Product Description
The BioDeviceLab C-Reactive Protein (CRP) ELISA Kit is a high-performance sandwich enzyme-linked immunosorbent assay developed for the quantitative determination of human CRP in biological samples. CRP is an acute-phase protein primarily synthesized by the liver in response to inflammation, infection, and tissue injury and is widely used as a biomarker of systemic inflammation and cardiovascular risk.
High-sensitivity CRP (hsCRP) measurements are clinically relevant for stratifying low-grade inflammation associated with cardiovascular disease, metabolic disorders, infection, and chronic inflammatory conditions. This assay combines high analytical sensitivity, excellent reproducibility, and a broad dynamic detection range, enabling accurate CRP quantification across both baseline and elevated inflammatory states. The kit is suitable for routine laboratory research as well as advanced biodevice validation and calibration workflows.
For Research Use Only (RUO).
Intended Use
This kit is intended for the quantitative determination of CRP in:
• Serum
• Plasma
• Cell culture supernatants
Applications include inflammation research, cardiovascular risk stratification (hsCRP), infectious disease studies, organ-on-chip inflammatory models, and biodevice validation and benchmarking.
Assay Principle
This assay employs a sandwich ELISA format:
• CRP present in the sample binds to capture antibodies immobilized on a 96-well microplate.
• A biotinylated detection antibody specific to CRP binds to the captured protein.
• An enzyme conjugate is added, followed by a chromogenic substrate (TMB).
• The enzymatic reaction generates a color signal measured at 450 nm.
• Absorbance is directly proportional to the CRP concentration in the sample.
Calibration Curve
• A calibration curve is generated using CRP standards with known concentrations.
• Mean absorbance values are plotted against CRP concentration on a semi-logarithmic scale.
• A four-parameter logistic (4PL) regression model is recommended for curve fitting.
• Sample concentrations are determined by interpolation from the standard curve.
Analytical Performance
Dynamic detection range: 100 – 10,000 ng/mL (0.1 – 10 µg/mL)
Limit of detection (LOD): ≤ 50 ng/mL
Intra-assay CV: < 10%
Inter-assay CV: < 12%
Selectivity & Specificity
The assay demonstrates high specificity for human CRP with minimal cross-reactivity to other acute-phase or serum proteins. Representative cross-reactivity levels:
• CRP: 100%
• Serum amyloid A, fibrinogen, albumin: < 1%
This specificity ensures reliable CRP quantification in complex biological matrices.
Kit Components
Each kit contains sufficient reagents for up to 96 determinations:
• Antibody-coated 96-well microplate
• CRP standards (lyophilized, multiple concentrations)
• Biotinylated detection antibody
• Enzyme conjugate
• Assay buffer
• Wash buffer (10×)
• TMB substrate
• Stop solution
• Detailed assay protocol
Required Materials (Not Provided)
• Microplate reader capable of measuring absorbance at 450 nm
• Adjustable micropipettes and disposable tips
• Plate washer or manual washing equipment
• Plate shaker (recommended)
• Deionized or distilled water
Sample Collection & Handling
• Collect samples using standard laboratory procedures.
• Avoid repeated freeze–thaw cycles.
• Samples exceeding the highest standard should be diluted using assay buffer.
• Hemolyzed or lipemic samples may affect assay accuracy.
Quality Control
• Standards and controls should be included in each assay run.
• Duplicate measurements are recommended.
• Acceptance criteria should be established by the user according to the intended application.
BioDeviceLab applies quality-controlled reagent preparation and batch-to-batch consistency practices to support reproducibility and scalability for biodevice development.
Storage & Stability
• Store all components at 2–8 °C.
• Do not freeze reagents unless explicitly stated.
• Unopened kits are stable until the stated expiration date.
• Opened reagents should be handled according to protocol recommendations.
Limitations
• For research use only.
• Not intended for diagnostic or therapeutic procedures.
• Results should be interpreted within the context of experimental design and sample matrix.
Applications
• Systemic inflammation and infection studies
• Cardiovascular risk assessment (hsCRP)
• Metabolic and chronic inflammatory disease research
• Organ-on-chip inflammatory models
• Biodevice calibration and benchmarking
