| Field | Specification |
|---|---|
| Mfr No | |
| Alternative Names | HuMax-CD38, CAS: 945721-28-8 |
| Assay Type | |
| Cas No. | |
| Detection Method | |
| Detection Range | |
| Product Type | |
| Reactivity | |
| Sample Type(s) | Plasma, Serum |
| Sensitivity | |
| Shipping | |
| Storage | |
| Target |
Overview
Daratumumab ELISA Kit is an ELISA-based immunoassay designed for quantitative measurement of Daratumumab 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 156.25 - 10,000 ng/mL; analytical sensitivity 104.76 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 competitive enzyme immunoassay technique. Recombinant Human CD38 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Daratumumab in the sample competitively binds to the pre-coated protein with biotin-labeled Daratumumab. 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 inversely proportion to the amount of Daratumumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Biological background
Daratumumab is human IgG1 monoclonal antibody to CD38, which is a transmembrane glycoprotein that is frequently overexpressed on cancer cells including multiple myeloma cells. The monoclonal antibody binds to the CD38 molecule and triggers cell apoptosis, probably as a result of antibody mediated cytotoxicity. Daratumumab has been evaluated in heavily pretreated patients with refractory multiple myeloma and shown overall response rates of higher than expected. Daratumumab was given accelerated approval in the United States in 2015 for use in multiple myeloma. Current indications are as therapy of patients with refractory multiple myeloma in combination with lenalidomide (or bortezomib) and dexamethasone or as monotherapy in patients who have failed at least three previous regimens. Daratumumab is available as a solution for intravenous infusion in single use vials of 100 mg in 5 mL or 400 mg in 20 mL (20 mg/mL). The recommended dose is 16 mg/kg intravenously every week for 8 to 9 weeks, and then every 2, 3 or 4 weeks based upon indications and other agents being used. Premedication with methylprednisolone is recommended. Side effects are common and can include infusion reactions, bone marrow suppression, fatigue, nausea and vomiting, diarrhea, muscle spasms, back pain, fever, cough, dyspnea, peripheral edema, peripheral neuropathy and upper respiratory infection. Rare, but potentially serious side effects include severe infusion reactions, neutropenia, thrombocytopenia and interference with cross matching and red blood cell antibody screening.
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 Daratumumab (CAS No. 945721-28-8) 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 156.25 - 10,000 ng/mL. The lower limit of quantification (LLOQ) is 104.76 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 Daratumumab?
The assay format (free vs. total Daratumumab 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 Daratumumab 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.
