Product Description
The BioDeviceLab Gluten Index ELISA Kit is a robust enzyme-linked immunosorbent assay developed for the quantitative determination of gluten proteins derived from wheat, barley, and rye. Gluten detection is essential for food safety, regulatory compliance, and quality control in gluten-free and low-gluten products.
This assay targets immunoreactive gluten epitopes commonly associated with celiac disease and gluten sensitivity, providing high analytical sensitivity and reproducibility across diverse food matrices. The kit is suitable for routine laboratory analysis as well as integration into automated, portable, and point-of-care biodevice platforms.
Intended Use
This kit is intended for the quantitative determination of gluten index in:
• Raw food ingredients
• Processed food products
• Beverages
• Environmental and surface swab extracts
Applications include gluten-free certification support, food quality control, allergen risk assessment, process validation, and biodevice calibration.
Assay Principle
This assay employs a sandwich ELISA format:
• Gluten proteins present in the sample bind to capture antibodies immobilized on a 96-well microplate.
• A secondary enzyme-labeled antibody binds to the captured gluten epitopes.
• Following substrate (TMB) addition, a colorimetric signal is generated and measured at 450 nm.
• Absorbance is directly proportional to the gluten concentration in the sample.
Calibration Curve
• A calibration curve is generated using gluten standards with known concentrations.
• Mean absorbance values are plotted against gluten 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: 1 – 250 ng/mL
Limit of detection (LOD): ≤ 0.5 ng/mL
Intra-assay CV: < 10%
Inter-assay CV: < 8%
(Performance aligned with commercial gluten ELISA kits used for food allergen testing.)
Selectivity & Specificity
The assay demonstrates high specificity for gluten proteins with minimal cross-reactivity. Representative specificity profile:
• Wheat gluten (gliadin/glutenin): 100%
• Barley and rye prolamins: detected
• Non-gluten cereals (rice, corn, oats*): minimal cross-reactivity
(*Non-certified oats may contain trace gluten contamination.)
Kit Components
Each kit contains sufficient reagents for up to 96 determinations:
• Antibody-coated 96-well microplate
• Gluten standards (multiple concentrations)
• Enzyme-labeled detection antibody
• 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 Preparation & Handling
• Extract gluten from samples using appropriate extraction buffers.
• Clarify extracts by centrifugation or filtration if necessary.
• Dilute samples exceeding the highest standard.
• Avoid particulate matter that may interfere with optical readings.
Quality Control
• Standards and controls should be included in each assay run.
• Duplicate measurements are recommended.
• Acceptance criteria should be established according to regulatory or internal QC requirements.
BioDeviceLab applies quality-controlled reagent preparation and batch-to-batch consistency practices to support reproducibility and scalability.
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 and food testing use only.
• Not intended for medical diagnostic procedures.
• Results depend on proper sample extraction and handling.
Applications
• Gluten-free product verification
• Food allergen monitoring
• Quality control and process validation
• Environmental and surface testing
• Biodevice calibration and benchmarking
