak frozen purple tube.
4.  To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

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.

Transport to the laboratory frozen. 

• Gross hemolysis
• Gross lipemia

See patient report.

As with other biologics, the optimal certolizumab concentration depends upon patient-specific factors including co-morbidities, disease, and desired therapeutic endpoint.

Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.

Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.

Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.

Lack of clinical response may be due to inadequate drug exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.

• Anti-TNF
• Anti-TNF drug
• Biologic drug level and anti-drug antibody
• Biologic monitoring
• Cimzia
• DoseASSURE
• Immunogenicity testing
• therapeutic drug monitoring (TDM)
• TNF inhibitor