| Field | Specification |
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| Mfr No | |
| Alternative Names | 17-1A, CAS: 156586-89-9 |
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| Cas No. | |
| Detection Method | |
| Detection Range | |
| Product Type | |
| Reactivity | |
| Sample Type(s) | Plasma, Serum |
| Sensitivity | |
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Overview
Edrecolomab ELISA Kit is an ELISA-based immunoassay designed for quantitative measurement of Edrecolomab 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 0.31-5 μg/mL; analytical sensitivity 0.156 μg/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.
This kit is supplied for research use in laboratory settings where defined, quantitative readouts are needed for experimental interpretation.
Biological background
Edrecolomab, also known as MAb17-1A, is a mouse-derived IgG2a monoclonal antibody targeted at the cell-surface glycoprotein EpCAM (17-1A). This drug was developed by Centocor in an attempt to prevent colorectal cancer and adenocarcinoma. Edrecolomab has been investigated in the clinical trials for the treatment of colon cancer. Edrecolomab was licensed as an adjuvant therapy for postoperative colorectal cancer by German authorities with the trade name Panorex in 1995. However, in 2004, researchers applied edrecolomab to the study of postoperative adjuvant therapy in patients with colorectal cancer. The results showed that edrecolomab adjuvant therapy can help Dukes'CCRC patients to restore the lack of immune response in the body, but the randomized trials of clinical efficacy were unsatisfactory. Then in 2005, Edrecolomab was studied in a phase 3 randomized trial of postoperative adjuvant therapy for colorectal cancer. However, the results showed that Edrecolomab did not improve overall survival or disease-free survival in patients with stage II colon cancer treated with postoperative adjuvant therapy. Subsequently, Edrecolomab in combination with fluorouracil (FU) was used to treat colorectal cancer in the III stage. However, the results showed that the addition of ED in the basic treatment of fluorouracil had no significant effect on OS. Edrecolomab also did not prolong patient survival in subsequent randomized trials. Although Edrecolomab has not shown very good results in previous studies of colorectal cancer, it is still a promising monoclonal antibody for the treatment of adenocarcinomas expressing EpCAM.
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 Edrecolomab (CAS No. 156586-89-9) 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 0.31-5 ?g/mL. The lower limit of quantification (LLOQ) is 0.156 ?g/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 Edrecolomab?
The assay format (free vs. total Edrecolomab 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 Edrecolomab 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.
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