| Field | Specification |
|---|---|
| Mfr No | |
| Alternative Names | BMS-663513, CAS: 934823-49-1 |
| Assay Type | |
| Cas No. | |
| Detection Method | |
| Detection Range | |
| Product Type | |
| Reactivity | |
| Sample Type(s) | Plasma, Serum |
| Sensitivity | |
| Shipping | |
| Storage | |
| Target |
Overview
Urelumab ELISA Kit is an ELISA-based immunoassay designed for quantitative measurement of Urelumab in research samples. It is commonly used to generate traceable concentration data for biomarker discovery, pathway studies, and comparative analyses across experimental conditions.
Key elements and design rationale
- Assay format: Quantitative Colorimetric ELISA. The format defines how signal scales with analyte abundance and how results are interpreted across a standard curve.
- Working range and sensitivity: dynamic range 31.25 - 2,000 ng/mL; analytical sensitivity 18.73 ng/mL. Use these values to plan dilutions and keep readouts within the linear portion of the calibration curve.
- Sample compatibility: Intended for Plasma, Serum matrices. As with most immunoassays, matrix composition can influence apparent signal and should be evaluated with dilution linearity and spike-recovery concepts.
- Recovery reference: Typical recovery is reported as 80-120%. Recovery helps assess whether the sample matrix interferes with detection of spiked analyte.
PRINCIPLE OF THE ASSAY This assay employs the quantitative indirect enzyme immunoassay technique. Recombinant Human CD137 has been pre-coated onto a microplate. Standards or samples are pipetted into the wells and any Urelumab present is bound by the immobilized protein. After washing away any unbound substances, a biotin-labeled Mouse Anti-Human IgG antibody is added to the wells. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of Urelumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Biological background
Urelumab is a fully humanized agonistic monoclonal antibody targeting the CD137 receptor with potential immunostimulatory and antineoplastic activities. Urelumab specifically binds to and activates CD137-expressing immune cells, stimulating an immune response, in particular a cytotoxic T cell response, against tumor cells. Urelumab has been used in trials studying the treatment of Leukemia, Multiple Myeloma, Malignant Tumors, and Cancer-Solid Tumors and B-Cell Non-Hodgkin's Lymphoma. The antibody product was developed using Medarex's UltiMAb(R) technology and was the first UltiMAb-derived antibody in clinical development by Bristol-Myers Squibb under the December 2003 agreement with Medarex. In December 2008, enrolment was stopped for all urelumab studies following the occurrence of two hepatotoxicity-related deaths. Several years later, the clinical study on Urelumab was restarted. At present, the approval of the monoclonal antibody has not been disclosed in the relevant drug approval agency.
Research relevance and current trends
- Biomarker translation in RUO settings: Increasing use of quantitative immunoassays to stratify experimental cohorts, track longitudinal changes, and benchmark model systems.
- Matrix-aware assay design: Greater emphasis on dilution linearity, spike-recovery, and control concepts to reduce matrix-driven artifacts in serum/plasma and complex lysates.
- Integration with multi-omics: ELISA measurements are often used alongside transcriptomics and proteomics to connect abundance changes with pathway activity and phenotype.
Common research applications
- Comparative quantification: Measure relative changes in analyte levels across treatments, time points, or genotypes to support mechanistic hypotheses.
- Assay development and standardization: Generate reproducible concentration inputs for method qualification, inter-operator comparisons, or bridging studies across platforms.
- Model and sample characterization: Profile baseline and stimulated levels to help interpret immune, endocrine, neurodegenerative, or metabolic phenotypes (as relevant to the target).
Interpretation typically focuses on direction and magnitude of change in the context of controls and sample handling metadata, rather than single-point absolute values.
Notes for experimental interpretation
- Matrix effects: Hemolysis, lipemia, and high protein content can alter background and apparent concentration. Consider consistent collection/processing and evaluate dilution behavior.
- Isoforms and modified forms: Some targets exist as isoforms, fragments, or post-translationally modified species. Ensure the measured form aligns with the biological question and the kit’s intended analyte definition.
- Control concepts: Use negative/blank controls, replicate wells, and—when feasible—orthogonal confirmation (e.g., WB or MS) to strengthen conclusions.
What is this PK ELISA kit designed for?
This pharmacokinetic (PK) ELISA kit is designed to quantitatively measure Urelumab (CAS No. 934823-49-1) concentrations in Human biological matrices. It supports PK profiling studies including determination of Cmax, AUC, half-life (t«), clearance, and volume of distribution in preclinical or clinical research settings.
What biological matrices are validated for this assay?
This PK ELISA has been validated for Plasma and Serum. For PK studies, serum or plasma (EDTA or heparin-treated) are the most common matrices. Non-validated matrices (e.g., CSF, urine, tissue lysate) require additional matrix validation before use, including matrix effect assessment and dilutional linearity testing.
What is the quantification range and LLOQ for this kit?
The standard curve (LLOQ?ULOQ) spans 31.25 - 2,000 ng/mL. The lower limit of quantification (LLOQ) is 18.73 ng/mL. Samples with drug concentrations above the ULOQ should be diluted in drug-free matrix and re-assayed. The LLOQ is defined as the lowest concentration that can be measured with acceptable accuracy (ó20% RE) and precision (ó20% CV).
Does the assay distinguish between free and total Urelumab?
The assay format (free vs. total Urelumab measurement) depends on the capture and detection antibodies used. Please refer to the datasheet for information on whether the kit measures free (unbound), total (free + target-bound), or both forms of the drug. This distinction is critical for interpreting PK parameters and receptor occupancy.
Can this kit be used for GLP-regulated bioanalytical studies?
This kit is classified as research use only (RUO). For regulated PK studies submitted to regulatory agencies (FDA, EMA), the bioanalytical method must be fully validated per FDA Guidance (2018 Bioanalytical Method Validation) or EMA equivalent. This kit may be used as a platform for method development prior to GLP validation.
Is there cross-reactivity with endogenous proteins or related drugs?
The selectivity of this assay for Urelumab over structurally related endogenous proteins or biosimilars depends on the antibody specificity described in the datasheet. Researchers should evaluate cross-reactivity with endogenous analogues (e.g., endogenous hormone counterparts) and co-administered drugs that share structural similarity when designing PK studies.
Can’t Find What You’re Looking For? We can help you source the best match or customize an ELISA solution for your study. Options may include alternative target synonyms, different species reactivity, sample type/matrix compatibility (serum/plasma/lysate/supernatant), assay format (sandwich/competitive), sensitivity/range, detection chemistry (colorimetric/fluorescent/chemiluminescent), plate format (pre-coated/uncoated, strips vs full plate), and bulk or custom packaging. Click Talk to a Scientist to submit a request form, email us at support@biohippo.com, or explore our Research Services for additional support. Our team will be in contact with you shortly.
