Rituximab and Anti-Rituximab Antibody, DoseASSURE™ RTX

Also known as: Anti-CD20, Biologics, Biopharmaceutical, DoseASSURE, Rituxan®

Clinical Use

Use

Therapeutic monitoring of rituximab and antidrug antibody development for individuals with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis. This test provides rituximab drug concentration as well as the level of anti-rituximab antibodies.

Special Instructions

Not provided.

Limitations

Failure of rituximab therapy may not always be due to the presence of anti-rituximab antibodies. Conversely, the absence of anti-rituximab antibodies does not guarantee positive response to treatment. 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.

Test Details

Methodology

Immunoassay (ECLIA)

Biomarkers

Anti-Rituximab Antibody

Analyte

Anti-Rituximab Antibody Level

Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

Rituximab

Analyte

Rituximab Drug Concentration

Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

LOINC Codes

Result Codes

82467-2 - riTUXimab SerPl IA-mCnc
82466-4 - riTUXimab Ab SerPl IA-mCnc

Result Turnaround Time

12-16 days

Specimen

Serum

Volume

3 mL

Minimum Volume

1 mL

Container

Gel-barrier tube, red-top tube, or serum transfer tube

Collection Instructions

Serum must be separated from cells within 45 minutes of venipuncture. Submit serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.